|
|
|
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)
|
| 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 |
| 01/30/2014 |
Sterility |
14-400 |
Complete |
ASTM |
F2203-13 (Reapproved 2022) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2022) |
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 |
| 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) |
| 07/09/2014 |
Radiology |
12-282 |
Complete |
ISO |
12609-1 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
| 05/26/2025 |
Radiology |
12-379 |
Complete |
IEC |
62127-2 Edition 2.0 2025-01 |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 05/26/2025 |
Radiology |
12-380 |
Complete |
IEC |
60601-2-37 Edition 3.0 2024-07 |
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| 01/14/2019 |
Nanotechnology |
18-6 |
Complete |
ASTM |
E2865-12 (Reapproved 2022) |
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials |
| 12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 06/27/2016 |
Dental/
ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 01/30/2014 |
Physical Medicine |
16-167 |
Complete |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
| 01/30/2014 |
Radiology |
12-262 |
Complete |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
| 07/09/2014 |
InVitro Diagnostics |
7-48 |
Complete |
CLSI |
C60-A |
Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline |
| 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 |
| 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 |
| ANSI AAMI ISO |
7198:2016 |
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches |
| 12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 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 |
| 08/06/2013 |
Orthopedic |
11-254 |
Complete |
ISO |
14630 Fourth edition 2012-12-01 |
Non-active surgical implants -- General requirements |
| 12/23/2019 |
Physical Medicine |
16-227 |
Complete |
RESNA |
WC-4:2017 Section 18 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles. |
| 12/23/2019 |
Physical Medicine |
16-229 |
Complete |
RESNA ANSI |
WC-4:2017 Section 20 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 20: Seating systems for use in motor vehicles |
| 12/21/2020 |
Sterility |
14-550 |
Complete |
ANSI AAMI |
ST67:2019 |
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
| 01/14/2019 |
Nanotechnology |
18-5 |
Complete |
ASTM |
E2859-11 (Reapproved 2017) |
Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy |
| 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 |
| 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 |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 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. |
| 06/07/2021 |
Orthopedic |
11-378 |
Complete |
ASTM |
F2502-17 |
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| 12/22/2025 |
Orthopedic |
11-439 |
Complete |
ASTM |
F3437-23 |
Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 06/07/2021 |
Orthopedic |
11-383 |
Complete |
ASTM |
F3143-20 |
Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
| 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 |
| 01/27/2015 |
Radiology |
12-286 |
Complete |
NEMA |
XR 27 Amendment 1-2013 |
X-ray equipment for interventional procedures - User Quality Control Mode |
| 09/17/2018 |
Materials |
8-478 |
Complete |
ASTM |
F1089-18 |
Standard Test Method for Corrosion of Surgical Instruments |
| 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 |
| 12/20/2021 |
Nanotechnology |
18-19 |
Complete |
ISO |
19749 First edition 2021-07 |
Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy |
| 01/14/2019 |
Cardiovascular |
3-66 |
Complete |
ASTM |
F2081-06 (Reapproved 2017) |
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents |
| 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 |
| 05/25/2026 |
Orthopedic |
11-445 |
Complete |
ASTM |
F2009-25 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
| 05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 06/07/2021 |
Radiology |
12-339 |
Complete |
IEC |
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| 01/14/2019 |
Dental/
ENT |
4-250 |
Complete |
ISO |
7494-1 Third edition 2018-06 |
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements |
| 01/14/2019 |
Dental/
ENT |
4-252 |
Complete |
ISO |
10650 Second edition 2018-08 |
Dentistry - Powered polymerization activators |
| ANSI ADA |
Standard No. 48-2020 |
Curing Lights (Powered Polymerization Activators) |
| 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 |
| 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 |
| 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 |
| 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 |
| 05/26/2025 |
Dental/
ENT |
4-340 |
Complete |
ANSI ADA |
Standard No. 46-2016 |
Dental Patient Chair |
| 08/14/2015 |
Radiology |
12-291 |
Complete |
IEC |
62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 12/22/2025 |
Anesthesiology |
1-197 |
Complete |
ISO |
17510 Second Edition 2025-11 |
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| 12/21/2020 |
Sterility |
14-551 |
Complete |
ISO |
14160 Third edition 2020-09 |
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 09/09/2008 |
Sterility |
14-239 |
Complete |
ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
| ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
| 06/07/2018 |
Neurology |
17-15 |
Complete |
ISO |
14708-3 Second edition 2017-04 |
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 (Reapproved 2023) |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 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)]. |
| 01/14/2019 |
Nanotechnology |
18-7 |
Complete |
ASTM |
E2834-12 (Reapproved 2022) |
Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA) |
| 05/26/2025 |
Radiology |
12-367 |
Complete |
ISO |
13695 Second edition 2024-11 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 12/23/2024 |
Sterility |
14-609 |
Complete |
AAMI |
TIR17:2024 |
Compatibility of materials subjected to sterilization |
| 12/23/2019 |
Physical Medicine |
16-226 |
Complete |
RESNA ANSI |
WC-4:2017 Section 10 |
American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers. |
| 07/15/2019 |
Materials |
8-513 |
Complete |
ISO |
20160 First edition 2006-05-01 |
Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-116 |
Complete |
ISO |
29943-2 First edition 2017-07 |
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports. |
| 06/07/2018 |
Dental/
ENT |
4-241 |
Complete |
ISO |
7491 Second edition 2000-09-01 |
Dental materials - Determination of colour stability |
| ANSI ADA |
Standard No. 80-2001 (R2020) |
Dental Materials-Determination of Color Stability |
| 09/17/2018 |
Biocompatibility |
2-255 |
Complete |
ISO |
10993-11 Third edition 2017-09 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| ANSI AAMI ISO |
10993-11: 2017 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| 09/17/2018 |
Materials |
8-465 |
Complete |
ISO |
5832-2 Fourth edition 2018-03 |
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium |
| 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 |
| 12/20/2021 |
Nanotechnology |
18-20 |
Complete |
ASTM |
E3275-21 |
Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis |
| 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 |
| 03/16/2012 |
Radiology |
12-115 |
Complete |
ISO |
13695:2004 |
Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers |
| 05/26/2025 |
InVitro Diagnostics |
7-337 |
Complete |
CLSI |
AUTO08-A |
Managing and Validating Laboratory Information Systems; Approved Guideline |
| 07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
| 12/20/2021 |
Materials |
8-574 |
Complete |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 07/15/2019 |
General II (ES/
EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
| 01/14/2019 |
Software/
Informatics |
13-105 |
Complete |
ANSI AAMI |
SW91:2018 |
Classification of defects in health software |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 12/21/2020 |
Ophthalmic |
10-121 |
Complete |
ISO |
16672 Third edition 2020-06 |
Ophthalmic implants - Ocular endotamponades |
| 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 |
| 06/15/2016 |
Cardiovascular |
3-132 |
Complete |
ISO |
27185 First edition 2012-02-15 |
Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements |
| ANSI AAMI ISO |
27185:2012 |
Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements |
| 06/07/2018 |
Materials |
8-337 |
Complete |
ASTM |
F621-12 (Reapproved 2017) |
Standard Specification for Stainless Steel Forgings for Surgical Implants |
| 12/23/2016 |
Biocompatibility |
2-245 |
Complete |
ISO |
10993-5 Third edition 2009-06-01 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ANSI AAMI ISO |
10993-5:2009/(R)2014 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-147 |
Complete |
ASTM |
D6978-05(2023) |
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 12/23/2019 |
Orthopedic |
11-362 |
Complete |
ISO |
22622 First edition 2019-07 |
Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test |
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