|
|
|
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)
|
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-256 |
Complete |
ANSI ADA |
Standard No. 132-2015 |
Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems |
| 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 |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-270 |
Complete |
ASTM |
F1840-10 (Reapproved 2023) |
Standard Terminology for Surgical Suture Needles |
| 12/21/2020 |
Ophthalmic |
10-119 |
Complete |
ISO |
11979-5 Third edition 2020-09 |
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| 06/07/2021 |
Dental/
ENT |
4-279 |
Complete |
ANSI ADA |
Standard No. 85-2004 (R2009) |
Part 1: Disposable Prophy Angles |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-467 |
Complete |
USP-NF |
M80200_04_01 |
Nonabsorbable Surgical Suture |
| 05/25/2026 |
Orthopedic |
11-441 |
Complete |
ASTM |
F2789-25 |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 12/22/2025 |
Orthopedic |
11-435 |
Complete |
ASTM |
F3292-25 |
Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| 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" |
| 07/09/2014 |
Radiology |
12-281 |
Complete |
IEC |
60601-2-62 Edition 1.0 2013-07 |
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment |
| 07/09/2014 |
Radiology |
12-283 |
Complete |
ISO |
12609-2 First edition 2013-07-15 |
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
| 03/14/2011 |
Radiology |
12-226 |
Complete |
IEC |
61223-2-6 Second Edition 2006-11 |
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment |
| 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 |
| 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) |
| 12/23/2016 |
Orthopedic |
11-312 |
Complete |
ISO |
7206-4 Third edition 2010-06-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 12/23/2024 |
Orthopedic |
11-416 |
Complete |
ASTM |
F2996-24 |
Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems |
| 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 |
| 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 |
| 08/21/2017 |
Anesthesiology |
1-124 |
Complete |
ISO |
8835-7 First edition 2011-11-01 |
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| 01/30/2014 |
General I (QS/
RM) |
5-84 |
Complete |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
| 04/04/2016 |
Materials |
8-116 |
Complete |
ASTM |
F2258-05 (Reapproved 2015) |
Standard Test Method for Strength Properties of Tissue Adhesives in Tension |
| 01/14/2019 |
Ophthalmic |
10-115 |
Complete |
ANSI |
Z80.29-2015 (R2020) |
American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| 06/07/2018 |
Cardiovascular |
3-150 |
Complete |
ISO |
7199 Third edition 2016-11-15 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| ANSI AAMI ISO |
7199:2016 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| 06/07/2021 |
Software/
Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
| 12/21/2020 |
Neurology |
17-17 |
Complete |
ASTM |
F3395/F3395M-19 |
Standard Specification for Neurosurgical Head Holder Devices |
| 06/07/2021 |
Materials |
8-562 |
Complete |
ISO ASTM |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 12/23/2024 |
Orthopedic |
11-410 |
Complete |
ASTM |
F3161-24 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 12/21/2020 |
Nanotechnology |
18-17 |
Complete |
ISO |
21363 First edition 2020-06 |
Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy |
| 12/21/2020 |
Materials |
8-549 |
Complete |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 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 |
| 12/23/2024 |
Orthopedic |
11-417 |
Complete |
ASTM |
F3090-24 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements |
| 12/23/2024 |
Orthopedic |
11-411 |
Complete |
ASTM |
F1611-20 (Reapproved 2024) |
Standard Specification for Intramedullary Reamers |
| 09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 12/21/2020 |
Biocompatibility |
2-282 |
Complete |
ISO |
14155 Third edition 2020-07 |
Clinical investigation of medical devices for human subjects - Good clinical practice |
| 09/17/2018 |
Orthopedic |
11-185 |
Complete |
ASTM |
F2267-04 (Reapproved 2018) |
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 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. |
| 05/25/2026 |
Dental/
ENT |
4-385 |
Complete |
ISO |
13397-2 Second edition 2005-06 [Including AMD1:2012] |
Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)] |
| 05/25/2026 |
Dental/
ENT |
4-386 |
Complete |
ISO |
13397-3 First edition 1996-09 |
Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type |
| 05/25/2026 |
Dental/
ENT |
4-387 |
Complete |
ISO |
13397-5 First edition 2015-09 |
Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 12/23/2024 |
Orthopedic |
11-418 |
Complete |
ASTM |
F3631-24 |
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
|
| 07/09/2014 |
Radiology |
12-275 |
Complete |
IEC |
61161 Edition 3.0 2013-01 |
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| 09/09/2008 |
Radiology |
12-166 |
Complete |
NEMA |
XR 23-2006 (R2020) |
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
| 05/25/2026 |
Dental/
ENT |
4-379 |
Complete |
ISO |
9173-3 First edition 2014-05 |
Dentistry - Extraction forceps - Part 3: Design |
| 05/25/2026 |
Dental/
ENT |
4-380 |
Complete |
ISO |
13017 Second edition 2020-07 |
Dentistry - Magnetic attachments |
| ANSI ADA |
Standard No. 201-2022 |
Dentistry - Magnetic Attachments |
| 06/27/2016 |
Orthopedic |
11-308 |
Complete |
ASTM |
F3161-16 |
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions |
| 12/22/2025 |
Ophthalmic |
10-139 |
Complete |
ISO |
11980 Fourth edition 2025-06 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 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 |
| 01/14/2019 |
Dental/
ENT |
4-255 |
Complete |
ANSI ADA |
Standard No. 131-2015 (R2020) |
Dental CAD/CAM Machinable Zirconia Blanks |
| 07/15/2019 |
Orthopedic |
11-355 |
Complete |
ISO |
15142-1 First edition 2003-08-01 |
Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails |
| 12/22/2025 |
Ophthalmic |
10-140 |
Complete |
ANSI |
Z80.1-2020 |
American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations |
| 12/22/2025 |
Orthopedic |
11-437 |
Complete |
ASTM |
F2033-25 |
Standard Specification for Hip Joint Replacement Bearing Surfaces |
| 07/06/2020 |
Cardiovascular |
3-164 |
Complete |
ASTM |
F1830-19 (Reapproved 2024) |
Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps |
| 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 |
8-499 |
Complete |
ASTM |
F1580-18 |
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| 07/09/2014 |
Sterility |
14-432 |
Complete |
ANSI AAMI |
ST58:2013/(R)2018 |
Chemical sterilization and high-level disinfection in health care facilities |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 08/21/2017 |
Software/
Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
| 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 |
| 06/07/2021 |
Orthopedic |
11-376 |
Complete |
ASTM |
F2033-20 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
| 12/22/2025 |
Materials |
8-635 |
Complete |
ASTM |
F75-23 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 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 |
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 |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-322 |
Complete |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 05/29/2024 |
Neurology |
17-18 |
Complete |
IEEE |
Std 2010-2023 |
Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems |
| 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 |
| 03/16/2012 |
Cardiovascular |
3-96 |
Complete |
ISO |
81060-1 First edition 2007-12-01 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
| ANSI AAMI ISO |
81060-1:2007/(R)2013 |
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
| 03/08/2004 |
InVitro Diagnostics |
7-86 |
Complete |
CLSI |
C29-A2 (Replaces C29-A) |
Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition |
| 03/08/2004 |
InVitro Diagnostics |
7-87 |
Complete |
CLSI |
C31-A2 (Replaces C31-A) |
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition. |
| 03/08/2004 |
InVitro Diagnostics |
7-88 |
Complete |
CLSI |
C37-A |
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline |
| 03/08/2004 |
InVitro Diagnostics |
7-89 |
Complete |
CLSI |
C39-A (Replaces C39-P) |
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
| 10/04/2004 |
InVitro Diagnostics |
7-105 |
Complete |
CLSI |
H30-A2 |
Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
| 10/04/2004 |
InVitro Diagnostics |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
| 06/07/2018 |
Tissue Engineering |
15-52 |
Complete |
ASTM |
F2064-17 |
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| 12/20/2021 |
Cardiovascular |
3-173 |
Complete |
ISO |
5840-3 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques |
| 05/25/2026 |
ObGyn/
Gastroenterology/
Urology |
9-153 |
Complete |
ISO |
23500-2 Second edition 2024-07 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 07/06/2020 |
Materials |
8-527 |
Complete |
ASTM |
F899-20 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
| 05/29/2024 |
Materials |
8-613 |
Complete |
ASTM |
F2527-24 |
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants |
| 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 |
| 05/29/2024 |
Materials |
8-615 |
Complete |
ISO ASTM |
52926-1 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators |
| 03/18/2009 |
InVitro Diagnostics |
7-192 |
Complete |
CLSI |
MM18-A (Replaces MM18-P) |
Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline |
| 03/16/2012 |
Tissue Engineering |
15-31 |
Complete |
ASTM |
F2312-11 (Reapproved 2020) |
Standard Terminology Relating to Tissue Engineered Medical Products |
| 01/30/2014 |
Dental/
ENT |
4-180 |
Complete |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 07/09/2014 |
General I (QS/
RM) |
5-88 |
Complete |
ISO |
2859-1 Second edition 1999-11-15 |
Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)] |
| 09/17/2018 |
InVitro Diagnostics |
7-276 |
Complete |
CLSI |
M38 3rd Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi |
| 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 |
| 05/25/2026 |
Dental/
ENT |
4-388 |
Complete |
ISO |
14356 Second edition 2024-10 |
Dentistry - Duplicating material |
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