|
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)
|
05/29/2024 |
Cardiovascular |
3-191 |
Complete |
ISO |
18242 First edition 2016-09-01 [Including AMD1:2023] |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)] |
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 |
01/30/2014 |
Sterility |
14-413 |
Complete |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
05/29/2024 |
Cardiovascular |
3-192 |
Complete |
ISO |
22679 First edition 2021-11 |
Cardiovascular implants - Transcatheter cardiac occluders
|
05/29/2024 |
Anesthesiology |
1-174 |
Complete |
ISO |
18562-2 Second edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
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) |
12/21/2020 |
Dental/ ENT |
4-270 |
Complete |
ANSI ADA |
Technical Report No. 146-2018 |
CAD/CAM Abutments in Dentistry |
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)] |
07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
05/29/2024 |
Anesthesiology |
1-175 |
Complete |
ISO |
18562-3 Second Edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
07/06/2020 |
Sterility |
14-540 |
Complete |
ISO |
11737-2 Third edition 2019-12 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
ANSI AAMI ISO |
11737-2:2019 |
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
06/07/2018 |
Anesthesiology |
1-135 |
Complete |
ISO |
18562-2 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter |
05/29/2024 |
General Plastic Surgery/ General Hospital |
6-499 |
Complete |
ISO |
10555-1 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements |
05/29/2024 |
Dental/ ENT |
4-326 |
Complete |
ISO |
9687 Second edition 2015-02 |
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
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 |
01/27/2015 |
Neurology |
17-13 |
Complete |
IEEE |
Std 2010-2012 |
Recommended Practice for Neurofeedback Systems |
12/21/2020 |
Biocompatibility |
2-282 |
Complete |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
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 |
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 |
12-328 |
Complete |
IEC |
61223-3-5 Edition 2.0 2019-09 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
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 |
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 |
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 |
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 |
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 |
07/15/2019 |
Materials |
8-510 |
Complete |
ASTM |
F997-18 |
Standard Specification for Polycarbonate Resin for Medical Applications |
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) |
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 |
12/23/2019 |
General Plastic Surgery/ General Hospital |
6-424 |
Complete |
ASTM |
D5151-19(2023) |
Standard Test Method for Detection of Holes in Medical Gloves |
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) |
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 |
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 |
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 |
05/29/2023 |
General Plastic Surgery/ General Hospital |
6-489 |
Complete |
IEC |
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
|
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)] |
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 |
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 |
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 |
Tissue Engineering |
15-59 |
Complete |
ASTM |
F2450-18 |
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |