|
|
|
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)
|
| 12/23/2019 |
Cardiovascular |
3-163 |
Partial |
ISO |
18242 First edition 2016-09-01 |
Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps |
| 05/29/2023 |
Dental/
ENT |
4-305 |
Partial |
ISO |
10637 Second edition 2018-05 |
Dentistry - Central suction source equipment |
| ANSI ADA |
Standard No. 177-2020 |
Central Suction Source Equipment |
| 01/14/2019 |
Cardiovascular |
3-159 |
Partial |
ISO |
5910 First edition 2018-06 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 12/23/2024 |
Cardiovascular |
3-196 |
Partial |
ISO |
81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024] |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)] |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-439 |
Partial |
ISO |
7886-2 Second edition 2020-04 |
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| 12/18/2023 |
Dental/
ENT |
4-319 |
Partial |
ISO |
17730 Second edition 2020-09 |
Dentistry - Fluoride varnishes |
| ANSI ADA |
Standard No. 117-2022 |
Dentistry - Fluoride Varnishes |
| 12/18/2023 |
InVitro Diagnostics |
7-320 |
Partial |
CLSI |
H62 1st Edition |
Validation of Assays Performed by Flow Cytometry |
| 12/22/2025 |
Orthopedic |
11-433 |
Partial |
ASTM |
F2028-25a |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening |
| 12/18/2023 |
General Plastic Surgery/
General Hospital |
6-497 |
Partial |
ASTM |
D7866-23 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 12/23/2016 |
Biocompatibility |
2-244 |
Partial |
ASTM |
F748-16 |
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-448 |
Partial |
ASTM |
F2407-20 |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 05/26/2025 |
Ophthalmic |
10-96 |
Partial |
ANSI |
Z80.10-2014 |
American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers |
| 05/26/2025 |
InVitro Diagnostics |
7-330 |
Partial |
CLSI |
M38M51S 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi |
| 05/26/2025 |
Neurology |
17-21 |
Partial |
ASTM |
F647-22 |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 12/23/2024 |
InVitro Diagnostics |
7-327 |
Partial |
CLSI |
M100 34th Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-496 |
Partial |
ASTM |
F739-20 |
Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact |
| 05/26/2025 |
InVitro Diagnostics |
7-328 |
Partial |
CLSI |
M100 35th Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-440 |
Partial |
ASTM |
D3578-19(2023) |
Standard Specification for Rubber Examination Gloves |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-140 |
Partial |
ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| 01/27/2015 |
Software/
Informatics |
13-71 |
Partial |
RII |
Version 2.48 |
Logical Observation Identifiers Names and Codes (LOINC) |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
| 06/07/2018 |
Neurology |
17-1 |
Partial |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
| 05/29/2023 |
Cardiovascular |
3-188 |
Partial |
ISO |
81060-3 First edition 2022-12 |
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
| 12/20/2021 |
General II (ES/
EMC) |
19-42 |
Partial |
IEC |
61326-1 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
| 12/21/2020 |
Orthopedic |
11-330 |
Partial |
ASTM |
F2028-17 |
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-516 |
Partial |
ASTM |
F2407/F2407M-23a |
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
| 12/20/2021 |
Cardiovascular |
3-174 |
Partial |
ISO |
5840-1 Second edition 2021-01 |
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements |
| 01/30/2014 |
InVitro Diagnostics |
7-220 |
Partial |
CLSI |
H59-A (Replaces H59-P) |
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
| 01/14/2019 |
Nanotechnology |
18-2 |
Partial |
ASTM |
E2535-07 (Reapproved 2018) |
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings |
| 01/14/2019 |
Cardiovascular |
3-86 |
Partial |
ASTM |
F2394-07 (Reapproved 2017) |
Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| 04/04/2016 |
Tissue Engineering |
15-44 |
Partial |
ASTM |
F2529-13 |
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
| 05/29/2023 |
InVitro Diagnostics |
7-317 |
Partial |
CLSI |
M100 33rd, Edition |
Performance Standards for Antimicrobial Susceptibility Testing |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-513 |
Partial |
ISO |
14607 Fourth edition 2024-12 |
Non-active surgical implants - Mammary implants - Specific requirements |
| 08/14/2015 |
Neurology |
17-4 |
Partial |
ASTM |
F647-94 (Reapproved 2014) |
Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application |
| 05/30/2022 |
Sterility |
14-578 |
Partial |
ISO |
17664-1 First edition 2021-07 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| 05/26/2025 |
Ophthalmic |
10-138 |
Partial |
ISO |
16971-1 First edition 2024-11 |
Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for the posterior segment of the human eye |
| 12/23/2024 |
InVitro Diagnostics |
7-326 |
Partial |
CLSI |
M24S 2nd Edition |
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes |
| 08/21/2017 |
Ophthalmic |
10-104 |
Partial |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| 04/04/2016 |
Anesthesiology |
1-106 |
Partial |
ISO |
17510 First Edition 2015-08-01 |
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories |
| 12/19/2022 |
InVitro Diagnostics |
7-314 |
Partial |
CLSI |
M27M44S, 3rd Edition |
Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| 12/21/2020 |
General Plastic Surgery/
General Hospital |
6-449 |
Partial |
ASTM |
F1169-19 |
Standard Consumer Safety Specification for Full-Size Baby Cribs |
| 09/21/2016 |
InVitro Diagnostics |
7-265 |
Partial |
CLSI |
C62-A |
Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
| 12/20/2021 |
General II (ES/
EMC) |
19-43 |
Partial |
IEC |
61326-2-6 Edition 3.0 2020-10 |
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 01/14/2019 |
Orthopedic |
11-348 |
Partial |
ISO |
19227 First edition 2018-03 |
Implants for surgery - Cleanliness of orthopedic implants - General requirements |
| 05/30/2022 |
Physical Medicine |
16-166 |
Partial |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| 01/14/2019 |
Materials |
8-179 |
Partial |
ASTM |
F754-08 (Reapproved 2015) |
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders |
| 12/21/2020 |
Materials |
8-543 |
Partial |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 12/20/2021 |
Biocompatibility |
2-295 |
Partial |
USP-NF |
M98900_01_01 |
<151> Pyrogen Test (USP Rabbit Test) |
| 12/19/2022 |
Biocompatibility |
2-296 |
Partial |
ISO |
10993-10 Fourth edition 2021-11 |
Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| 12/23/2024 |
InVitro Diagnostics |
7-325 |
Partial |
CLSI |
M02 14th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
| 07/15/2019 |
Ophthalmic |
10-116 |
Partial |
ANSI |
Z80.35-2018 (R2023) |
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
| 07/15/2019 |
Nanotechnology |
18-13 |
Partial |
ISO |
TS 18827 First edition 2017-06 |
Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials |
| 12/21/2020 |
General II (ES/
EMC) |
19-36 |
Partial |
IEC |
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ANSI AAMI IEC |
60601-1-2:2014 [Including AMD 1:2021] |
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] |
| 12/19/2022 |
Ophthalmic |
10-132 |
Partial |
ISO |
10942 Third edition 2022-01 |
Ophthalmic instruments - Direct ophthalmoscopes |
| 06/07/2021 |
Ophthalmic |
10-122 |
Partial |
ISO |
10939 Third edition 2017-05 |
Ophthalmic instruments - Slit-lamp microscopes |
| 12/19/2022 |
Biocompatibility |
2-298 |
Partial |
ISO |
10993-18 Second edition 2020-01 Amendment 1 2022-05 |
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]. |
| 12/21/2020 |
Biocompatibility |
2-288 |
Partial |
ISO |
10993-15 Second edition 2019-11 |
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys |
| 05/30/2022 |
Sterility |
14-572 |
Partial |
ANSI AAMI |
ST91:2021 |
Flexible and semi-rigid endoscope processing in health care facilities |
| 06/07/2021 |
Ophthalmic |
10-123 |
Partial |
ISO |
15004-1 Second edition 2020-5 |
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments |
| 12/22/2025 |
Dental/
ENT |
4-354 |
Partial |
ISO |
17730 Third edition 2025-09 |
Dentistry - Fluoride varnishes |
| ANSI ADA |
Standard No. 117-2022 |
Dentistry - Fluoride Varnishes |
| 06/07/2021 |
InVitro Diagnostics |
7-292 |
Partial |
CLSI |
M62 1st Edition |
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-389 |
Partial |
IEC |
60601-2-2 Edition 6.0 2017-03 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ANSI AAMI IEC |
60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 08/21/2017 |
Software/
Informatics |
13-92 |
Partial |
ISO IEEE |
11073-10421 First edition 2012-11-01 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 06/07/2021 |
Cardiovascular |
3-168 |
Partial |
IEEE |
Std 1708-2014 |
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| 01/14/2019 |
Ophthalmic |
10-108 |
Partial |
ISO |
18369-2 Third edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| 12/21/2020 |
Cardiovascular |
3-169 |
Partial |
IEC |
60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ANSI AAMI IEC |
60601-2-4:2010/A1:2018 (Consolidated Text) |
Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1 |
| 12/23/2024 |
Biocompatibility |
2-304 |
Partial |
ASTM |
F2382-24 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 06/07/2021 |
Cardiovascular |
3-129 |
Partial |
ANSI AAMI |
EC53:2013/(R)2020 |
ECG trunk cables and patient leadwires |
| 06/07/2021 |
Biocompatibility |
2-291 |
Partial |
ISO |
10993-23 First edition 2021-01 |
Biological evaluation of medical devices - Part 23: Tests for irritation |
| 07/15/2019 |
Nanotechnology |
18-14 |
Partial |
ISO |
TR 11360 First edition 2010-07-15 |
Nanotechnologies - Methodology for the classification and categorization of nanomaterials |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-361 |
Partial |
ISO |
8536-11 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment |
| 12/23/2016 |
InVitro Diagnostics |
7-268 |
Partial |
CLSI |
EP21 2nd Edition (Replaces EP21-A) |
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| 06/07/2021 |
InVitro Diagnostics |
7-262 |
Partial |
CLSI |
M45 3rd Edition |
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-358 |
Partial |
ISO |
8536-8 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-360 |
Partial |
ISO |
8536-10 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-445 |
Partial |
ASTM |
D5250-19(2023) |
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application |
| 07/06/2020 |
InVitro Diagnostics |
7-296 |
Partial |
CLSI |
EP09c 3rd Edition |
Measurement Procedure Comparison and Bias Estimation Using Patient Samples |
| 12/22/2025 |
Cardiovascular |
3-203 |
Partial |
IEC |
80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| 01/14/2019 |
Sterility |
14-396 |
Partial |
ANSI AAMI |
ST77:2013/(R)2018 |
Containment devices for reusable medical device sterilization |
| 12/23/2016 |
Materials |
8-439 |
Partial |
ASTM |
F3001-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
| 12/20/2021 |
Biocompatibility |
2-294 |
Partial |
USP-NF |
M98834_01_01 |
<88> Biological Reactivity Tests, In Vivo |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-118 |
Partial |
ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 06/07/2021 |
Cardiovascular |
3-166 |
Partial |
ISO |
81060-2 Third edition 2018-11 [Including AMD1:2020] |
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)] |
| 06/07/2021 |
Software/
Informatics |
13-117 |
Partial |
IEEE |
Std 11073-40101-2020 |
Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment. |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-446 |
Partial |
ASTM |
D6319-19(2023) |
Standard Specification for Nitrile Examination Gloves for Medical Application |
| 06/07/2021 |
Biocompatibility |
2-290 |
Partial |
ISO |
TS 37137-1 First edition 2021-03 |
Biological evaluation of absorbable medical devices - Part 1: General requirements. |
| 01/30/2014 |
Sterility |
14-334 |
Partial |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
| ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
| 01/14/2019 |
Ophthalmic |
10-85 |
Partial |
ISO |
11980 Third edition 2012-11-15 Corrected version 2012-12-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
| 01/14/2019 |
Ophthalmic |
10-74 |
Partial |
ISO |
10940 Second edition 2009-08-01 |
Ophthalmic instruments - Fundus cameras |
| 01/14/2019 |
Ophthalmic |
10-86 |
Partial |
ISO |
14729 First edition 2001-04-15 |
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
| 01/14/2019 |
Ophthalmic |
10-93 |
Partial |
ANSI |
Z80.27-2014 (R2025) |
American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| 07/15/2019 |
InVitro Diagnostics |
7-289 |
Partial |
CLSI |
MM17 2nd Edition |
Verification and Validation of Multiplex Nucleic Acid Assays |
| 07/15/2019 |
Ophthalmic |
10-89 |
Partial |
ANSI |
Z80.7-2013 (R2023) |
American National Standard for Ophthalmic Optics - Intraocular Lenses |
| 06/07/2021 |
InVitro Diagnostics |
7-236 |
Partial |
CLSI |
M43-A October 2011 |
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline |
| 12/18/2023 |
Biocompatibility |
2-303 |
Partial |
ISO |
10993-17 Second edition 2023-09 |
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-359 |
Partial |
ISO |
8536-9 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
| 05/29/2024 |
Neurology |
17-19 |
Partial |
ISO |
80601-2-85 Edition 1.0 2021-03 |
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment |
| 06/07/2021 |
Dental/
ENT |
4-276 |
Partial |
ISO |
14457 Second edition 2017-10 |
Dentistry - Handpieces and motors |
| ANSI ADA |
Standard No. 35-2019 |
Dental Handpieces and Motors |
| 07/26/2016 |
Biocompatibility |
2-228 |
Partial |
ISO |
10993-3 Third edition 2014-10-1 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ANSI AAMI ISO |
10993-3:2014 |
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
| 05/29/2024 |
Anesthesiology |
1-179 |
Partial |
ISO |
26782 First edition 2009-07 |
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] |
| 05/29/2023 |
Cardiovascular |
3-185 |
Partial |
ANSI AAMI |
PC76:2021 |
Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging |
| 09/17/2018 |
General II (ES/
EMC) |
19-19 |
Partial |
IEC |
TR 60601-4-2 Edition 1.0 2016-05 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 12/23/2024 |
Cardiovascular |
3-195 |
Partial |
ISO |
5910 Second edition 2024-07 |
Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| 04/04/2016 |
InVitro Diagnostics |
7-259 |
Partial |
CLSI |
GP23-A2 (Replaces GP23-A) |
Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
| 06/27/2016 |
General I (QS/
RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-487 |
Partial |
ANSI AAMI |
PB70:2022 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 07/26/2016 |
Biocompatibility |
2-169 |
Partial |
ISO |
10993-13 Second edition 2010-06-15 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ANSI AAMI ISO |
10993-13:2010/(R)2014 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| 12/18/2023 |
Radiology |
12-348 |
Partial |
IEC |
60601-2-54 Edition 2.0 2022-09 |
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| 12/23/2019 |
ObGyn/
Gastroenterology/
Urology |
9-123 |
Partial |
ISO |
8600-3 Second edition 2019-08 |
Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
| 08/06/2013 |
InVitro Diagnostics |
7-234 |
Partial |
CLSI |
EP24-A2 (Replaces GP 10-A) |
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition |
| 06/07/2018 |
Anesthesiology |
1-134 |
Partial |
ISO |
18562-1 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| 08/06/2013 |
InVitro Diagnostics |
7-243 |
Partial |
CLSI |
M51-A (Replaces M51-P) |
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
| 01/27/2015 |
InVitro Diagnostics |
7-250 |
Partial |
CLSI |
M40-A2 (Reaffirmed: September 2019) |
Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. |
| 01/14/2019 |
InVitro Diagnostics |
7-269 |
Partial |
CLSI |
MM23-1st Edition |
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) |
| 01/14/2019 |
Cardiovascular |
3-52 |
Partial |
ANSI AAMI |
EC12:2000/(R)2015 |
Disposable ECG electrodes |
| 07/26/2016 |
Biocompatibility |
2-243 |
Partial |
ISO |
TR 10993-33 First Edition 2015-03-01 |
Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 |
| 01/30/2014 |
InVitro Diagnostics |
7-210 |
Partial |
CLSI |
H26-A2 |
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
| 08/21/2017 |
InVitro Diagnostics |
7-272 |
Partial |
CLSI |
C57 1st Edition (Reaffirmed: January 2020) |
Mass Spectrometry for Androgen and Estrogen Measurements in Serum |
| 05/29/2024 |
Ophthalmic |
10-134 |
Partial |
ISO |
10943 Fourth edition 2023-01 |
Ophthalmic instruments - Indirect ophthalmoscopes |
| 05/29/2024 |
Ophthalmic |
10-135 |
Partial |
ISO |
11979-7 Fifth edition 2024-01 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-443 |
Partial |
ASTM |
D3577-19 (Reapproved 2023) |
Standard Specification for Rubber Surgical Gloves |
| 07/26/2016 |
Biocompatibility |
2-240 |
Partial |
ANSI AAMI ISO |
TIR 10993-20:2006 |
Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO |
TS 10993-20 First edition 2006-08-01 |
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices |
| 05/29/2024 |
Anesthesiology |
1-173 |
Partial |
ISO |
18562-1 Second edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process |
| 12/18/2023 |
Nanotechnology |
18-24 |
Partial |
ASTM |
E2524-22 |
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles |
| 08/14/2015 |
InVitro Diagnostics |
7-255 |
Partial |
CLSI |
MM09-A2 (Replaces MM09-A) |
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-408 |
Partial |
ISO |
10555-1 Second edition 2013-06-15 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
| 09/17/2018 |
Materials |
8-473 |
Partial |
ASTM |
F2885-17 |
Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications |
| 06/27/2016 |
Radiology |
12-302 |
Partial |
IEC |
60601-2-44 Edition 3.2: 2016 |
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography |
| 01/14/2019 |
Orthopedic |
11-184 |
Partial |
ISO |
8827 First edition 1988-10-15 |
Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-442 |
Partial |
ASTM |
D6977-19(2023) |
Standard Specification for Polychloroprene Examination Gloves for Medical Application |
| 07/15/2019 |
InVitro Diagnostics |
7-290 |
Partial |
CLSI |
EP34 1st Edition |
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-178 |
Partial |
ASTM |
D6124-06(2022) |
Standard Test Method for Residual Powder on Medical Gloves |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
| 07/06/2020 |
Cardiovascular |
3-123 |
Partial |
IEC |
80601-2-30: Edition 2.0 2018-03 |
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ANSI AAMI IEC |
80601-2-30:2018 |
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers |
| 07/15/2019 |
Dental/
ENT |
4-259 |
Partial |
ISO |
14801 Third edition 2016-11-01 |
Dentistry - Implants - Dynamic loading test for endosseous dental implants |
| ANSI ADA |
Standard No. 127-2018 |
Dynamic Loading Test for Endosseous Dental Implants |
| 09/17/2018 |
Anesthesiology |
1-139 |
Partial |
ISO |
80601-2-61 Second edition 2017-12 (Corrected version 2018-02) |
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 12/21/2020 |
General II (ES/
EMC) |
19-38 |
Partial |
IEC |
60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 05/29/2023 |
Dental/
ENT |
4-306 |
Partial |
ISO |
22052 First edition 2020-06 |
Dentistry - Compressed air source equipment |
| ANSI ADA |
Standard No. 94-2021 |
Central Compressed Air Source Equipment |
| 01/14/2019 |
Biocompatibility |
2-258 |
Partial |
ISO |
10993-1 Fifth edition 2018-08 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ANSI AAMI ISO |
10993-1: 2018 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| 12/21/2020 |
Tissue Engineering |
15-64 |
Partial |
ISO |
22442-1 Third edition 2020-09 |
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| 07/26/2016 |
Biocompatibility |
2-237 |
Partial |
ISO |
10993-17 First edition 2002-12-01 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| ANSI AAMI ISO |
10993-17:2002/(R)2012 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| 12/18/2023 |
Cardiovascular |
3-105 |
Partial |
IEC |
60601-2-25 Edition 2.0 2011-10 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| ANSI AAMI IEC |
60601-2-25:2011/(R)2016 |
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| 12/18/2023 |
Cardiovascular |
3-126 |
Partial |
IEC |
60601-2-27 Edition 3.0 2011-03 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] |
| ANSI AAMI IEC |
60601-2-27:2011(R)2016 |
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| 08/06/2013 |
Software/
Informatics |
13-54 |
Partial |
ISO IEEE |
11073-10404 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
| IEEE |
Std 11073-10404-2008 |
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter |
| 08/14/2015 |
Software/
Informatics |
13-73 |
Partial |
IHTSDO |
SNOMED-CT RF2 Release 2015 |
Systematized Nomenclature of Medicine - Clinical Terms |
| 05/29/2024 |
InVitro Diagnostics |
7-321 |
Partial |
CLSI |
MM24 1st Edition |
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
| 01/27/2015 |
Nanotechnology |
18-3 |
Partial |
ISO |
TS 14101 First edition 2012-11-01 |
Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method |
| 04/04/2016 |
Materials |
8-409 |
Partial |
ASTM |
F2924-14 |
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
| 06/27/2016 |
InVitro Diagnostics |
7-264 |
Partial |
CLSI |
MM21-1st Edition (Reaffirmed: January 2020) |
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications |
| 06/07/2018 |
Anesthesiology |
1-137 |
Partial |
ISO |
18562-4 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| 12/18/2023 |
Radiology |
12-353 |
Partial |
ANSI |
Z136.1-2022 |
American National Standard for Safe Use of Lasers |
| 05/29/2024 |
General II (ES/
EMC) |
19-50 |
Partial |
IEC |
TS 60601-4-2 Edition 1.0 2024-03 |
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| 05/29/2024 |
Anesthesiology |
1-167 |
Complete |
CGA |
V-5:2019 |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
| 12/23/2024 |
Anesthesiology |
1-183 |
Complete |
ASTM |
G175-24 |
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications |
| 12/23/2024 |
Anesthesiology |
1-184 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 [Including AMD1:2023] |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor [Including Amendment 1 (2023)]. |
| 01/14/2019 |
Anesthesiology |
1-138 |
Complete |
ISO |
80601-2-74 First edition 2017-05 |
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| 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 |
| 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 |
| 12/20/2021 |
Dental/
ENT |
4-291 |
Complete |
ISO |
28399 First edition 2011-01 |
Dentistry - Products for external tooth bleaching |
| ANSI ADA |
Standard No. 136-2015 (R2020) |
Products for External Tooth Bleaching |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-509 |
Complete |
ASTM |
F3186-24 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-464 |
Complete |
ISO |
11040-4 Third edition 2015-04-01 |
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| 12/22/2025 |
Software/
Informatics |
13-153 |
Complete |
AAMI |
CR515:2025 |
Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices |
| 12/22/2025 |
Cardiovascular |
3-202 |
Complete |
IEC |
60601-2-34 Edition 4.0 2024-10 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| 07/15/2019 |
Orthopedic |
11-350 |
Complete |
ASTM |
F2554-18 |
Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems |
| 05/29/2024 |
Materials |
8-616 |
Complete |
ISO ASTM |
52926-2 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB |
| 05/29/2024 |
Radiology |
12-355 |
Complete |
IEC |
60601-2-57 Edition 2.0 2023-07 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use |
| 05/29/2024 |
Sterility |
14-603 |
Complete |
AAMI |
TIR28:2016/(R)2020 |
Product adoption and process equivalence for ethylene oxide sterilization |
| 12/23/2016 |
Materials |
8-435 |
Complete |
ISO |
5832-1 Fifth edition 2016-07-15 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| 06/07/2021 |
Orthopedic |
11-382 |
Complete |
ASTM |
F3090-20 |
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement |
| 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 |
| 05/29/2024 |
Radiology |
12-354 |
Complete |
NEMA |
MS 4-2023 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 12/23/2024 |
Materials |
8-618 |
Complete |
ASTM |
F1350-24 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
| 04/04/2016 |
Materials |
8-393 |
Complete |
ASTM |
F1350-15 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
| 12/23/2024 |
Materials |
8-625 |
Complete |
ASTM |
F1295-24 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 12/23/2024 |
Materials |
8-623 |
Complete |
ASTM |
F1314-24 |
Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
| 07/15/2019 |
Biocompatibility |
2-266 |
Complete |
ASTM |
F2382-18 |
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) |
| 12/23/2024 |
General I (QS/
RM) |
5-143 |
Complete |
ISO |
14630 Fffth edition 2024-09 |
Non-active surgical implants -- General requirements |
| 05/29/2023 |
Materials |
8-602 |
Complete |
ASTM |
F2503-23 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 07/06/2020 |
Materials |
8-528 |
Complete |
ASTM |
F2503-20 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| 12/18/2023 |
Dental/
ENT |
4-317 |
Complete |
ISO |
8325 Third edition 2023-03 |
Dentistry - Test methods for rotary instruments |
| 12/18/2023 |
InVitro Diagnostics |
7-319 |
Complete |
CLSI |
M23 6th Edition |
Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
| 12/22/2025 |
Dental/
ENT |
4-352 |
Complete |
ANSI ASA |
S3.35-2025 |
American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 05/29/2024 |
Software/
Informatics |
13-132 |
Complete |
ISO IEEE |
11073-10408 Second edition 2022-12 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| IEEE |
Std 11073-10408-2019 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| 12/23/2019 |
Materials |
8-481 |
Complete |
ASTM |
F1314-18 |
Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
| 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 |
| 10/09/2023 |
Software/
Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
| 05/26/2025 |
Radiology |
12-375 |
Complete |
ANSI UL |
122-2019 |
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019] |
| 12/23/2024 |
Materials |
8-621 |
Complete |
ISO |
5832-1 Sixth edition 2024-04 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
| 12/18/2023 |
Dental/
ENT |
4-310 |
Complete |
ISO |
22112 Second edition 2017-08 |
Dentistry - Artificial teeth for dental prostheses |
| ANSI ADA |
Standard No. 15-2021 |
Artificial Teeth for Dental Prostheses |
| 03/16/2012 |
Radiology |
12-232 |
Complete |
NEMA |
MS 4-2010 |
Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices |
| 05/26/2025 |
Radiology |
12-381 |
Complete |
IEC |
60601-2-68 Edition 2.0 2025-02 |
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| 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 |
| 09/17/2018 |
Orthopedic |
11-326 |
Complete |
ASTM |
F384-17 |
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| 05/29/2024 |
Sterility |
14-599 |
Complete |
ISO |
14644-9 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration |
| 01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
| 08/06/2013 |
Software/
Informatics |
13-52 |
Complete |
ISO IEEE |
11073-10408 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer |
| 12/18/2023 |
Dental/
ENT |
4-311 |
Complete |
ISO |
9917-2 Third edition 2017-09 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 12/22/2025 |
Anesthesiology |
1-199 |
Complete |
ISO |
80601-2-70 Third edition 2025-11 |
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| 05/26/2025 |
Anesthesiology |
1-195 |
Complete |
ISO |
80369-2 First edition 2024-09 |
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications |
| 05/29/2023 |
Physical Medicine |
16-235 |
Complete |
ISO |
7176-25 Second Edition 2022 |
Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods |
| 05/29/2023 |
Physical Medicine |
16-236 |
Complete |
ISO |
7176-19 Third Edition 2022 |
Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles |
| 07/26/2016 |
Biocompatibility |
2-222 |
Complete |
ISO |
10993-2 Second edition 2006-07-15 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| ANSI AAMI ISO |
10993-2:2006/(R)2014 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| 12/18/2023 |
Dental/
ENT |
4-320 |
Complete |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| 04/04/2016 |
Software/
Informatics |
13-81 |
Complete |
ISO IEEE |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| IEEE |
Std 11073-10419:2015 |
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
| 08/06/2013 |
Software/
Informatics |
13-56 |
Complete |
ISO IEEE |
11073-10406 First edition 2012-12-01 |
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| IEEE |
Std 11073-10406-2011 |
Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 12/18/2023 |
Orthopedic |
11-403 |
Complete |
ASTM |
F3047M-23 |
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
| 12/18/2023 |
Orthopedic |
11-402 |
Complete |
ASTM |
F1798-21 |
Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| 05/26/2025 |
Sterility |
14-610 |
Complete |
ISO |
11138-7 First edition 2019-03 |
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results |
| 12/18/2023 |
Orthopedic |
11-404 |
Complete |
ASTM |
F2887-23 |
Standard Specification for Total Elbow Prostheses |
| 12/18/2023 |
Orthopedic |
11-405 |
Complete |
ASTM |
F1829-23 |
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| 06/07/2018 |
Anesthesiology |
1-136 |
Complete |
ISO |
18562-3 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds |
| 07/06/2020 |
Software/
Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
| 08/21/2017 |
Biocompatibility |
2-248 |
Complete |
ISO |
10993-4 Third edition 2017-04 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| ANSI AAMI ISO |
10993-4: 2017 |
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood |
| 05/26/2025 |
Cardiovascular |
3-200 |
Complete |
ASTM |
F2477-24 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 07/06/2020 |
Software/
Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
| 05/29/2024 |
Anesthesiology |
1-176 |
Complete |
ISO |
18562-4 Second Edition 2024-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| 06/27/2016 |
Cardiovascular |
3-143 |
Complete |
ISO |
12417-1 First edition 2015-10-01 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 05/29/2024 |
Sterility |
14-601 |
Complete |
ISO |
17665 First edition 2024-03 |
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 05/29/2023 |
InVitro Diagnostics |
7-315 |
Complete |
CLSI |
EP12 3rd Edition |
Evaluation of Qualitative, Binary Output Examination Performance |
| 04/04/2016 |
Cardiovascular |
3-125 |
Complete |
ISO |
5841-3 Third edition 2013-04-15 |
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers |
| 05/26/2025 |
Ophthalmic |
10-137 |
Complete |
ISO |
11979-2 Third edition 2024-10 |
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-483 |
Complete |
IEC |
60601-2-35 Edition 2.0 2020-09 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 08/06/2013 |
Software/
Informatics |
13-53 |
Complete |
ISO IEEE |
11073-10415 First edition 2010-05-01 |
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale |
| 05/29/2024 |
Software/
Informatics |
13-136 |
Complete |
ISO IEEE |
11073-20601 Third Edition 2022-12 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol |
| ISO IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol |
| 05/26/2025 |
Software/
Informatics |
13-148 |
Complete |
IEEE |
Std 11073-10417-2023 |
Health informatics - Device Interoperability Part 10417: Personal health device communication - Device Specialization - Glucose Meter |
| 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 |
| 09/17/2018 |
Cardiovascular |
3-110 |
Complete |
AAMI |
TIR41:2011/(R)2025 |
Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators |
| 12/19/2022 |
Cardiovascular |
3-183 |
Complete |
ISO |
11658 First edition 2012-05-15 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ANSI AAMI ISO |
11658: 2012 |
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| 12/19/2022 |
Orthopedic |
11-394 |
Complete |
ASTM |
F1820-22 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| 05/30/2022 |
Radiology |
12-345 |
Complete |
IEC |
61223-3-7 Edition 1.0 2021-12 |
Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| 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 |
| 12/18/2023 |
Orthopedic |
11-409 |
Complete |
ASTM |
F3495-23 |
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
| 05/26/2025 |
Software/
Informatics |
13-146 |
Complete |
IEEE |
11073-10103 Second edition 2023 |
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
| 03/16/2012 |
Radiology |
12-242 |
Complete |
IEC |
60601-2-57 Edition 1.0 2011-01 |
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| 12/23/2024 |
Materials |
8-619 |
Complete |
ISO |
5832-4 Fourth edition 2024-04 |
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy |
| 12/23/2024 |
Materials |
8-620 |
Complete |
ISO |
5832-11 Third edition 2024-03 |
Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
| 12/23/2024 |
Materials |
8-622 |
Complete |
ASTM |
F2004-24 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
| 09/17/2018 |
Materials |
8-476 |
Complete |
ASTM |
F2004-17 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
| 05/26/2025 |
Neurology |
17-20 |
Complete |
IEC |
60601-2-40 Third edition 2024-12 |
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| 09/17/2018 |
Materials |
8-412 |
Complete |
ASTM |
F2537-06 (Reapproved 2017) |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 12/18/2023 |
Materials |
8-607 |
Complete |
ASTM |
F2082/F2082M-23 |
Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
| 05/26/2025 |
Software/
Informatics |
13-142 |
Complete |
FIRST |
CVSS v3.1 |
Common Vulnerability Scoring System version 3.1 |
| 12/22/2025 |
Radiology |
12-385 |
Complete |
NEMA |
PS 3.1 - 3.20 2025d |
Digital Imaging and Communications in Medicine (DICOM) Set |
| 12/18/2023 |
Sterility |
14-591 |
Complete |
ISO |
14644-10 Second edition 2022-05 |
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination |
| 01/27/2015 |
Sterility |
14-390 |
Complete |
ISO |
14644-10 First edition 2013-03-01 |
Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
| 12/18/2023 |
Sterility |
14-592 |
Complete |
ISO |
13408-1 Third edition 2023-08 |
Aseptic processing of health care products - Part 1: General requirements |
| 12/18/2023 |
Materials |
8-606 |
Complete |
ASTM |
F2537-23 |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
| 01/27/2015 |
Sterility |
14-141 |
Complete |
ISO |
14644-4 First edition 2001-04-01 |
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
| 12/18/2023 |
Sterility |
14-590 |
Complete |
ISO |
14644-8 Third edition 2022-06 |
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) |
| 08/21/2017 |
Dental/
ENT |
4-215 |
Complete |
ANSI ADA |
Standard No. 96-2012 |
Dental Water-based Cements |
| 05/29/2024 |
Sterility |
14-602 |
Complete |
AAMI |
TIR12:2020/(R)2023 |
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers |
| 05/29/2023 |
InVitro Diagnostics |
7-316 |
Complete |
CLSI |
NBS01 7th Edition |
Dried Blood Spot Specimen Collection for Newborn Screening |
| 08/06/2013 |
Software/
Informatics |
13-57 |
Complete |
ISO IEEE |
11073-10407 First edition 2010-05-01 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| IEEE |
Std 11073-10407-2008 |
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-145 |
Complete |
ASTM |
D7661-18 |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| 05/29/2023 |
ObGyn/
Gastroenterology/
Urology |
9-146 |
Complete |
ISO |
8600-4 Third Edition 2023-01 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 01/30/2014 |
Sterility |
14-336 |
Complete |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
| ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
| 08/06/2013 |
Software/
Informatics |
13-44 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| 12/18/2023 |
Orthopedic |
11-407 |
Complete |
ASTM |
F3140-23 |
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements |
| 05/29/2024 |
Software/
Informatics |
13-138 |
Complete |
ISO IEEE |
11073-10700 First Edition 2024-09 |
Health informatics - Device interoperability Part 10700: Point-of-care medical device communication - Standard for base requirements for participants in a Service-oriented Device Connectivity (SDC) system |
| IEEE |
Std 11073-10700-2022 |
Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System |
| 05/29/2024 |
Materials |
8-617 |
Complete |
ISO ASTM |
52926-3 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB |
| 07/15/2019 |
Sterility |
14-528 |
Complete |
ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
| ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
| 12/19/2022 |
Anesthesiology |
1-156 |
Complete |
ISO |
10079-3 Fourth edition 2022-03 |
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| 12/19/2022 |
Anesthesiology |
1-158 |
Complete |
ISO |
10079-4 First edition 2021-08 |
Medical suction equipment - Part 4: General requirements |
| 10/19/2020 |
Software/
Informatics |
13-116 |
Complete |
FIRST |
CVSS v3.0 |
Common Vulnerability Scoring System version 3.0 |
| 05/26/2025 |
Software/
Informatics |
13-145 |
Complete |
IEEE |
Std 11073-10419:2023 |
Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump |
| 05/29/2024 |
Radiology |
12-359 |
Complete |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties |
| 05/29/2024 |
Dental/
ENT |
4-325 |
Complete |
ANSI ADA |
Standard No. 96-2020 |
Dental Water-based Cements |
| 07/15/2019 |
Sterility |
14-531 |
Complete |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| 07/15/2019 |
Sterility |
14-530 |
Complete |
ISO |
11607-1 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ANSI AAMI ISO |
11607-1:2019 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 10/09/2023 |
Software/
Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
| 01/27/2015 |
Sterility |
14-242 |
Complete |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 12/18/2023 |
Sterility |
14-593 |
Complete |
ASTM |
F3039-23 |
Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
| 06/07/2021 |
Ophthalmic |
10-126 |
Complete |
IEC |
80601-2-58 Edition 2.0 2014-09 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| ANSI AAMI IEC |
80601-2-58:2014 |
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)] |
| 05/29/2024 |
Radiology |
12-357 |
Complete |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties |
| 05/29/2024 |
Radiology |
12-358 |
Complete |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display - Part 20-20: Fundamental measurement methods - Image quality |
| 08/21/2017 |
Materials |
8-451 |
Complete |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| 12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 12/18/2023 |
Sterility |
14-596 |
Complete |
ASTM |
F88/F88M-23 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 12/18/2023 |
Sterility |
14-597 |
Complete |
AAMI ANSI |
ST108:2023 |
Water for the processing of medical devices |
| 05/29/2023 |
Physical Medicine |
16-234 |
Complete |
ISO |
7176-14 Third Edition 2022 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
| 05/29/2023 |
Biocompatibility |
2-300 |
Complete |
ISO |
10993-2 Third edition 2022-11 |
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
| 12/18/2023 |
Dental/
ENT |
4-318 |
Complete |
ISO |
20749 Second edition 2023-06 |
Dentistry - Pre-capsulated dental amalgam |
| 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 |
| 12/20/2021 |
Materials |
8-563 |
Complete |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 12/23/2016 |
Materials |
8-441 |
Complete |
ASTM |
F3109-16 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 12/20/2021 |
Software/
Informatics |
13-120 |
Complete |
ANSI AAMI |
2700-1:2019 |
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2022) |
Standard Specification for Silicone Elastomer Facial Implants |
| 05/26/2025 |
Software/
Informatics |
13-140 |
Complete |
FIRST |
CVSS v4.0 |
Common Vulnerability Scoring System version 4.0 |
| 03/16/2012 |
Radiology |
12-142 |
Complete |
ISO |
11146-2 First edition 2005-02-15 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-437 |
Complete |
ISO |
23907-2 First edition 2019-11 |
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. |
| 05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 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 |
| 09/09/2008 |
Sterility |
14-142 |
Complete |
ISO |
14698-1:2003 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
| 03/18/2009 |
InVitro Diagnostics |
7-170 |
Complete |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
| 03/18/2009 |
InVitro Diagnostics |
7-176 |
Complete |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-180 |
Complete |
CLSI |
M34-A (Replaces M24-P) |
Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-182 |
Complete |
CLSI |
M36-A |
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. |
| 03/18/2009 |
InVitro Diagnostics |
7-185 |
Complete |
CLSI |
M41-A |
Viral Culture; Approved Guideline. |
| 03/18/2009 |
General Plastic Surgery/
General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
| 01/14/2019 |
Materials |
8-482 |
Complete |
ASTM |
D1505-18 |
Standard Test Method for Density of Plastics by the Density-Gradient Technique |
| 01/14/2019 |
Dental/
ENT |
4-171 |
Complete |
ANSI ASA |
S3.37-1987 (Reaffirmed 2025) |
American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids |
| 07/15/2019 |
Orthopedic |
11-352 |
Complete |
ISO |
14242-1 Third edition 2014-10-15 |
Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)] |
| 01/14/2019 |
Dental/
ENT |
4-217 |
Complete |
ANSI ASA |
S3.36-2012 (Reaffirmed 2022) |
American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements |
| 12/20/2021 |
Orthopedic |
11-393 |
Complete |
ASTM |
F2724-21 |
Standard Test Method for Evaluating Mobile Bearing Knee Dislocation |
| 12/20/2021 |
Orthopedic |
11-390 |
Complete |
ISO |
23089-2 First edition 2021-05 |
Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices |
| 03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-166 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
| 03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
| 08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
| 08/02/2011 |
Ophthalmic |
10-65 |
Complete |
ISO |
15752 Second edition 2010-01-15 |
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety |
| 01/15/2013 |
General Plastic Surgery/
General Hospital |
6-122 |
Complete |
ISO |
8536-5 Second edition 2004-02-01 |
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 03/16/2012 |
InVitro Diagnostics |
7-227 |
Complete |
CLSI |
M53-A (Replaces M53-P) |
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline |
| 01/15/2013 |
InVitro Diagnostics |
7-233 |
Complete |
CLSI |
EP17-A2 |
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition |
| 05/26/2025 |
Anesthesiology |
1-193 |
Complete |
ISO |
18190 Second edition 2025-02 |
Anaesthetic and respiratory equipment - General requirements for airways and related 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 |
| 12/22/2025 |
Orthopedic |
11-434 |
Complete |
ASTM |
F3018-25 |
Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement |
| 12/18/2023 |
Materials |
8-605 |
Complete |
ASTM |
F1609-23 |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
| 01/27/2015 |
Sterility |
14-379 |
Complete |
ISO |
14644-8 Second edition 2013-02-15 |
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| 08/06/2013 |
Ophthalmic |
10-78 |
Complete |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
| 08/21/2017 |
Tissue Engineering |
15-49 |
Complete |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| 08/06/2013 |
Physical Medicine |
16-190 |
Complete |
ISO |
7176-11 Second edition 2012-12-01 |
Wheelchairs - Part 11: Test dummies |
| 06/07/2018 |
Ophthalmic |
10-107 |
Complete |
ISO |
18369-4 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
| 08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
| 01/30/2014 |
Sterility |
14-401 |
Complete |
ASTM |
F2217/F2217M-13 (Reapproved 2023) |
Standard Practice for Coating/Adhesive Weight Determination |
| 05/30/2022 |
Materials |
8-593 |
Complete |
ISO |
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
Implants for surgery - Hydroxyapatite - Part 6: Powders |
| 05/30/2022 |
Radiology |
12-343 |
Complete |
IEC |
62127-1 Edition 2.0 2022-03 |
Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields |
| 07/09/2014 |
InVitro Diagnostics |
7-213 |
Complete |
CLSI |
GP44-A4 (Formerly H18-A4) |
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
| 12/20/2021 |
Orthopedic |
11-385 |
Complete |
ASTM |
F2345-21 |
Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
| 08/21/2017 |
Orthopedic |
11-175 |
Complete |
ASTM |
F1582-98 (Reapproved 2016) |
Standard Terminology Relating to Spinal Implants |
| 08/21/2017 |
Orthopedic |
11-309 |
Complete |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
| 01/30/2014 |
Radiology |
12-59 |
Complete |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
| 01/30/2014 |
Radiology |
12-264 |
Complete |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
| 06/07/2018 |
Radiology |
12-312 |
Complete |
IEC |
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION |
Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response |
| 06/07/2018 |
Radiology |
12-313 |
Complete |
IEC |
TS 62462 Edition 2.0 2017-07 |
Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems |
| 12/20/2021 |
Materials |
8-573 |
Complete |
ASTM |
F2695-12(2025) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] |
| 12/19/2022 |
General I (QS/
RM) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 12/19/2022 |
General Plastic Surgery/
General Hospital |
6-485 |
Complete |
ISO |
7886-4 Second Edition 2018-11 |
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| 08/06/2013 |
Physical Medicine |
16-192 |
Complete |
ISO |
7176-3 Third edition 2012-12-15 |
Wheelchairs - Part 3: Determination of effectiveness of brakes |
| 04/04/2016 |
Radiology |
12-288 |
Complete |
NEMA |
MS 9-2008 (R2020) |
Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
| 07/09/2014 |
InVitro Diagnostics |
7-175 |
Complete |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
| 07/09/2014 |
Materials |
8-377 |
Complete |
ASTM |
F136-13 |
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| 07/09/2014 |
Orthopedic |
11-277 |
Complete |
ISO |
7206-6 Second edition 2013-11-15 |
Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| 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)] |
| 06/27/2016 |
Dental/
ENT |
4-202 |
Complete |
ANSI ADA |
Standard No. 58-2010 (R2015) |
Root Canal Files, Type H (Hedstrom) |
| 12/23/2016 |
Orthopedic |
11-316 |
Complete |
ASTM |
F1264-16 |
Standard Specification and Test Methods for Intramedullary Fixation Devices |
| 12/22/2025 |
Orthopedic |
11-428 |
Complete |
ASTM |
F1541-24 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 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 |
| 01/30/2014 |
Materials |
8-344 |
Complete |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| 06/27/2016 |
Dental/
ENT |
4-228 |
Complete |
ANSI ASA |
S3.20-2015 (Reaffirmed 2025) |
American National Standard Bioacoustical Terminology |
| 06/07/2018 |
Sterility |
14-510 |
Complete |
ISO |
11137-3 Second edition 2017-06 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ANSI AAMI ISO |
11137-3:2017/(R)2023 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 07/15/2019 |
Ophthalmic |
10-117 |
Complete |
ANSI |
Z80.37-2017 (R2021) |
American National Standard for Ophthalmics - Slit-Lamp Microscopes |
| 01/27/2015 |
Software/
Informatics |
13-72 |
Complete |
ISO IEEE |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
| IEEE |
Std 11073-10425-2014 |
Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM) |
| 05/26/2025 |
Radiology |
12-370 |
Complete |
ISO |
11146-2 Second edition 2021-07 |
Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams |
| 05/26/2025 |
InVitro Diagnostics |
7-342 |
Complete |
CLSI |
AUTO12-A |
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
| 12/20/2021 |
Orthopedic |
11-386 |
Complete |
ASTM |
F2665-21 |
Standard Specification for Total Ankle Replacement Prosthesis |
| 12/19/2022 |
Physical Medicine |
16-233 |
Complete |
ISO |
16840-10 Second edition 2021-06 Corrected version 2022-01 |
Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method |
| 05/29/2023 |
Materials |
8-600 |
Complete |
ASTM |
F1978-22 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
| 05/29/2023 |
Materials |
8-601 |
Complete |
ASTM |
F2516-22 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
| 12/23/2016 |
Materials |
8-440 |
Complete |
ASTM |
F3091/F3091M-14 |
Standard Specification for Powder Bed Fusion of Plastic Materials |
| 08/21/2017 |
Materials |
8-226 |
Complete |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
| 12/04/2017 |
Radiology |
12-307 |
Complete |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
| 08/21/2017 |
Materials |
8-459 |
Complete |
SAE |
AMS2750 Rev. E 2012-07 |
Pyrometry |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-70 |
Complete |
ASTM |
E825-98 (Reapproved 2023) |
Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-124 |
Complete |
ASTM |
E1104-98 (Reapproved 2023) |
Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 08/21/2017 |
Materials |
8-333 |
Complete |
ASTM |
F2393-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-125 |
Complete |
ASTM |
E1965-98 (Reapproved 2023) |
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 12/22/2025 |
Biocompatibility |
2-311 |
Complete |
ISO |
10993-4 Third edition 2017-04 [Including AMD1:2025] |
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)] |
| 12/22/2025 |
Orthopedic |
11-426 |
Complete |
ASTM |
F2943-25 |
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants |
| 09/17/2018 |
Materials |
8-467 |
Complete |
ASTM |
F1978-18 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
| 12/18/2023 |
Anesthesiology |
1-164 |
Complete |
ISO |
5361 Fourth edition 2023-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| 09/09/2008 |
Sterility |
14-239 |
Complete |
ISO |
13408-3 First edition 2006-09-15 |
Aseptic processing of health care products - Part 3: Lyophilization |
| ANSI AAMI ISO |
13408-3:2006/(R)2015 |
Aseptic processing of health care products - Part 3: Lyophilization |
| 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 |
| 12/23/2016 |
Anesthesiology |
1-118 |
Complete |
ISO |
5361 Third edition 2016-09-01 |
Anaesthetic and respiratory equipment - Tracheal tubes and connectors |
| 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 |
| 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 |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 12/23/2016 |
Materials |
8-437 |
Complete |
ASTM |
F2082/F2082M-16 |
Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
| 05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
| 05/29/2023 |
General Plastic Surgery/
General Hospital |
6-486 |
Complete |
ISO |
10535 Third edition 2021-10 |
Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods |
| 12/18/2023 |
Dental/
ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 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 |
| 12/19/2022 |
Nanotechnology |
18-22 |
Complete |
ISO |
17200 First edition 2020-09 |
Nanotechnology - Nanoparticles in powder form - Characteristics and measurements |
| 07/15/2019 |
Materials |
8-506 |
Complete |
ASTM |
F2516-18 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
| 05/29/2023 |
Materials |
8-603 |
Complete |
ASTM |
F1472-23 |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 05/29/2023 |
Biocompatibility |
2-299 |
Complete |
ASTM |
F1904-23 |
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
| 05/29/2023 |
Orthopedic |
11-399 |
Complete |
ASTM |
F1357-23 |
Standard Specification for Articulating Total Wrist Implants |
| 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 |
| 05/30/2022 |
Sterility |
14-579 |
Complete |
ISO |
17664-2 First edition 2021-02 |
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
| 05/30/2022 |
Cardiovascular |
3-181 |
Complete |
ISO |
25539-2 Third edition 2020-09 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
| 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) |
| 05/26/2025 |
Cardiovascular |
3-198 |
Complete |
ISO |
25539-3 Second edition 2024-10 |
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters |
| 09/17/2018 |
Anesthesiology |
1-140 |
Complete |
ISO |
80601-2-55 Second edition 2018-02 |
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 07/26/2016 |
Biocompatibility |
2-213 |
Complete |
ASTM |
F1904-14 |
Standard Practice for Testing the Biological Responses to Particles In Vivo |
| 05/29/2024 |
Sterility |
14-598 |
Complete |
ISO |
14644-3 Second edition 2020-06 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
| 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 |
Dental/
ENT |
4-322 |
Complete |
ISO |
18675 First edition 2022-05 |
Dentistry - Machinable ceramic blanks |
| 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 |
| 12/22/2025 |
Orthopedic |
11-423 |
Complete |
ASTM |
F2267-24 |
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| 05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
| 05/29/2023 |
Dental/
ENT |
4-302 |
Complete |
ISO |
10477 Fourth edition 2020-10 |
Dentistry - Polymer-based crown and veneering materials |
| ANSI ADA |
Standard No. 53-2022 |
Polymer-Based Crown and Veneering Materials |
| 12/19/2022 |
Anesthesiology |
1-155 |
Complete |
ISO |
10079-2 Fourth edition 2022-03 |
Medical suction equipment - Part 2: Manually powered suction equipment |
| 05/26/2025 |
Anesthesiology |
1-194 |
Complete |
ISO |
27427 Fourth edition 2023-07 |
Anaesthetic and respiratory equipment - Nebulizing systems and components |
| 09/17/2018 |
Orthopedic |
11-322 |
Complete |
ASTM |
F1541-17 |
Standard Specification and Test Methods for External Skeletal Fixation Devices |
| 12/21/2020 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
| 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) |
| 07/15/2019 |
Anesthesiology |
1-143 |
Complete |
ISO |
80601-2-79 First edition 2018-07 |
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment |
| 12/19/2022 |
Radiology |
12-346 |
Complete |
ISO |
12005 Third edition 2022-05 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization |
| 12/20/2021 |
InVitro Diagnostics |
7-310 |
Complete |
ISO |
19238 Second edition 2014-02-01 |
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics |
| 12/20/2021 |
InVitro Diagnostics |
7-311 |
Complete |
CLSI |
EP39, 1st Edition |
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 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 |
| 12/20/2021 |
Materials |
8-568 |
Complete |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
| 12/20/2021 |
Materials |
8-569 |
Complete |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 12/20/2021 |
General Plastic Surgery/
General Hospital |
6-471 |
Complete |
USP-NF |
M88880_05_01 |
Sterile Water for Irrigation |
| 12/20/2021 |
Sterility |
14-571 |
Complete |
ISO |
11138-8 First edition 2021-07 |
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator |
| 12/23/2016 |
InVitro Diagnostics |
7-267 |
Complete |
CLSI |
C24 4th Edition (Replaces C24-A3) |
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
| 12/22/2025 |
Biocompatibility |
2-312 |
Complete |
ASTM |
F720-24 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
| 09/17/2018 |
Biocompatibility |
2-256 |
Complete |
ASTM |
F720-17 |
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
| 12/22/2025 |
Orthopedic |
11-429 |
Complete |
ASTM |
F366-24 |
Standard Specification for Fixation Pins and Wires |
| 09/17/2018 |
Orthopedic |
11-324 |
Complete |
ASTM |
F366-17 |
Standard Specification for Fixation Pins and Wires |
| 05/29/2023 |
Dental/
ENT |
4-300 |
Complete |
ISO |
22674 Third edition 2022-08 |
Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA |
Standard No. 134-2023 |
Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances |
| 12/20/2021 |
Physical Medicine |
16-232 |
Complete |
IEC |
80601-2-78 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| 05/30/2022 |
Materials |
8-584 |
Complete |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 12/22/2025 |
Orthopedic |
11-430 |
Complete |
ASTM |
F564-24 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 09/17/2018 |
Orthopedic |
11-325 |
Complete |
ASTM |
F564-17 |
Standard Specification and Test Methods for Metallic Bone Staples |
| 07/06/2020 |
Cardiovascular |
3-165 |
Complete |
ASTM |
F1841-19 |
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps |
| 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 |
| 05/29/2023 |
Dental/
ENT |
4-301 |
Complete |
ISO |
21563 Second edition 2021-08 |
Dentistry - Hydrocolloid impression materials |
| ANSI ADA |
Standard No. 128-2022 |
Hydrocolloid Impression Materials |
| 01/14/2019 |
Orthopedic |
11-343 |
Complete |
ASTM |
F2346-18 |
Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| 08/21/2017 |
Orthopedic |
11-242 |
Complete |
ASTM |
F1839-08 (Reapproved 2021) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 01/30/2014 |
Materials |
8-358 |
Complete |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| 05/26/2025 |
InVitro Diagnostics |
7-333 |
Complete |
CLSI |
AUTO04-A |
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-334 |
Complete |
CLSI |
AUTO05-A |
Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 05/26/2025 |
InVitro Diagnostics |
7-335 |
Complete |
CLSI |
POCT01-A2 |
Point-of-Care Connectivity - Second Edition |
| 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 |
| 05/26/2025 |
InVitro Diagnostics |
7-336 |
Complete |
CLSI |
LIS02-A2 |
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. |
| 05/26/2025 |
InVitro Diagnostics |
7-340 |
Complete |
CLSI |
LIS01-A2 |
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition. |
| 05/26/2025 |
InVitro Diagnostics |
7-338 |
Complete |
CLSI |
AUTO10-A |
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| 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 |
| 01/14/2019 |
Anesthesiology |
1-117 |
Complete |
ISO |
5366 First edition 2016-10-01 |
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
| 05/26/2025 |
InVitro Diagnostics |
7-341 |
Complete |
CLSI |
AUTO03-A2 |
Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition |
| 05/26/2025 |
InVitro Diagnostics |
7-343 |
Complete |
CLSI |
AUTO07-A |
Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
| 08/21/2017 |
Dental/
ENT |
4-232 |
Complete |
ISO |
20795-1 Second edition 2013-03-01 |
Dentistry - Base polymers - Part 1: Denture base polymers |
| 12/21/2020 |
Biocompatibility |
2-280 |
Complete |
ASTM |
F1408-20a |
Standard Practice for Subcutaneous Screening Test for Implant Materials |
| 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 |
| 08/06/2013 |
Dental/
ENT |
4-204 |
Complete |
ANSI ASA |
S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025) |
American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard) |
| 01/27/2015 |
Dental/
ENT |
4-185 |
Complete |
ANSI ASA |
S3.45-2009 (Reaffirmed 2024) |
American National Standard Procedures for Testing Basic Vestibular Function |
| 07/09/2014 |
Dental/
ENT |
4-211 |
Complete |
ANSI ASA |
S3.46-2013 (Reaffirmed 2023) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
| 12/19/2007 |
Radiology |
12-173 |
Complete |
ISO |
14880-4:2006 |
Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties |
| 12/23/2016 |
General II (ES/
EMC) |
19-20 |
Complete |
IEEE ANSI |
C63.16-2016 (Revision of ANSI C63.16-1993) |
American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment |
| 08/06/2013 |
Software/
Informatics |
13-59 |
Complete |
ISO IEC IEEE |
15026-4 First edition 2021-10-01 |
Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle |
| 12/04/2017 |
Software/
Informatics |
13-99 |
Complete |
ISO IEC |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| 12/23/2024 |
Orthopedic |
11-418 |
Complete |
ASTM |
F3631-24 |
Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
|
| 12/21/2020 |
Nanotechnology |
18-18 |
Complete |
ASTM |
E3247-20 |
Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering |
| 12/21/2020 |
Materials |
8-552 |
Complete |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 01/14/2019 |
InVitro Diagnostics |
7-178 |
Complete |
CLSI |
M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 |
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition |
| 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 |
| 12/23/2024 |
Cardiovascular |
3-193 |
Complete |
ISO |
12417-1 Second edition 2024-02 |
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-512 |
Complete |
IEC |
60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use |
| 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 |
Software/
Informatics |
13-144 |
Complete |
ISO IEEE |
11073-10425 Edition 3, 2024-09 |
Health informatics - Device interoperability Part 10425: Personal health device communication - Device specialization - Continuous Glucose Monitor (CGM) |
| IEEE |
Std 11073-10425-2023 |
Health informatics - Device Interoperability Part 10425: Personal Health Device Communication - Device Specialization - Continuous Glucose Monitor (CGM) |
| 12/22/2025 |
Dental/
ENT |
4-348 |
Complete |
ISO |
9917-1 Third Edition 2025-05 |
Dentistry - Water-based cements - Part 1: Acid-base cements |
| 05/26/2025 |
General Plastic Surgery/
General Hospital |
6-510 |
Complete |
IEC |
80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| 12/23/2019 |
General Plastic Surgery/
General Hospital |
6-438 |
Complete |
IEC |
80601-2-77 Edition 1.0 2019-07 |
Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT |
| ANSI AAMI IEC |
80601-2-77:2020 |
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment |
| 05/26/2025 |
Software/
Informatics |
13-147 |
Complete |
IEEE |
Std 11073-10406-2023 |
Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 08/21/2017 |
Software/
Informatics |
13-90 |
Complete |
ISO IEEE |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
| IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
| 07/15/2019 |
Anesthesiology |
1-144 |
Complete |
ISO |
80601-2-80 First edition 2018-07 |
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency |
| 01/30/2014 |
Dental/
ENT |
4-153 |
Complete |
ISO |
9917-1 Second edition 2007-10-01 |
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements |
| 12/22/2025 |
General I (QS/
RM) |
5-147 |
Complete |
ISO |
80369-1 Third edition 2025-10 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 01/14/2019 |
General I (QS/
RM) |
5-121 |
Complete |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 12/22/2025 |
General I (QS/
RM) |
5-148 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 [Including AMD1: 2025] |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)] |
| 12/20/2021 |
General I (QS/
RM) |
5-134 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 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 |
| 12/22/2025 |
Dental/
ENT |
4-362 |
Complete |
ISO |
3630-3 Third edition 2021-06 Corrected version 2023-05 |
Dentistry - Endodontic instruments - Part 3: Compactors |
| ANSI ADA |
Standard No. 71-2022 |
Dentistry - Endodontic Instruments: Compactors |
| 05/29/2023 |
Cardiovascular |
3-184 |
Complete |
ASTM |
F2477-23 |
Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses |
| 05/26/2025 |
Orthopedic |
11-420 |
Complete |
ASTM |
F2580-24 |
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses |
| 01/14/2019 |
Orthopedic |
11-344 |
Complete |
ASTM |
F2580-18 |
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| 12/22/2025 |
General Plastic Surgery/
General Hospital |
6-514 |
Complete |
ISO |
1135-4 Seventh edition 2025-05 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-384 |
Complete |
ISO |
1135-4 Sixth edition 2015-12-01 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
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