|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 12/23/2016 |
Materials |
8-444 |
ISO |
17296-2 First edition 2015-01-15 |
Additive manufacturing - General principles - Part 2: Overview of process categories and feedstock |
| 08/14/2015 |
Dental/
ENT |
4-130 |
ANSI ADA |
Standard No. 17-1983 (R2014) |
Denture Base Temporary Relining Resins |
| 07/09/2014 |
Anesthesiology |
1-99 |
ASTM |
G175-13 |
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| 07/09/2014 |
Anesthesiology |
1-101 |
CGA |
C-9:2013 |
Standard Color Marking of Compressed Gas Containers for Medical Use |
| 07/09/2014 |
Dental/
ENT |
4-165 |
ANSI ASA |
S3.13-1987 (Reaffirmed 2020) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-88 |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-472 |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-473 |
USP-NF |
M80190_04_01 |
Absorbable Surgical Suture |
| 12/20/2021 |
Orthopedic |
11-387 |
ASTM |
F1781-21 |
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 12/20/2021 |
Materials |
8-569 |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 07/26/2016 |
Biocompatibility |
2-222 |
ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| 07/26/2016 |
Biocompatibility |
2-227 |
ASTM |
F1983-14 |
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
| 01/14/2019 |
Dental/
ENT |
4-248 |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-129 |
ISO |
594-2 Second edition 1998-09-01 |
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-471 |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
| 12/20/2021 |
Sterility |
14-571 |
ISO |
11138-8 First edition 2021-07 |
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator |
| 12/23/2016 |
InVitro Diagnostics |
7-267 |
CLSI |
C24 4th Edition (Replaces C24-A3) |
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
| 08/06/2013 |
Materials |
8-336 |
ASTM |
F562-13 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| 05/30/2022 |
Materials |
8-584 |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 08/21/2017 |
Software/
Informatics |
13-95 |
IEEE ISO |
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 |
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 |
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 |
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 |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
| 08/21/2017 |
InVitro Diagnostics |
7-270 |
CLSI |
I/LA-20 3rd Edition (Replaces I/LA20-A3) |
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities |
| 04/04/2016 |
Materials |
8-136 |
ASTM |
F2458-05 (Reapproved 2015) |
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants |
| 08/21/2017 |
Sterility |
14-501 |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
| 09/17/2018 |
Materials |
8-412 |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 09/09/2008 |
Sterility |
14-239 |
ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
| ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
| 04/04/2016 |
Materials |
8-404 |
ASTM |
E647-15 |
Standard Test Method for Measurement of Fatigue Crack Growth Rates |
| 04/04/2016 |
Materials |
8-406 |
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 |
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 |
CLSI |
MM03-3rd Edition (Replaces MM03-A2) |
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
| 04/04/2016 |
Materials |
8-107 |
ASTM |
F746-04 (Reapproved 2014) |
Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials |
| 04/04/2016 |
Materials |
8-115 |
ASTM |
F2256-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading |
| 08/21/2017 |
Sterility |
14-502 |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
| ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
| 12/04/2017 |
Software/
Informatics |
13-100 |
IEC ISO |
15459-4 Third edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages |
| 03/16/2012 |
Sterility |
14-332 |
ANSI AAMI ISO |
11140-5:2007/(R)2012 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |
| ISO |
11140-5 Second edition 2007-03-15 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| 06/07/2018 |
Radiology |
12-316 |
IEC |
62359 Edition 2.1 2017-09 CONSOLIDATED VERSION |
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| 06/07/2018 |
Nanotechnology |
18-9 |
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)]. |
| 06/07/2018 |
Dental/
ENT |
4-240 |
ANSI ADA |
Standard No. 128-2015 |
Hydrocolloid Impression Materials |
| ISO |
21563 First edition 2013-08-15 |
Dentistry - Hydrocolloid impression materials |
| 01/30/2014 |
Dental/
ENT |
4-151 |
ANSI ADA |
Standard No. 15-2008 (R2013) |
Artificial Teeth for Dental Prostheses |
| ISO |
22112 First edition 2005-11-01 |
Dentistry - Artificial teeth for dental prostheses |
| 09/17/2018 |
Orthopedic |
11-310 |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 09/17/2018 |
Orthopedic |
11-334 |
ASTM |
F1829-17 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 12/23/2019 |
Physical Medicine |
16-215 |
ANSI RESNA |
WC-2:2019 Section 9 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs |
| 08/21/2017 |
Materials |
8-447 |
ISO |
5832-3 Fourth edition 2016-10-15 |
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 12/20/2021 |
Materials |
8-572 |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 12/19/2022 |
Anesthesiology |
1-157 |
ISO |
10079-1 Fourth edition 2022-03 |
Medical suction equipment - Part 1: Electrically powered suction equipment |
| 07/15/2019 |
Anesthesiology |
1-142 |
ISO |
10079-1 Third Edition 2015-11-01 |
Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)] |
| 05/30/2022 |
Materials |
8-589 |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 12/19/2022 |
Biocompatibility |
2-297 |
ASTM |
F763-22 |
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
| 01/30/2014 |
Materials |
8-362 |
ASTM |
F2989-13 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 01/30/2014 |
Materials |
8-344 |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| 12/20/2021 |
Materials |
8-573 |
ASTM |
F2695-12(2020) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
IEC |
/TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice |
| 12/19/2022 |
General I (QS/
RM) |
5-136 |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 04/04/2016 |
General I (QS/
RM) |
5-99 |
ASTM |
D4332-14 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 12/19/2022 |
General II (ES/
EMC) |
19-48 |
ANSI IEEE |
USEMCSC C63.27-2021 |
American National Standard for Evaluation of Wireless Coexistence |
| 08/21/2017 |
General II (ES/
EMC) |
19-29 |
ANSI IEEE |
C63.27-2017 |
American National Standard for Evaluation of Wireless Coexistence |
| 12/19/2022 |
InVitro Diagnostics |
7-313 |
CLSI |
EP27 2nd Edition |
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-142 |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| 09/17/2018 |
Materials |
8-471 |
ASTM |
F1925-17 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 01/14/2019 |
General II (ES/
EMC) |
19-34 |
IEC |
61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION |
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] |
| 12/19/2022 |
Nanotechnology |
18-21 |
ISO |
/TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
| 01/30/2014 |
Materials |
8-347 |
ASTM |
F2146-13 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 12/19/2022 |
Orthopedic |
11-395 |
ASTM |
F1814-22 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| 06/27/2016 |
Orthopedic |
11-306 |
ASTM |
F1814-15 |
Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| 12/19/2022 |
Orthopedic |
11-396 |
ISO |
7206-13 First edition 2016-07-01 [Including AMD1:2022] |
Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)] |
| 05/30/2022 |
Materials |
8-585 |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
| 01/30/2014 |
Materials |
8-354 |
ASTM |
F1377-13 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| 05/30/2022 |
Materials |
8-586 |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-570 |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 05/30/2022 |
Materials |
8-592 |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Cardiovascular |
3-182 |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
| 01/30/2014 |
Orthopedic |
11-83 |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| 01/27/2015 |
Dental/
ENT |
4-219 |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
| 03/31/2006 |
Radiology |
12-136 |
ISO |
9236-1 Second edition 2004-02-01 |
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient |
| 11/08/2005 |
Radiology |
12-6 |
IEC |
60806 First edition 1984-01 |
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis |
| 08/02/2011 |
Ophthalmic |
10-66 |
ISO |
10936-2 Second edition 2010-01-15 |
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
| 01/30/2014 |
Sterility |
14-429 |
ASTM ISO |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
| 09/17/2018 |
General II (ES/
EMC) |
19-30 |
AIM |
Standard 7351731 Rev. 2.00 2017-02-23 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
| 12/20/2021 |
Orthopedic |
11-392 |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
| 12/19/2022 |
General I (QS/
RM) |
5-139 |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 07/15/2019 |
Software/
Informatics |
13-109 |
AAMI ANSI UL |
2800-1:2019 |
Standard for Safety for Medical Device Interoperability |
| 12/20/2021 |
Orthopedic |
11-389 |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 12/19/2022 |
Radiology |
12-347 |
IEC |
60601-2-33 Edition 4.0 2022-08 |
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| 01/14/2019 |
InVitro Diagnostics |
7-285 |
CLSI |
M48-A 2nd Edition |
Laboratory Detection and Identification of Mycobacteria |
| 12/19/2022 |
General I (QS/
RM) |
5-141 |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 12/19/2022 |
Radiology |
12-346 |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 12/20/2021 |
InVitro Diagnostics |
7-310 |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 12/20/2021 |
Physical Medicine |
16-232 |
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 |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 12/20/2021 |
Software/
Informatics |
13-120 |
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 |
| 12/20/2021 |
Materials |
8-563 |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 12/23/2019 |
Radiology |
12-317 |
IEC |
60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 12/19/2022 |
Radiology |
12-349 |
NEMA |
PS 3.1 - 3.20 2022d |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-128 |
CIE ISO |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 05/30/2022 |
Materials |
8-590 |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
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