|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Extent of
Recognition
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Standard Title
(click for recognition information)
|
| 03/18/2009 |
InVitro Diagnostics |
7-71 |
Complete |
CLSI |
H15-A3 (Replaces H15-A2) |
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
| 03/18/2009 |
InVitro Diagnostics |
7-145 |
Complete |
CLSI |
H42-A2 (Replaces H42-A) |
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
| 09/09/2008 |
Radiology |
12-165 |
Complete |
NEMA |
XR 22-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography |
| 05/05/2010 |
InVitro Diagnostics |
7-205 |
Complete |
CLSI |
H47-A2 |
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition. |
| 05/05/2010 |
InVitro Diagnostics |
7-207 |
Complete |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
| 08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
| 01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
| 09/17/2018 |
Materials |
8-478 |
Complete |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
| 04/04/2016 |
Materials |
8-404 |
Complete |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 04/04/2016 |
ObGyn/
Gastroenterology/
Urology |
9-110 |
Complete |
ISO |
8600-1 Fourth Edition 2015-10-15 |
Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
| 04/04/2016 |
InVitro Diagnostics |
7-260 |
Complete |
CLSI |
MM03-3rd Edition (Replaces MM03-A2) |
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
| 03/16/2012 |
Anesthesiology |
1-75 |
Complete |
ISO |
5362 Fourth edition 2006-06-01 |
Anaesthetic Reservoir Bags |
| ANSI AAMI ISO |
5362:2006 |
Anaesthetic Reservoir Bags |
| 05/30/2022 |
General II (ES/
EMC) |
19-47 |
Complete |
ANSI AAMI |
HA60601-1-11:2015 [Including AMD1:2021] |
Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)] |
| 01/14/2019 |
Nanotechnology |
18-6 |
Complete |
ASTM |
E2865-12 (Reapproved 2022) |
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials |
| 12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 08/14/2015 |
Software/
Informatics |
13-75 |
Complete |
ISO IEEE |
11073-10102 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG |
| 08/14/2015 |
Software/
Informatics |
13-78 |
Complete |
INCITS ISO IEC |
30111 First edition 2013-11-01 (R2019) |
Information technology - Security techniques - Vulnerability handling processes |
| 06/27/2016 |
Sterility |
14-481 |
Complete |
ISO |
14644-2 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| 06/27/2016 |
Sterility |
14-483 |
Complete |
ISO ASTM |
52303 First edition 2015-07-15 |
Guide for absorbed-dose mapping in radiation processing facilities |
| 12/23/2024 |
Dental/
ENT |
4-336 |
Complete |
ISO |
18397 First edition 2016-01 |
Dentistry - Powered scaler |
| ANSI ADA |
Standard No. 157-2020 |
Powered Dental Scaler Handpieces and Tips |
| 12/23/2024 |
Dental/
ENT |
4-337 |
Complete |
ISO |
20608 First edition 2018-04 |
Dentistry - Powder jet handpieces and powders |
| 12/23/2016 |
Materials |
8-444 |
Complete |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
| 08/14/2015 |
Dental/
ENT |
4-130 |
Complete |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
| 07/09/2014 |
Dental/
ENT |
4-165 |
Complete |
ANSI ASA |
S3.13-1987 (Reaffirmed 2024) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
| 04/04/2016 |
Radiology |
12-196 |
Complete |
NEMA |
MS 2-2008 (R2020) |
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
| 08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
| 05/29/2023 |
Radiology |
12-350 |
Complete |
IEC |
60806 Edition 2.0 2022-11 |
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
| 12/21/2020 |
Dental/
ENT |
4-271 |
Complete |
ANSI ADA |
Standard No. 34-2013 |
Dental Cartridge Syringes |
| 12/23/2019 |
Physical Medicine |
16-213 |
Complete |
RESNA ANSI |
WC-1:2019 Section 7 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions |
| 12/23/2019 |
Physical Medicine |
16-214 |
Complete |
RESNA ANSI |
WC-1:2019 Section 8 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-271 |
Complete |
ASTM |
F1874-98 (Reapproved 2011) |
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| 03/16/2012 |
Radiology |
12-117 |
Complete |
ISO |
15367-1 First edition 2003-09-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects |
| 08/20/2012 |
InVitro Diagnostics |
7-148 |
Complete |
CLSI |
M28-A2 (Replaces M28-A) |
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-268 |
Complete |
ASTM |
F921-10 (Reapproved 2024) |
Standard Terminology Relating to Hemostatic Forceps |
| 01/30/2014 |
Orthopedic |
11-274 |
Complete |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
| 03/16/2012 |
Dental/
ENT |
4-173 |
Complete |
ANSI ASA |
S3.44-1996 (Reaffirmed 2006) |
American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
| 07/09/2014 |
Sterility |
14-257 |
Complete |
ASTM |
D3078-02 (Reapproved 2021)e1 |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
| 08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
| 05/29/2024 |
Anesthesiology |
1-177 |
Complete |
ISO |
80601-2-74 Second edition 2021-07 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 12/19/2022 |
Software/
Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| 12/20/2021 |
Cardiovascular |
3-173 |
Complete |
ISO |
5840-3 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-466 |
Complete |
USP-NF |
M76070_03_01 |
Sodium Chloride Injection |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
| 04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
| 07/09/2014 |
InVitro Diagnostics |
7-175 |
Complete |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
| 07/09/2014 |
Materials |
8-377 |
Complete |
ASTM |
F136-13 |
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| 07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| 07/09/2014 |
General I (QS/
RM) |
5-88 |
Complete |
ISO |
2859-1 Second edition 1999-11-15 |
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)] |
| 07/15/2019 |
Orthopedic |
11-349 |
Complete |
ISO |
14242-3 First edition 2009-03-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
| 07/15/2019 |
Sterility |
14-529 |
Complete |
ISO |
11135 Second edition 2014-07-15 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] |
| ANSI AAMI ISO |
11135:2014/A1:2018 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release |
| 07/06/2020 |
Materials |
8-534 |
Complete |
ISO ASTM |
52911-1: First Edition 2019-07 |
Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals |
| 07/06/2020 |
Materials |
8-535 |
Complete |
ISO ASTM |
52911-2: First Edition 2019-09 |
Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers |
| 12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
| 12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
| 05/29/2023 |
Dental/
ENT |
4-299 |
Complete |
ISO |
3107 Fifth edition 2022-09 |
Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements |
| ANSI ADA |
Standard No. 30-2023 |
Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements |
| 12/23/2024 |
Anesthesiology |
1-185 |
Complete |
ISO |
80601-2-79 Second edition 2024-08 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 12/20/2021 |
Dental/
ENT |
4-292 |
Complete |
ISO |
28888 First edition 2013-10 |
Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues |
| ANSI ADA |
Standard No. 151-2015 (R2020) |
Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues |
| 12/20/2021 |
Cardiovascular |
3-180 |
Complete |
ASTM |
F3505-21 |
Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance |
| 12/19/2022 |
Orthopedic |
11-397 |
Complete |
ASTM |
F3210-22e1 |
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
| 09/17/2018 |
Sterility |
14-513 |
Complete |
ASTM |
F2825-18 |
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery |
| 09/17/2018 |
Radiology |
12-318 |
Complete |
IEC |
60601-2-64 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment |
| 09/17/2018 |
Radiology |
12-320 |
Complete |
IEC |
62667 Edition 1.0 2017-08 |
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| 09/17/2018 |
Sterility |
14-517 |
Complete |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| 09/17/2018 |
General II (ES/
EMC) |
19-31 |
Complete |
IEEE ANSI |
C63.15-2017 (Revision of ANSI C63.15-2010) |
American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-447 |
Complete |
ISO |
8536-4 Sixth edition 2019-09 |
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed |
| 12/23/2019 |
Materials |
8-519 |
Complete |
ISO |
13782 Second edition 2019-04 |
Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
| 12/23/2019 |
Materials |
8-520 |
Complete |
ASTM |
F799-19 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
| 07/15/2019 |
Materials |
8-497 |
Complete |
ISO |
5834-5 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method |
| 12/21/2020 |
Materials |
8-539 |
Complete |
ASTM |
F139-19 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
| 04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-477 |
Complete |
ISO |
11608-3:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-475 |
Complete |
ISO |
11608-4:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics |
| 01/14/2019 |
Dental/
ENT |
4-254 |
Complete |
ANSI ADA |
Standard No. 99-2001 (R2023) |
Athletic Mouth Protectors and Materials |
| 12/23/2019 |
Physical Medicine |
16-225 |
Complete |
RESNA ANSI |
WC-1:2019 Section 26 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
| 06/07/2021 |
Materials |
8-555 |
Complete |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 09/17/2018 |
Sterility |
14-293 |
Complete |
ANSI AAMI |
ST50:2004/(R)2018 |
Dry heat (heated air) sterilizers |
| 04/04/2016 |
Materials |
8-413 |
Complete |
ASTM |
F2819-10 (Reapproved 2015) |
Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices |
| 06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
| 07/15/2019 |
Biocompatibility |
2-264 |
Complete |
ASTM |
F2148-18 |
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). |
| 07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-422 |
Complete |
AAMI |
TIR38:2019 |
Medical device safety assurance case guidance |
| 07/06/2020 |
Sterility |
14-543 |
Complete |
ISO |
11139 First edition 2018-08 |
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards |
| 07/06/2020 |
Sterility |
14-544 |
Complete |
ISO |
18472 Second edition 2018-08 |
Sterilization of health care products - Biological and chemical indicators - Test equipment |
| 12/19/2022 |
Anesthesiology |
1-158 |
Complete |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
| 12/19/2022 |
Biocompatibility |
2-289 |
Complete |
ISO |
10993-12 Fifth edition 2021-01 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
| 09/17/2018 |
Orthopedic |
11-340 |
Complete |
ASTM |
F3018-17 |
Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices |
| 09/17/2018 |
General I (QS/
RM) |
5-42 |
Complete |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
| 09/17/2018 |
Ophthalmic |
10-57 |
Complete |
ANSI |
Z80.13-2007 (R2022) |
American National Standard for Ophthalmics - Phakic Intraocular Lenses |
| 09/17/2018 |
Ophthalmic |
10-111 |
Complete |
ISO |
11981 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
| 12/21/2020 |
Biocompatibility |
2-282 |
Complete |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-488 |
Complete |
ASTM |
F1671/F1671M-22 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
| 12/18/2023 |
Anesthesiology |
1-166 |
Complete |
ISO |
11195 Second edition 2018-01 |
Gas mixers for medical use - Stand-alone gas mixers |
| 12/18/2023 |
Sterility |
14-589 |
Complete |
ISO |
14644-4 Second edition 2022-11 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
| 06/07/2018 |
Materials |
8-464 |
Complete |
ISO |
TS 10974 Second edition 2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| 09/17/2018 |
Materials |
8-479 |
Complete |
ISO |
13781 Second edition 2017-07 |
Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing |
| 09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
| 09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 06/07/2018 |
Radiology |
12-315 |
Complete |
NEMA |
MS 8-2016 (R2003) |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
| 04/04/2016 |
Sterility |
14-337 |
Complete |
ISO |
14937 Second edition 2009-10-15 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
14937:2009/(R)2013 |
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices |
| 06/07/2018 |
Tissue Engineering |
15-53 |
Complete |
ASTM |
F3206-17 |
Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies |
| 06/07/2018 |
Materials |
8-463 |
Complete |
ISO ASTM |
52901 First edition 2017-08 |
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts |
| 07/06/2020 |
Tissue Engineering |
15-59 |
Complete |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
| 01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-509 |
Complete |
ASTM |
F3186-24 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 05/26/2025 |
ObGyn/
Gastroenterology/
Urology |
9-151 |
Complete |
ASTM |
F1828-22 |
Standard Specification for Ureteral Stents |
| 08/20/2012 |
Cardiovascular |
3-102 |
Complete |
IEC |
60601-2-31 Edition 2.1 2011-09 |
Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| 08/20/2012 |
Cardiovascular |
3-104 |
Complete |
ASTM |
F2914-12 (Reapproved 2018) |
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
| 08/20/2012 |
General Plastic Surgery/
General Hospital |
6-278 |
Complete |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 08/20/2012 |
InVitro Diagnostics |
7-76 |
Complete |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
| 08/20/2012 |
Radiology |
12-249 |
Complete |
IEC |
62471 First edition 2006-07 |
Photobiological safety of lamps and lamp systems |
| 08/20/2012 |
Anesthesiology |
1-87 |
Complete |
IEC |
60601-2-23 Edition 3.0 2011-02 |
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-505 |
Complete |
ISO |
21649 Second Edition 2023-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 12/20/2021 |
Ophthalmic |
10-129 |
Complete |
ASTM |
D790-17 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| 12/19/2022 |
Dental/
ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
| 07/09/2014 |
Sterility |
14-282 |
Complete |
ASTM |
F2338-09 (Reapproved 2020) |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method |
| 01/27/2015 |
ObGyn/
Gastroenterology/
Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
| 07/09/2014 |
Sterility |
14-286 |
Complete |
ANSI AAMI |
ST65:2008/(R)2018 |
Processing of reusable surgical textiles for use in health care facilities |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-177 |
Complete |
ASTM |
E1112-00 (Reapproved 2018) |
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 12/23/2024 |
General II (ES/
EMC) |
19-52 |
Complete |
UL |
2054 Third Edition November 17, 2021 |
Standard For Safety Household and Commercial Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-53 |
Complete |
IEC |
TS 60601-4-6 Edition 1.0 2024-04 |
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| 01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
| 05/29/2023 |
Dental/
ENT |
4-298 |
Complete |
ISO |
4049 Fifth edition 2019-05 |
Dentistry - Polymer-based restorative materials |
| ANSI ADA |
Standard No. 27-2022 |
Polymer-based Restorative Materials |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 12/20/2021 |
Sterility |
14-564 |
Complete |
USP-NF |
M98910_01_01 |
<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests |
| 12/20/2021 |
Sterility |
14-565 |
Complete |
USP-NF |
M98802_01_01 |
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms |
| 12/20/2021 |
Sterility |
14-566 |
Complete |
USP-NF |
M98795_02_01 |
<55> Biological Indicators -- Resistance Performance Tests |
| 01/15/2013 |
Sterility |
14-212 |
Complete |
AOAC |
6.2.02:2006 |
Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method |
| 04/04/2016 |
Tissue Engineering |
15-43 |
Complete |
ASTM |
F2791-15 |
Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2022) |
Standard Specification for Soft-Tissue Expander Devices |
| 08/06/2013 |
Cardiovascular |
3-115 |
Complete |
IEC |
60601-2-34 Edition 3.0 2011-05 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
| 05/26/2025 |
Radiology |
12-375 |
Complete |
ANSI UL |
122-2019 |
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019] |
| 12/19/2022 |
Anesthesiology |
1-159 |
Complete |
ISO |
18778 Second edition 2022-06 |
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors |
| 12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 06/27/2016 |
Materials |
8-431 |
Complete |
ASTM |
F2971-13 |
Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing |
| 08/14/2015 |
Radiology |
12-289 |
Complete |
IEC |
62220-1-1 Edition 1.0 2015-03 |
Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging |
| 08/06/2013 |
Sterility |
14-381 |
Complete |
ISO ASTM |
51261 Second edition 2013-04-15 |
Practice for calibration of routine dosimetry systems for radiation processing |
| 08/14/2015 |
InVitro Diagnostics |
7-251 |
Complete |
CLSI |
EP05-A3 (Reaffirmed: September 2019) |
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
| 08/21/2017 |
Materials |
8-457 |
Complete |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
| 08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 06/07/2021 |
General II (ES/
EMC) |
19-40 |
Complete |
IEC |
60086-4 Edition 5.0 2019-04 |
Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)] |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-512 |
Complete |
IEC |
60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| 12/20/2021 |
Sterility |
14-567 |
Complete |
USP-NF |
M7414_01_01 |
<1229.5> Biological Indicators for Sterilization |
| 05/29/2023 |
Dental/
ENT |
4-300 |
Complete |
ISO |
22674 Third edition 2022-08 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA |
Standard No. 134-2023 |
Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances |
| 08/14/2015 |
InVitro Diagnostics |
7-252 |
Complete |
CLSI |
EP14-A3 |
Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
| 04/04/2016 |
Materials |
8-135 |
Complete |
ASTM |
F2392-04 (Reapproved 2015) |
Standard Test Method for Burst Strength of Surgical Sealants |
| 01/27/2015 |
Materials |
8-383 |
Complete |
ASTM |
F1926/F1926M-14 |
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
| 07/09/2014 |
Software/
Informatics |
13-69 |
Complete |
ISO IEEE |
11073-10472 First edition 2012-11-01 |
Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor |
| 07/09/2014 |
Sterility |
14-434 |
Complete |
ASTM |
F2228-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method |
| 07/15/2019 |
Anesthesiology |
1-144 |
Complete |
ISO |
80601-2-80 First edition 2018-07 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 03/16/2012 |
Radiology |
12-142 |
Complete |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 05/26/2025 |
Software/
Informatics |
13-144 |
Complete |
ISO IEEE |
11073-10425 Edition 3, 2024-09 |
Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM) |
| IEEE |
Std 11073-10425-2023 |
Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM) |
| 07/06/2020 |
Biocompatibility |
2-274 |
Complete |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 12/18/2023 |
Orthopedic |
11-402 |
Complete |
ASTM |
F1798-21 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 05/26/2025 |
Sterility |
14-610 |
Complete |
ISO |
11138-7 First edition 2019-03 |
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-147 |
Complete |
ASTM |
D6978-05(2023) |
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 04/04/2016 |
General I (QS/
RM) |
5-98 |
Complete |
ANSI ESD |
S20.20-2014 |
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) |
| 12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
| 05/26/2025 |
Neurology |
17-20 |
Complete |
IEC |
60601-2-40 Third edition 2024-12 |
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| 06/07/2021 |
Dental/
ENT |
4-273 |
Complete |
ANSI ASA |
S3.7-2016 (Reaffirmed 2025) |
American National Standard Method for Coupler Calibration of Earphones |
| 06/07/2021 |
Dental/
ENT |
4-275 |
Complete |
ANSI ASA |
S3.6-2018 (Reaffirmed 2023) |
American National Standard Specification for Audiometers |
| 01/14/2019 |
Cardiovascular |
3-44 |
Complete |
ANSI AAMI |
BP22:1994 (R2016) |
Blood pressure transducers |
| 06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| 12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
| 12/19/2022 |
Dental/
ENT |
4-294 |
Complete |
ANSI ADA |
Standard No. 139-2020 |
Dental Base Polymers |
| 12/19/2022 |
Dental/
ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/20/2021 |
General II (ES/
EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
| 07/06/2020 |
Radiology |
12-333 |
Complete |
IEC |
TR 63183 Edition 1.0 2019-12 |
Guidance on error and warning messages for software used in radiotherapy |
| 06/07/2021 |
Dental/
ENT |
4-283 |
Complete |
ISO |
16409 Second edition 2016-10 |
Dentistry - Oral care products - Manual interdental brushes |
| ANSI ADA |
Standard No. 125-2018 |
Manual Interdental Brushes |
| 12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
| 12/21/2020 |
Biocompatibility |
2-281 |
Complete |
ISO |
TS 10993-19 Second edition 2020-03 |
Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials |
| 12/23/2019 |
Physical Medicine |
16-210 |
Complete |
RESNA ANSI |
WC-2:2019 Section 4 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range |
| 12/23/2019 |
Physical Medicine |
16-211 |
Complete |
RESNA ANSI |
WC-1:2019 Section 5 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space |
| 06/07/2021 |
Anesthesiology |
1-151 |
Complete |
ISO |
80601-2-70 Second edition 2020-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 12/23/2019 |
Physical Medicine |
16-219 |
Complete |
RESNA ANSI |
WC-2:2019 Section 14 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods |
| 07/06/2020 |
Radiology |
12-331 |
Complete |
NEMA |
Standards Publication MS 14-2019 |
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| 07/15/2019 |
Orthopedic |
11-358 |
Complete |
ISO |
14242-4 First edition 2018-05 |
Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-450 |
Complete |
IEC |
60601-2-50 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| 07/06/2020 |
General I (QS/
RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
| 06/07/2021 |
Dental/
ENT |
4-278 |
Complete |
ISO |
4823 Fifth edition 2021-02 |
Dentistry - Elastomeric impression and bite registration materials |
| ANSI ADA |
Standard No. 19-2022 |
Elastomeric Impression and Bite Registration |
| 07/15/2019 |
Materials |
8-495 |
Complete |
ISO |
5834-3 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods |
| 06/07/2021 |
Dental/
ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 12/21/2020 |
Biocompatibility |
2-277 |
Complete |
ASTM |
F813-20 |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
| 06/07/2021 |
Radiology |
12-340 |
Complete |
IEC |
60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment |
| 08/06/2013 |
Radiology |
12-205 |
Complete |
IEC |
60601-2-5: Edition 3.0 2009-07 |
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
| 12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
| 05/30/2022 |
Sterility |
14-577 |
Complete |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-381 |
Complete |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
Materials |
8-541 |
Complete |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/21/2020 |
Materials |
8-542 |
Complete |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 06/07/2021 |
Orthopedic |
11-384 |
Complete |
ASTM |
F3446-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator |
| 06/07/2021 |
Radiology |
12-336 |
Complete |
IEC |
60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| 06/07/2021 |
Radiology |
12-338 |
Complete |
IEC |
60601-2-1 Edition 4.0 2020-10 |
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| 12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 05/26/2025 |
Anesthesiology |
1-196 |
Complete |
ISO |
80601-2-90 First edition 2021-08 |
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
| 07/15/2019 |
Biocompatibility |
2-267 |
Complete |
ASTM |
F2888-19 |
Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. |
| 05/26/2025 |
Anesthesiology |
1-194 |
Complete |
ISO |
27427 Fourth edition 2023-07 |
Anaesthetic and respiratory equipment - Nebulizing systems and components |
| 05/26/2025 |
Anesthesiology |
1-195 |
Complete |
ISO |
80369-2 First edition 2024-09 |
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications |
| 12/19/2022 |
Ophthalmic |
10-133 |
Complete |
ISO |
11979-10 Second edition 2018-03 |
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes. |
| 12/19/2022 |
Sterility |
14-580 |
Complete |
ISO |
11137-2 Third edition 2013-06 [Including AMD1:2022] |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)] |
| 12/19/2022 |
Orthopedic |
11-398 |
Complete |
ASTM |
F3574-22 |
Standard Test Methods for Sacroiliac Joint Fusion Devices |
| 06/07/2021 |
Materials |
8-562 |
Complete |
ISO ASTM |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 06/07/2021 |
Software/
Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
| 05/26/2025 |
Radiology |
12-368 |
Complete |
ISO |
13696 Second edition 2022-06 |
Optics and photonics - Test methods for radiation scattered by optical components |
| 10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
| 05/26/2025 |
Radiology |
12-367 |
Complete |
ISO |
13695 Second edition 2024-11 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 05/26/2025 |
InVitro Diagnostics |
7-331 |
Complete |
CLSI |
AUTO02-A2 |
Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-333 |
Complete |
CLSI |
AUTO04-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
| 12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| 12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
| 12/20/2021 |
Dental/
ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
| 12/19/2022 |
Sterility |
14-581 |
Complete |
ASTM |
F2638-22 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
| 12/19/2022 |
Sterility |
14-583 |
Complete |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| 05/26/2025 |
Software/
Informatics |
13-143 |
Complete |
AAMI |
TIR45:2023 |
Guidance on the use of AGILE practices in the development of medical device software |
| 06/07/2021 |
Tissue Engineering |
15-67 |
Complete |
ASTM |
F2212-20 |
Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 01/14/2019 |
Orthopedic |
11-347 |
Complete |
ASTM |
F2077-18 |
Test Methods for Intervertebral Body Fusion Devices |
| 05/26/2025 |
Orthopedic |
11-422 |
Complete |
ASTM |
F1798-24 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 10/19/2020 |
Software/
Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
| 05/26/2025 |
Software/
Informatics |
13-145 |
Complete |
IEEE |
Std 11073-10419:2023 |
Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump |
| 12/23/2019 |
Materials |
8-491 |
Complete |
ASTM |
F1088-18 |
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation |
| 07/06/2020 |
Materials |
8-526 |
Complete |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 06/07/2021 |
Dental/
ENT |
4-274 |
Complete |
ANSI ASA |
S3.2-2020 |
American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems |
| 12/23/2024 |
Sterility |
14-606 |
Complete |
ANSI AAMI |
ST24:2024 |
General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
|
| 01/30/2014 |
Sterility |
14-336 |
Complete |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
| 06/07/2021 |
Orthopedic |
11-379 |
Complete |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
| 05/26/2025 |
Software/
Informatics |
13-147 |
Complete |
IEEE |
Std 11073-10406-2023 |
Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 08/21/2017 |
Software/
Informatics |
13-90 |
Complete |
ISO IEEE |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
| IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-463 |
Complete |
IEC |
60601-2-21 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| 07/06/2020 |
General I (QS/
RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-128 |
Complete |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
| 05/26/2025 |
Sterility |
14-611 |
Complete |
ISO |
11137-1 Second edition 2025-04 |
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 12/21/2020 |
General II (ES/
EMC) |
19-39 |
Complete |
IEC |
60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| ANSI AAMI IEC |
60601-1-12:2016 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)] |
| 07/15/2019 |
Sterility |
14-528 |
Complete |
ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
| ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
| 07/06/2020 |
Biocompatibility |
2-273 |
Complete |
ISO |
10993-9 Third edition 2019-11 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
| 12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
| 12/21/2020 |
Nanotechnology |
18-17 |
Complete |
ISO |
21363 First edition 2020-06 |
Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy |
| 07/15/2019 |
Materials |
8-517 |
Complete |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 12/21/2020 |
Biocompatibility |
2-278 |
Complete |
ASTM |
F719-20 e1 |
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation |
| 07/09/2014 |
Radiology |
12-283 |
Complete |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
| 03/14/2011 |
Radiology |
12-226 |
Complete |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| 03/16/2012 |
Radiology |
12-105 |
Complete |
NEMA |
UD 2-2004 (R2009) |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
| 12/21/2020 |
Ophthalmic |
10-120 |
Complete |
ISO |
TR 22979 Second Edition 2017-05 |
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| 08/21/2017 |
Software/
Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
| 05/26/2025 |
Radiology |
12-380 |
Complete |
IEC |
60601-2-37 Edition 3.0 2024-07 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 06/27/2016 |
Radiology |
12-293 |
Complete |
IEC |
60601-2-37 Edition 2.1 2015 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
| 12/19/2007 |
Radiology |
12-171 |
Complete |
ISO |
14880-2:2006 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
| 06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| 12/21/2020 |
Materials |
8-545 |
Complete |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
| 12/21/2020 |
InVitro Diagnostics |
7-300 |
Complete |
CLSI |
MM13 2nd Edition |
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| 07/06/2020 |
Anesthesiology |
1-146 |
Complete |
ISO |
80601-2-12 Second edition 2020-02 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 06/07/2021 |
InVitro Diagnostics |
7-306 |
Complete |
CLSI |
EP06 2nd Edition |
Evaluation of the Linearity of Quantitative Measurement Procedures |
| 12/21/2020 |
InVitro Diagnostics |
7-301 |
Complete |
CLSI |
GP42 7th Edition |
Collection of Capillary Blood Specimens |
| 12/23/2024 |
Cardiovascular |
3-193 |
Complete |
ISO |
12417-1 Second edition 2024-02 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 06/27/2016 |
Cardiovascular |
3-143 |
Complete |
ISO |
12417-1 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 12/21/2020 |
InVitro Diagnostics |
7-302 |
Complete |
CLSI |
C34 4th Edition |
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis |
| 12/21/2020 |
InVitro Diagnostics |
7-305 |
Complete |
ISO |
17511 Second edition 2020-04 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples |
| 07/15/2019 |
Biocompatibility |
2-268 |
Complete |
ISO |
TS 21726 First edition 2019-02 |
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents |
| 12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 07/06/2020 |
General I (QS/
RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| 05/26/2025 |
Dental/
ENT |
4-343 |
Complete |
ANSI ADA |
Standard No. 105-2024 |
Elastomeric Auxiliaries for Use in Orthodontics |
| 05/26/2025 |
Dental/
ENT |
4-346 |
Complete |
ISO |
9680 Fourth edition 2021-11 |
Dentistry - Operating lights |
| ANSI ADA |
Standard No. 89-2023 |
Dentistry - Dental Operating Lights |
| 05/26/2025 |
Neurology |
17-22 |
Complete |
IEC |
60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 05/26/2025 |
InVitro Diagnostics |
7-334 |
Complete |
CLSI |
AUTO05-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-335 |
Complete |
CLSI |
POCT01-A2 |
Point-of-Care Connectivity - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-336 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. |
| 05/26/2025 |
InVitro Diagnostics |
7-340 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition. |
| 12/21/2020 |
Materials |
8-549 |
Complete |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 12/21/2020 |
Biocompatibility |
2-279 |
Complete |
ASTM |
F750-20 |
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse |
| 12/21/2020 |
Dental/
ENT |
4-269 |
Complete |
ISO |
3964 Third edition 11-2016 |
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| ANSI ADA |
Standard No. 158-2020 |
Coupling Dimensions for Dental Handpiece Connectors |
| 05/26/2025 |
Dental/
ENT |
4-339 |
Complete |
ANSI ADA |
Standard No. 119-2023 |
Dentistry-Manual Toothbrushes |
| 05/30/2022 |
Dental/
ENT |
4-293 |
Complete |
ANSI ADA |
Standard No. 119-2021 |
Manual Toothbrushes |
| 05/26/2025 |
Dental/
ENT |
4-340 |
Complete |
ANSI ADA |
Standard No. 46-2016 |
Dental Patient Chair |
| 05/26/2025 |
Dental/
ENT |
4-341 |
Complete |
ANSI ADA |
Standard No. 47-1-2021 |
Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
| 05/26/2025 |
Dental/
ENT |
4-342 |
Complete |
ANSI ADA |
Standard No. 47-2-2021 |
Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems |
| 12/21/2020 |
Anesthesiology |
1-149 |
Complete |
ISO |
7376 Third edition 2020-08 |
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation |
| 06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/21/2020 |
Anesthesiology |
1-150 |
Complete |
ISO |
8836 Fifth edition 2019-12 |
Suction catheters for use in the respiratory tract |
| 06/07/2021 |
Ophthalmic |
10-124 |
Complete |
ISO |
11979-1 Fourth edition 2018-11 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 12/23/2019 |
Physical Medicine |
16-207 |
Complete |
RESNA ANSI |
WC-1:2019 Section 1 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability |
| 01/15/2013 |
Software/
Informatics |
13-36 |
Complete |
AAMI |
TIR 45:2012 |
Guidance on the use of AGILE practices in the development of medical device software |
| 06/07/2018 |
Neurology |
17-16 |
Complete |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 05/26/2025 |
InVitro Diagnostics |
7-338 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| 12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
| 12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-510 |
Complete |
IEC |
80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 12/23/2024 |
InVitro Diagnostics |
7-323 |
Complete |
CLSI |
EP19 3rd Edition |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
| 05/26/2025 |
Radiology |
12-371 |
Complete |
ISO |
14880-2 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations |
| 12/23/2019 |
Physical Medicine |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
| 06/07/2021 |
Orthopedic |
11-383 |
Complete |
ASTM |
F3143-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
| 05/26/2025 |
Ophthalmic |
10-137 |
Complete |
ISO |
11979-2 Third edition 2024-10 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| 12/20/2021 |
General II (ES/
EMC) |
19-44 |
Complete |
IEEE ANSI |
C63.24-2021 |
American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems |
| 12/20/2021 |
General I (QS/
RM) |
5-134 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 12/19/2022 |
Software/
Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
| 12/19/2022 |
Software/
Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-483 |
Complete |
IEC |
60601-2-35 Edition 2.0 2020-09 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 05/26/2025 |
InVitro Diagnostics |
7-329 |
Complete |
CLSI |
EP06-EG 2nd Edition |
Developer Validation of Linearity, Establishment Guide |
| 08/14/2015 |
Ophthalmic |
10-98 |
Complete |
ISO |
11979-2 Second edition 2014-08-15 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| 05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 05/26/2025 |
InVitro Diagnostics |
7-339 |
Complete |
CLSI |
AUTO09-A |
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| 06/27/2016 |
Software/
Informatics |
13-84 |
Complete |
ISO IEEE |
11073-10103 First edition 2014-03-01 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| 06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| 01/14/2019 |
Dental/
ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 05/26/2025 |
Software/
Informatics |
13-146 |
Complete |
IEEE |
11073-10103 Second edition 2023 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| 01/27/2015 |
Software/
Informatics |
13-72 |
Complete |
ISO IEEE |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
| IEEE |
Std 11073-10425-2014 |
Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
| 05/26/2025 |
InVitro Diagnostics |
7-345 |
Complete |
CLSI |
AUTO13-A2 (Formerly GP19-A2) |
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
| 05/30/2022 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
| 04/04/2016 |
Sterility |
14-340 |
Complete |
ISO |
20857 First edition 2010-08-15 |
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ANSI AAMI ISO |
20857:2010/(R)2015 |
(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-476 |
Complete |
ISO |
11608-2:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 01/14/2019 |
Materials |
8-485 |
Complete |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 05/26/2025 |
InVitro Diagnostics |
7-332 |
Complete |
CLSI |
AUTO01-A |
Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
| 03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 05/26/2025 |
Radiology |
12-369 |
Complete |
ISO |
11146-1 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 03/16/2012 |
Radiology |
12-134 |
Complete |
ISO |
11146-1 First edition 2005-01-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 05/26/2025 |
InVitro Diagnostics |
7-341 |
Complete |
CLSI |
AUTO03-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-343 |
Complete |
CLSI |
AUTO07-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-344 |
Complete |
CLSI |
AUTO11-A2 |
Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition. |
| 12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| 01/14/2019 |
Software/
Informatics |
13-106 |
Complete |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |
| 01/14/2019 |
Software/
Informatics |
13-107 |
Complete |
ISO IEEE |
11073-20702 First edition 2018-09 |
Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services |
| IEEE |
Std 11073-20702-2016 |
Health informatics - Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services |
| 05/26/2025 |
Software/
Informatics |
13-148 |
Complete |
IEEE |
Std 11073-10417-2023 |
Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter |
| 01/14/2019 |
Dental/
ENT |
4-163 |
Complete |
ANSI ASA |
S3.5-1997 (Reaffirmed 2024) |
American National Standard Methods for Calculation of the Speech Intelligibility Index |
| 07/06/2020 |
InVitro Diagnostics |
7-298 |
Complete |
CLSI |
EP35, 1st Edition |
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
| 12/23/2024 |
InVitro Diagnostics |
7-324 |
Complete |
CLSI |
M07 12th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| 05/26/2025 |
Radiology |
12-381 |
Complete |
IEC |
60601-2-68 Edition 2.0 2025-02 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 07/06/2020 |
Cardiovascular |
3-164 |
Complete |
ASTM |
F1830-19 (Reapproved 2024) |
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps |
| 12/23/2016 |
Radiology |
12-303 |
Complete |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
| 12/23/2016 |
Radiology |
12-304 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| 12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| 12/23/2019 |
Materials |
8-494 |
Complete |
ISO |
6474-1 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
| 12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 12/23/2024 |
Sterility |
14-609 |
Complete |
AAMI |
TIR17:2024 |
Compatibility of materials subjected to sterilization |
| 12/23/2019 |
Materials |
8-499 |
Complete |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| 08/06/2013 |
Software/
Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-127 |
Complete |
ISO CIE |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
| 12/23/2024 |
Cardiovascular |
3-197 |
Complete |
ISO |
25539-4 First edition 2021-11 |
Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices |
| 12/23/2024 |
Orthopedic |
11-410 |
Complete |
ASTM |
F3161-24 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 05/26/2025 |
Radiology |
12-377 |
Complete |
IEC |
62127-03 Edition 2.0 2022-12 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 07/06/2020 |
Nanotechnology |
18-16 |
Complete |
ISO |
TS 21362 First edition 2018-06 |
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation |
| 07/06/2020 |
Radiology |
12-330 |
Complete |
NEMA |
Standards Publication XR 28-2018 (R2023) |
Supplemental Requirements for User Information and System Function Related to Dose in CT |
| 12/23/2019 |
Physical Medicine |
16-222 |
Complete |
RESNA ANSI |
WC-1:2019 Section 20 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-223 |
Complete |
RESNA ANSI |
WC-1:2019 Section 22 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures |
| 12/23/2019 |
Physical Medicine |
16-224 |
Complete |
RESNA ANSI |
WC-2:2019 Section 21 |
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters |
| 07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
| 12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 07/09/2014 |
Radiology |
12-279 |
Complete |
IEC |
62127-03 Edition 1.1 2013-05 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-378 |
Complete |
ISO |
12609-1 Second edition 2021-10 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| 12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 09/17/2018 |
Radiology |
12-319 |
Complete |
IEC |
60601-2-68 Edition 1.0 2014-09 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 05/26/2025 |
Radiology |
12-382 |
Complete |
NEMA |
NU 2-2024 |
Performance Measurements of Positron Emission Tomographs |
| 12/19/2022 |
Anesthesiology |
1-160 |
Complete |
ISO |
80601-2-84 First edition 2020-07 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| 01/14/2019 |
Dental/
ENT |
4-250 |
Complete |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-252 |
Complete |
ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| 12/23/2019 |
Software/
Informatics |
13-111 |
Complete |
IEEE |
Std 11073-10201-2018 |
Health informatics - Point-of-care medical device communication Part 10201: Domain Information Model |
| 06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| 07/15/2019 |
Orthopedic |
11-351 |
Complete |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 07/15/2019 |
Physical Medicine |
16-206 |
Complete |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-444 |
Complete |
ASTM |
D7103-19(2023) |
Standard Guide for Assessment of Medical Gloves |
| 08/14/2015 |
General I (QS/
RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 06/27/2016 |
Materials |
8-429 |
Complete |
ASTM |
F2224-09 (Reapproved 2020) |
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| 08/21/2017 |
Cardiovascular |
3-149 |
Complete |
ISO |
25539-1 Second edition 2017-02 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| ANSI AAMI ISO |
25539-1:2017 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 07/15/2019 |
Materials |
8-513 |
Complete |
ISO |
20160 First edition 2006-05-01 |
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 05/26/2025 |
Cardiovascular |
3-200 |
Complete |
ASTM |
F2477-24 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 07/15/2019 |
Orthopedic |
11-353 |
Complete |
ISO |
18192-3 First edition 2017-06 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions |
| 07/15/2019 |
Materials |
8-514 |
Complete |
ISO |
5834-2 Fifth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms |
| 12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 12/21/2020 |
Materials |
8-537 |
Complete |
ASTM |
F620-20 |
Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition |
| 12/21/2020 |
Anesthesiology |
1-147 |
Complete |
ISO |
26825 Second edition 2020-10 |
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance |
| 05/26/2025 |
Cardiovascular |
3-198 |
Complete |
ISO |
25539-3 Second edition 2024-10 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| 08/20/2012 |
Cardiovascular |
3-103 |
Complete |
ISO |
25539-3 First edition 2011-12-01 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| ANSI AAMI ISO |
25539-3:2011 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| 05/26/2025 |
Cardiovascular |
3-199 |
Complete |
ASTM |
F1841-25 |
Standard Practice for Assessment of Hemolysis in Blood Pumps |
| 12/21/2020 |
ObGyn/
Gastroenterology/
Urology |
9-130 |
Complete |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| 12/21/2020 |
Materials |
8-538 |
Complete |
ASTM |
F2759-19 |
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 08/06/2013 |
Software/
Informatics |
13-56 |
Complete |
ISO IEEE |
11073-10406 First edition 2012-12-01 |
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics [Including: Corrigendum 1 (2022)] |
| 05/26/2025 |
Radiology |
12-370 |
Complete |
ISO |
11146-2 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 05/26/2025 |
InVitro Diagnostics |
7-342 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
| 05/26/2025 |
Software/
Informatics |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 12/21/2020 |
Dental/
ENT |
4-266 |
Complete |
ISO |
19023 First edition 2018-02 |
Dentistry - Orthodontic anchor screws |
| ANSI ADA |
Standard No. 178-2019 |
Orthodontic Anchor Screws |
| 12/21/2020 |
Dental/
ENT |
4-268 |
Complete |
ISO |
15841 Second edition 2014-08 |
Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] |
| ANSI ADA |
Standard No. 32-2017 |
Orthodontic Wires |
| 07/15/2019 |
Orthopedic |
11-357 |
Complete |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| 07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
| 07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 12/23/2024 |
Radiology |
12-362 |
Complete |
IEC |
61674 Edition 3.0 2024-07 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 01/30/2014 |
Radiology |
12-259 |
Complete |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 09/17/2018 |
InVitro Diagnostics |
7-279 |
Complete |
CLSI |
M07 11th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| 07/06/2020 |
Orthopedic |
11-364 |
Complete |
ISO |
14243-1 Second edition 2009-11-15 |
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 01/14/2019 |
Nanotechnology |
18-8 |
Complete |
ASTM |
E2578-07 (Reapproved 2022) |
Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions |
| 01/14/2019 |
Radiology |
12-321 |
Complete |
ANSI IES |
RP-27.3-17 |
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
| 09/17/2018 |
InVitro Diagnostics |
7-280 |
Complete |
CLSI |
M02 13th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-504 |
Complete |
ASTM |
F1862/F1862M-24 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 07/09/2014 |
Radiology |
12-282 |
Complete |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 05/26/2025 |
Radiology |
12-379 |
Complete |
IEC |
62127-2 Edition 2.0 2025-01 |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 12/23/2019 |
General I (QS/
RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
| ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
| 07/15/2019 |
Biocompatibility |
2-265 |
Complete |
ASTM |
F2901-19 |
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
| 12/23/2019 |
Orthopedic |
11-360 |
Complete |
ASTM |
F1378-18e1 |
Standard Specification for Shoulder Prostheses |
| 01/14/2019 |
Radiology |
12-323 |
Complete |
ISO |
11990 Third edition 2018-08 |
Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
| 01/14/2019 |
Radiology |
12-324 |
Complete |
ISO |
13694 Third edition 2018-11 |
Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution |
| 05/26/2025 |
Orthopedic |
11-420 |
Complete |
ASTM |
F2580-24 |
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses |
| 01/14/2019 |
Orthopedic |
11-344 |
Complete |
ASTM |
F2580-18 |
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| 05/26/2025 |
Orthopedic |
11-421 |
Complete |
ASTM |
F2077-24 |
Standard Test Methods for Intervertebral Body Fusion Devices |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-121 |
Complete |
IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
| ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| 12/23/2019 |
General I (QS/
RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 12/23/2019 |
Radiology |
12-328 |
Complete |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2022)] |
| 01/14/2019 |
Radiology |
12-102 |
Complete |
ANSI IES |
RP-27.2-00/R17 |
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
| 06/27/2016 |
Orthopedic |
11-308 |
Complete |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 12/23/2024 |
Orthopedic |
11-418 |
Complete |
ASTM |
F3631-24 |
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
|
| 12/23/2024 |
Orthopedic |
11-419 |
Complete |
ASTM |
F3690-24 |
Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance |
| 05/26/2025 |
General I (QS/
RM) |
5-145 |
Complete |
IEC |
60417:2025 DB |
Graphical symbols for use on equipment |
| 06/07/2021 |
InVitro Diagnostics |
7-307 |
Complete |
CLSI |
POCT05 2nd Edition |
Performance Metrics for Continuous Interstitial Glucose Monitoring |
| 06/07/2021 |
Orthopedic |
11-381 |
Complete |
ASTM |
F2582-20 |
Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
| 01/14/2019 |
Dental/
ENT |
4-162 |
Complete |
ANSI ASA |
S3.4-2007 (Reaffirmed 2025) |
American National Standard Procedure for the Computation of Loudness of Steady Sounds |
| 09/17/2018 |
Orthopedic |
11-327 |
Complete |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
| 12/23/2024 |
Orthopedic |
11-414 |
Complete |
ASTM |
F382-24 |
Standard Specification and Test Method for Metallic Bone Plates |
| 12/23/2019 |
Cardiovascular |
3-162 |
Complete |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 06/07/2021 |
Software/
Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
| 12/23/2024 |
Orthopedic |
11-417 |
Complete |
ASTM |
F3090-24 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 12/23/2024 |
Orthopedic |
11-411 |
Complete |
ASTM |
F1611-20 (Reapproved 2024) |
Standard Specification for Intramedullary Reamers |
| 09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 12/23/2019 |
Dental/
ENT |
4-260 |
Complete |
ANSI ASA |
S12.2-2019 (Reaffirmed 2023) |
American National Standard for Criteria for Evaluating Room Noise |
| 08/06/2013 |
Software/
Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 12/23/2024 |
Software/
Informatics |
13-141 |
Complete |
ISO IEEE |
11073-10701 First Edition, 2024-09 |
Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system |
| IEEE |
11073-10701-2022 |
IEEE Standard for Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System |
| 07/15/2019 |
Biocompatibility |
2-266 |
Complete |
ASTM |
F2382-18 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 08/21/2017 |
Software/
Informatics |
13-67 |
Complete |
ISO IEEE |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
| IEEE |
Std 11073-10418-2011 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor |
| 12/23/2019 |
Materials |
8-501 |
Complete |
ISO |
5834-1 Fourth edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form |
| 12/23/2019 |
Materials |
8-502 |
Complete |
ASTM |
F2038-18 |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
| 12/23/2019 |
Materials |
8-507 |
Complete |
ASTM |
F688-19 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 12/23/2024 |
General I (QS/
RM) |
5-143 |
Complete |
ISO |
14630 Fffth edition 2024-09 |
Non-active surgical implants -- General requirements |
| 08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
| 07/09/2014 |
Sterility |
14-290 |
Complete |
ANSI AAMI |
ST24:1999/(R)2018 |
Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed. |
| 05/26/2025 |
Radiology |
12-372 |
Complete |
ISO |
14880-3 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 12/23/2019 |
InVitro Diagnostics |
7-293 |
Complete |
CLSI |
QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
A Quality Management System Model for Laboratory Services. |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-461 |
Complete |
IEC |
60601-2-19 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)] |
| 12/23/2024 |
Anesthesiology |
1-187 |
Complete |
ISO |
80601-2-12 Third edition 2023-11 |
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| 01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| 01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
| 01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
| 04/04/2016 |
Radiology |
12-195 |
Complete |
NEMA |
MS 6-2008 (R2014, R2020) |
Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging |
| 07/09/2014 |
Radiology |
12-273 |
Complete |
IEC |
60825-1 Edition 2.0 2007-03 |
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
| 12/23/2024 |
Anesthesiology |
1-188 |
Complete |
ISO |
80601-2-84 Second edition 2023-11 |
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment |
| 07/06/2020 |
Orthopedic |
11-365 |
Complete |
ASTM |
F1800-19 e1 |
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| 07/06/2020 |
Orthopedic |
11-366 |
Complete |
ASTM |
F2381-19 |
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy |
| 12/23/2019 |
Materials |
8-480 |
Complete |
ASTM |
F2063-18 |
Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| 05/26/2025 |
Software/
Informatics |
13-142 |
Complete |
FIRST |
CVSS v3.1 |
Common Vulnerability Scoring System version 3.1 |
| 04/04/2016 |
Software/
Informatics |
13-81 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 12/23/2016 |
Software/
Informatics |
13-87 |
Complete |
ISO IEC |
15026-2 First edition 2011-02-15 |
Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
| 04/04/2016 |
Tissue Engineering |
15-24 |
Complete |
ASTM |
F2721-09 (Reapproved 2014) |
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects |
| 07/15/2019 |
Tissue Engineering |
15-57 |
Complete |
ASTM |
F2315-18 |
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels |
| 12/23/2024 |
Anesthesiology |
1-189 |
Complete |
ISO |
4135 Fourth edition 2022-01 |
Anaesthetic and respiratory equipment - Vocabulary |
| 12/23/2024 |
InVitro Diagnostics |
7-322 |
Complete |
CLSI |
M47 2nd Edition |
Principles and Procedures for Blood Cultures |
| 05/26/2025 |
General II (ES/
EMC) |
19-54 |
Complete |
IEC |
60086-5 Edition 5.0 2021-09 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)] |
| 08/21/2017 |
General II (ES/
EMC) |
19-24 |
Complete |
IEC |
60086-5 Edition 4.0 2016-07 |
Primary batteries - Part 5: Safety of batteries with aqueous electrolyte |
| 05/26/2025 |
General II (ES/
EMC) |
19-55 |
Complete |
IEC |
62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-129 |
Complete |
ISO CIE |
61966-2-1 First edition 1999-10 |
Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] |
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