|
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 |
Dental/ ENT |
4-181 |
Complete |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
06/27/2016 |
Dental/ ENT |
4-227 |
Complete |
ISO |
22674 Second edition 2016-01-15 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
ANSI ADA |
Standard No. 134-2018 |
Metallic Materials for Fixed and Removable Restorations and Appliances |
12/19/2022 |
General I (QS/ RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
12/19/2022 |
General I (QS/ RM) |
5-138 |
Complete |
AAMI |
TIR66: 2017/(R)2020 |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
05/29/2023 |
Dental/ ENT |
4-301 |
Complete |
ISO |
21563 Second edition 2021-08 |
Dentistry - Hydrocolloid impression materials |
ANSI ADA |
Standard No. 128-2022 |
Hydrocolloid Impression Materials |
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 |
05/29/2023 |
Dental/ ENT |
4-302 |
Complete |
ISO |
10477 Fourth edition 2020-10 |
Dentistry - Polymer-based crown and veneering materials |
ANSI ADA |
Standard No. 53-2022 |
Polymer-Based Crown and Veneering Materials |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
05/30/2022 |
General Plastic Surgery/ General Hospital |
6-479 |
Complete |
ISO |
11608-5:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions |
12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
12/20/2021 |
Dental/ ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2014) |
Dental Impression Trays |
12/19/2022 |
Sterility |
14-581 |
Complete |
ASTM |
F2638-22 |
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier |
12/19/2022 |
Sterility |
14-582 |
Complete |
AAMI ISO |
TIR11137-4:2022 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
ISO |
TS 11137-4 First edition 2020-06 |
Sterilization of health care products - Radiation - Part 4: Guidance on process control |
12/19/2022 |
Sterility |
14-583 |
Complete |
ANSI AAMI |
ST98:2022 |
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
12/20/2021 |
Ophthalmic |
10-130 |
Complete |
ANSI |
Z80.36-2021 |
American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments |
12/20/2021 |
Dental/ ENT |
4-284 |
Complete |
ISO |
10873 Second edition 2021-07 |
Dentistry - Denture adhesives |
12/19/2022 |
Dental/ ENT |
4-296 |
Complete |
ISO |
9873 Fourth edition 2019-03 |
Dentistry - Intra-oral mirrors |
ANSI ADA |
Standard No. 191-2020 |
Intra-Oral Mirrors |
12/19/2022 |
Dental/ ENT |
4-297 |
Complete |
ISO |
20126 Third edition 2022-03 |
Dentistry - Manual toothbrushes - General requirements and test methods |
06/07/2021 |
Materials |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
06/07/2021 |
Software/ Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
06/07/2021 |
Materials |
8-561 |
Complete |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
08/06/2013 |
Ophthalmic |
10-77 |
Complete |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
12/21/2020 |
Orthopedic |
11-375 |
Complete |
ASTM |
F2193-20 |
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
12/23/2016 |
Sterility |
14-497 |
Complete |
ASTM |
F1980-16 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
01/14/2019 |
Anesthesiology |
1-141 |
Complete |
ISO |
80601-2-13 First edition 2011-08-11 |
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
12/18/2023 |
Sterility |
14-589 |
Complete |
ISO |
14644-4 Second edition 2022-11 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
05/30/2022 |
Cardiovascular |
3-181 |
Complete |
ISO |
25539-2 Third edition 2020-09 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
12/20/2021 |
Dental/ ENT |
4-287 |
Complete |
ANSI ADA |
Standard No. 116-2020 |
Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses) |
12/20/2021 |
InVitro Diagnostics |
7-309 |
Complete |
ISO |
17099 First edition 2014-11-15 |
Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
12/20/2021 |
Dental/ ENT |
4-288 |
Complete |
ISO |
7488 Second edition 2018-04 |
Dentistry - Mixing machines for dental amalgam |
ANSI ADA |
Standard No. 43-2020 |
Electrically Powered Dental Amalgamators |
12/20/2021 |
Dental/ ENT |
4-289 |
Complete |
ISO |
18556 Frist edition 2016-04 |
Dentistry - Intraoral spatulas |
12/20/2021 |
Dental/ ENT |
4-290 |
Complete |
ISO |
28158 Second edition 2018-09 |
Dentistry - Integrated dental floss and handles |
ANSI ADA |
Standard No. 185-2020 |
Integrated Dental Floss and Handles |
05/30/2022 |
General Plastic Surgery/ General Hospital |
6-480 |
Complete |
ISO |
11608-6:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery |
02/07/2022 |
General II (ES/ EMC) |
19-45 |
Complete |
AIM |
Standard 7351731 Rev. 3.00 2021-06-04 |
Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard |
12/19/2022 |
General I (QS/ RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-468 |
Complete |
USP-NF |
M99670_02_01 |
<881> Tensile Strength |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-469 |
Complete |
USP-NF |
M99650_02_01 |
<861> Sutures - Diameter |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-470 |
Complete |
USP-NF |
M99660_03_01 |
<871> Sutures - Needle Attachment |
05/30/2022 |
General Plastic Surgery/ General Hospital |
6-481 |
Complete |
ANSI AAMI |
CN27:2021 |
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
05/30/2022 |
General Plastic Surgery/ General Hospital |
6-482 |
Complete |
AAMI |
TIR101:2021 |
Fluid delivery performance testing for infusion pumps |
05/30/2022 |
General Plastic Surgery/ General Hospital |
6-478 |
Complete |
ISO |
11608-1:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
12/20/2021 |
Orthopedic |
11-392 |
Complete |
ASTM |
F2723-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-472 |
Complete |
USP-NF |
M36660_04_01 |
Heparin Lock Flush Solution |
04/03/2023 |
General II (ES/ EMC) |
19-49 |
Complete |
IEC |
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
06/07/2021 |
Materials |
8-555 |
Complete |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
05/29/2023 |
Materials |
8-604 |
Complete |
ASTM |
F2257-22 |
Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673) |
12/20/2021 |
General Plastic Surgery/ General Hospital |
6-465 |
Complete |
USP-NF |
M76090_03_01 |
Sodium Chloride Irrigation |
12/21/2020 |
Orthopedic |
11-371 |
Complete |
ASTM |
F2009-20 |
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses |
12/21/2020 |
Orthopedic |
11-372 |
Complete |
ASTM |
F2996-20 |
Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
06/07/2021 |
Sterility |
14-562 |
Complete |
ANSI AAMI |
ST79:2017 & 2020 Amendments A1, A2, A3, A4 |
(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
12/20/2021 |
Cardiovascular |
3-171 |
Complete |
ASTM |
F2514-21 |
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
05/30/2022 |
Cardiovascular |
3-182 |
Complete |
ASTM |
F3036-21 |
Standard Guide for Testing Absorbable Stents |
01/27/2015 |
Dental/ ENT |
4-219 |
Complete |
ISO |
29022 First edition 2013-06-01 |
Dentistry - Adhesive - Notched-edge sheer bond strength test |
01/30/2014 |
Materials |
8-344 |
Complete |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
12/18/2023 |
Dental/ ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
12/18/2023 |
Dental/ ENT |
4-322 |
Complete |
ISO |
18675 First edition 2022-05 |
Dentistry - Machinable ceramic blanks |
12/18/2023 |
Dental/ ENT |
4-323 |
Complete |
ISO |
5139 First edition 2023-05 |
Dentistry - Polymer-based composite machinable blanks |
12/18/2023 |
Dental/ ENT |
4-324 |
Complete |
ISO |
TS 16506 First edition 2018-03 |
Dentistry - Polymer-based luting materials containing adhesive components |
12/18/2023 |
Anesthesiology |
1-166 |
Complete |
ISO |
11195 Second edition 2018-01 |
Gas mixers for medical use - Stand-alone gas mixers |
12/21/2020 |
Materials |
8-546 |
Complete |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
12/21/2020 |
Materials |
8-547 |
Complete |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
07/15/2019 |
Radiology |
12-326 |
Complete |
NEMA |
NU 2-2018 |
Performance Measurements of Positron Emission Tomographs |
07/06/2020 |
General I (QS/ RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
12/21/2020 |
Materials |
8-553 |
Complete |
ISO ASTM |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
04/04/2016 |
Materials |
8-200 |
Complete |
ASTM |
F2003-02 (Reapproved 2015) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
06/07/2021 |
Tissue Engineering |
15-67 |
Complete |
ASTM |
F2212-20 |
Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
01/30/2014 |
Cardiovascular |
3-118 |
Complete |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
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 |
12/23/2016 |
Anesthesiology |
1-118 |
Complete |
ISO |
5361 Third edition 2016-09-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
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 |
Anesthesiology |
1-145 |
Complete |
ISO |
19223 First edition 2019-07 |
Lung ventilators and related equipment - Vocabulary and semantics. |
05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
12/20/2021 |
Cardiovascular |
3-175 |
Complete |
ISO |
5840-2 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes |
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 |
12/19/2022 |
Anesthesiology |
1-159 |
Complete |
ISO |
18778 Second edition 2022-06 |
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors |
05/30/2022 |
Sterility |
14-576 |
Complete |
ASTM |
D4169-22 |
Standard Practice for Performance Testing of Shipping Containers and Systems |
12/20/2021 |
Cardiovascular |
3-179 |
Complete |
ASTM |
F3172-15 (Reapproved 2021) |
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices |
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 |
12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
07/15/2019 |
Biocompatibility |
2-266 |
Complete |
ASTM |
F2382-18 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
12/23/2019 |
Physical Medicine |
16-216 |
Complete |
RESNA ANSI |
WC-2:2019 Section 10 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
12/23/2019 |
Physical Medicine |
16-217 |
Complete |
RESNA ANSI |
WC-1:2019 Section 11 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins |
12/23/2019 |
Physical Medicine |
16-220 |
Complete |
RESNA ANSI |
WC-1:2019 Section 15 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling |
12/23/2019 |
Physical Medicine |
16-221 |
Complete |
RESNA ANSI |
WC-1:2019 Section 16 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods |
07/15/2019 |
Sterility |
14-533 |
Complete |
ISO |
TS 19930 First edition 2017-12 |
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
07/06/2020 |
Nanotechnology |
18-16 |
Complete |
ISO |
TS 21362 First edition 2018-06 |
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation |
05/30/2022 |
Anesthesiology |
1-152 |
Complete |
ISO |
80601-2-87 First edition 2021-04 |
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators |
05/30/2022 |
Ophthalmic |
10-131 |
Complete |
ISO |
15798 Fourth edition 2022-01 |
Ophthalmic implants - Ophthalmic viscosurgical devices |
04/04/2016 |
Sterility |
14-340 |
Complete |
ISO |
20857 First edition 2010-08-15 |
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
20857:2010/(R)2015 |
(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |