|
|
|
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 |
Materials |
8-558 |
Complete |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 01/14/2019 |
Tissue Engineering |
15-47 |
Complete |
ISO |
22442-3 First edition 2007-12-15 |
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents. |
| 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) |
| 01/14/2019 |
Materials |
8-485 |
Complete |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 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) |
| 12/22/2025 |
Materials |
8-630 |
Complete |
ASTM |
F90-24 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| 04/04/2016 |
Materials |
8-399 |
Complete |
ASTM |
F90-14 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| 08/06/2013 |
Software/
Informatics |
13-55 |
Complete |
IEEE |
Std 11073-10421-2010 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 12/20/2021 |
Materials |
8-564 |
Complete |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/20/2021 |
Materials |
8-565 |
Complete |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
| 12/19/2022 |
Nanotechnology |
18-21 |
Complete |
ISO |
TS 80004-6 Second edition 2021-03 |
Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
| 12/19/2022 |
Nanotechnology |
18-22 |
Complete |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
| 01/14/2019 |
InVitro Diagnostics |
7-232 |
Complete |
CLSI |
MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 |
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
| 05/25/2026 |
Dental/
ENT |
4-392 |
Complete |
ISO |
17254 First edition 2016-07 [Including AMD1:2020] |
Dentistry - Coiled springs for use in orthodontics [Including AMENDMENT 1 (2020)] |
| 01/30/2014 |
Software/
Informatics |
13-63 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
| IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
| 05/26/2025 |
General I (QS/
RM) |
5-145 |
Complete |
IEC |
60417:2025 DB |
Graphical symbols for use on equipment |
| 01/14/2019 |
Anesthesiology |
1-120 |
Complete |
ISO |
18190 First edition 2016-11-01 |
Anaesthetic and respiratory equipment - General requirements for airways and related equipment |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-494 |
Complete |
ASTM |
F3352/F3352M-23a |
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 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 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| 08/14/2015 |
General I (QS/
RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 12/22/2025 |
Dental/
ENT |
4-360 |
Complete |
ISO |
3630-1 Third edition 2019-08 |
Dentistry - Endodontic instruments - Part 1: General requirements |
| ANSI ADA |
Standard No. 101-2021 |
Endodontic Instruments - General Requirements |
| 12/22/2025 |
Dental/
ENT |
4-361 |
Complete |
ISO |
3630-2 Fourth edition 2023-02 |
Dentistry - Endodontic instruments - Part 2: Enlargers |
| ANSI ADA |
Standard No. 101-2-2025 |
Dentistry - Endodontic Instruments - Part 2: Enlargers |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-493 |
Complete |
ASTM |
F2101-23 |
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus |
| 07/15/2019 |
Orthopedic |
11-354 |
Complete |
ASTM |
F3295-18 |
Standard Guide for Impingement Testing of Total Disc Prostheses |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ISO ASTM |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 12/18/2023 |
Dental/
ENT |
4-312 |
Complete |
ANSI ASA |
S3.35-2021 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/22/2025 |
Dental/
ENT |
4-353 |
Complete |
ISO |
20127 Third edition 2025-05 |
Dentistry - Physical properties of powered toothbrushes |
| 12/18/2023 |
Dental/
ENT |
4-316 |
Complete |
ISO |
20127 Second edition 2020-08 |
Dentistry - Physical properties of powered toothbrushes |
| ANSI ADA |
Standard No.120-2022 |
Dentistry - Physical Properties of Powered Toothbrushes |
| 05/26/2025 |
Radiology |
12-372 |
Complete |
ISO |
14880-3 Second edition 2024-11 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 12/19/2007 |
Radiology |
12-172 |
Complete |
ISO |
14880-3:2006 |
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
| 05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 12/22/2025 |
Anesthesiology |
1-200 |
Complete |
ISO |
7376-2 First edition 2025-09 |
Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes |
| 12/22/2025 |
Biocompatibility |
2-310 |
Complete |
ASTM |
F748-25 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 05/26/2025 |
General II (ES/
EMC) |
19-55 |
Complete |
IEC |
62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION |
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 2: Lithium systems |
| 12/23/2019 |
Cardiovascular |
3-161 |
Complete |
ISO |
14117 Second edition 2019-09 |
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. |
| 07/15/2019 |
General Plastic Surgery/
General Hospital |
6-423 |
Complete |
IEC |
60601-2-6 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| 05/30/2022 |
Materials |
8-588 |
Complete |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 05/30/2022 |
Materials |
8-583 |
Complete |
ASTM |
F562-22 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| 12/20/2021 |
Materials |
8-566 |
Complete |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
| 12/20/2021 |
Materials |
8-567 |
Complete |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
| 03/16/2012 |
Radiology |
12-177 |
Complete |
UL |
122-2007 (R2011) |
Standard for Photographic Equipment - Ed. 5.0 |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-517 |
Complete |
ASTM |
F3502-25 |
Standard Specification for Barrier Face Coverings |
| 05/26/2025 |
Dental/
ENT |
4-347 |
Complete |
ISO |
22254 First edition 2005-08 |
Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 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 |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-484 |
Complete |
ASTM |
F3502-22a |
Standard Specification for Barrier Face Coverings |
| 03/16/2012 |
Anesthesiology |
1-73 |
Complete |
ISO |
10651-4 First edition 2002-03-01 |
Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
| 12/18/2023 |
Orthopedic |
11-408 |
Complete |
ASTM |
F2777-23 |
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion |
| 09/17/2018 |
Orthopedic |
11-199 |
Complete |
ASTM |
F565-04 (Reapproved 2018) |
Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| 05/26/2025 |
General I (QS/
RM) |
5-144 |
Complete |
ISO |
80369-20 Second edition 2024-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 12/19/2022 |
Dental/
ENT |
4-295 |
Complete |
ANSI ADA |
Standard No. 41-2020 |
Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| 01/27/2015 |
Orthopedic |
11-283 |
Complete |
ASTM |
F2943-14 (Reapproved 2019) |
Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
| 12/22/2025 |
Orthopedic |
11-427 |
Complete |
ASTM |
F1264-24 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/23/2019 |
General II (ES/
EMC) |
19-33 |
Complete |
IEC |
62133-2 Edition1.0 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 2: Lithium systems |
| 01/30/2014 |
Sterility |
14-427 |
Complete |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
| 12/18/2023 |
Dental/
ENT |
4-314 |
Complete |
ISO |
7494-2 Third edition 2022-07 |
Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems |
| 12/18/2023 |
Dental/
ENT |
4-315 |
Complete |
ISO |
24234 Third edition 2021-08 |
Dentistry - Dental Amalgam |
| 12/18/2023 |
Materials |
8-610 |
Complete |
ASTM |
F601-23 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 01/14/2019 |
Materials |
8-483 |
Complete |
ASTM |
F601-18 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
| 12/22/2025 |
Materials |
8-631 |
Complete |
ASTM |
F1854-25 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Using Digital Images |
| 04/04/2016 |
Materials |
8-400 |
Complete |
ASTM |
F1854-15 |
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
| 12/22/2025 |
Materials |
8-637 |
Complete |
ASTM |
F2579-24 |
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants |
| 12/21/2020 |
Materials |
8-540 |
Complete |
ASTM |
F1091-20 |
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605) |
| 12/20/2021 |
General II (ES/
EMC) |
19-41 |
Complete |
ANSI UL |
61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 |
Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements |
| 12/22/2025 |
Materials |
8-640 |
Complete |
ASTM |
F961-25 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/21/2020 |
Materials |
8-544 |
Complete |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 04/04/2016 |
Orthopedic |
11-247 |
Complete |
ASTM |
F2789-10 (Reapproved 2020) |
Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| 05/25/2026 |
Orthopedic |
11-444 |
Complete |
ISO |
18192-3 Second edition 2025-11 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses |
| 12/20/2021 |
Cardiovascular |
3-178 |
Complete |
ASTM |
F3067-14 (Reapproved 2021) |
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
| 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 |
| 12/19/2022 |
Software/
Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
| 12/20/2021 |
Dental/
ENT |
4-286 |
Complete |
ANSI ADA |
Standard No. 87-1995 (R2024) |
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 |
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) |
| 12/23/2024 |
General Plastic Surgery/
General Hospital |
6-504 |
Complete |
ASTM |
F1862/F1862M-24 |
Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) |
| 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 |
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)] |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-518 |
Complete |
ASTM |
F1670/F1670M-24a |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-491 |
Complete |
ASTM |
F1670/F1670M-17a |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 09/17/2018 |
InVitro Diagnostics |
7-279 |
Complete |
CLSI |
M07 11th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| 09/17/2018 |
InVitro Diagnostics |
7-280 |
Complete |
CLSI |
M02 13th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
| 05/30/2022 |
Sterility |
14-577 |
Complete |
ISO |
11737-1 Third edition 2018-01 [Including AMD1:2021] |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)] |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-381 |
Complete |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
| 12/20/2021 |
Ophthalmic |
10-129 |
Complete |
ASTM |
D790-17 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| 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 |
| 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. |
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