|
|
|
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)
|
| 10/04/2004 |
InVitro Diagnostics |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
| 03/31/2006 |
Radiology |
12-137 |
Complete |
ISO |
4090 Third eidition 2001-08-15 |
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications |
| 03/31/2006 |
Radiology |
12-138 |
Complete |
ISO |
5799 Second edition 1991-08-01 |
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
| 10/04/2004 |
Radiology |
12-116 |
Complete |
ISO |
13696:2002 |
Optics and optical instruments -- Test methods for radiation scattered by optical components |
| 01/30/2014 |
General I (QS/
RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
| 11/08/2005 |
InVitro Diagnostics |
7-113 |
Complete |
CLSI |
I/LA23-A (Replaces I/LA23-P) |
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
| 01/14/2019 |
Sterility |
14-518 |
Complete |
AAMI ANSI |
ST55:2016/(R)2023 |
Table-top steam sterilizers |
| 07/26/2016 |
Biocompatibility |
2-170 |
Complete |
ISO |
10993-14 First edition 2001-11-15 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics |
| ANSI AAMI ISO |
10993-14:2001/(R) 2011 |
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics |
| 01/14/2019 |
Neurology |
17-14 |
Complete |
ANSI AAMI |
NS4:2013(R)2017 |
Transcutaneous Electrical Nerve Stimulators |
| 01/14/2019 |
Physical Medicine |
16-204 |
Complete |
ISO |
7176-6 Third edition 2018-06 |
Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs |
| 01/14/2019 |
Cardiovascular |
3-79 |
Complete |
ASTM |
F2079-09 (Reapproved 2017) |
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| 08/14/2015 |
Software/
Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| 04/04/2016 |
Software/
Informatics |
13-81 |
Complete |
IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 08/21/2017 |
Software/
Informatics |
13-91 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| 08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
| 08/14/2015 |
Ophthalmic |
10-94 |
Complete |
ISO |
14730 Second edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date |
| 08/14/2015 |
Ophthalmic |
10-95 |
Complete |
ISO |
11979-6 Third edition 2014-10-01 |
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
| 08/06/2013 |
Orthopedic |
11-252 |
Complete |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
| 09/21/2016 |
InVitro Diagnostics |
7-266 |
Complete |
CLSI |
EP19 2nd Edition (Replaces EP19-R) |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
| 01/27/2015 |
Radiology |
12-230 |
Complete |
NEMA |
XR 24-2008 (R2014) |
Primary user controls for interventional angiography x-ray equipment |
| 07/06/2020 |
Materials |
8-536 |
Complete |
ISO ASTM |
52902:First Edition 2019-07 |
Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems |
| 01/30/2014 |
Cardiovascular |
3-54 |
Complete |
ANSI AAMI ISO |
7198:2016 Second edition |
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
| 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 |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-421 |
Complete |
ISO |
80601-2-56 Second edition 2017-03 |
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. |
| 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 |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 01/14/2019 |
Dental/
ENT |
4-255 |
Complete |
ANSI ADA |
Standard No. 131-2015 (R2020) |
Dental CAD/CAM Machinable Zirconia Blanks |
| 07/15/2019 |
Orthopedic |
11-355 |
Complete |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
| 07/15/2019 |
Ophthalmic |
10-118 |
Complete |
ANSI |
Z80.38-2017 (R2021) |
American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery |
| 03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
| 03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
| 08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| 07/15/2019 |
Anesthesiology |
1-143 |
Complete |
ISO |
80601-2-79 First edition 2018-07 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 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 |
| 12/23/2019 |
Dental/
ENT |
4-261 |
Complete |
ISO |
7405 Third edition 2018-10 Corrected version 2018-12 |
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
| 12/20/2021 |
Orthopedic |
11-388 |
Complete |
ASTM |
F1717-21 |
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| 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 |
| 12/23/2019 |
Dental/
ENT |
4-262 |
Complete |
IEC |
80601-2-60 Edition 2.0 2019-06 |
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| 12/23/2019 |
Orthopedic |
11-361 |
Complete |
ISO |
14243-5 First edition 2019-05 |
Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
| 06/07/2018 |
Dental/
ENT |
4-240 |
Complete |
ISO |
21563 First edition 2013-08-15 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2015 |
Hydrocolloid Impression Materials |
| 12/20/2021 |
Software/
Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| 12/19/2022 |
Biocompatibility |
2-297 |
Complete |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| 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 |
| 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 |
| 05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 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 |
4-251 |
Complete |
ISO |
6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] |
Dentistry - Ceramic materials |
| ANSI ADA |
Standard No. 69-2020 |
Dental Ceramic |
| 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) |
| 01/14/2019 |
Dental/
ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 05/30/2022 |
Radiology |
12-343 |
Complete |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| 05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| 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. |
| 05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 12/18/2023 |
Anesthesiology |
1-165 |
Complete |
ISO |
80601-2-13 Second edition 2022-04 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| 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 |
| 01/15/2013 |
InVitro Diagnostics |
7-237 |
Complete |
CLSI |
MM01-A3 (Replaces MM01-A2) |
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition |
| 01/15/2013 |
InVitro Diagnostics |
7-238 |
Complete |
CLSI |
MM06-A2 (Replaces MM06-A) |
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition |
| 01/15/2013 |
Software/
Informatics |
13-35 |
Complete |
ANSI AAMI |
SW87:2012 |
Application of quality management system concepts to medical device data systems |
| 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 |
| 01/15/2013 |
Sterility |
14-213 |
Complete |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
| 01/15/2013 |
Sterility |
14-215 |
Complete |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
| 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) |
| 12/23/2019 |
Materials |
8-499 |
Complete |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| 12/23/2019 |
Materials |
8-500 |
Complete |
ISO |
5832-12 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
| 07/15/2019 |
Software/
Informatics |
13-108 |
Complete |
IEEE |
Std 11073-20701-2018 |
Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-426 |
Complete |
ISO |
23907-1 First edition 2019-01 |
Sharps injury protection - Requirements and test methods - Sharps containers |
| 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 |
Tissue Engineering |
15-31 |
Complete |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-177 |
Complete |
ASTM |
E1112-00(2018) |
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 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 |
6-493 |
Complete |
ASTM |
F2101-23 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 09/17/2018 |
Materials |
8-412 |
Complete |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 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 |
| 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 |
| 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 |
| 09/17/2018 |
Sterility |
14-293 |
Complete |
ANSI AAMI |
ST50:2004/(R)2018 |
Dry heat (heated air) sterilizers |
| 01/30/2014 |
InVitro Diagnostics |
7-239 |
Complete |
CLSI |
EP32-R (Formerly X05-R) |
Metrological Traceability and Its Implementation; A Report |
| 07/09/2014 |
Radiology |
12-272 |
Complete |
IEC |
60601-2-17 Edition 3.0 2013-11 |
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
| 01/30/2014 |
Radiology |
12-266 |
Complete |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
| 07/09/2014 |
InVitro Diagnostics |
7-221 |
Complete |
CLSI |
GP39-A6 (Formerly H01-A6) |
Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 07/06/2020 |
Materials |
8-532 |
Complete |
ASTM |
F3335-20 |
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion |
| 07/06/2020 |
Materials |
8-533 |
Complete |
ISO ASTM |
52907: First Edition 2019-11 |
Additive Manufacturing - Feedstock materials - Methods to characterize metal powders |
| 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 |
| 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 |
| 01/27/2015 |
Sterility |
14-166 |
Complete |
ISO |
14644-7 First edition 2004-10-01 |
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| 12/23/2016 |
Cardiovascular |
3-144 |
Complete |
ISO |
7198 Second edition 2016-08-01 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2014) |
Standard Specification for Soft-Tissue Expander Devices |
| 07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| 09/09/2008 |
Radiology |
12-166 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-270 |
Complete |
ASTM |
F1840-10 (Reapproved 2016) |
Standard Terminology for Surgical Suture Needles |
| 09/17/2018 |
Materials |
8-472 |
Complete |
ASTM |
F2847-17 |
Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments |
| 09/17/2018 |
Materials |
8-474 |
Complete |
ASTM |
F2886-17 |
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications |
| 09/09/2008 |
Sterility |
14-240 |
Complete |
ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
| ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
| 08/06/2013 |
Software/
Informatics |
13-56 |
Complete |
IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph |
| 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)] |
| 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 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 03/18/2009 |
InVitro Diagnostics |
7-185 |
Complete |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
| 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 |
| 08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
| 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 |
| 01/30/2014 |
Sterility |
14-400 |
Complete |
ASTM |
F2203-13 (Reapproved 2022) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
| 01/27/2015 |
General I (QS/
RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 06/07/2021 |
Ophthalmic |
10-126 |
Complete |
IEC |
80601-2-58 Edition 2.0 2014-09 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| ANSI AAMI IEC |
80601-2-58:2014 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| 07/09/2014 |
Radiology |
12-281 |
Complete |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| 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 |
| 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 |
| 08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| 06/07/2018 |
Nanotechnology |
18-9 |
Complete |
ISO |
TR 13014 First edition 2012-05-15 |
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-111 |
Complete |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
| 12/18/2023 |
Dental/
ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
| 12/18/2023 |
Sterility |
14-595 |
Complete |
ISO |
11607-2 Second edition 2019-02 [Including AMD1:2023] |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]. |
| 12/18/2023 |
Dental/
ENT |
4-317 |
Complete |
ISO |
8325 Third edition 2023-03 |
Dentistry - Test methods for rotary instruments |
| 12/21/2020 |
Biocompatibility |
2-280 |
Complete |
ASTM |
F1408-20a |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
| 07/06/2020 |
Orthopedic |
11-367 |
Complete |
ISO |
14243-3 Second edition 2014-11-01 |
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| 07/06/2020 |
Orthopedic |
11-368 |
Complete |
ASTM |
F3334-19 |
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-70 |
Complete |
ASTM |
E825-98 (Reapproved 2016) |
Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-124 |
Complete |
ASTM |
E1104-98 (Reapproved 2016) |
Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 08/21/2017 |
Materials |
8-333 |
Complete |
ASTM |
F2393-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-384 |
Complete |
ISO |
1135-4 Sixth edition 2015-12-01 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-125 |
Complete |
ASTM |
E1965-98 (Reapproved 2016) |
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-400 |
Complete |
ASTM |
F3212-16(2023) |
Standard Test Method for Coring Testing of Huber Needles |
| 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 |
| 01/14/2019 |
Software/
Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
| 09/09/2008 |
Sterility |
14-191 |
Complete |
ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
| ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
| 09/17/2018 |
Materials |
8-470 |
Complete |
ASTM |
F2102-17 |
Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants |
| 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 |
| 01/14/2019 |
InVitro Diagnostics |
7-139 |
Complete |
CLSI |
QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 |
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
| 09/17/2018 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| 09/17/2018 |
Dental/
ENT |
4-242 |
Complete |
ISO |
10139-1 Third edition 2018-03 |
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use |
| ANSI ADA |
Standard No. 75-2020 |
Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-119 |
Complete |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
| 09/17/2018 |
Cardiovascular |
3-153 |
Complete |
ASTM |
F2743-11 |
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems |
| 09/17/2018 |
InVitro Diagnostics |
7-284 |
Complete |
CLSI |
EP37 1st Edition |
Supplemental Tables for Interference Testing in Clinical Chemistry |
| 09/17/2018 |
InVitro Diagnostics |
7-277 |
Complete |
CLSI |
GP41 7th Edition |
Collection of Diagnostic Venous Blood Specimens |
| 09/17/2018 |
InVitro Diagnostics |
7-278 |
Complete |
CLSI |
M27 4th Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
| 06/07/2018 |
Sterility |
14-510 |
Complete |
ISO |
11137-3 Second edition 2017-06 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ANSI AAMI ISO |
11137-3:2017/(R)2023 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 06/07/2018 |
Biocompatibility |
2-249 |
Complete |
ISO |
10993-16 Third edition 2017-05 |
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| 09/17/2018 |
Cardiovascular |
3-154 |
Complete |
ASTM |
F3211-17 |
Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| 06/07/2021 |
Materials |
8-560 |
Complete |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 05/30/2022 |
Sterility |
14-573 |
Complete |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 12/18/2023 |
Dental/
ENT |
4-318 |
Complete |
ISO |
20749 Second edition 2023-06 |
Dentistry - Pre-capsulated dental amalgam |
| 07/06/2020 |
Tissue Engineering |
15-61 |
Complete |
ASTM |
F2150-19 |
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products |
| 12/23/2019 |
Materials |
8-523 |
Complete |
ASTM |
F3275-19 |
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device |
| 12/23/2019 |
Materials |
8-524 |
Complete |
ASTM |
F3276-19 |
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device |
| 09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 08/06/2013 |
Software/
Informatics |
13-40 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-1 2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples |
| IEC |
TR 80001-2-1 Edition 1.0 2012-07 |
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples |
| 08/06/2013 |
Software/
Informatics |
13-44 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| 06/07/2018 |
Ophthalmic |
10-105 |
Complete |
ISO |
11979-8 Third edition 2017-04 |
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
| 06/07/2018 |
Ophthalmic |
10-106 |
Complete |
ISO |
18369-3 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
| 06/07/2018 |
Ophthalmic |
10-107 |
Complete |
ISO |
18369-4 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
| 04/04/2016 |
Dental/
ENT |
4-190 |
Complete |
ANSI ASA |
S3.35-2010 (Reaffirmed 2020) |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions |
| 01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
| 01/14/2019 |
General I (QS/
RM) |
5-121 |
Complete |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 08/21/2017 |
Orthopedic |
11-269 |
Complete |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| 12/23/2016 |
Orthopedic |
11-312 |
Complete |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
| 12/20/2021 |
Cardiovascular |
3-177 |
Complete |
ASTM |
F2606-08 (Reapproved 2021) |
Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems |
| 12/21/2020 |
Materials |
8-552 |
Complete |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 01/14/2019 |
InVitro Diagnostics |
7-178 |
Complete |
CLSI |
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
| 01/14/2019 |
InVitro Diagnostics |
7-232 |
Complete |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| 08/06/2013 |
Software/
Informatics |
13-38 |
Complete |
IEC |
80001-1 Edition 1.0 2010-10 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ANSI AAMI IEC |
80001-1:2010 |
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| 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 |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-411 |
Complete |
ASTM |
D6499-18 |
Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
| 12/19/2022 |
Nanotechnology |
18-22 |
Complete |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
| 01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2023) |
Standard Practice for Coating/Adhesive Weight Determination |
| 05/29/2024 |
Software/
Informatics |
13-137 |
Complete |
IEEE |
Std 11073-10101b-2023 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 05/29/2023 |
InVitro Diagnostics |
7-316 |
Complete |
CLSI |
NBS01 7th Edition |
Dried Blood Spot Specimen Collection for Newborn Screening |
| 10/04/2010 |
Radiology |
12-214 |
Complete |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| 07/09/2014 |
Radiology |
12-280 |
Complete |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
| 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 |
| 01/14/2019 |
Orthopedic |
11-342 |
Complete |
ASTM |
F732-17 |
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| 01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| 07/09/2014 |
ObGyn/
Gastroenterology/
Urology |
9-94 |
Complete |
ISO |
8600-4 Second Edition 2014-03-15 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-500 |
Complete |
IEC |
63045 Edition 1.0 2020-05 |
Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields |
| 05/29/2024 |
Sterility |
14-601 |
Complete |
ISO |
17665 First edition 2024-03 |
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-200 |
Complete |
ASTM |
E1061-01(2022) |
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
Complete |
ISO |
23908 First edition 2011-06-11 |
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 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 |
| 01/27/2015 |
Dental/
ENT |
4-136 |
Complete |
ASTM |
F2504-05 (Reapproved 2022) |
Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices |
| 07/09/2014 |
Dental/
ENT |
4-149 |
Complete |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
| 07/06/2020 |
Materials |
8-527 |
Complete |
ASTM |
F899-20 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| 12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 12/19/2007 |
Radiology |
12-176 |
Complete |
IEC |
61223-3-2 Second eidtion 2007-07 |
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment |
| 09/09/2008 |
InVitro Diagnostics |
7-21 |
Complete |
CLSI |
C42-A |
Erythrocyte Protoporphyrin Testing; Approved Guideline |
| 09/09/2008 |
InVitro Diagnostics |
7-136 |
Complete |
CLSI |
I/LA2-A2 (Replaces I/LA2-A) |
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition. |
| 09/09/2008 |
InVitro Diagnostics |
7-159 |
Complete |
CLSI |
H21-A5 |
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
| 09/09/2008 |
InVitro Diagnostics |
7-163 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
| 01/14/2019 |
Nanotechnology |
18-5 |
Complete |
ASTM |
E2859-11 (Reapproved 2017) |
Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy |
| 04/04/2016 |
Ophthalmic |
10-100 |
Complete |
ISO |
18259 First Edition 2014-10-01 |
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms |
| 08/21/2017 |
Dental/
ENT |
4-232 |
Complete |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 08/06/2013 |
Software/
Informatics |
13-42 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-2:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC |
TR 80001-2-2 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| 12/18/2023 |
Orthopedic |
11-407 |
Complete |
ASTM |
F3140-23 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| 08/14/2015 |
Anesthesiology |
1-105 |
Complete |
ISO |
80601-2-72 First edition 2015-04-11 |
Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| 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 |
| 04/04/2016 |
General II (ES/
EMC) |
19-17 |
Complete |
IEEE ANSI |
C63.18-2014 |
American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters |
| 12/04/2017 |
Software/
Informatics |
13-103 |
Complete |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
| 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. |
| 10/04/2010 |
Radiology |
12-215 |
Complete |
IEC |
62494-1 Edition 1.0 (2008-08) |
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| 03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
| 01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
| 07/09/2014 |
Software/
Informatics |
13-15 |
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 |
| 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 |
| 08/14/2015 |
Dental/
ENT |
4-220 |
Complete |
ANSI ASA |
S3.22-2014 (Reaffirmed 2020) |
American National Standard Specification of Hearing Aid Characteristics |
| 08/14/2015 |
Dental/
ENT |
4-184 |
Complete |
ANSI ASA |
S3.25-2009 (Reaffirmed 2024) |
American National Standard For an Occluded Ear Simulator |
| 09/09/2008 |
Dental/
ENT |
4-145 |
Complete |
ISO |
22803 First edition 2004-09-01 |
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
| 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 |
| 08/14/2015 |
Ophthalmic |
10-97 |
Complete |
ISO |
13212 Third edition 2014-09-01 |
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life |
| 08/06/2013 |
Dental/
ENT |
4-204 |
Complete |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) |
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
| 01/30/2014 |
Sterility |
14-403 |
Complete |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
| 01/30/2014 |
Sterility |
14-430 |
Complete |
ISO ASTM |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
| 01/14/2019 |
Materials |
8-487 |
Complete |
ISO ASTM |
52910-18 |
Additive manufacturing - Design - Requirements, guidelines and recommendations |
| 09/09/2008 |
Software/
Informatics |
13-19 |
Complete |
CLSI |
LIS04-A |
Standard Guide for Documentation of Clinical Laboratory Computer Systems |
| 09/09/2008 |
Software/
Informatics |
13-20 |
Complete |
CLSI |
LIS05-A |
Standand Specification for Transferring Clinical Observations Between Independent Computer Systems |
| 09/09/2008 |
Software/
Informatics |
13-21 |
Complete |
CLSI |
LIS06-A |
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems |
| 09/09/2008 |
Software/
Informatics |
13-22 |
Complete |
CLSI |
LIS07-A |
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
| 09/09/2008 |
Software/
Informatics |
13-23 |
Complete |
CLSI |
LIS08-A |
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems |
| 09/09/2008 |
Software/
Informatics |
13-24 |
Complete |
CLSI |
LIS09-A |
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
| 05/05/2010 |
InVitro Diagnostics |
7-207 |
Complete |
CLSI |
GP16-A3 (Replaces GP16-A2) |
Urinalysis; Approved Guideline - Third Edition |
| 03/14/2011 |
Radiology |
12-217 |
Complete |
IEC |
62083 Edition 2.0 2009-09 |
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| 10/04/2010 |
InVitro Diagnostics |
7-212 |
Complete |
CLSI |
EP18-A2 |
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
| 06/07/2018 |
Tissue Engineering |
15-51 |
Complete |
ASTM |
F2347-15 |
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| 06/07/2018 |
Tissue Engineering |
15-52 |
Complete |
ASTM |
F2064-17 |
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| 06/07/2018 |
Materials |
8-113 |
Complete |
ASTM |
F1147-05 (Reapproved 2017)e1 |
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| 06/27/2016 |
Materials |
8-432 |
Complete |
ISO ASTM |
52921 First Edition 2013-06-01 |
Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies. |
| 12/23/2016 |
General II (ES/
EMC) |
19-20 |
Complete |
IEEE ANSI |
C63.16-2016 (Revision of ANSI C63.16-1993) |
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment |
| 08/06/2013 |
Software/
Informatics |
13-59 |
Complete |
ISO IEC IEEE |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
| 03/16/2012 |
InVitro Diagnostics |
7-166 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
| 08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
| 08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| 01/15/2013 |
Software/
Informatics |
13-33 |
Complete |
AAMI |
TIR 36:2007 |
Validation of software for regulated processes |
| 01/15/2013 |
General Plastic Surgery/
General Hospital |
6-122 |
Complete |
ISO |
8536-5 Second edition 2004-02-01 |
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 03/16/2012 |
InVitro Diagnostics |
7-227 |
Complete |
CLSI |
M53-A (Replaces M53-P) |
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| 06/27/2016 |
Materials |
8-434 |
Complete |
ISO ASTM |
52900 First Edition 2015-12-15 |
Additive manufacturing -- General principles - Terminology |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-380 |
Complete |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-382 |
Complete |
ISO |
11608-7 First edition 2016-08-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
| 01/14/2019 |
Tissue Engineering |
15-47 |
Complete |
ISO |
22442-3 First edition 2007-12-15 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. |
| 03/16/2012 |
Anesthesiology |
1-72 |
Complete |
ISO |
10651-5 First edition 2006-02-01 |
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators |
| 08/06/2013 |
Ophthalmic |
10-78 |
Complete |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
| 12/23/2019 |
General II (ES/
EMC) |
19-13 |
Complete |
IEC |
62133 Edition 2.0 2012-12 |
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 [Including: Corrigendum 1 (2013)] |
| 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 |
| 08/06/2013 |
Sterility |
14-388 |
Complete |
ISO |
13408-7 First edition 2012-08-01 |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
| ANSI AAMI ISO |
13408-7:2012 (R2018) |
Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-356 |
Complete |
ASTM |
D5712-15(2020) |
Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
| 06/27/2016 |
Orthopedic |
11-307 |
Complete |
ASTM |
F2385-15 (Reapproved 2019) |
Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs |
| 08/21/2017 |
Dental/
ENT |
4-239 |
Complete |
ANSI AAMI |
CI86:2017 |
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting |
| 01/14/2019 |
Biocompatibility |
2-141 |
Complete |
ASTM |
F1984-99 (Reapproved 2018) |
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials |
| 07/09/2014 |
Sterility |
14-433 |
Complete |
ASTM |
F2227-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |
| 08/14/2015 |
Software/
Informatics |
13-74 |
Complete |
IEEE |
Std 11073-10424-2014 |
Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) |
| 06/15/2016 |
General I (QS/
RM) |
5-102 |
Complete |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
| 12/23/2016 |
Anesthesiology |
1-119 |
Complete |
ISO |
14408 Third edition 2016-02-15 |
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information |
| 01/30/2014 |
Materials |
8-157 |
Complete |
ISO |
9583 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
| 07/09/2014 |
Sterility |
14-437 |
Complete |
ISO ASTM |
52701 First edition 2013-11-15 (R2020) |
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
| 04/04/2016 |
Materials |
8-114 |
Complete |
ASTM |
F2255-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading |
| 08/21/2017 |
Materials |
8-195 |
Complete |
ASTM |
F2024-10 (Reapproved 2016) |
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
| 08/21/2017 |
Materials |
8-428 |
Complete |
ASTM |
F1581-08 (Reapproved 2020) |
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| 08/21/2017 |
Materials |
8-452 |
Complete |
ASTM |
F1635-16 |
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| 07/09/2014 |
Software/
Informatics |
13-65 |
Complete |
UL ANSI |
1998 Third Edition 2013 |
Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
| 08/21/2017 |
Software/
Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| 04/04/2016 |
Orthopedic |
11-299 |
Complete |
ASTM |
F2068-15 |
Standard Specification for Femoral Prostheses - Metallic Implants |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-492 |
Complete |
ASTM |
F2100-23 |
Standard Specification for Performance of Materials Used in Medical Face Masks |
| 01/14/2019 |
Software/
Informatics |
13-79 |
Complete |
IEC |
62304 Edition 1.1 2015-06 CONSOLIDATED VERSION |
Medical device software - Software life cycle processes |
| ANSI AAMI IEC |
62304:2006/A1:2016 |
Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
| 12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |
| 04/04/2016 |
Dental/
ENT |
4-222 |
Complete |
ISO |
6874 Third edition 2015-09-01 |
Dentistry - Polymer-based pit and fissure sealants |
| 03/14/2011 |
Radiology |
12-221 |
Complete |
IEC |
61223-3-4 First edition 2000-03 |
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray |
| 08/06/2013 |
Radiology |
12-211 |
Complete |
IEC |
60601-2-29 Edition 3.0 2008-06 |
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| 08/06/2013 |
Software/
Informatics |
13-62 |
Complete |
IEC |
TR 62443-3-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems |
| 04/04/2016 |
Materials |
8-401 |
Complete |
ASTM |
F2118-14 (Reapproved 2020) |
Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials |
| 12/21/2020 |
Sterility |
14-554 |
Complete |
ASTM |
F17-20 |
Standard Terminology Relating to Flexible Barrier Packaging |
| 12/23/2019 |
Materials |
8-521 |
Complete |
ASTM |
F2313-18 |
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide |
| 07/06/2020 |
Sterility |
14-539 |
Complete |
ASTM |
F2475-20 |
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| 07/06/2020 |
Materials |
8-529 |
Complete |
ASTM |
F2633-19 |
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
| 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 |
Nanotechnology |
18-11 |
Complete |
ISO |
TR 13121 First edition 2011-05-15 |
Nanotechnologies - Nanomaterial risk evaluation |
| 01/14/2019 |
Radiology |
12-322 |
Complete |
NEMA |
MS 5-2018 |
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
| 07/06/2020 |
Tissue Engineering |
15-63 |
Complete |
ASTM |
F2739-19 |
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds |
| 05/29/2024 |
Radiology |
12-354 |
Complete |
NEMA |
MS 4-2023 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 12/18/2023 |
Dental/
ENT |
4-309 |
Complete |
ISO |
6877 Third edition 2021-09 |
Dentistry - Endodontic obturating materials |
| ANSI ADA |
Standard No. 78-2021 |
Dentistry - Endodontic Obturating Materials |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-404 |
Complete |
ISO |
7886-1 Second edition 2017-05 |
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-405 |
Complete |
IEC |
80601-2-59 Edition 2.0 2017-09 |
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-406 |
Complete |
ASTM |
F1862/F1862M-17 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 09/17/2018 |
Materials |
8-476 |
Complete |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
| 04/04/2016 |
Materials |
8-415 |
Complete |
ASTM |
F2778-09 (Reapproved 2020) |
Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR) |
| 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 |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-379 |
Complete |
ISO |
7864 Fourth edition 2016-08-01 |
Sterile hypodermic needles for single use - Requirements and test methods |
| 08/14/2015 |
ObGyn/
Gastroenterology/
Urology |
9-108 |
Complete |
ISO |
8009 Second edition 2014-11-15 |
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
| 09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 01/27/2015 |
Dental/
ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2024) |
American National Standard Procedures for Testing Basic Vestibular Function |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-128 |
Complete |
ISO CIE |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 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 |
| 01/25/2013 |
Cardiovascular |
3-89 |
Complete |
ISO |
27186 First edition 2010-03-15 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| ANSI AAMI ISO |
27186:2010 |
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-272 |
Complete |
ASTM |
F2062-00 (Reapproved 2018) |
Standard Specification for Square Drive Interconnections on Surgical Instruments |
| 08/14/2015 |
Sterility |
14-463 |
Complete |
ISO ASTM |
51608 Second edition 2015-03-15 |
Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV |
| 12/04/2017 |
Software/
Informatics |
13-98 |
Complete |
ISO IEC |
646 Third edition 1991-12-15 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
| INCITS ISO IEC |
646:1991 (R2018) |
Information technology - ISO 7-bit coded character set for information interchange |
| 07/26/2016 |
Biocompatibility |
2-227 |
Complete |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-120 |
Complete |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
| 09/17/2018 |
Physical Medicine |
16-202 |
Complete |
ISO |
7176-2 Third edition 2017-10 |
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| 09/17/2018 |
Physical Medicine |
16-203 |
Complete |
ASME |
A18.1-2017 |
Safety Standard for Platform Lifts and Stairway Chairlifts |
| 09/17/2018 |
Cardiovascular |
3-156 |
Complete |
ISO |
14708-1 Second edition 2014-08-15 |
Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ANSI AAMI ISO |
14708-1:2014 |
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| 09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 09/17/2018 |
Materials |
8-468 |
Complete |
ASTM |
F2459-18 |
Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis |
| 09/17/2018 |
Materials |
8-380 |
Complete |
ASTM |
F1160-14 (Reapproved 2017)e1 |
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| 05/29/2024 |
Software/
Informatics |
13-139 |
Complete |
IEEE |
Std 11073-10206-2022 |
Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model |
| 05/29/2024 |
Anesthesiology |
1-172 |
Complete |
ISO |
11712 Second edition 2023-11 |
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| 01/30/2014 |
Neurology |
17-12 |
Complete |
ISO |
7197 Third edition 2006-06-01 |
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
| 09/17/2018 |
Dental/
ENT |
4-247 |
Complete |
ISO |
28319 Second edition 2018-04 |
Dentistry - Laser welding and filler materials |
| ANSI ADA |
Standard No. 84-2020 |
Laser Welding and Filler Materials in Dentistry |
| 04/04/2016 |
Orthopedic |
11-304 |
Complete |
ASTM |
F3107-14 (Reapproved 2023) |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
| 07/06/2020 |
Orthopedic |
11-369 |
Complete |
ASTM |
F3292-19 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 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) |
| 05/29/2024 |
Cardiovascular |
3-192 |
Complete |
ISO |
22679 First edition 2021-11 |
Cardiovascular implants - Transcatheter cardiac occluders
|
| 05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
| 07/09/2014 |
General II (ES/
EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
| 12/04/2017 |
Software/
Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
| 12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
| 08/14/2015 |
Sterility |
14-464 |
Complete |
ISO ASTM |
51649 Third edition 2015-03-15 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV |
| 01/14/2019 |
Anesthesiology |
1-138 |
Complete |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 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 |
| 01/14/2019 |
Cardiovascular |
3-157 |
Complete |
ANSI AAMI ISO |
25539-1: 2017 |
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses |
| 01/14/2019 |
InVitro Diagnostics |
7-286 |
Complete |
CLSI |
M11 9th Edition |
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-68 |
Complete |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
| 03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 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 |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-306 |
Complete |
ASTM |
F1671/F1671M-13 |
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 |
| 07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
| 07/15/2019 |
Anesthesiology |
1-116 |
Complete |
ISO |
5360 Fourth edition 2016-02-15 |
Anaesthetic vaporizers - Agent specific filling systems |
| 07/15/2019 |
Anesthesiology |
1-122 |
Complete |
ISO |
5364 Fifth edition 2016-09-01 |
Anaesthetic and respiratory equipment-Oropharyngeal airways |
| 06/07/2018 |
Tissue Engineering |
15-54 |
Complete |
ASTM |
F3207-17 |
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model |
| 06/07/2018 |
Biocompatibility |
2-250 |
Complete |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
| 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 |
| 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 |
| 12/23/2016 |
Biocompatibility |
2-94 |
Complete |
ASTM |
F981-04 (Reapproved 2016) |
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
| 12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
| 08/21/2017 |
Materials |
8-226 |
Complete |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
| 12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
| 08/21/2017 |
Materials |
8-459 |
Complete |
SAE |
AMS2750 Rev. E 2012-07 |
Pyrometry |
| 08/21/2017 |
Biocompatibility |
2-155 |
Complete |
ASTM |
F2147-01 (Reapproved 2016) |
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens |
| 09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
| 12/21/2020 |
Dental/
ENT |
4-265 |
Complete |
ISO |
10271 Third edition 2020-08 |
Dentistry - Corrosion test methods for metallic materials |
| ANSI ADA |
Standard No. 97-2020 |
Corrosion Test Methods for Metallic Materials |
| 09/17/2018 |
Sterility |
14-294 |
Complete |
ANSI AAMI |
ST40:2004/(R)2018 |
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities |
| 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 |
| 12/21/2020 |
Dental/
ENT |
4-264 |
Complete |
ISO |
9333 Second edition 2006-07 |
Dentistry - Brazing materials |
| ANSI ADA |
Standard No. 88-2019 |
Dental Brazing Alloys |
| 05/29/2023 |
Dental/
ENT |
4-304 |
Complete |
ISO |
21606 Second edition 2022-08 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 12/21/2020 |
Dental/
ENT |
4-267 |
Complete |
ISO |
21606 First edition 2007-06 |
Dentistry - Elastomeric auxiliaries for use in orthodontics |
| ANSI ADA |
Standard No. 105-2010 (R2015) |
Orthodontic Elastomeric Materials |
| 12/18/2023 |
Biocompatibility |
2-302 |
Complete |
ASTM |
F981-23 |
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-498 |
Complete |
ISO |
10555-4 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
| 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 |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
| 08/21/2017 |
General I (QS/
RM) |
5-107 |
Complete |
IEC |
80369-5: Edition 1.0 2016-03 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] |
| ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| 06/07/2018 |
Nanotechnology |
18-10 |
Complete |
ISO |
29701 First edition 2010-09-15 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test. |
| 07/09/2014 |
Materials |
8-378 |
Complete |
ASTM |
D792-13 |
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| 07/09/2014 |
Materials |
8-379 |
Complete |
ISO |
11542-2 First edition 1998-11-15 |
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)] |
| 08/21/2017 |
Orthopedic |
11-280 |
Complete |
ASTM |
F2624-12 (Reapproved 2020) |
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
| 06/27/2016 |
Materials |
8-430 |
Complete |
ISO |
13356:2015 Third Edition 2015-09-15 |
Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
| 08/14/2015 |
Software/
Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
| 01/30/2014 |
Software/
Informatics |
13-63 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
| IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
| 07/06/2020 |
Orthopedic |
11-363 |
Complete |
ASTM |
F897-19 |
Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| 12/04/2017 |
Software/
Informatics |
13-99 |
Complete |
ISO IEC |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| 12/04/2017 |
Software/
Informatics |
13-101 |
Complete |
ISO IEC |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
| 05/29/2024 |
Materials |
8-614 |
Complete |
ASTM |
F3456-22 |
Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials |
| 05/29/2024 |
Materials |
8-615 |
Complete |
ISO ASTM |
52926-1 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-407 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 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 |
Cardiovascular |
3-150 |
Complete |
ISO |
7199 Third edition 2016-11-15 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| ANSI AAMI ISO |
7199:2016 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| 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 |
| 12/23/2016 |
Orthopedic |
11-314 |
Complete |
ISO |
14242-2 Second edition 2016-09-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/23/2016 |
Orthopedic |
11-317 |
Complete |
ASTM |
F3129-16 |
Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses |
| 08/21/2017 |
Anesthesiology |
1-124 |
Complete |
ISO |
8835-7 First edition 2011-11-01 |
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| 08/21/2017 |
Software/
Informatics |
13-97 |
Complete |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
| 01/14/2019 |
Anesthesiology |
1-120 |
Complete |
ISO |
18190 First edition 2016-11-01 |
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-410 |
Complete |
ISO |
8536-6 Third edition 2016-12-01 |
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles |
| 08/21/2017 |
InVitro Diagnostics |
7-273 |
Complete |
CLSI |
M58 1st Edition |
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
| 08/21/2017 |
Software/
Informatics |
13-88 |
Complete |
ISO IEEE |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
| 06/07/2018 |
Anesthesiology |
1-129 |
Complete |
ISO |
5359 Fourth edition 2014-10-01 |
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] |
| 12/23/2016 |
Orthopedic |
11-319 |
Complete |
ISO |
7206-12 First edition 2016-10-01 |
Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells |
| 08/21/2017 |
Orthopedic |
11-242 |
Complete |
ASTM |
F1839-08 (Reapproved 2016) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 01/30/2014 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| 07/15/2019 |
Tissue Engineering |
15-58 |
Complete |
ASTM |
F2103-18 |
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications |
| 07/06/2020 |
Software/
Informatics |
13-115 |
Complete |
ISO IEC IEEE |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
| 07/15/2019 |
Biocompatibility |
2-263 |
Complete |
ASTM |
F1903-18 |
Standard Practice for Testing for Cellular Responses to Particles in vitro |
| 07/06/2020 |
Materials |
8-531 |
Complete |
ASTM |
F3321-19 |
Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| 08/21/2017 |
General II (ES/
EMC) |
19-25 |
Complete |
IEC |
62485-1 Edition 1.0 2015-04 |
Safety requirements for secondary batteries and battery installations - Part 1: General safety information. |
| 08/21/2017 |
General II (ES/
EMC) |
19-27 |
Complete |
IEC |
62485-3 Edition 2.0 2014-07 |
Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries |
| 04/04/2016 |
Nanotechnology |
18-1 |
Complete |
ASTM |
E2490-09 (Reapproved 2021) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) |
| 01/14/2019 |
Materials |
8-489 |
Complete |
ASTM |
F3302-18 |
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
| 12/23/2016 |
Biocompatibility |
2-189 |
Complete |
ASTM |
F895-11 (Reapproved 2016) |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
| 01/14/2019 |
Orthopedic |
11-272 |
Complete |
ASTM |
F1714-96 (Reapproved 2018) |
Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices |
| 07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 12/23/2019 |
Radiology |
12-309 |
Complete |
IEC |
60601-2-28 Edition 3.0 2017-06 |
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| 12/23/2019 |
Radiology |
12-327 |
Complete |
ISO |
11551 Third eidtion 2019-10 |
Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components |
| 12/23/2019 |
General II (ES/
EMC) |
19-33 |
Complete |
IEC |
62133-2 Edition1.0 2017-02 |
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 |
Tissue Engineering |
15-62 |
Complete |
ASTM |
F2602-18 |
Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS) |
| 07/06/2020 |
Dental/
ENT |
4-263 |
Complete |
ISO |
9693 Third edition 2019-10 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA |
Standard No. 38-2020 |
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| 12/23/2019 |
General II (ES/
EMC) |
19-32 |
Complete |
IEC |
62133-1 Edition 1.0 2017-02 |
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 1: Nickel systems |
| 01/14/2019 |
Orthopedic |
11-344 |
Complete |
ASTM |
F2580-18 |
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| 12/23/2016 |
Software/
Informatics |
13-86 |
Complete |
ISO IEC |
15026-1 First edition 2013-11-01 |
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
| 08/21/2017 |
Software/
Informatics |
13-89 |
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) |
| 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). |
| 07/09/2014 |
Anesthesiology |
1-100 |
Complete |
CGA |
V-1:2013 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-501 |
Complete |
ISO |
15747 Third edition 2018-09 |
Plastic containers for intravenous injections |
| 01/27/2015 |
Software/
Informatics |
13-70 |
Complete |
ANSI AAMI IEC |
TIR80001-2-5:2014 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
| IEC |
TR 80001-2-5 Edition 1.0 2014-12 |
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 08/14/2015 |
InVitro Diagnostics |
7-257 |
Complete |
CLSI |
M56-A |
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
| 01/30/2014 |
Physical Medicine |
16-164 |
Complete |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
| 09/17/2018 |
Ophthalmic |
10-84 |
Complete |
ANSI |
Z80.11-2012 (R2022) |
American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping |
| 09/17/2018 |
Ophthalmic |
10-113 |
Complete |
ANSI |
Z80.30-2018 (R2023) |
American National Standard for Ophthalmics - Toric Intraocular Lenses |
| 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 |
| 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 |
| 08/14/2015 |
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 |
| 09/17/2018 |
Materials |
8-465 |
Complete |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
| 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 |
| 07/09/2014 |
Sterility |
14-256 |
Complete |
ASTM |
F2095-07 (Reapproved 2021) |
Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates |
| 07/09/2014 |
Sterility |
14-435 |
Complete |
ASTM |
F2251-13 (Reapproved 2023) |
Standard Test Method for Thickness Measurement of Flexible Packaging Material |
| 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. |
| 01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
| 09/09/2008 |
ObGyn/
Gastroenterology/
Urology |
9-7 |
Complete |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| 09/09/2008 |
Sterility |
14-142 |
Complete |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
| 09/08/2009 |
Software/
Informatics |
13-29 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems |
| 03/18/2009 |
InVitro Diagnostics |
7-170 |
Complete |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
| 03/18/2009 |
InVitro Diagnostics |
7-176 |
Complete |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-180 |
Complete |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-182 |
Complete |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| 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 |
Materials |
8-406 |
Complete |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 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 |
| 04/04/2016 |
Materials |
8-107 |
Complete |
ASTM |
F746-04 (Reapproved 2014) |
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials |
| 08/06/2013 |
Software/
Informatics |
13-37 |
Complete |
CLSI |
AUTO7-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
| 08/06/2013 |
Dental/
ENT |
4-167 |
Complete |
ANSI ASA |
S3.21-2004 (Reaffirmed 2023) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
| 08/06/2013 |
ObGyn/
Gastroenterology/
Urology |
9-31 |
Complete |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
| 08/14/2015 |
Orthopedic |
11-290 |
Complete |
ISO |
8828 Second edition 2014-11-15 |
Implants for surgery -- Guidance on care and handling of orthopaedic implants |
| 01/30/2014 |
Dental/
ENT |
4-153 |
Complete |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 01/30/2014 |
Dental/
ENT |
4-180 |
Complete |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 08/06/2013 |
Software/
Informatics |
13-60 |
Complete |
IEC |
TS 62443-1-1 Edition 1.0 2009-07 |
Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models |
| 07/15/2019 |
General I (QS/
RM) |
5-123 |
Complete |
ISO |
80369-3 First Edition 2016-07-01 |
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. |
| 12/21/2020 |
Dental/
ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
| 05/30/2022 |
Materials |
8-593 |
Complete |
ISO |
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
Implants for surgery - Hydroxyapatite - Part 6: Powders |
| 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 |
| 03/16/2012 |
Radiology |
12-143 |
Complete |
ISO |
15367-2 First edition 2005-03-15 |
Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors |
| 03/16/2012 |
Radiology |
12-248 |
Complete |
ISO |
21254-3 First edition 2011-07-15 |
Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities |
| 03/16/2012 |
Radiology |
12-174 |
Complete |
ISO |
13697 First edition 2006-05-15 |
Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components |
| 03/16/2012 |
Radiology |
12-175 |
Complete |
ISO |
24013 First edition 2006-11-15 |
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
| 08/20/2012 |
Software/
Informatics |
13-31 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
| 01/15/2013 |
Software/
Informatics |
13-34 |
Complete |
ANSI AAMI IEC |
TIR80002-1:2009 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| IEC |
TR 80002-1 Edition 1.0 2009-09 |
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| 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 |
| 12/23/2019 |
Cardiovascular |
3-161 |
Complete |
ISO |
14117 Second edition 2019-09 |
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-423 |
Complete |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 01/30/2014 |
Dental/
ENT |
4-199 |
Complete |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
| 01/30/2014 |
Physical Medicine |
16-27 |
Complete |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
| 01/30/2014 |
Physical Medicine |
16-163 |
Complete |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-216 |
Complete |
ISO |
8536-7 Third edition 2009-01-15 |
Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
| 01/30/2014 |
Cardiovascular |
3-63 |
Complete |
ISO |
11318:2002 |
Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements. |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-240 |
Complete |
ISO |
8536-3 Third edition 2009-06-01 |
Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-276 |
Complete |
ISO |
8536-1 Fourth edition 2011-09-01 |
Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-115 |
Complete |
ISO |
29943-1 First edition 2017-07. |
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-473 |
Complete |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
| 08/06/2013 |
Dental/
ENT |
4-90 |
Complete |
ANSI ASA |
S3.39:1987 (Reaffirmed 2020) |
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-117 |
Complete |
ASTM |
F2172-02 (Reapproved 2011) |
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-303 |
Complete |
ISO |
10555-5 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-305 |
Complete |
ISO |
10555-3 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters |
| 01/30/2014 |
Orthopedic |
11-232 |
Complete |
ISO |
7207-1 Third edition 2007-02-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
| 09/21/2016 |
Ophthalmic |
10-101 |
Complete |
ISO |
18189 First edition 2016-06-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
| 08/21/2017 |
Ophthalmic |
10-103 |
Complete |
ANSI |
Z80.18-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology |
| 08/21/2017 |
Software/
Informatics |
13-95 |
Complete |
ISO IEEE |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
| 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 |
| 08/21/2017 |
General II (ES/
EMC) |
19-26 |
Complete |
IEC |
62485-2 Edition 1.0 2010-06 |
Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries. |
| 08/21/2017 |
General II (ES/
EMC) |
19-28 |
Complete |
IEC |
62485-4 Edition 1.0 2015-01 |
Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances |
| 08/21/2017 |
Radiology |
12-306 |
Complete |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
| 05/29/2024 |
Anesthesiology |
1-178 |
Complete |
ISO |
23747 Second edition 2015-08 |
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-322 |
Complete |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 04/04/2016 |
Materials |
8-405 |
Complete |
ISO |
5832-4 Third edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy |
| 12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| 12/23/2016 |
Materials |
8-368 |
Complete |
ASTM |
F2625-10 (Reapproved 2016) |
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry |
| 01/30/2014 |
Sterility |
14-395 |
Complete |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
| 01/30/2014 |
Sterility |
14-397 |
Complete |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
| 01/30/2014 |
Sterility |
14-398 |
Complete |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
| 01/30/2014 |
Sterility |
14-399 |
Complete |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
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