Recognized Consensus Standards: Medical Devices

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Date of Entry	Specialty Task Group Area	Recognition Number	Extent of Recognition	Standards Developing Organization	Standard Designation Number and Date	Standard Title (click for recognition information)
05/29/2023	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
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
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)]
12/18/2023	Cardiovascular	3-126	Partial	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
12/18/2023	Nanotechnology	18-24	Partial	ASTM	E2524-22	Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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
08/06/2013	Software/ Informatics	13-54	Partial	IEEE	Std 11073-10404-2008	Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
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)]
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)
06/07/2018	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
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
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020	General Plastic Surgery/ General Hospital	6-178	Partial	ASTM	D6124-06(2022)	Standard Test Method for Residual Powder on Medical Gloves
05/29/2023	InVitro Diagnostics	7-317	Partial	CLSI	M100 33rd, Edition	Performance Standards for Antimicrobial Susceptibility Testing
05/26/2025	InVitro Diagnostics	7-328	Partial	CLSI	M100 35th Edition	Performance Standards for Antimicrobial Susceptibility Testing
12/23/2024	InVitro Diagnostics	7-327	Partial	CLSI	M100 34th Edition	Performance Standards for Antimicrobial Susceptibility Testing
12/20/2021	Biocompatibility	2-294	Partial	USP-NF	M98834_01_01	<88> Biological Reactivity Tests, In Vivo
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
01/14/2019	Ophthalmic	10-108	Partial	ISO	18369-2 Third edition 2017-08	Ophthalmic optics - Contact lenses - Part 2: Tolerances
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
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
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
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
07/26/2016	Biocompatibility	2-240	Partial	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
05/30/2022	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
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
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-118	Partial	ANSI AAMI ISO	8637-1:2017	Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
01/14/2019	InVitro Diagnostics	7-269	Partial	CLSI	MM23-1st Edition	Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
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
05/26/2025	Neurology	17-21	Partial	ASTM	F647-22	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
04/04/2016	Materials	8-409	Partial	ASTM	F2924-14	Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
05/26/2025	Ophthalmic	10-96	Partial	ANSI	Z80.10-2014	American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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)
05/26/2025	InVitro Diagnostics	7-330	Partial	CLSI	M38M51S 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
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
01/14/2019	Biocompatibility	2-258	Partial	ANSI AAMI ISO	10993-1: 2018	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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
09/17/2018	Materials	8-473	Partial	ASTM	F2885-17	Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
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
07/26/2016	Biocompatibility	2-228	Partial	ANSI AAMI ISO	10993-3:2014	Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
12/20/2021	Biocompatibility	2-295	Partial	USP-NF	M98900_01_01	<151> Pyrogen Test (USP Rabbit Test)
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
12/18/2023	InVitro Diagnostics	7-320	Partial	CLSI	H62 1st Edition	Validation of Assays Performed by Flow Cytometry
12/18/2023	General Plastic Surgery/ General Hospital	6-497	Partial	ASTM	D7866-23	Standard Specification for Radiation Attenuating Protective Gloves
07/15/2019	Nanotechnology	18-14	Partial	ISO	TR 11360 First edition 2010-07-15	Nanotechnologies - Methodology for the classification and categorization of nanomaterials
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
12/19/2022	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)].
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
01/27/2015	Software/ Informatics	13-71	Partial	RII	Version 2.48	Logical Observation Identifiers Names and Codes (LOINC)
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
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
12/22/2025	Orthopedic	11-433	Partial	ASTM	F2028-25a	Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
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
06/07/2021	Ophthalmic	10-122	Partial	ISO	10939 Third edition 2017-05	Ophthalmic instruments - Slit-lamp microscopes
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
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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
07/26/2016	Biocompatibility	2-169	Partial	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
01/14/2019	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
08/14/2015	Neurology	17-4	Partial	ASTM	F647-94 (Reapproved 2014)	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
12/18/2023	Dental/ ENT	4-319	Partial	ISO	17730 Second edition 2020-09	Dentistry - Fluoride varnishes
12/18/2023	Dental/ ENT	4-319	Partial	ANSI ADA	Standard No. 117-2022	Dentistry - Fluoride Varnishes
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
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
12/23/2024	InVitro Diagnostics	7-325	Partial	CLSI	M02 14th Edition	Performance Standards for Antimicrobial Disk Susceptibility Tests
12/22/2025	Dental/ ENT	4-354	Partial	ISO	17730 Third edition 2025-09	Dentistry - Fluoride varnishes
12/22/2025	Dental/ ENT	4-354	Partial	ANSI ADA	Standard No. 117-2022	Dentistry - Fluoride Varnishes
12/20/2021	Cardiovascular	3-174	Partial	ISO	5840-1 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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
12/20/2021	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
05/30/2022	Sterility	14-572	Partial	ANSI AAMI	ST91:2021	Flexible and semi-rigid endoscope processing in health care facilities
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
12/21/2020	General II (ES/ EMC)	19-36	Partial	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
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
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
07/06/2020	General Plastic Surgery/ General Hospital	6-440	Partial	ASTM	D3578-19(2023)	Standard Specification for Rubber Examination Gloves
12/21/2020	Materials	8-543	Partial	ASTM	F755-19	Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
12/19/2022	InVitro Diagnostics	7-314	Partial	CLSI	M27M44S, 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Yeasts
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)
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
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
12/21/2020	Cardiovascular	3-169	Partial	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
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
06/07/2021	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
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.
07/06/2020	InVitro Diagnostics	7-296	Partial	CLSI	EP09c 3rd Edition	Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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
12/22/2025	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
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.
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
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	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
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
06/07/2021	InVitro Diagnostics	7-236	Partial	CLSI	M43-A October 2011	Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
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
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
06/07/2021	Dental/ ENT	4-276	Partial	ISO	14457 Second edition 2017-10	Dentistry - Handpieces and motors
06/07/2021	Dental/ ENT	4-276	Partial	ANSI ADA	Standard No. 35-2019	Dental Handpieces and Motors
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
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
01/14/2019	Sterility	14-396	Partial	ANSI AAMI	ST77:2013/(R)2018	Containment devices for reusable medical device sterilization
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	Orthopedic	11-348	Partial	ISO	19227 First edition 2018-03	Implants for surgery - Cleanliness of orthopedic implants - General requirements
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
07/06/2020	Cardiovascular	3-123	Partial	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
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)]
01/14/2019	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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
01/30/2014	Sterility	14-334	Partial	ANSI AAMI ISO	15882:2008/(R)2013	Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
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
12/23/2024	Cardiovascular	3-195	Partial	ISO	5910 Second edition 2024-07	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
09/21/2016	InVitro Diagnostics	7-265	Partial	CLSI	C62-A	Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
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
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
07/15/2019	Ophthalmic	10-116	Partial	ANSI	Z80.35-2018 (R2023)	American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
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
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
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
07/26/2016	Biocompatibility	2-237	Partial	ANSI AAMI ISO	10993-17:2002/(R)2012	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-143	Partial	ISO	20696 First edition 2018-06; Corrected 2019-12	Sterile urethral catheters for single use
05/29/2024	Ophthalmic	10-134	Partial	ISO	10943 Fourth edition 2023-01	Ophthalmic instruments - Indirect ophthalmoscopes
05/29/2023	Dental/ ENT	4-306	Partial	ISO	22052 First edition 2020-06	Dentistry - Compressed air source equipment
05/29/2023	Dental/ ENT	4-306	Partial	ANSI ADA	Standard No. 94-2021	Central Compressed Air Source 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
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
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	General Plastic Surgery/ General Hospital	6-446	Partial	ASTM	D6319-19(2023)	Standard Specification for Nitrile Examination Gloves for Medical Application
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
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
05/29/2023	Dental/ ENT	4-305	Partial	ISO	10637 Second edition 2018-05	Dentistry - Central suction source equipment
05/29/2023	Dental/ ENT	4-305	Partial	ANSI ADA	Standard No. 177-2020	Central Suction Source 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
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
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
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
05/29/2023	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
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]
07/06/2020	General Plastic Surgery/ General Hospital	6-443	Partial	ASTM	D3577-19 (Reapproved 2023)	Standard Specification for Rubber Surgical Gloves
01/27/2015	InVitro Diagnostics	7-250	Partial	CLSI	M40-A2 (Reaffirmed: September 2019)	Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
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
05/29/2024	InVitro Diagnostics	7-321	Partial	CLSI	MM24 1st Edition	Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
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
12/23/2019	Cardiovascular	3-163	Partial	ISO	18242 First edition 2016-09-01	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
12/18/2023	Radiology	12-353	Partial	ANSI	Z136.1-2022	American National Standard for Safe Use of Lasers
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
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
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)]
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
07/15/2019	InVitro Diagnostics	7-290	Partial	CLSI	EP34 1st Edition	Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
06/07/2018	Neurology	17-1	Partial	AAMI	NS28:1988/(R) 2015	Intracranial pressure monitoring devices
07/15/2019	Ophthalmic	10-89	Partial	ANSI	Z80.7-2013 (R2023)	American National Standard for Ophthalmic Optics - Intraocular Lenses
07/15/2019	Dental/ ENT	4-259	Partial	ISO	14801 Third edition 2016-11-01	Dentistry - Implants - Dynamic loading test for endosseous dental implants
07/15/2019	Dental/ ENT	4-259	Partial	ANSI ADA	Standard No. 127-2018	Dynamic Loading Test for Endosseous Dental Implants
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
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-133	Partial	ANSI AAMI ISO	23500-1:2019	Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
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
12/18/2023	Cardiovascular	3-105	Partial	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
12/21/2020	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
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
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
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
08/21/2017	InVitro Diagnostics	7-272	Partial	CLSI	C57 1st Edition (Reaffirmed: January 2020)	Mass Spectrometry for Androgen and Estrogen Measurements in Serum
01/30/2014	InVitro Diagnostics	7-210	Partial	CLSI	H26-A2	Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
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
08/14/2015	Software/ Informatics	13-73	Partial	IHTSDO	SNOMED-CT RF2 Release 2015	Systematized Nomenclature of Medicine - Clinical Terms
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)]
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.
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
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-140	Partial	ANSI AAMI ISO	8637-2:2018	Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
09/11/2023	Orthopedic	11-401	Complete	ISO	21535 Third edition 2023-07	Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
12/18/2023	Cardiovascular	3-189	Complete	ASTM	F2942-19	Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
10/04/2004	InVitro Diagnostics	7-104	Complete	CLSI	H7-A3	Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-148	Complete	ISO CIE	11664-6 Second edition 2022-08	Colorimetry - Part 6: CIEDE2000 colour-difference formula
05/29/2023	Radiology	12-351	Complete	IEC	60601-2-43 Edition 3.0 2022-12	Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
05/29/2024	Anesthesiology	1-167	Complete	CGA	V-5:2019	Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
09/09/2024	Sterility	14-605	Complete	ISO	13004 First edition 2022-10	Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
09/09/2024	Sterility	14-605	Complete	ANSI AAMI ISO	13004:2022	Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
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
07/15/2019	Anesthesiology	1-126	Complete	ISO	11712 First edition 2009-05-15	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
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
03/16/2012	Ophthalmic	10-70	Complete	ISO	10943 Third edition 2011-08-15	Ophthalmic instruments - Indirect ophthalmoscopes
04/04/2016	Sterility	14-333	Complete	ISO	17665-1 First edition 2006-08-15	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-333	Complete	ANSI AAMI ISO	17665-1:2006/(R)2013	Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
05/29/2023	General Plastic Surgery/ General Hospital	6-488	Complete	ASTM	F1671/F1671M-22	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
12/22/2025	InVitro Diagnostics	7-346	Complete	CLSI	EP32 2nd Edition	Implementation of Metrological Traceability in Laboratory Medicine
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
10/04/2010	Radiology	12-215	Complete	IEC	62494-1 Edition 1.0 (2008-08)	Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
08/20/2012	Cardiovascular	3-104	Complete	ASTM	F2914-12 (Reapproved 2018)	Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
08/06/2013	ObGyn/ Gastroenterology/ Urology	9-31	Complete	ANSI AAMI	ID54:1996/(R)2012	Enteral feeding set adapters and connectors
08/14/2015	Software/ Informatics	13-74	Complete	IEEE	Std 11073-10424-2014	Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
01/30/2014	Sterility	14-397	Complete	AOAC	6.2.04:2013	Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
09/17/2018	Biocompatibility	2-255	Complete	ISO	10993-11 Third edition 2017-09	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018	Biocompatibility	2-255	Complete	ANSI AAMI ISO	10993-11: 2017	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
12/22/2025	InVitro Diagnostics	7-347	Complete	CLSI	EP21 3rd Edition	Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
12/22/2025	InVitro Diagnostics	7-351	Complete	CLSI	EP46 1st Edition	Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
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
12/23/2016	Materials	8-442	Complete	ASTM	F3127-16	Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
08/14/2015	Sterility	14-463	Complete	ISO ASTM	51608 Second edition 2015-03-15	Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
06/07/2018	General Plastic Surgery/ General Hospital	6-270	Complete	ASTM	F1840-10 (Reapproved 2023)	Standard Terminology for Surgical Suture Needles
07/15/2019	Tissue Engineering	15-57	Complete	ASTM	F2315-18	Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
05/26/2025	General Plastic Surgery/ General Hospital	6-511	Complete	ISO	11040-4 Fourth edition 2024-06	Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
05/26/2025	ObGyn/ Gastroenterology/ Urology	9-151	Complete	ASTM	F1828-22	Standard Specification for Ureteral Stents
01/14/2019	Biocompatibility	2-145	Complete	ASTM	F1439-03 (Reapproved 2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
05/29/2024	Anesthesiology	1-174	Complete	ISO	18562-2 Second edition 2024-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
01/25/2013	Cardiovascular	3-89	Complete	ISO	27186 First edition 2010-03-15	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/25/2013	Cardiovascular	3-89	Complete	ANSI AAMI ISO	27186:2010	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
09/17/2018	Orthopedic	11-336	Complete	ISO	17853 Third edition 2011-03-01	Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
08/21/2017	Orthopedic	11-269	Complete	ASTM	F2423-11 (Reapproved 2020)	Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
08/21/2017	Biocompatibility	2-246	Complete	ASTM	F1877-16	Standard Practice for Characterization of Particles
12/23/2024	Cardiovascular	3-194	Complete	ISO	7199 Fourth edition 2024-09	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
05/29/2023	Nanotechnology	18-23	Complete	ASTM	E3025-22	Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles
01/30/2014	Neurology	17-12	Complete	ISO	7197 Third edition 2006-06-01	Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
08/14/2015	Sterility	14-465	Complete	ISO ASTM	51707 Third edition 2015-03-15	Guide for estimating uncertainties in dosimetry for radiation processing
01/14/2019	Orthopedic	11-343	Complete	ASTM	F2346-18	Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
12/23/2019	Materials	8-499	Complete	ASTM	F1580-18	Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
09/17/2018	Orthopedic	11-327	Complete	ASTM	F543-17	Standard Specification and Test Methods for Metallic Medical Bone Screws
12/23/2024	Orthopedic	11-415	Complete	ASTM	F2554-22	Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems
05/29/2024	Software/ Informatics	13-134	Complete	ISO IEEE	11073-10404 Second edition 2022-12	Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
05/29/2024	Software/ Informatics	13-134	Complete	IEEE	Std 11073-10404-2020	Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
05/29/2023	Anesthesiology	1-161	Complete	ISO	16628 Second edition 2022-06	Anaesthetic and respiratory equipment - Tracheobronchial tubes
08/06/2013	Software/ Informatics	13-42	Complete	ANSI AAMI IEC	TIR 80001-2-2:2012	Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
08/06/2013	Software/ Informatics	13-42	Complete	IEC	TR 80001-2-2 Edition 1.0 2012-07	Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
04/04/2016	Tissue Engineering	15-24	Complete	ASTM	F2721-09 (Reapproved 2014)	Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
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
05/29/2024	Software/ Informatics	13-132	Complete	IEEE	Std 11073-10408-2019	Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
01/14/2019	Tissue Engineering	15-47	Complete	ISO	22442-3 First edition 2007-12-15	Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
12/21/2020	Anesthesiology	1-147	Complete	ISO	26825 Second edition 2020-10	Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
12/23/2019	Physical Medicine	16-218	Complete	RESNA ANSI	WC-1:2019 Section 13	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of Coefficient of Friction of Test Surfaces
12/23/2024	Cardiovascular	3-197	Complete	ISO	25539-4 First edition 2021-11	Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
01/14/2019	InVitro Diagnostics	7-232	Complete	CLSI	MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17	Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
07/15/2019	Sterility	14-529	Complete	ISO	11135 Second edition 2014-07-15	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
07/15/2019	Sterility	14-529	Complete	ANSI AAMI ISO	11135:2014/A1:2018	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
01/14/2019	Nanotechnology	18-11	Complete	ISO	TR 13121 First edition 2011-05-15	Nanotechnologies - Nanomaterial risk evaluation
12/23/2019	Physical Medicine	16-223	Complete	RESNA ANSI	WC-1:2019 Section 22	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
12/22/2025	Dental/ ENT	4-364	Complete	ISO	3990 First edition 2023-07	Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials
12/22/2025	Materials	8-635	Complete	ASTM	F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
12/22/2025	Materials	8-638	Complete	ASTM	F2313-24	Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
12/20/2021	Dental/ ENT	4-286	Complete	ANSI ADA	Standard No. 87-1995 (R2014)	Dental Impression Trays
05/30/2022	Materials	8-586	Complete	ASTM	F2989-21	Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
12/18/2023	Dental/ ENT	4-315	Complete	ISO	24234 Third edition 2021-08	Dentistry - Dental Amalgam
07/06/2020	Materials	8-534	Complete	ISO ASTM	52911-1: First Edition 2019-07	Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals
07/06/2020	Materials	8-535	Complete	ISO ASTM	52911-2: First Edition 2019-09	Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
07/06/2020	Materials	8-536	Complete	ISO ASTM	52902:First Edition 2019-07	Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
12/23/2019	Materials	8-523	Complete	ASTM	F3275-19	Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
12/23/2019	Materials	8-524	Complete	ASTM	F3276-19	Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
12/22/2025	Orthopedic	11-435	Complete	ASTM	F3292-25	Standard Practice for Inspection of Spinal Implants Undergoing Testing
12/22/2025	Materials	8-644	Complete	ASTM	F2848-25	Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/22/2025	Orthopedic	11-439	Complete	ASTM	F3437-23	Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
12/19/2022	Software/ Informatics	13-123	Complete	ANSI NEMA	HN 1-2019	American National Standard Manufacturer Disclosure Statement for Medical Device Security
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
05/26/2025	Orthopedic	11-421	Complete	ASTM	F2077-24	Standard Test Methods for Intervertebral Body Fusion Devices
01/14/2019	Orthopedic	11-347	Complete	ASTM	F2077-18	Test Methods for Intervertebral Body Fusion Devices
07/06/2020	Tissue Engineering	15-61	Complete	ASTM	F2150-19	Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
07/06/2020	Orthopedic	11-363	Complete	ASTM	F897-19	Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
12/20/2021	Nanotechnology	18-19	Complete	ISO	19749 First edition 2021-07	Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
12/23/2024	Anesthesiology	1-187	Complete	ISO	80601-2-12 Third edition 2023-11	Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
12/20/2021	Materials	8-570	Complete	ASTM	F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021	Materials	8-571	Complete	ASTM	F2052-21	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
12/19/2022	Anesthesiology	1-155	Complete	ISO	10079-2 Fourth edition 2022-03	Medical suction equipment - Part 2: Manually powered suction equipment
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
01/14/2019	InVitro Diagnostics	7-285	Complete	CLSI	M48-A 2nd Edition	Laboratory Detection and Identification of Mycobacteria
07/06/2020	InVitro Diagnostics	7-297	Complete	ISO	TS 20914 First edition 2019-07	Medical laboratories - Practical guidance for the estimation of measurement uncertainty
05/26/2025	Orthopedic	11-422	Complete	ASTM	F1798-24	Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
12/23/2024	Sterility	14-606	Complete	ANSI AAMI	ST24:2024	General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
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
01/14/2019	Radiology	12-322	Complete	NEMA	MS 5-2018	Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
07/06/2020	Tissue Engineering	15-63	Complete	ASTM	F2739-19	Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
07/06/2020	Orthopedic	11-365	Complete	ASTM	F1800-19 e1	Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
12/22/2025	Materials	8-630	Complete	ASTM	F90-24	Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
12/22/2025	Dental/ ENT	4-353	Complete	ISO	20127 Third edition 2025-05	Dentistry - Physical properties of powered toothbrushes
12/22/2025	General Plastic Surgery/ General Hospital	6-517	Complete	ASTM	F3502-25	Standard Specification for Barrier Face Coverings
09/17/2018	Materials	8-475	Complete	ASTM	F2026-17	Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
01/30/2014	Sterility	14-427	Complete	ISO	13408-1 Second edition 2008-06-15	Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
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
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
01/30/2014	Sterility	14-336	Complete	ANSI AAMI ISO	14161-2009/(R)2014	Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
12/21/2020	Sterility	14-554	Complete	ASTM	F17-20	Standard Terminology Relating to Flexible Barrier Packaging
07/06/2020	Sterility	14-539	Complete	ASTM	F2475-20	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
07/06/2020	Materials	8-529	Complete	ASTM	F2633-19	Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
12/22/2025	Anesthesiology	1-197	Complete	ISO	17510 Second Edition 2025-11	Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
12/18/2023	Dental/ ENT	4-314	Complete	ISO	7494-2 Third edition 2022-07	Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
12/18/2023	InVitro Diagnostics	7-318	Complete	CLSI	EP25 2nd Edition	Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
05/26/2025	Sterility	14-611	Complete	ISO	11137-1 Second edition 2025-04	Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
07/15/2019	General Plastic Surgery/ General Hospital	6-421	Complete	ISO	80601-2-56 Second edition 2017-03 [Including AMD1:2018]	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
12/21/2020	Dental/ ENT	4-266	Complete	ISO	19023 First edition 2018-02	Dentistry - Orthodontic anchor screws
12/21/2020	Dental/ ENT	4-266	Complete	ANSI ADA	Standard No. 178-2019	Orthodontic Anchor Screws
12/21/2020	Dental/ ENT	4-268	Complete	ISO	15841 Second edition 2014-08	Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
12/21/2020	Dental/ ENT	4-268	Complete	ANSI ADA	Standard No. 32-2017	Orthodontic Wires
07/15/2019	Orthopedic	11-357	Complete	ISO	15142-3 First edition 2003-08-01	Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
07/06/2020	Sterility	14-549	Complete	ASTM	F3004-13 (Reapproved 2020)	Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/06/2020	Anesthesiology	1-146	Complete	ISO	80601-2-12 Second edition 2020-02	Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
09/11/2023	Orthopedic	11-400	Complete	ISO	21536 Third edition 2023-07	Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
05/29/2023	Sterility	14-585	Complete	AAMI ISO	TIR16775:2023	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
05/29/2023	Sterility	14-585	Complete	ISO	TS 16775 Second edition 2021-11	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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)]
07/15/2019	Sterility	14-528	Complete	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)]
12/21/2020	Biocompatibility	2-280	Complete	ASTM	F1408-20a	Standard Practice for Subcutaneous Screening Test for Implant Materials
07/06/2020	Orthopedic	11-367	Complete	ISO	14243-3 Second edition 2014-11-01	Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/15/2019	General I (QS/ RM)	5-123	Complete	ISO	80369-3 First Edition 2016-07-01	Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
12/21/2020	Anesthesiology	1-149	Complete	ISO	7376 Third edition 2020-08	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
07/28/2025	General II (ES/ EMC)	19-57	Complete	IEC	61326-2-6 Edition 4.0 2025-06	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
01/27/2015	Orthopedic	11-283	Complete	ASTM	F2943-14 (Reapproved 2019)	Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
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
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
07/15/2019	Sterility	14-531	Complete	ANSI AAMI ISO	11607-2:2019	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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
07/15/2019	Tissue Engineering	15-58	Complete	ASTM	F2103-18	Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
07/06/2020	Software/ Informatics	13-115	Complete	ISO IEC IEEE	29119-1 First edition 2013-09-01	Software and systems engineering - Software testing - Part 1: Concepts and definitions
07/15/2019	Biocompatibility	2-263	Complete	ASTM	F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
07/06/2020	Materials	8-531	Complete	ASTM	F3321-19	Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
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
01/14/2019	General Plastic Surgery/ General Hospital	6-411	Complete	ASTM	D6499-18	Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
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
07/15/2019	Sterility	14-530	Complete	ANSI AAMI ISO	11607-1:2019	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
12/18/2023	Sterility	14-595	Complete	ISO	11607-2 Second edition 2019-02 [Including AMD1:2023]	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
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
07/06/2020	Sterility	14-545	Complete	ISO ASTM	51276 Fourth edition 2019-08	Practice for use of a polymethylmethacrylate dosimetry system
07/15/2019	Materials	8-518	Complete	ASTM	F3306-19	Standard Test Method for Ion Release Evaluation of Medical Implants
12/23/2019	Sterility	14-538	Complete	ASTM	F3357-19	Standard Guide for Designing Reusable Medical Devices for Cleanability
12/19/2022	Nanotechnology	18-21	Complete	ISO	TS 80004-6 Second edition 2021-03	Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
01/30/2014	Sterility	14-401	Complete	ASTM	F2217/F2217M-13 (Reapproved 2023)	Standard Practice for Coating/Adhesive Weight Determination
05/26/2025	Anesthesiology	1-196	Complete	ISO	80601-2-90 First edition 2021-08	Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
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
12/20/2021	Biocompatibility	2-292	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021	Biocompatibility	2-293	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Elution Test
01/14/2019	Dental/ ENT	4-163	Complete	ANSI ASA	S3.5-1997 (Reaffirmed 2024)	American National Standard Methods for Calculation of the Speech Intelligibility Index
05/26/2025	Cardiovascular	3-198	Complete	ISO	25539-3 Second edition 2024-10	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
12/23/2024	Materials	8-627	Complete	ASTM	F3604-23	Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion.
12/23/2024	Materials	8-626	Complete	ASTM	E2948-24	Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire
12/23/2019	Dental/ ENT	4-262	Complete	IEC	80601-2-60 Edition 2.0 2019-06	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
12/23/2019	Orthopedic	11-361	Complete	ISO	14243-5 First edition 2019-05	Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
12/23/2016	Radiology	12-303	Complete	IEC	61303 Edition 1.0 1994-09	Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
12/23/2016	Radiology	12-304	Complete	IEC	60731 Edition 3.1 2016-04	Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
12/22/2025	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
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
03/16/2012	Radiology	12-241	Complete	IEC	62274 First Edition 2005-05	Medical electrical equipment - Safety of radiotherapy record and verify systems
08/06/2013	Radiology	12-253	Complete	IEC	60976 Edition 2.0 2007-10	Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/06/2013	Radiology	12-255	Complete	IEC	60601-2-11 Edition 3.0 2013-01	Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
12/23/2024	Dental/ ENT	4-338	Complete	ISO	22683 First edition 2022-05	Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
05/29/2024	General Plastic Surgery/ General Hospital	6-501	Complete	ISO	15747 Third edition 2018-09	Plastic containers for intravenous injections
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
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
05/29/2024	Software/ Informatics	13-138	Complete	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	Ophthalmic	10-136	Complete	IEC	80601-2-58 Edition 3.0 2024-03	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
05/29/2024	Ophthalmic	10-136	Complete	ANSI AAMI IEC	80601-2-58:2024	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
09/17/2018	Materials	8-465	Complete	ISO	5832-2 Fourth edition 2018-03	Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
09/17/2018	Materials	8-112	Complete	ASTM	F1044-05 (Reapproved 2017)e1	Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
09/17/2018	Materials	8-466	Complete	ASTM	F2213-17	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
06/07/2018	Radiology	12-316	Complete	IEC	62359 Edition 2.1 2017-09 CONSOLIDATED VERSION	Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
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
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	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
12/23/2019	Physical Medicine	16-213	Complete	RESNA ANSI	WC-1:2019 Section 7	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions
12/23/2019	Physical Medicine	16-214	Complete	RESNA ANSI	WC-1:2019 Section 8	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
12/20/2021	Dental/ ENT	4-288	Complete	ISO	7488 Second edition 2018-04	Dentistry - Mixing machines for dental amalgam
12/20/2021	Dental/ ENT	4-288	Complete	ANSI ADA	Standard No. 43-2020	Electrically Powered Dental Amalgamators
06/15/2016	Cardiovascular	3-132	Complete	ISO	27185 First edition 2012-02-15	Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
06/15/2016	Cardiovascular	3-132	Complete	ANSI AAMI ISO	27185:2012	Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
06/07/2018	Materials	8-337	Complete	ASTM	F621-12 (Reapproved 2017)	Standard Specification for Stainless Steel Forgings for Surgical Implants
12/23/2016	Biocompatibility	2-245	Complete	ISO	10993-5 Third edition 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
12/23/2016	Biocompatibility	2-245	Complete	ANSI AAMI ISO	10993-5:2009/(R)2014	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
06/07/2018	Biocompatibility	2-249	Complete	ISO	10993-16 Third edition 2017-05	Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
07/15/2019	Anesthesiology	1-116	Complete	ISO	5360 Fourth edition 2016-02-15	Anaesthetic vaporizers - Agent specific filling systems
12/22/2025	Ophthalmic	10-141	Complete	ISO	11978 Third edition 2017-08 [Including AMD1:2020]	Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)]
12/20/2021	Dental/ ENT	4-289	Complete	ISO	18556 Frist edition 2016-04	Dentistry - Intraoral spatulas
12/20/2021	Dental/ ENT	4-290	Complete	ISO	28158 Second edition 2018-09	Dentistry - Integrated dental floss and handles
12/20/2021	Dental/ ENT	4-290	Complete	ANSI ADA	Standard No. 185-2020	Integrated Dental Floss and Handles
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-144	Complete	ISO	20697 First edition 2018-06; Corrected 2018-09	Sterile drainage catheters and accessory devices for single use
12/19/2022	Orthopedic	11-395	Complete	ASTM	F1814-22	Standard Guide for Evaluating Modular Hip and Knee Joint Components
12/19/2022	Orthopedic	11-396	Complete	ISO	7206-13 First edition 2016-07-01 [Including AMD1:2022]	Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
12/20/2021	Dental/ ENT	4-292	Complete	ISO	28888 First edition 2013-10	Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
12/20/2021	Dental/ ENT	4-292	Complete	ANSI ADA	Standard No. 151-2015 (R2020)	Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
12/21/2020	Dental/ ENT	4-270	Complete	ANSI ADA	Technical Report No. 146-2018	CAD/CAM Abutments in Dentistry
01/14/2019	Software/ Informatics	13-79	Complete	IEC	62304 Edition 1.1 2015-06 CONSOLIDATED VERSION	Medical device software - Software life cycle processes
01/14/2019	Software/ Informatics	13-79	Complete	ANSI AAMI IEC	62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
07/06/2020	Sterility	14-541	Complete	ANSI AAMI	ST72:2019	Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
12/20/2021	Radiology	12-341	Complete	IEC	62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION	Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
05/30/2022	Materials	8-591	Complete	ASTM	F2229-21	Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
09/17/2018	Orthopedic	11-338	Complete	ISO	11491 First edition 2017-07	Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-117	Complete	ISO	16038 Second edition 2017-11	Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-120	Complete	ASTM	D3492-16	Standard Specification for Rubber Contraceptives (Male Condoms)
09/17/2018	Physical Medicine	16-202	Complete	ISO	7176-2 Third edition 2017-10	Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
06/07/2021	Dental/ ENT	4-275	Complete	ANSI ASA	S3.6-2018 (Reaffirmed 2023)	American National Standard Specification for Audiometers
12/22/2025	Dental/ ENT	4-351	Complete	ISO	6877 Fourth edition 2025-08	Dentistry - Endodontic obturating materials
12/18/2023	Dental/ ENT	4-309	Complete	ISO	6877 Third edition 2021-09	Dentistry - Endodontic obturating materials
12/18/2023	Dental/ ENT	4-309	Complete	ANSI ADA	Standard No. 78-2022	Dentistry - Endodontic Obturating Materials
12/21/2020	Biocompatibility	2-277	Complete	ASTM	F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
06/07/2021	Radiology	12-340	Complete	IEC	60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
08/06/2013	Radiology	12-205	Complete	IEC	60601-2-5: Edition 3.0 2009-07	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
12/20/2021	Cardiovascular	3-180	Complete	ASTM	F3505-21	Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
05/27/2005	Radiology	12-121	Complete	IEC	61847: 1998	Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
06/07/2018	Materials	8-356	Complete	ASTM	F67-13 (Reapproved 2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
12/19/2022	Orthopedic	11-397	Complete	ASTM	F3210-22e1	Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022	Orthopedic	11-398	Complete	ASTM	F3574-22	Standard Test Methods for Sacroiliac Joint Fusion Devices
12/20/2021	General II (ES/ EMC)	19-44	Complete	IEEE ANSI	C63.24-2021	American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
04/04/2016	Materials	8-403	Complete	ASTM	D638-14	Standard Test Method for Tensile Properties of Plastics
04/04/2016	Materials	8-408	Complete	ASTM	F3122-14	Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
08/21/2017	Materials	8-457	Complete	ISO	13175-3 First edition 2012-10-01	Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
12/21/2020	Dental/ ENT	4-265	Complete	ISO	10271 Third edition 2020-08	Dentistry - Corrosion test methods for metallic materials
12/21/2020	Dental/ ENT	4-265	Complete	ANSI ADA	Standard No. 97-2020	Corrosion Test Methods for Metallic Materials
01/14/2019	Nanotechnology	18-5	Complete	ASTM	E2859-11 (Reapproved 2017)	Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
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
01/30/2014	Sterility	14-430	Complete	ISO ASTM	51607 Third edition 2013-06-01	Practice for use of an alanine-EPR dosimery system
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
08/21/2017	Biocompatibility	2-248	Complete	ANSI AAMI ISO	10993-4: 2017	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
12/22/2025	Orthopedic	11-430	Complete	ASTM	F564-24	Standard Specification and Test Methods for Metallic Bone Staples
07/06/2020	Cardiovascular	3-164	Complete	ASTM	F1830-19 (Reapproved 2024)	Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps
07/15/2019	Software/ Informatics	13-108	Complete	IEEE	Std 11073-20701-2018	Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding
12/23/2019	General Plastic Surgery/ General Hospital	6-426	Complete	ISO	23907-1 First edition 2019-01	Sharps injury protection - Requirements and test methods - Sharps containers
12/22/2025	Anesthesiology	1-200	Complete	ISO	7376-2 First edition 2025-09	Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes
05/26/2025	Neurology	17-22	Complete	IEC	60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
01/15/2013	Software/ Informatics	13-36	Complete	AAMI	TIR 45:2012	Guidance on the use of AGILE practices in the development of medical device software
06/07/2018	Neurology	17-16	Complete	IEC	60601-2-10 Edition 2.1 2016-04	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
05/26/2025	InVitro Diagnostics	7-329	Complete	CLSI	EP06-EG 2nd Edition	Developer Validation of Linearity, Establishment Guide
01/14/2019	InVitro Diagnostics	7-286	Complete	CLSI	M11 9th Edition	Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
12/22/2025	Dental/ ENT	4-350	Complete	ANSI ASA	S3.6-2025	American National Standard Specification for Audiometers
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	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
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
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
05/26/2025	InVitro Diagnostics	7-331	Complete	CLSI	AUTO02-A2	Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
01/14/2019	Tissue Engineering	15-56	Complete	ASTM	F3224-17	Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
08/21/2017	General II (ES/ EMC)	19-25	Complete	IEC	62485-1 Edition 1.0 2015-04	Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
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
04/04/2016	Nanotechnology	18-1	Complete	ASTM	E2490-09 (Reapproved 2021)	Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
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
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
10/04/2004	Radiology	12-116	Complete	ISO	13696:2002	Optics and optical instruments -- Test methods for radiation scattered by optical components
05/26/2025	Radiology	12-367	Complete	ISO	13695 Second edition 2024-11	Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
07/06/2020	Sterility	14-540	Complete	ISO	11737-2 Third edition 2019-12	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020	Sterility	14-540	Complete	ANSI AAMI ISO	11737-2:2019	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
05/26/2025	Radiology	12-368	Complete	ISO	13696 Second edition 2022-06	Optics and photonics - Test methods for radiation scattered by optical components
06/27/2016	Software/ Informatics	13-84	Complete	ISO IEEE	11073-10103 First edition 2014-03-01	Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
01/27/2015	Dental/ ENT	4-136	Complete	ASTM	F2504-05 (Reapproved 2022)	Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/14/2019	Orthopedic	11-272	Complete	ASTM	F1714-96 (Reapproved 2025)	Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
12/20/2021	Orthopedic	11-391	Complete	ASTM	F2722-21	Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
12/19/2022	Biocompatibility	2-297	Complete	ASTM	F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
05/30/2022	Materials	8-587	Complete	ISO	5832-3 Fifth Edition 2021-11	Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
08/21/2017	Materials	8-453	Complete	ASTM	F1295-16	Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
12/19/2022	Anesthesiology	1-157	Complete	ISO	10079-1 Fourth edition 2022-03	Medical suction equipment - Part 1: Electrically powered suction equipment
09/17/2018	Orthopedic	11-339	Complete	ISO	7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15	Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
09/17/2018	General Plastic Surgery/ General Hospital	6-123	Complete	ASTM	E667-98 (Reapproved 2017)	Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
09/17/2018	Radiology	12-318	Complete	IEC	60601-2-64 Edition 1.0 2014-09	Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
12/18/2023	Dental/ ENT	4-318	Complete	ISO	20749 Second edition 2023-06	Dentistry - Pre-capsulated dental amalgam
12/18/2023	Orthopedic	11-403	Complete	ASTM	F3047M-23	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
09/17/2018	Radiology	12-320	Complete	IEC	62667 Edition 1.0 2017-08	Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
09/17/2018	Sterility	14-517	Complete	ASTM	F3293-18	Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
09/17/2018	General II (ES/ EMC)	19-31	Complete	IEEE ANSI	C63.15-2017 (Revision of ANSI C63.15-2010)	American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
09/17/2018	General I (QS/ RM)	5-42	Complete	ASTM	D903-98 (Reapproved 2017)	Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
09/17/2018	Ophthalmic	10-57	Complete	ANSI	Z80.13-2007 (R2022)	American National Standard for Ophthalmics - Phakic Intraocular Lenses
09/17/2018	Ophthalmic	10-111	Complete	ISO	11981 Third edition 2017-11	Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
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
12/18/2023	Dental/ ENT	4-322	Complete	ISO	18675 First edition 2022-05	Dentistry - Machinable ceramic blanks
12/18/2023	Dental/ ENT	4-323	Complete	ISO	5139 First edition 2023-05	Dentistry - Polymer-based composite machinable blanks
04/04/2016	General Plastic Surgery/ General Hospital	6-355	Complete	ASTM	D3772-15(2021)	Standard Specification for Industrial Rubber Finger Cots
01/27/2015	Radiology	12-230	Complete	NEMA	XR 24-2008 (R2014)	Primary user controls for interventional angiography x-ray equipment
01/27/2015	Radiology	12-286	Complete	NEMA	XR 27 Amendment 1-2013	X-ray equipment for interventional procedures - User Quality Control Mode
09/17/2018	Materials	8-478	Complete	ASTM	F1089-18	Standard Test Method for Corrosion of Surgical Instruments
06/07/2018	Nanotechnology	18-9	Complete	ISO	TR 13014 First edition 2012-05-15	Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
10/09/2023	Software/ Informatics	13-129	Complete	ISO IEC IEEE	29119-1 Second edition 2022-01	Software and systems engineering - Software testing - Part 1: General concepts
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
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
01/27/2015	Sterility	14-242	Complete	ISO	14644-3 First edition 2005-12-15	Cleanrooms and associated controlled environments - Part 3: Test methods
09/17/2018	Materials	8-472	Complete	ASTM	F2847-17	Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
09/17/2018	Materials	8-474	Complete	ASTM	F2886-17	Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
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)
08/06/2013	Software/ Informatics	13-40	Complete	ANSI AAMI IEC	TIR 80001-2-1 2012	Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
08/06/2013	Software/ Informatics	13-40	Complete	IEC	TR 80001-2-1 Edition 1.0 2012-07	Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
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
08/06/2013	Software/ Informatics	13-44	Complete	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
06/07/2018	Ophthalmic	10-105	Complete	ISO	11979-8 Third edition 2017-04	Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
06/07/2018	Ophthalmic	10-106	Complete	ISO	18369-3 Second edition 2017-08	Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
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
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
09/17/2018	Materials	8-468	Complete	ASTM	F2459-18	Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis
06/07/2018	Tissue Engineering	15-54	Complete	ASTM	F3207-17	Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
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
07/26/2016	Biocompatibility	2-222	Complete	ANSI AAMI ISO	10993-2:2006/(R)2014	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
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
06/07/2018	Biocompatibility	2-250	Complete	ASTM	F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
12/20/2021	Materials	8-572	Complete	ASTM	F2565-21	Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
04/04/2016	Materials	8-413	Complete	ASTM	F2819-10 (Reapproved 2015)	Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
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)
01/27/2015	Software/ Informatics	13-72	Complete	IEEE	Std 11073-10425-2014	Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
05/26/2025	InVitro Diagnostics	7-332	Complete	CLSI	AUTO01-A	Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
03/16/2012	Radiology	12-115	Complete	ISO	13695:2004	Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
05/26/2025	Radiology	12-369	Complete	ISO	11146-1 Second edition 2021-07	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
03/16/2012	Radiology	12-134	Complete	ISO	11146-1 First edition 2005-01-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
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
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
12/22/2025	Physical Medicine	16-238	Complete	ISO	11199-1 Second edition 2021-05	Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames
08/14/2015	Anesthesiology	1-105	Complete	ISO	80601-2-72 First edition 2015-04-11	Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
12/18/2023	Anesthesiology	1-162	Complete	ISO	10651-4 Second edition 2023-03	Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
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
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
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
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
08/06/2013	General Plastic Surgery/ General Hospital	6-147	Complete	ASTM	D6978-05(2023)	Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
04/04/2016	General I (QS/ RM)	5-98	Complete	ANSI ESD	S20.20-2014	Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
12/23/2019	Physical Medicine	16-216	Complete	RESNA ANSI	WC-2:2019 Section 10	American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
12/23/2019	Physical Medicine	16-217	Complete	RESNA ANSI	WC-1:2019 Section 11	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins
09/17/2018	Orthopedic	11-322	Complete	ASTM	F1541-17	Standard Specification and Test Methods for External Skeletal Fixation Devices
12/22/2025	General Plastic Surgery/ General Hospital	6-515	Complete	ASTM	D6499-24	Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
12/23/2019	Physical Medicine	16-210	Complete	RESNA ANSI	WC-2:2019 Section 4	American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range
12/23/2019	Physical Medicine	16-211	Complete	RESNA ANSI	WC-1:2019 Section 5	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
12/21/2020	General I (QS/ RM)	5-133	Complete	ISO	80369-7 Second edition 2021-05	Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
05/29/2023	Materials	8-604	Complete	ASTM	F2257-22	Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
01/30/2014	Sterility	14-429	Complete	ISO ASTM	51275 Third edition 2013-06-01	Practice for use of a radiochromic film dosimetry system
12/22/2025	Orthopedic	11-431	Complete	ASTM	F384-24	Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
09/17/2018	Orthopedic	11-326	Complete	ASTM	F384-17	Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
12/22/2025	Orthopedic	11-432	Complete	ASTM	F2180-24	Standard Specification for Metallic Implantable Strands and Cables
12/23/2019	Physical Medicine	16-219	Complete	RESNA ANSI	WC-2:2019 Section 14	American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
07/06/2020	Radiology	12-331	Complete	NEMA	Standards Publication MS 14-2019	Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
12/21/2020	Orthopedic	11-375	Complete	ASTM	F2193-20	Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
05/29/2023	General Plastic Surgery/ General Hospital	6-493	Complete	ASTM	F2101-23	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/22/2025	General Plastic Surgery/ General Hospital	6-520	Complete	ASTM	F3352/F3352M-23b	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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	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
05/29/2024	General I (QS/ RM)	5-142	Complete	ISO	780 Fifth edition 2015-12-01	Packaging - Distribution packaging - Graphical symbols for handling and storage of packages
12/23/2024	Dental/ ENT	4-335	Complete	ISO	11499 Third edition 2014-06	Dentistry - Single-use cartridges for local anaesthetics
12/23/2024	Dental/ ENT	4-335	Complete	ANSI ADA	Standard No. 190-2020	Single-Use Dental Cartridges for Local Anesthetics

Recognized Consensus Standards: Medical Devices

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