|
|
|
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)
|
| 12/21/2020 |
Anesthesiology |
1-147 |
Complete |
ISO |
26825 Second edition 2020-10 |
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance |
| 12/21/2020 |
ObGyn/
Gastroenterology/
Urology |
9-130 |
Complete |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| 07/15/2019 |
Materials |
8-496 |
Complete |
ISO |
5834-4 Second edition 2019-02 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method |
| 12/23/2024 |
Materials |
8-624 |
Complete |
ASTM |
F2129-24 |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| 12/18/2023 |
Dental/
ENT |
4-311 |
Complete |
ISO |
9917-2 Third edition 2017-09 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 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 |
| 12/23/2019 |
Materials |
8-522 |
Complete |
ASTM |
F2129-19a |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
| 05/29/2023 |
Radiology |
12-351 |
Complete |
IEC |
60601-2-43 Edition 3.0 2022-12 |
Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
| 12/23/2016 |
Radiology |
12-303 |
Complete |
IEC |
61303 Edition 1.0 1994-09 |
Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)] |
| 12/23/2016 |
Radiology |
12-304 |
Complete |
IEC |
60731 Edition 3.1 2016-04 |
Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| 12/23/2019 |
Materials |
8-492 |
Complete |
ISO |
5832-9 Third edition 2019-02 |
Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
| 12/23/2019 |
Materials |
8-494 |
Complete |
ISO |
6474-1 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina |
| 12/23/2019 |
Materials |
8-498 |
Complete |
ASTM |
F75-18 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 12/23/2019 |
Materials |
8-499 |
Complete |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| 05/29/2024 |
Anesthesiology |
1-167 |
Complete |
CGA |
V-5:2019 |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
| 12/19/2022 |
Anesthesiology |
1-153 |
Complete |
NFPA |
99:2021 |
Health Care Facilities Code |
| 12/23/2019 |
Physical Medicine |
16-215 |
Complete |
RESNA ANSI |
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 |
| 07/06/2020 |
Biocompatibility |
2-274 |
Complete |
ASTM |
F749-20 |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
| 12/23/2024 |
Sterility |
14-607 |
Complete |
ANSI AAMI |
ST58:2024 |
Chemical sterilization and high-level disinfection in health care facilities |
| 12/19/2022 |
Anesthesiology |
1-154 |
Complete |
ASME |
PVHO-1-2019 |
Safety Standard for Pressure Vessels for Human Occupancy |
| 12/21/2020 |
Sterility |
14-552 |
Complete |
ISO ASTM |
51818 Fourth edition 2020-06 |
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV |
| 06/07/2021 |
Software/
Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
| 05/29/2023 |
Biocompatibility |
2-301 |
Complete |
ASTM |
F1983-23 |
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
| 05/29/2024 |
Anesthesiology |
1-171 |
Complete |
ISO |
5367 Sixth edition 2023-07 |
Anaesthetic and respiratory equipment - Breathing sets and connectors |
| 12/23/2019 |
Materials |
8-505 |
Complete |
ISO |
6474-2 Second edition 2019-03 |
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
| 12/23/2019 |
Materials |
8-507 |
Complete |
ASTM |
F688-19 |
Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) |
| 05/29/2024 |
Software/
Informatics |
13-139 |
Complete |
ISO IEEE |
11073-10206:2024 |
Health informatics - Device interoperability Part 10206: Personal health device communication - Abstract content information model |
| IEEE |
Std 11073-10206-2022 |
Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model |
| 05/29/2024 |
Anesthesiology |
1-172 |
Complete |
ISO |
11712 Second edition 2023-11 |
Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| 12/23/2019 |
General II (ES/
EMC) |
19-32 |
Complete |
IEC |
62133-1 Edition 1.0 2017-02 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-439 |
Complete |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-441 |
Complete |
ISO |
7886-3 Second edition 2020-05 |
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization |
| 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 |
| 08/14/2015 |
Software/
Informatics |
13-76 |
Complete |
ISO |
11073-91064 First edition 2009-05-01 |
Health informatics - Standard communication protocol - Computer-assisted electrocardiography |
| 03/16/2012 |
Radiology |
12-241 |
Complete |
IEC |
62274 First Edition 2005-05 |
Medical electrical equipment - Safety of radiotherapy record and verify systems |
| 08/06/2013 |
Radiology |
12-253 |
Complete |
IEC |
60976 Edition 2.0 2007-10 |
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| 08/06/2013 |
Radiology |
12-255 |
Complete |
IEC |
60601-2-11 Edition 3.0 2013-01 |
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
| 05/29/2024 |
Anesthesiology |
1-177 |
Complete |
ISO |
80601-2-74 Second edition 2021-07 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 12/21/2020 |
Orthopedic |
11-373 |
Complete |
ASTM |
F1223-20 |
Standard Test Method for Determination of Total Knee Replacement Constraint |
| 12/21/2020 |
Orthopedic |
11-370 |
Complete |
ISO |
14879-1 Second edition 2020-07 |
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays |
| 06/07/2021 |
Radiology |
12-335 |
Complete |
IEC |
60336 Edition 5.0 2020-12 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics [Including: Corrigendum 1 (2022)] |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/21/2020 |
Materials |
8-541 |
Complete |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/23/2024 |
Anesthesiology |
1-185 |
Complete |
ISO |
80601-2-79 Second edition 2024-08 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 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 |
| 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)]. |
| 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 |
| 03/16/2012 |
Ophthalmic |
10-70 |
Complete |
ISO |
10943 Third edition 2011-08-15 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 08/06/2013 |
Software/
Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
| 01/30/2014 |
Radiology |
12-228 |
Complete |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| 01/30/2014 |
Radiology |
12-261 |
Complete |
ISO IEC |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
| 01/30/2014 |
Radiology |
12-267 |
Complete |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
| 05/29/2024 |
Dental/
ENT |
4-326 |
Complete |
ISO |
9687 Second edition 2015-02 |
Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
| 05/29/2024 |
Dental/
ENT |
4-327 |
Complete |
ISO |
21531 First edition 2009-02 |
Dentistry - Graphical symbols for dental instruments |
| 07/06/2020 |
Sterility |
14-541 |
Complete |
ANSI AAMI |
ST72:2019 |
Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing |
| 07/15/2019 |
Anesthesiology |
1-116 |
Complete |
ISO |
5360 Fourth edition 2016-02-15 |
Anaesthetic vaporizers - Agent specific filling systems |
| 07/15/2019 |
Anesthesiology |
1-122 |
Complete |
ISO |
5364 Fifth edition 2016-09-01 |
Anaesthetic and respiratory equipment-Oropharyngeal airways |
| 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 |
| 12/23/2019 |
Materials |
8-484 |
Complete |
ASTM |
F2066-18 |
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 01/14/2019 |
Cardiovascular |
3-158 |
Complete |
ASTM |
F3320-18 |
Standard Guide forCoating Characterization of Drug Coated Balloons |
| 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 |
| 07/06/2020 |
Sterility |
14-542 |
Complete |
ISO ASTM |
52628 Second edition 2020-04 |
Standard practice for dosimetry in radiation processing |
| 07/15/2019 |
Orthopedic |
11-357 |
Complete |
ISO |
15142-3 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| 07/06/2020 |
Sterility |
14-545 |
Complete |
ISO ASTM |
51276 Fourth edition 2019-08 |
Practice for use of a polymethylmethacrylate dosimetry system |
| 07/06/2020 |
Sterility |
14-549 |
Complete |
ASTM |
F3004-13 (Reapproved 2020) |
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound |
| 12/23/2019 |
General I (QS/
RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
| ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
| 12/23/2024 |
Dental/
ENT |
4-336 |
Complete |
ISO |
18397 First edition 2016-01 |
Dentistry - Powered scaler |
| ANSI ADA |
Standard No. 157-2020 |
Powered Dental Scaler Handpieces and Tips |
| 12/23/2024 |
Dental/
ENT |
4-337 |
Complete |
ISO |
20608 First edition 2018-04 |
Dentistry - Powder jet handpieces and powders |
| 12/23/2024 |
Dental/
ENT |
4-338 |
Complete |
ISO |
22683 First edition 2022-05 |
Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-503 |
Complete |
ISO |
16571 Second edition 2024-03 |
Systems for evacuation of plume generated by medical device |
| 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 [Including AMD1:2018] |
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 |
| 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 |
| 05/29/2024 |
Neurology |
17-18 |
Complete |
IEEE |
Std 2010-2023 |
Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems |
| 12/23/2019 |
InVitro Diagnostics |
7-293 |
Complete |
CLSI |
QMS01, 5th ed. June 2019 (Replaces QMS01-A4) |
A Quality Management System Model for Laboratory Services. |
| 12/23/2019 |
Cardiovascular |
3-162 |
Complete |
ASTM |
F3374-19 |
Standard Guide for Active Fixation Durability of Endovascular Prostheses |
| 12/23/2019 |
InVitro Diagnostics |
7-295 |
Complete |
CLSI |
M52, 1st ed. August 2015 (Reaffirmed: January 2020) |
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
| 12/23/2019 |
Physical Medicine |
16-208 |
Complete |
RESNA ANSI |
WC-2:2019 Section 2 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs |
| 12/23/2019 |
Physical Medicine |
16-212 |
Complete |
RESNA ANSI |
WC-2:2019 Section 6 |
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs. |
| 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 |
| 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 |
| 12/23/2019 |
Materials |
8-508 |
Complete |
ASTM |
F2579-18 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 12/23/2019 |
Sterility |
14-538 |
Complete |
ASTM |
F3357-19 |
Standard Guide for Designing Reusable Medical Devices for Cleanability |
| 07/15/2019 |
Ophthalmic |
10-117 |
Complete |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 07/15/2019 |
InVitro Diagnostics |
7-287 |
Complete |
CLSI |
M44-S3 (2018) |
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement |
| 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 |
| 10/04/2010 |
Radiology |
12-214 |
Complete |
IEC |
62220-1-3 Edition 1.0 2008-06 |
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| 07/09/2014 |
Radiology |
12-280 |
Complete |
IEC |
62555 Edition 1.0 2013-11 |
Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems |
| 08/21/2017 |
Software/
Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| 08/14/2015 |
Software/
Informatics |
13-77 |
Complete |
ISO IEC |
29147 First edition 2014-02-15 |
Information technology - Security techniques - Vulnerability disclosure |
| 01/14/2019 |
Anesthesiology |
1-114 |
Complete |
ISO |
18835 First Edition 2015-04-01 |
Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems |
| 04/04/2016 |
Materials |
8-406 |
Complete |
ISO |
5832-11 Second edition 2014-09-15 |
Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 12/23/2024 |
Sterility |
14-608 |
Complete |
AAMI |
TIR106:2024 |
Microbiological methods - Understanding and use of product bioburden data |
| 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 |
| 05/29/2024 |
General Plastic Surgery/
General Hospital |
6-498 |
Complete |
ISO |
10555-4 Third edition 2023-11 |
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters |
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