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)
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)
12/22/2025	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	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
05/29/2023	InVitro Diagnostics	7-317	Partial	CLSI	M100 33rd, Edition	Performance Standards for Antimicrobial Susceptibility Testing
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
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
07/06/2020	General Plastic Surgery/ General Hospital	6-440	Partial	ASTM	D3578-19(2023)	Standard Specification for Rubber Examination Gloves
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-140	Partial	ISO	8637-2 First Edition 2018-07	Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters
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
12/19/2022	Biocompatibility	2-298	Partial	ISO	10993-18 Second edition 2020-01 Amendment 1 2022-05	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
12/20/2021	Biocompatibility	2-294	Partial	USP-NF	M98834_01_01	<88> Biological Reactivity Tests, In Vivo
12/20/2021	Biocompatibility	2-295	Partial	USP-NF	M98900_01_01	<151> Pyrogen Test (USP Rabbit Test)
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
12/19/2022	InVitro Diagnostics	7-314	Partial	CLSI	M27M44S, 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/20/2021	Cardiovascular	3-174	Partial	ISO	5840-1 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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
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
05/30/2022	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
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
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
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
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
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
12/23/2016	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
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
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
05/30/2022	Physical Medicine	16-166	Partial	ISO	7176-21 Second edition 2009-04-01	Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
01/14/2019	Materials	8-179	Partial	ASTM	F754-08 (Reapproved 2015)	Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
05/30/2022	Sterility	14-572	Partial	ANSI AAMI	ST91:2021	Flexible and semi-rigid endoscope processing in health care facilities
12/23/2024	InVitro Diagnostics	7-325	Partial	CLSI	M02 14th Edition	Performance Standards for Antimicrobial Disk Susceptibility Tests
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
12/22/2025	Orthopedic	11-433	Partial	ASTM	F2028-25a	Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
06/07/2021	Ophthalmic	10-122	Partial	ISO	10939 Third edition 2017-05	Ophthalmic instruments - Slit-lamp microscopes
12/22/2025	Cardiovascular	3-203	Partial	IEC	80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
01/14/2019	Orthopedic	11-348	Partial	ISO	19227 First edition 2018-03	Implants for surgery - Cleanliness of orthopedic implants - General requirements
12/21/2020	Orthopedic	11-330	Partial	ASTM	F2028-17	Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
07/15/2019	Ophthalmic	10-116	Partial	ANSI	Z80.35-2018 (R2023)	American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
12/19/2022	Ophthalmic	10-132	Partial	ISO	10942 Third edition 2022-01	Ophthalmic instruments - Direct ophthalmoscopes
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
09/21/2016	InVitro Diagnostics	7-265	Partial	CLSI	C62-A	Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
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
12/22/2025	General Plastic Surgery/ General Hospital	6-516	Partial	ASTM	F2407/F2407M-23a	Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
12/23/2024	InVitro Diagnostics	7-326	Partial	CLSI	M24S 2nd Edition	Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes
12/23/2024	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)]
06/07/2021	Cardiovascular	3-168	Partial	IEEE	Std 1708-2014	Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
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
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
07/15/2019	Nanotechnology	18-13	Partial	ISO	TS 18827 First edition 2017-06	Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
12/21/2020	General II (ES/ EMC)	19-36	Partial	IEC	60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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)]
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
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	InVitro Diagnostics	7-262	Partial	CLSI	M45 3rd Edition	Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
12/23/2024	Cardiovascular	3-195	Partial	ISO	5910 Second edition 2024-07	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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	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
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
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)
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.
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
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
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
09/17/2018	Materials	8-473	Partial	ASTM	F2885-17	Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
06/07/2021	InVitro Diagnostics	7-236	Partial	CLSI	M43-A October 2011	Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
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
01/14/2019	Ophthalmic	10-74	Partial	ISO	10940 Second edition 2009-08-01	Ophthalmic instruments - Fundus cameras
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.
12/21/2020	General Plastic Surgery/ General Hospital	6-448	Partial	ASTM	F2407-20	Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
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
12/21/2020	Materials	8-543	Partial	ASTM	F755-19	Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
05/26/2025	Neurology	17-21	Partial	ASTM	F647-22	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
08/14/2015	Neurology	17-4	Partial	ASTM	F647-94 (Reapproved 2014)	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
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
01/14/2019	Sterility	14-396	Partial	ANSI AAMI	ST77:2013/(R)2018	Containment devices for reusable medical device sterilization
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
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
05/26/2025	Ophthalmic	10-96	Partial	ANSI	Z80.10-2014	American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
07/15/2019	InVitro Diagnostics	7-289	Partial	CLSI	MM17 2nd Edition	Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019	InVitro Diagnostics	7-290	Partial	CLSI	EP34 1st Edition	Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
01/14/2019	Ophthalmic	10-108	Partial	ISO	18369-2 Third edition 2017-08	Ophthalmic optics - Contact lenses - Part 2: Tolerances
05/26/2025	InVitro Diagnostics	7-330	Partial	CLSI	M38M51S 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
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
05/29/2024	Ophthalmic	10-134	Partial	ISO	10943 Fourth edition 2023-01	Ophthalmic instruments - Indirect ophthalmoscopes
05/29/2024	Ophthalmic	10-135	Partial	ISO	11979-7 Fifth edition 2024-01	Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
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
12/18/2023	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
05/29/2023	General Plastic Surgery/ General Hospital	6-487	Partial	ANSI AAMI	PB70:2022	Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
07/15/2019	Nanotechnology	18-14	Partial	ISO	TR 11360 First edition 2010-07-15	Nanotechnologies - Methodology for the classification and categorization of nanomaterials
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
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
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
12/18/2023	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
04/04/2016	Materials	8-409	Partial	ASTM	F2924-14	Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
07/06/2020	General Plastic Surgery/ General Hospital	6-443	Partial	ASTM	D3577-19 (Reapproved 2023)	Standard Specification for Rubber Surgical Gloves
01/14/2019	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
07/15/2019	Ophthalmic	10-89	Partial	ANSI	Z80.7-2013 (R2023)	American National Standard for Ophthalmic Optics - Intraocular Lenses
12/23/2016	InVitro Diagnostics	7-268	Partial	CLSI	EP21 2nd Edition (Replaces EP21-A)	Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
06/07/2018	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
12/18/2023	Nanotechnology	18-24	Partial	ASTM	E2524-22	Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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
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)]
05/26/2025	InVitro Diagnostics	7-328	Partial	CLSI	M100 35th Edition	Performance Standards for Antimicrobial Susceptibility Testing
07/06/2020	InVitro Diagnostics	7-296	Partial	CLSI	EP09c 3rd Edition	Measurement Procedure Comparison and Bias Estimation Using Patient Samples
12/23/2024	InVitro Diagnostics	7-327	Partial	CLSI	M100 34th Edition	Performance Standards for Antimicrobial Susceptibility Testing
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]
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-143	Partial	ISO	20696 First edition 2018-06; Corrected 2019-12	Sterile urethral catheters for single use
07/06/2020	General Plastic Surgery/ General Hospital	6-178	Partial	ASTM	D6124-06(2022)	Standard Test Method for Residual Powder on Medical Gloves
06/07/2018	Neurology	17-1	Partial	AAMI	NS28:1988/(R) 2015	Intracranial pressure monitoring devices
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
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
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)
01/27/2015	InVitro Diagnostics	7-250	Partial	CLSI	M40-A2 (Reaffirmed: September 2019)	Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
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	InVitro Diagnostics	7-269	Partial	CLSI	MM23-1st Edition	Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
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
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
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
01/14/2019	Ophthalmic	10-93	Partial	ANSI	Z80.27-2014 (R2025)	American National Standard for Ophthalmics - Implantable Glaucoma Devices
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	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
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
06/07/2021	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
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
01/30/2014	InVitro Diagnostics	7-210	Partial	CLSI	H26-A2	Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
08/21/2017	InVitro Diagnostics	7-272	Partial	CLSI	C57 1st Edition (Reaffirmed: January 2020)	Mass Spectrometry for Androgen and Estrogen Measurements in Serum
01/14/2019	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
12/18/2023	General Plastic Surgery/ General Hospital	6-497	Partial	ASTM	D7866-23	Standard Specification for Radiation Attenuating Protective Gloves
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
08/14/2015	Software/ Informatics	13-73	Partial	IHTSDO	SNOMED-CT RF2 Release 2015	Systematized Nomenclature of Medicine - Clinical Terms
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
01/27/2015	Software/ Informatics	13-71	Partial	RII	Version 2.48	Logical Observation Identifiers Names and Codes (LOINC)
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
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)]
12/18/2023	InVitro Diagnostics	7-320	Partial	CLSI	H62 1st Edition	Validation of Assays Performed by Flow Cytometry
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
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
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
08/06/2013	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
05/29/2024	Anesthesiology	1-179	Partial	ISO	26782 First edition 2009-07	Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
05/29/2024	InVitro Diagnostics	7-321	Partial	CLSI	MM24 1st Edition	Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
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
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
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
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
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
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
12/20/2021	Dental/ ENT	4-291	Complete	ISO	28399 First edition 2011-01	Dentistry - Products for external tooth bleaching
12/20/2021	Dental/ ENT	4-291	Complete	ANSI ADA	Standard No. 136-2015 (R2020)	Products for External Tooth Bleaching
06/07/2018	Software/ Informatics	13-104	Complete	UL ANSI	2900-2-1 First Edition 2017	Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
05/26/2025	General Plastic Surgery/ General Hospital	6-508	Complete	IEC	80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
05/26/2025	ObGyn/ Gastroenterology/ Urology	9-151	Complete	ASTM	F1828-22	Standard Specification for Ureteral Stents
06/27/2016	Software/ Informatics	13-83	Complete	AAMI	TIR57:2016	Principles for medical device security - Risk management.
12/23/2024	Cardiovascular	3-194	Complete	ISO	7199 Fourth edition 2024-09	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
12/23/2024	General II (ES/ EMC)	19-51	Complete	UL	1642 Sixth Edition September 29, 2020	Standard For Safety Lithium Batteries
12/23/2024	General II (ES/ EMC)	19-53	Complete	IEC	TS 60601-4-6 Edition 1.0 2024-04	Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
12/23/2024	Orthopedic	11-419	Complete	ASTM	F3690-24	Standard Test Method for Evaluating Suture Anchor Insertion and Pull Displacement Resistance
12/22/2025	Sterility	14-612	Complete	USP-NF	M16015_02_01	<86> Bacterial Endotoxins Test Using Recombinant Reagents
12/20/2021	Materials	8-578	Complete	ASTM	F2848-21	Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
12/22/2025	Tissue Engineering	15-68	Complete	ASTM	F2212-25	Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
12/22/2025	Materials	8-633	Complete	ASTM	F2902-24	Standard Guide for Assessment of Absorbable Polymeric Implants
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
12/23/2024	General Plastic Surgery/ General Hospital	6-504	Complete	ASTM	F1862/F1862M-24	Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
01/30/2014	Radiology	12-266	Complete	IEC	61689 Edition 3.0 2013-02	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
05/26/2025	Radiology	12-377	Complete	IEC	62127-03 Edition 2.0 2022-12	Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
07/09/2014	Radiology	12-279	Complete	IEC	62127-03 Edition 1.1 2013-05	Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
09/17/2018	InVitro Diagnostics	7-279	Complete	CLSI	M07 11th Edition	Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018	InVitro Diagnostics	7-280	Complete	CLSI	M02 13th Edition	Performance Standards for Antimicrobial Disk Susceptibility Tests
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)]
09/17/2018	Radiology	12-319	Complete	IEC	60601-2-68 Edition 1.0 2014-09	Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
05/26/2025	Radiology	12-382	Complete	NEMA	NU 2-2024	Performance Measurements of Positron Emission Tomographs
12/22/2025	Anesthesiology	1-198	Complete	ISO	7376 Third edition 2020-08 [Including AMD1:2025]	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)]
12/18/2023	Sterility	14-594	Complete	ISO	11607-1 Second edition 2019-02 [Including AMD1:2023]	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
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
12/23/2024	Sterility	14-609	Complete	AAMI	TIR17:2024	Compatibility of materials subjected to sterilization
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)].
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
12/22/2025	General Plastic Surgery/ General Hospital	6-519	Complete	ASTM	F2101-25	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/18/2023	Dental/ ENT	4-318	Complete	ISO	20749 Second edition 2023-06	Dentistry - Pre-capsulated dental amalgam
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
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
12/22/2025	Dental/ ENT	4-361	Complete	ISO	3630-2 Fourth edition 2023-02	Dentistry - Endodontic instruments - Part 2: Enlargers
05/29/2023	General Plastic Surgery/ General Hospital	6-493	Complete	ASTM	F2101-23	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
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
05/26/2025	Dental/ ENT	4-343	Complete	ANSI ADA	Standard No. 105-2024	Elastomeric Auxiliaries for Use in Orthodontics
12/18/2023	Sterility	14-596	Complete	ASTM	F88/F88M-23	Standard Test Method for Seal Strength of Flexible Barrier Materials
12/18/2023	Sterility	14-597	Complete	AAMI ANSI	ST108:2023	Water for the processing of medical devices
05/29/2023	Physical Medicine	16-234	Complete	ISO	7176-14 Third Edition 2022	Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
12/22/2025	Orthopedic	11-434	Complete	ASTM	F3018-25	Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement
05/26/2025	Anesthesiology	1-195	Complete	ISO	80369-2 First edition 2024-09	Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
12/23/2024	Sterility	14-608	Complete	AAMI	TIR106:2024	Microbiological methods - Understanding and use of product bioburden data
12/23/2019	Radiology	12-329	Complete	IEC	60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/22/2025	Biocompatibility	2-308	Complete	ASTM	F1984-25	Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
05/26/2025	Cardiovascular	3-198	Complete	ISO	25539-3 Second edition 2024-10	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ISO	25539-3 First edition 2011-12-01	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ANSI AAMI ISO	25539-3:2011	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
09/17/2018	Biocompatibility	2-256	Complete	ASTM	F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
10/09/2023	Software/ Informatics	13-131	Complete	ANSI AAMI	SW96:2023	Standard for medical device security - Security risk management for device manufacturers
05/26/2025	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
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
05/30/2022	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)
12/20/2021	Orthopedic	11-391	Complete	ASTM	F2722-21	Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
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)
12/22/2025	Biocompatibility	2-311	Complete	ISO	10993-4 Third edition 2017-04 [Including AMD1:2025]	Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
12/22/2025	Orthopedic	11-426	Complete	ASTM	F2943-25	Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
12/19/2022	Biocompatibility	2-297	Complete	ASTM	F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
12/20/2021	Materials	8-573	Complete	ASTM	F2695-12(2025)	Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
07/15/2019	Anesthesiology	1-143	Complete	ISO	80601-2-79 First edition 2018-07	Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
12/18/2023	Orthopedic	11-407	Complete	ASTM	F3140-23	Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
12/23/2024	General Plastic Surgery/ General Hospital	6-503	Complete	ISO	16571 Second edition 2024-03	Systems for evacuation of plume generated by medical device
12/18/2023	Cardiovascular	3-190	Complete	ISO	PAS 7020 First edition 2023-05	Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
05/26/2025	Cardiovascular	3-199	Complete	ASTM	F1841-25	Standard Practice for Assessment of Hemolysis in Blood Pumps
09/17/2018	Anesthesiology	1-140	Complete	ISO	80601-2-55 Second edition 2018-02	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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
05/29/2023	Biocompatibility	2-299	Complete	ASTM	F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
07/26/2016	Biocompatibility	2-213	Complete	ASTM	F1904-14	Standard Practice for Testing the Biological Responses to Particles In Vivo
05/26/2025	Radiology	12-378	Complete	ISO	12609-1 Second edition 2021-10	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
12/22/2025	General Plastic Surgery/ General Hospital	6-518	Complete	ASTM	F1670/F1670M-24a	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2023	General Plastic Surgery/ General Hospital	6-491	Complete	ASTM	F1670/F1670M-17a	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/26/2025	Dental/ ENT	4-344	Complete	ANSI ADA	Standard No. 186-2024	Dentistry - Polymer-based Machinable Blanks
05/29/2024	Sterility	14-598	Complete	ISO	14644-3 Second edition 2020-06	Cleanrooms and associated controlled environments - Part 3: Test methods
12/18/2023	Anesthesiology	1-164	Complete	ISO	5361 Fourth edition 2023-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/21/2020	Anesthesiology	1-149	Complete	ISO	7376 Third edition 2020-08	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
01/30/2014	Materials	8-344	Complete	ISO	7153-1 Second edition 1991-04-01	Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
01/30/2014	Sterility	14-401	Complete	ASTM	F2217/F2217M-13 (Reapproved 2023)	Standard Practice for Coating/Adhesive Weight Determination
05/30/2022	Materials	8-593	Complete	ISO	13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15	Implants for surgery - Hydroxyapatite - Part 6: Powders
05/30/2022	Radiology	12-343	Complete	IEC	62127-1 Edition 2.0 2022-03	Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
07/09/2014	InVitro Diagnostics	7-213	Complete	CLSI	GP44-A4 (Formerly H18-A4)	Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
06/27/2016	General Plastic Surgery/ General Hospital	6-363	Complete	ISO	11810 Second edition 2015-12-15	Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
05/26/2025	Dental/ ENT	4-345	Complete	ANSI ADA	Standard No. 187-2024	Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
05/26/2025	Dental/ ENT	4-346	Complete	ISO	9680 Fourth edition 2021-11	Dentistry - Operating lights
05/26/2025	Dental/ ENT	4-346	Complete	ANSI ADA	Standard No. 89-2023	Dentistry - Dental Operating Lights
05/26/2025	Dental/ ENT	4-347	Complete	ISO	22254 First edition 2005-08	Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection
05/26/2025	Anesthesiology	1-193	Complete	ISO	18190 Second edition 2025-02	Anaesthetic and respiratory equipment - General requirements for airways and related equipment
01/14/2019	Anesthesiology	1-120	Complete	ISO	18190 First edition 2016-11-01	Anaesthetic and respiratory equipment - General requirements for airways and related equipment
12/22/2025	Dental/ ENT	4-362	Complete	ISO	3630-3 Third edition 2021-06 Corrected version 2023-05	Dentistry - Endodontic instruments - Part 3: Compactors
12/22/2025	Dental/ ENT	4-362	Complete	ANSI ADA	Standard No. 71-2022	Dentistry - Endodontic Instruments: Compactors
12/23/2016	Anesthesiology	1-118	Complete	ISO	5361 Third edition 2016-09-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/18/2023	Anesthesiology	1-165	Complete	ISO	80601-2-13 Second edition 2022-04	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
05/29/2023	General Plastic Surgery/ General Hospital	6-490	Complete	ISO	10555-6 First edition 2015-04-15 [Including AMD1:2019]	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
05/29/2023	General Plastic Surgery/ General Hospital	6-495	Complete	ISO	20698 First Edition 2018-07	Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
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	Biocompatibility	2-312	Complete	ASTM	F720-24	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
05/29/2023	Sterility	14-587	Complete	AAMI	TIR104:2022	Guidance on transferring health care products between radiation sterilization sources
05/29/2023	General Plastic Surgery/ General Hospital	6-486	Complete	ISO	10535 Third edition 2021-10	Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
12/18/2023	Dental/ ENT	4-321	Complete	ISO	23450 First edition 2021-03	Dentistry - Intraoral camera
12/18/2023	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
05/26/2025	Radiology	12-375	Complete	ANSI UL	122-2019	Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019]
08/21/2017	General II (ES/ EMC)	19-24	Complete	IEC	60086-5 Edition 4.0 2016-07	Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
12/22/2025	Dental/ ENT	4-363	Complete	ISO	3630-5 Second edition 2020-08	Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments
12/22/2025	Dental/ ENT	4-363	Complete	ANSI ADA	Standard No. 28-2021	Endodontic Instruments - Shaping and Cleaning Instruments
01/27/2015	Sterility	14-242	Complete	ISO	14644-3 First edition 2005-12-15	Cleanrooms and associated controlled environments - Part 3: Test methods
05/29/2024	Sterility	14-599	Complete	ISO	14644-9 Second edition 2022-05	Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
01/27/2015	Sterility	14-389	Complete	ISO	14644-9 First edition 2012-08-15	Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
12/22/2025	Dental/ ENT	4-365	Complete	ISO	6873 Third edition 2013-04	Dentistry - Gypsum products
12/22/2025	Dental/ ENT	4-365	Complete	ANSI ADA	Standards No. 25-2015 (R2021)	Dental Gypsum Products
12/22/2025	Dental/ ENT	4-366	Complete	ISO	7551 Second edition 2023-05	Dentistry - Endodontic absorbent points
12/22/2025	Dental/ ENT	4-366	Complete	ANSI ADA	Standard No. 73-2024	Dentistry - Endodontic Absorbent Points
12/22/2025	Dental/ ENT	4-367	Complete	ISO	9997 Third edition 2020-01	Dentistry - Cartridge Syringes
05/29/2023	General Plastic Surgery/ General Hospital	6-494	Complete	ASTM	F3352/F3352M-23a	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/18/2023	Dental/ ENT	4-324	Complete	ISO	TS 16506 First edition 2017-07 Corrected version 2018-03	Dentistry - Polymer-based luting materials containing adhesive components
01/14/2019	Anesthesiology	1-141	Complete	ISO	80601-2-13 First edition 2011-08-11	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
12/18/2023	Materials	8-606	Complete	ASTM	F2537-23	Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
12/22/2025	Orthopedic	11-423	Complete	ASTM	F2267-24	Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
05/26/2025	Anesthesiology	1-194	Complete	ISO	27427 Fourth edition 2023-07	Anaesthetic and respiratory equipment - Nebulizing systems and components
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)
06/07/2018	General Plastic Surgery/ General Hospital	6-406	Complete	ASTM	F1862/F1862M-17	Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
07/09/2014	Radiology	12-282	Complete	ISO	12609-1 First edition 2013-07-15	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
05/26/2025	Radiology	12-379	Complete	IEC	62127-2 Edition 2.0 2025-01	Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
12/22/2025	Orthopedic	11-429	Complete	ASTM	F366-24	Standard Specification for Fixation Pins and Wires
12/18/2023	Orthopedic	11-403	Complete	ASTM	F3047M-23	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
05/29/2024	Sterility	14-600	Complete	ASTM	F1929-23	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
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
08/21/2017	Materials	8-451	Complete	ASTM	F2214-16	Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
12/18/2023	Sterility	14-593	Complete	ASTM	F3039-23	Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
12/23/2016	Orthopedic	11-316	Complete	ASTM	F1264-16	Standard Specification and Test Methods for Intramedullary Fixation Devices
12/22/2025	Orthopedic	11-428	Complete	ASTM	F1541-24	Standard Specification and Test Methods for External Skeletal Fixation Devices
06/07/2021	Ophthalmic	10-126	Complete	IEC	80601-2-58 Edition 2.0 2014-09	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
06/07/2021	Ophthalmic	10-126	Complete	ANSI AAMI IEC	80601-2-58:2014	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
05/29/2024	Radiology	12-357	Complete	IEC	63145-20-10 Edition 1.0 2019-08	Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties
05/29/2024	Radiology	12-358	Complete	IEC	63145-20-20 Edition 1.0 2019-09	Eyewear display - Part 20-20: Fundamental measurement methods - Image quality
05/29/2024	Radiology	12-359	Complete	IEC	63145-22-10 Edition 1.0 2020-01	Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties
05/29/2024	Dental/ ENT	4-325	Complete	ANSI ADA	Standard No. 96-2020	Dental Water-based Cements
09/17/2018	Materials	8-412	Complete	ASTM	F2537-06 (Reapproved 2017)	Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
12/18/2023	Materials	8-607	Complete	ASTM	F2082/F2082M-23	Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
12/23/2016	Materials	8-437	Complete	ASTM	F2082/F2082M-16	Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
09/17/2018	Orthopedic	11-199	Complete	ASTM	F565-04 (Reapproved 2018)	Standard Practice for Care and Handling of Orthopedic Implants and Instruments
05/26/2025	General I (QS/ RM)	5-144	Complete	ISO	80369-20 Second edition 2024-11	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015	General I (QS/ RM)	5-97	Complete	ISO	80369-20 First edition 2015-05-15	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015	General I (QS/ RM)	5-97	Complete	ANSI AAMI ISO	80369-20:2015	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
05/26/2025	General I (QS/ RM)	5-145	Complete	IEC	60417:2025 DB	Graphical symbols for use on equipment
05/26/2025	General II (ES/ EMC)	19-54	Complete	IEC	60086-5 Edition 5.0 2021-09	Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]
06/07/2021	Anesthesiology	1-151	Complete	ISO	80601-2-70 Second edition 2020-11	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
05/26/2025	Cardiovascular	3-200	Complete	ASTM	F2477-24	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
12/22/2025	Dental/ ENT	4-348	Complete	ISO	9917-1 Third Edition 2025-05	Dentistry - Water-based cements - Part 1: Acid-base cements
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	Dental/ ENT	4-357	Complete	ANSI ADA	Standard No. 54-1986 (R2024)	Double-Pointed, Parenteral, Single Use Needles for Dentistry
12/22/2025	Dental/ ENT	4-358	Complete	ANSI ADA	Standard No. 95-2020	Endodontics Instruments - Enlargers
12/22/2025	Dental/ ENT	4-359	Complete	ANSI ADA	Standard No. 159-2024	Dentistry - Coiled Springs for Use in Orthodontics
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
04/04/2016	Materials	8-200	Complete	ASTM	F2003-02 (Reapproved 2015)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
12/20/2021	Biocompatibility	2-293	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Elution Test
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.
12/20/2021	Software/ Informatics	13-120	Complete	ANSI AAMI	2700-1:2019	Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
12/20/2021	Materials	8-563	Complete	ASTM	F1801-20	Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
12/23/2019	Anesthesiology	1-145	Complete	ISO	19223 First edition 2019-07	Lung ventilators and related equipment - Vocabulary and semantics.
12/23/2019	General Plastic Surgery/ General Hospital	6-437	Complete	ISO	23907-2 First edition 2019-11	Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
05/29/2023	Sterility	14-586	Complete	ISO	22441 First edition 2022-08	Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
12/18/2023	Materials	8-608	Complete	ASTM	F2214-23	Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
12/18/2023	Sterility	14-591	Complete	ISO	14644-10 Second edition 2022-05	Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
12/19/2022	General I (QS/ RM)	5-137	Complete	IEC	TR 60878 Ed. 4.0 2022-11	Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022	General I (QS/ RM)	5-136	Complete	ASTM	D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022	General Plastic Surgery/ General Hospital	6-485	Complete	ISO	7886-4 Second Edition 2018-11	Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/20/2021	Biocompatibility	2-292	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Direct Contact Test
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	ObGyn/ Gastroenterology/ Urology	9-142	Complete	ASTM	D1894-14	Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
12/19/2022	Physical Medicine	16-233	Complete	ISO	16840-10 Second edition 2021-06 Corrected version 2022-01	Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
12/21/2020	Sterility	14-553	Complete	ASTM	F2097-20	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/20/2021	Sterility	14-571	Complete	ISO	11138-8 First edition 2021-07	Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
05/30/2022	Materials	8-584	Complete	ASTM	F2146-22	Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
12/20/2021	Materials	8-570	Complete	ASTM	F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/19/2022	Anesthesiology	1-155	Complete	ISO	10079-2 Fourth edition 2022-03	Medical suction equipment - Part 2: Manually powered suction equipment
05/26/2025	Dental/ ENT	4-339	Complete	ANSI ADA	Standard No. 119-2023	Dentistry-Manual Toothbrushes
05/30/2022	Dental/ ENT	4-293	Complete	ANSI ADA	Standard No. 119-2021	Manual Toothbrushes
05/26/2025	Dental/ ENT	4-340	Complete	ANSI ADA	Standard No. 46-2016	Dental Patient Chair
05/26/2025	Dental/ ENT	4-341	Complete	ANSI ADA	Standard No. 47-1-2021	Stationary Dental Units and Patient Chairs-Part 1: General Requirements
05/26/2025	Dental/ ENT	4-342	Complete	ANSI ADA	Standard No. 47-2-2021	Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
12/19/2022	General II (ES/ EMC)	19-48	Complete	IEEE ANSI	USEMCSC C63.27-2021	American National Standard for Evaluation of Wireless Coexistence
12/19/2022	InVitro Diagnostics	7-313	Complete	CLSI	EP27 2nd Edition	Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
05/30/2022	Materials	8-592	Complete	ASTM	F3384-21	Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
05/30/2022	Cardiovascular	3-182	Complete	ASTM	F3036-21	Standard Guide for Testing Absorbable Stents
12/22/2025	Orthopedic	11-430	Complete	ASTM	F564-24	Standard Specification and Test Methods for Metallic Bone Staples
09/17/2018	Orthopedic	11-325	Complete	ASTM	F564-17	Standard Specification and Test Methods for Metallic Bone Staples
07/06/2020	Cardiovascular	3-165	Complete	ASTM	F1841-19	Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
05/29/2023	Materials	8-600	Complete	ASTM	F1978-22	Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
09/17/2018	Materials	8-467	Complete	ASTM	F1978-18	Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
05/29/2023	Materials	8-601	Complete	ASTM	F2516-22	Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
07/15/2019	Materials	8-506	Complete	ASTM	F2516-18	Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
05/29/2023	Materials	8-603	Complete	ASTM	F1472-23	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
01/27/2015	Sterility	14-379	Complete	ISO	14644-8 Second edition 2013-02-15	Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
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
05/29/2023	Biocompatibility	2-300	Complete	ISO	10993-2 Third edition 2022-11	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
12/22/2025	Dental/ ENT	4-355	Complete	ISO	18397 Second edition 2025-07	Dentistry - Powered scaler
03/16/2012	Radiology	12-177	Complete	UL	122-2007 (R2011)	Standard for Photographic Equipment - Ed. 5.0
12/20/2021	General II (ES/ EMC)	19-41	Complete	ANSI UL	61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019	Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
05/30/2022	Materials	8-588	Complete	ASTM	F560-22	Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
09/17/2018	Cardiovascular	3-110	Complete	AAMI	TIR41:2011/(R)2025	Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
12/20/2021	Dental/ ENT	4-285	Complete	ANSI ADA	Standard No. 37-1986 (R2020)	Dental Abrasive Powders
12/19/2022	Sterility	14-580	Complete	ISO	11137-2 Third edition 2013-06 [Including AMD1:2022]	Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
12/20/2021	Cardiovascular	3-178	Complete	ASTM	F3067-14 (Reapproved 2021)	Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/19/2022	Materials	8-594	Complete	ISO	5832-6 Third Edition 2022-03	Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
12/20/2021	Dental/ ENT	4-286	Complete	ANSI ADA	Standard No. 87-1995 (R2014)	Dental Impression Trays
12/23/2019	Materials	8-484	Complete	ASTM	F2066-18	Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
12/22/2025	General Plastic Surgery/ General Hospital	6-517	Complete	ASTM	F3502-25	Standard Specification for Barrier Face Coverings
08/14/2015	Radiology	12-291	Complete	IEC	62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION	Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
12/19/2022	General I (QS/ RM)	5-138	Complete	AAMI	TIR66: 2017/(R)2025	Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
05/30/2022	General Plastic Surgery/ General Hospital	6-480	Complete	ISO	11608-6:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022	General Plastic Surgery/ General Hospital	6-481	Complete	ANSI AAMI	CN27:2021	General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022	General Plastic Surgery/ General Hospital	6-482	Complete	AAMI	TIR101:2021	Fluid delivery performance testing for infusion pumps
12/23/2024	Anesthesiology	1-189	Complete	ISO	4135 Fourth edition 2022-01	Anaesthetic and respiratory equipment - Vocabulary
08/21/2017	Materials	8-455	Complete	ASTM	F2902-16	Standard Guide for Assessment of Absorbable Polymeric Implants
12/22/2025	Materials	8-634	Complete	ASTM	F2066-23	Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
05/30/2022	General Plastic Surgery/ General Hospital	6-478	Complete	ISO	11608-1:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
04/03/2023	General II (ES/ EMC)	19-49	Complete	IEC	60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
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
03/16/2012	InVitro Diagnostics	7-227	Complete	CLSI	M53-A (Replaces M53-P)	Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
07/09/2014	Sterility	14-437	Complete	ISO ASTM	52701 First edition 2013-11-15 (R2020)	Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
01/27/2015	Materials	8-383	Complete	ASTM	F1926/F1926M-14	Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
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
12/19/2022	Sterility	14-583	Complete	ANSI AAMI	ST98:2022	Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
05/30/2022	Sterility	14-579	Complete	ISO	17664-2 First edition 2021-02	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
05/30/2022	Cardiovascular	3-181	Complete	ISO	25539-2 Third edition 2020-09	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021	Dental/ ENT	4-287	Complete	ANSI ADA	Standard No. 116-2020	Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
09/17/2018	Tissue Engineering	15-55	Complete	ASTM	F3259-17	Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
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
02/07/2022	General II (ES/ EMC)	19-45	Complete	AIM	Standard 7351731 Rev. 3.00 2021-06-04	Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
12/20/2021	Orthopedic	11-392	Complete	ASTM	F2723-21	Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/19/2022	General I (QS/ RM)	5-139	Complete	ISO	18250-3 First edition 2018-06	Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
06/07/2018	ObGyn/ Gastroenterology/ Urology	9-116	Complete	ISO	29943-2 First edition 2017-07	Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
06/07/2018	Dental/ ENT	4-241	Complete	ISO	7491 Second edition 2000-09-01	Dental materials - Determination of colour stability
06/07/2018	Dental/ ENT	4-241	Complete	ANSI ADA	Standard No. 80-2001 (R2020)	Dental Materials-Determination of Color Stability
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
09/17/2018	Materials	8-465	Complete	ISO	5832-2 Fourth edition 2018-03	Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
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
07/06/2020	Sterility	14-543	Complete	ISO	11139 First edition 2018-08	Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-119	Complete	IEC	60601-2-36 Edition 2.0 2014-04	Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/17/2018	Cardiovascular	3-153	Complete	ASTM	F2743-11	Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
09/17/2018	InVitro Diagnostics	7-277	Complete	CLSI	GP41 7th Edition	Collection of Diagnostic Venous Blood Specimens
09/17/2018	InVitro Diagnostics	7-278	Complete	CLSI	M27 4th Edition	Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
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
12/21/2020	Orthopedic	11-370	Complete	ISO	14879-1 Second edition 2020-07	Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
03/31/2006	Radiology	12-136	Complete	ISO	9236-1 Second edition 2004-02-01	Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
08/02/2011	Ophthalmic	10-66	Complete	ISO	10936-2 Second edition 2010-01-15	Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
01/30/2014	Sterility	14-429	Complete	ISO ASTM	51275 Third edition 2013-06-01	Practice for use of a radiochromic film dosimetry system
01/27/2015	Dental/ ENT	4-219	Complete	ISO	29022 First edition 2013-06-01	Dentistry - Adhesive - Notched-edge sheer bond strength test
06/27/2016	Materials	8-426	Complete	ASTM	F3087-15 (2024)	Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016	Materials	8-430	Complete	ISO	13356:2015 Third Edition 2015-09-15	Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016	Materials	8-432	Complete	ISO ASTM	52921 First Edition 2013-06-01	Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016	Materials	8-434	Complete	ISO ASTM	52900 First Edition 2015-12-15	Additive manufacturing -- General principles - Terminology
09/21/2016	General Plastic Surgery/ General Hospital	6-380	Complete	ISO	9626 Second edition 2016-08-01	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
05/29/2023	Materials	8-598	Complete	ASTM	F3109-22	Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
05/30/2022	Materials	8-590	Complete	ISO	TS 17137 Third edition 2021-09	Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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	8-491	Complete	ASTM	F1088-18	Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
05/29/2023	Dental/ ENT	4-298	Complete	ISO	4049 Fifth edition 2019-05	Dentistry - Polymer-based restorative materials
05/29/2023	Dental/ ENT	4-298	Complete	ANSI ADA	Standard No. 27-2022	Polymer-based Restorative Materials
12/19/2022	General I (QS/ RM)	5-140	Complete	ASME	V&V 10-2019	Standard for Verification and Validation in Computational Solid Mechanics
12/20/2021	Sterility	14-564	Complete	USP-NF	M98910_01_01	<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021	Sterility	14-565	Complete	USP-NF	M98802_01_01	<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021	Sterility	14-566	Complete	USP-NF	M98795_02_01	<55> Biological Indicators -- Resistance Performance Tests
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
09/21/2016	General Plastic Surgery/ General Hospital	6-382	Complete	ISO	11608-7 First edition 2016-08-01	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
12/20/2021	Cardiovascular	3-171	Complete	ASTM	F2514-21	Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/19/2022	Sterility	14-581	Complete	ASTM	F2638-22	Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/20/2021	InVitro Diagnostics	7-309	Complete	ISO	17099 First edition 2014-11-15	Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/20/2021	Cardiovascular	3-173	Complete	ISO	5840-3 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
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
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
12/20/2021	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
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)]
04/04/2016	General Plastic Surgery/ General Hospital	6-356	Complete	ASTM	D5712-15(2020)	Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
04/04/2016	Orthopedic	11-247	Complete	ASTM	F2789-10 (Reapproved 2020)	Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
12/21/2020	Biocompatibility	2-283	Complete	ASTM	F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
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
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)
12/20/2021	General Plastic Surgery/ General Hospital	6-468	Complete	USP-NF	M99670_02_01	<881> Tensile Strength
12/20/2021	Materials	8-568	Complete	ASTM	F1586-21	Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
12/19/2022	General Plastic Surgery/ General Hospital	6-484	Complete	ASTM	F3502-22a	Standard Specification for Barrier Face Coverings
12/23/2019	Physical Medicine	16-221	Complete	RESNA ANSI	WC-1:2019 Section 16	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
12/21/2020	Nanotechnology	18-17	Complete	ISO	21363 First edition 2020-06	Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
12/21/2020	Biocompatibility	2-278	Complete	ASTM	F719-20 e1	Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
07/06/2020	Nanotechnology	18-16	Complete	ISO	TS 21362 First edition 2018-06	Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
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	14-403	Complete	ASTM	F2054/F2054M-13 (Reapproved 2020)	Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014	Sterility	14-430	Complete	ISO ASTM	51607 Third edition 2013-06-01	Practice for use of an alanine-EPR dosimery system
01/14/2019	Materials	8-487	Complete	ISO ASTM	52910-18	Additive manufacturing - Design - Requirements, guidelines and recommendations
12/19/2022	Anesthesiology	1-160	Complete	ISO	80601-2-84 First edition 2020-07	Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/22/2025	Anesthesiology	1-200	Complete	ISO	7376-2 First edition 2025-09	Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes
05/30/2022	General Plastic Surgery/ General Hospital	6-477	Complete	ISO	11608-3:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022	General Plastic Surgery/ General Hospital	6-475	Complete	ISO	11608-4:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
01/14/2019	Dental/ ENT	4-254	Complete	ANSI ADA	Standard No. 99-2001 (R2023)	Athletic Mouth Protectors and Materials
12/23/2019	Physical Medicine	16-225	Complete	RESNA ANSI	WC-1:2019 Section 26	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
06/07/2021	Materials	8-555	Complete	ASTM	F1472-20a	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
12/04/2017	Software/ Informatics	13-99	Complete	ISO IEC	15459-2 Third edition 2015-03-01	Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
12/04/2017	Software/ Informatics	13-101	Complete	ISO IEC	15459-6 Second edition 2014 Corrected 2016	Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
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.
05/29/2023	Orthopedic	11-399	Complete	ASTM	F1357-23	Standard Specification for Articulating Total Wrist Implants
12/23/2016	Biocompatibility	2-189	Complete	ASTM	F895-11 (Reapproved 2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
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
05/26/2025	General II (ES/ EMC)	19-55	Complete	IEC	62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/20/2021	Orthopedic	11-388	Complete	ASTM	F1717-21	Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
12/20/2021	Sterility	14-567	Complete	USP-NF	M7414_01_01	<1229.5> Biological Indicators for Sterilization
05/29/2023	Dental/ ENT	4-300	Complete	ISO	22674 Third edition 2022-08	Dentistry - Metallic materials for fixed and removable restorations and appliances
05/29/2023	Dental/ ENT	4-300	Complete	ANSI ADA	Standard No. 134-2023	Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
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.
12/18/2023	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
05/29/2024	General Plastic Surgery/ General Hospital	6-500	Complete	IEC	63045 Edition 1.0 2020-05	Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
05/29/2023	Sterility	14-588	Complete	AAMI	TIR17:2017/(R)2020	Compatibility of materials subjected to sterilization
12/19/2022	Dental/ ENT	4-295	Complete	ANSI ADA	Standard No. 41-2020	Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-141	Complete	ISO	8637-3 First Edition 2018-07	Extracorporeal systems for blood purification - Part 3: Plasmafilters
12/20/2021	Materials	8-577	Complete	ISO	13179-1 Second Edition 2021-09	Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
12/20/2021	Sterility	14-563	Complete	ISO	13408-6 Second edition 2021-04	Aseptic processing of health care products - Part 6: Isolator systems
09/17/2018	Cardiovascular	3-156	Complete	ISO	14708-1 Second edition 2014-08-15	Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018	Cardiovascular	3-156	Complete	ANSI AAMI ISO	14708-1:2014	Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018	Cardiovascular	3-154	Complete	ASTM	F3211-17	Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
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)]
12/23/2024	Anesthesiology	1-182	Complete	ISO	5362 Fifth edition 2024-07	Anaesthetic and respiratory equipment - Anaesthetic reservoir bags
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
12/20/2021	Cardiovascular	3-179	Complete	ASTM	F3172-15 (Reapproved 2021)	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
12/20/2021	Materials	8-579	Complete	ISO	13779-3 Second Edition 2018-12	Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
04/04/2016	Sterility	14-337	Complete	ISO	14937 Second edition 2009-10-15	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-337	Complete	ANSI AAMI ISO	14937:2009/(R)2013	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
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
06/07/2018	Materials	8-337	Complete	ASTM	F621-12 (Reapproved 2017)	Standard Specification for Stainless Steel Forgings for Surgical Implants
12/20/2021	Materials	8-569	Complete	ASTM	F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
12/20/2021	General Plastic Surgery/ General Hospital	6-471	Complete	USP-NF	M88880_05_01	Sterile Water for Irrigation
12/23/2016	InVitro Diagnostics	7-267	Complete	CLSI	C24 4th Edition (Replaces C24-A3)	Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
08/06/2013	Ophthalmic	10-77	Complete	ISO	9394 Third edition 2012-10-01	Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
12/21/2020	Orthopedic	11-375	Complete	ASTM	F2193-20	Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
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
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)].
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
03/14/2011	Radiology	12-217	Complete	IEC	62083 Edition 2.0 2009-09	Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
10/04/2010	InVitro Diagnostics	7-212	Complete	CLSI	EP18-A2	Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
03/14/2011	Radiology	12-221	Complete	IEC	61223-3-4 First edition 2000-03	Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/16/2012	Radiology	12-143	Complete	ISO	15367-2 First edition 2005-03-15	Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012	Radiology	12-248	Complete	ISO	21254-3 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012	Radiology	12-174	Complete	ISO	13697 First edition 2006-05-15	Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
09/17/2018	Dental/ ENT	4-247	Complete	ISO	28319 Second edition 2018-04	Dentistry - Laser welding and filler materials
09/17/2018	Dental/ ENT	4-247	Complete	ANSI ADA	Standard No. 84-2020	Laser Welding and Filler Materials in Dentistry
04/04/2016	Orthopedic	11-304	Complete	ASTM	F3107-14 (Reapproved 2023)	Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

Recognized Consensus Standards: Medical Devices

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