|
|
|
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)
|
| 05/26/2025 |
ObGyn/
Gastroenterology/
Urology |
9-151 |
Complete |
ASTM |
F1828-22 |
Standard Specification for Ureteral Stents |
| 05/26/2025 |
Biocompatibility |
2-305 |
Complete |
ASTM |
E1262-24 |
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 09/17/2018 |
Orthopedic |
11-310 |
Complete |
ASTM |
F1611-00 (Reapproved 2018) |
Standard Specification for Intramedullary Reamers |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 07/06/2020 |
Cardiovascular |
3-167 |
Complete |
ISO |
TS 81060-5 First edition 2020-02 |
Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
| 07/15/2019 |
General II (ES/
EMC) |
19-35 |
Complete |
UL |
Standard for Standby Batteries |
1989 Edition 5, 2013-10-02, ANSI November 2018 |
| 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 |
| 01/14/2019 |
Biocompatibility |
2-136 |
Complete |
ASTM |
E1262-88 (Reapproved 2018) |
Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
| 05/26/2025 |
Biocompatibility |
2-306 |
Complete |
ASTM |
F1439-24 |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 05/26/2025 |
Radiology |
12-377 |
Complete |
IEC |
62127-03 Edition 2.0 2022-12 |
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz |
| 07/15/2019 |
Orthopedic |
11-351 |
Complete |
ISO |
18192-1 Second edition 2011-03-01 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 12/21/2020 |
Materials |
8-554 |
Complete |
ISO ASTM |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 12/19/2022 |
Software/
Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
| 12/19/2022 |
Software/
Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
| 12/20/2021 |
Sterility |
14-563 |
Complete |
ISO |
13408-6 Second edition 2021-04 |
Aseptic processing of health care products - Part 6: Isolator systems |
| 01/14/2019 |
Biocompatibility |
2-145 |
Complete |
ASTM |
F1439-03 (Reapproved 2018) |
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
| 05/26/2025 |
Biocompatibility |
2-307 |
Complete |
ASTM |
F1877-24 |
Standard Practice for Characterization of Particles |
| 05/26/2025 |
Radiology |
12-379 |
Complete |
IEC |
62127-2 Edition 2.0 2025-01 |
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz |
| 06/07/2021 |
Cardiovascular |
3-170 |
Complete |
ISO |
14708-5 Second edition 2020-05 |
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
| 06/07/2021 |
Materials |
8-556 |
Complete |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Materials |
8-561 |
Complete |
ISO ASTM |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 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 |
| 12/20/2021 |
Ophthalmic |
10-128 |
Complete |
ASTM |
D882-18 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
| 08/21/2017 |
Biocompatibility |
2-246 |
Complete |
ASTM |
F1877-16 |
Standard Practice for Characterization of Particles |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-505 |
Complete |
ISO |
21649 Second Edition 2023-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 12/23/2024 |
Radiology |
12-362 |
Complete |
IEC |
61674 Edition 3.0 2024-07 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
| 07/15/2019 |
Biocompatibility |
2-268 |
Complete |
ISO |
TS 21726 First edition 2019-02 |
Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
| 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)2025 |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 12/23/2024 |
Radiology |
12-363 |
Complete |
NEMA |
PS 3.1 - 3.20 2024e |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 05/26/2025 |
General II (ES/
EMC) |
19-56 |
Complete |
IEC |
60086-4 Edition 6.0 2025-01 |
Primary batteries - Part 4: Safety of lithium batteries |
| 05/26/2025 |
Dental/
ENT |
4-344 |
Complete |
ANSI ADA |
Standard No. 186-2024 |
Dentistry - Polymer-based Machinable Blanks |
| 06/07/2021 |
Orthopedic |
11-379 |
Complete |
ASTM |
F2978-20 |
Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging |
| 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 |
| 06/07/2021 |
Orthopedic |
11-380 |
Complete |
ASTM |
F2979-20 (Reapproved 2025) |
Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses |
| 12/19/2022 |
Software/
Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
| 02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| 12/23/2024 |
Cardiovascular |
3-194 |
Complete |
ISO |
7199 Fourth edition 2024-09 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) |
| 05/26/2025 |
InVitro Diagnostics |
7-334 |
Complete |
CLSI |
AUTO05-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 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" |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-477 |
Complete |
ISO |
11608-3:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-475 |
Complete |
ISO |
11608-4:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics |
| 01/14/2019 |
Dental/
ENT |
4-254 |
Complete |
ANSI ADA |
Standard No. 99-2001 (R2023) |
Athletic Mouth Protectors and Materials |
| 12/23/2019 |
Physical Medicine |
16-225 |
Complete |
RESNA ANSI |
WC-1:2019 Section 26 |
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
| 12/18/2023 |
Radiology |
12-352 |
Complete |
NEMA |
PS 3.1 - 3.20 2023e |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 12/23/2024 |
Radiology |
12-364 |
Complete |
IEC |
61223-3-8 Edition 1.0 2024-03 |
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
|
| 05/26/2025 |
Radiology |
12-369 |
Complete |
ISO |
11146-1 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| 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 |
| 12/20/2021 |
Materials |
8-575 |
Complete |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| 12/23/2024 |
Radiology |
12-365 |
Complete |
IEC |
60627 Edition 3.0 2013-07 |
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| 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 |
| 05/30/2022 |
General Plastic Surgery/
General Hospital |
6-476 |
Complete |
ISO |
11608-2:2022 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles |
| 01/14/2019 |
Materials |
8-485 |
Complete |
ASTM |
F3260-18 |
Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| 09/17/2018 |
Orthopedic |
11-327 |
Complete |
ASTM |
F543-17 |
Standard Specification and Test Methods for Metallic Medical Bone Screws |
| 12/23/2024 |
Orthopedic |
11-414 |
Complete |
ASTM |
F382-24 |
Standard Specification and Test Method for Metallic Bone Plates |
| 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 |
8-557 |
Complete |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 12/23/2024 |
Radiology |
12-366 |
Complete |
IEC |
61223-3-6 Edition 1.0 2020-02 |
Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation |
| 12/23/2024 |
General II (ES/
EMC) |
19-51 |
Complete |
UL |
1642 Sixth Edition September 29, 2020 |
Standard For Safety Lithium Batteries |
| 06/07/2021 |
Tissue Engineering |
15-66 |
Complete |
ASTM |
F2260-18 |
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy |
| 12/21/2020 |
InVitro Diagnostics |
7-299 |
Complete |
CLSI |
POCT14 2nd Edition |
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| 06/07/2021 |
Physical Medicine |
16-231 |
Complete |
ISO |
10328 Second edition 2016-06-01 |
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods |
| 05/30/2022 |
Sterility |
14-574 |
Complete |
ASTM |
F1608-21 |
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| 12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
| 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 |
Ophthalmic |
10-127 |
Complete |
ANSI |
Z80.21-2020 |
American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
| 09/17/2018 |
Orthopedic |
11-333 |
Complete |
ASTM |
F382-17 |
Standard Specification and Test Method for Metallic Bone Plates |
| 12/23/2024 |
Orthopedic |
11-415 |
Complete |
ASTM |
F2554-22 |
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems |
| 07/06/2020 |
Materials |
8-526 |
Complete |
ASTM |
F2182-19e2 |
Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-462 |
Complete |
IEC |
60601-2-20 Edition 3.0 2020-09 |
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
| 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 |
| 07/09/2014 |
General II (ES/
EMC) |
19-10 |
Complete |
UL |
1642 5th Edition |
Lithium Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-52 |
Complete |
UL |
2054 Third Edition November 17, 2021 |
Standard For Safety Household and Commercial Batteries |
| 07/15/2019 |
Materials |
8-517 |
Complete |
ISO |
17327-1 First edition 2018-02 |
Non-active surgical implants - Implant coating - Part 1: General requirements |
| 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 |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-114 |
Complete |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 07/15/2019 |
Sterility |
14-532 |
Complete |
ASTM |
F3287-17e1 |
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method |
| 12/20/2021 |
Orthopedic |
11-389 |
Complete |
ISO |
7206-10 Second edition 2018-08 |
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| 05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
| 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 |
| 12/23/2024 |
Orthopedic |
11-411 |
Complete |
ASTM |
F1611-20 (Reapproved 2024) |
Standard Specification for Intramedullary Reamers |
| 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 |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-490 |
Complete |
ISO |
10555-6 First edition 2015-04-15 [Including AMD1:2019] |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)] |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-495 |
Complete |
ISO |
20698 First Edition 2018-07 |
Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| 05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
Complete |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
| 12/23/2024 |
General II (ES/
EMC) |
19-53 |
Complete |
IEC |
TS 60601-4-6 Edition 1.0 2024-04 |
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| 12/23/2024 |
Cardiovascular |
3-197 |
Complete |
ISO |
25539-4 First edition 2021-11 |
Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices |
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