|
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)
|
04/04/2016 |
Materials |
8-403 |
Complete |
ASTM |
D638-14 |
Standard Test Method for Tensile Properties of Plastics |
08/21/2017 |
Materials |
8-457 |
Complete |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
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)] |
07/15/2019 |
Physical Medicine |
16-206 |
Complete |
ISO |
7176 - 30 First edition 2018-12 |
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements |
12/21/2020 |
Physical Medicine |
16-230 |
Complete |
RESNA ANSI |
WC-2:2019 Section 25 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs |
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 |
Neurology |
17-16 |
Complete |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
06/07/2018 |
General Plastic Surgery/ General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
08/20/2012 |
Cardiovascular |
3-103 |
Complete |
ISO |
25539-3 First edition 2011-12-01 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
ANSI AAMI ISO |
25539-3:2011 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
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 |
06/07/2018 |
Materials |
8-356 |
Complete |
ASTM |
F67-13 (Reapproved 2017) |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
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 |
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 |
09/17/2018 |
Ophthalmic |
10-112 |
Complete |
ISO |
11986 Third edition 2017-11 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release |
09/17/2018 |
Anesthesiology |
1-140 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-123 |
Complete |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-488 |
Complete |
ASTM |
F1671/F1671M-22 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System |
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 |
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 |
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 |
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) |
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. |
12/18/2023 |
Radiology |
12-352 |
Complete |
NEMA |
PS 3.1 - 3.20 2023e |
Digital Imaging and Communications in Medicine (DICOM) Set |
01/14/2019 |
Tissue Engineering |
15-56 |
Complete |
ASTM |
F3224-17 |
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging |
08/21/2017 |
Biocompatibility |
2-247 |
Complete |
ISO |
10993-6 Third edition 2016-12-01 |
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |
01/30/2014 |
Dental/ ENT |
4-151 |
Complete |
ISO |
22112 First edition 2005-11-01 |
Dentistry - Artificial teeth for dental prostheses |
ANSI ADA |
Standard No. 15-2008 (R2013) |
Artificial Teeth for Dental Prostheses |
01/30/2014 |
Dental/ ENT |
4-188 |
Complete |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-149 |
Complete |
IEC |
60601-2-39 Edition 3.0 2018-04 |
Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
|
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 |
Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
01/27/2015 |
Dental/ ENT |
4-218 |
Complete |
ISO |
27020 First edition 2010-12-15 |
Dentistry - Brackets and tubes for use in orthodontics |
ANSI ADA |
Standard No.100-2012 |
Orthodontic Brackets and Tubes |
12/23/2019 |
Radiology |
12-329 |
Complete |
IEC |
60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
05/29/2023 |
Biocompatibility |
2-301 |
Complete |
ASTM |
F1983-23 |
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
08/06/2013 |
Software/ Informatics |
13-61 |
Complete |
IEC |
62443-2-1 Edition 1.0 2010-11 |
Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program |
01/14/2019 |
Anesthesiology |
1-117 |
Complete |
ISO |
5366 First edition 2016-10-01 |
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
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 |
12/21/2020 |
Tissue Engineering |
15-65 |
Complete |
ISO |
22442-2 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
06/07/2021 |
Tissue Engineering |
15-66 |
Complete |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
05/29/2023 |
Radiology |
12-350 |
Complete |
IEC |
60806 Edition 2.0 2022-11 |
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
05/29/2023 |
Sterility |
14-588 |
Complete |
AAMI |
TIR17:2017/(R)2020 |
Compatibility of materials subjected to sterilization |
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 |
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 |
12/18/2023 |
ObGyn/ Gastroenterology/ Urology |
9-150 |
Complete |
ISO |
7439 Fourth edition 2023-04 |
Copper-bearing contraceptive intrauterine devices - Requirements and tests |
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 |
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 |
05/29/2023 |
Dental/ ENT |
4-307 |
Complete |
ISO |
13504 First edition 2012-07 |
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment |
05/29/2023 |
Dental/ ENT |
4-308 |
Complete |
ISO |
14708-7 Second edition 2019-12 |
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems |
01/14/2019 |
Dental/ ENT |
4-248 |
Complete |
ISO |
10477 Third edition 2018-06 |
Dentistry - Polymer-based crown and veneering materials |
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 |
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 |
09/17/2018 |
General Plastic Surgery/ General Hospital |
6-409 |
Complete |
ASTM |
F703-18 |
Standard Specification for Implantable Breast Prostheses |
09/17/2018 |
Sterility |
14-512 |
Complete |
ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
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 |
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 |
12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
08/21/2017 |
Dental/ ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
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 |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-296 |
Complete |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
01/14/2019 |
General I (QS/ RM) |
5-120 |
Complete |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
08/21/2017 |
Materials |
8-451 |
Complete |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
05/29/2023 |
Dental/ ENT |
4-303 |
Complete |
ISO |
9333 Third edition 2022-08 |
Dentistry - Brazing materials |
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 |
06/07/2018 |
Radiology |
12-315 |
Complete |
NEMA |
MS 8-2016 |
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
12/19/2022 |
Radiology |
12-349 |
Complete |
NEMA |
PS 3.1 - 3.20 2022d |
Digital Imaging and Communications in Medicine (DICOM) Set |
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. |
09/17/2018 |
Tissue Engineering |
15-55 |
Complete |
ASTM |
F3259-17 |
Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds |
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. |
05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
01/30/2014 |
General Plastic Surgery/ General Hospital |
6-321 |
Complete |
IEC |
60601-2-52 Edition 1.0 2009-12 |
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
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 |
04/04/2016 |
Sterility |
14-277 |
Complete |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
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 |
09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
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 |
07/06/2020 |
Orthopedic |
11-369 |
Complete |
ASTM |
F3292-19 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
12/18/2023 |
Orthopedic |
11-403 |
Complete |
ASTM |
F3047M-23 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
09/17/2018 |
Materials |
8-466 |
Complete |
ASTM |
F2213-17 |
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
06/07/2018 |
Software/ Informatics |
13-104 |
Complete |
UL ANSI |
2900-2-1 First Edition 2017 |
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
06/07/2018 |
Radiology |
12-316 |
Complete |
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 |
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)]. |
05/29/2023 |
Anesthesiology |
1-161 |
Complete |
ISO |
16628 Second edition 2022-06 |
Anaesthetic and respiratory equipment - Tracheobronchial tubes |
08/21/2017 |
Anesthesiology |
1-127 |
Complete |
ISO |
16628 First edition 2008-11-15 |
Tracheobronchial tubes-Sizing and marking |
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 |
01/30/2014 |
Anesthesiology |
1-97 |
Complete |
CGA |
V-7.1:2011 |
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases |