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)
01/14/2019	Sterility	14-396	Partial	ANSI AAMI	ST77:2013/(R)2018	Containment devices for reusable medical device sterilization
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
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)
07/06/2020	General Plastic Surgery/ General Hospital	6-178	Partial	ASTM	D6124-06(2022)	Standard Test Method for Residual Powder on Medical Gloves
01/14/2019	Ophthalmic	10-74	Partial	ISO	10940 Second edition 2009-08-01	Ophthalmic instruments - Fundus cameras
01/14/2019	Ophthalmic	10-85	Partial	ISO	11980 Third edition 2012-11-15 Corrected version 2012-12-01	Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
01/14/2019	Ophthalmic	10-86	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]
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
01/30/2014	InVitro Diagnostics	7-210	Partial	CLSI	H26-A2	Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
12/23/2019	Cardiovascular	3-163	Partial	ISO	18242 First edition 2016-09-01	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps.
07/15/2019	Ophthalmic	10-89	Partial	ANSI	Z80.7-2013 (R2023)	American National Standard for Ophthalmic Optics - Intraocular Lenses
07/15/2019	Dental/ ENT	4-259	Partial	ISO	14801 Third edition 2016-11-01	Dentistry - Implants - Dynamic loading test for endosseous dental implants
07/15/2019	Dental/ ENT	4-259	Partial	ANSI ADA	Standard No. 127-2018	Dynamic Loading Test for Endosseous Dental Implants
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-133	Partial	ISO	23500-1 First edition 2019-02	Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-133	Partial	ANSI AAMI ISO	23500-1:2019	Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements
12/23/2019	ObGyn/ Gastroenterology/ Urology	9-123	Partial	ISO	8600-3 Second edition 2019-08	Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
01/14/2019	Orthopedic	11-184	Partial	ISO	8827 First edition 1988-10-15	Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
12/21/2020	Materials	8-543	Partial	ASTM	F755-19	Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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)
08/21/2017	Ophthalmic	10-104	Partial	ANSI	Z80.20-2016 (R2021)	American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
07/06/2020	General Plastic Surgery/ General Hospital	6-446	Partial	ASTM	D6319-19(2023)	Standard Specification for Nitrile Examination Gloves for Medical Application
06/07/2021	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
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
06/07/2021	Cardiovascular	3-166	Partial	ISO	81060-2 Third edition 2018-11	Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
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
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
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
01/14/2019	Orthopedic	11-348	Partial	ISO	19227 First edition 2018-03	Implants for surgery - Cleanliness of orthopedic implants - General requirements
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
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
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
01/14/2019	Ophthalmic	10-93	Partial	ANSI	Z80.27-2014 (R2019)	American National Standard for Ophthalmics - Implantable Glaucoma Devices
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)].
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
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
05/29/2023	General Plastic Surgery/ General Hospital	6-496	Partial	ASTM	F739-20	Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
05/29/2023	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	Anesthesiology	1-139	Partial	ISO	80601-2-61 Second edition 2017-12 (Corrected version 2018-02)	Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
06/27/2016	Radiology	12-295	Partial	IEC	60601-2-33 Ed. 3.2 b:2015	Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
12/18/2023	Radiology	12-348	Partial	IEC	60601-2-54 Edition 2.0 2022-09	Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
12/18/2023	Radiology	12-353	Partial	ANSI	Z136.1-2022	American National Standard for Safe Use of Lasers
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
05/29/2023	Cardiovascular	3-185	Partial	ANSI AAMI	PC76:2021	Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
12/18/2023	Nanotechnology	18-24	Partial	ASTM	E2524-22	Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
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
01/14/2019	InVitro Diagnostics	7-269	Partial	CLSI	MM23-1st Edition	Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
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	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
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
07/06/2020	General Plastic Surgery/ General Hospital	6-443	Partial	ASTM	D3577-19	Standard Specification for Rubber Surgical Gloves
09/17/2018	General II (ES/ EMC)	19-19	Partial	IEC	TR 60601-4-2 Edition 1.0 2016-05	Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
12/23/2016	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	Ophthalmic	10-96	Partial	ANSI	Z80.10-2014	American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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
01/30/2014	Sterility	14-336	Partial	ISO	14161 Second edition 2009-09-15	Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
01/30/2014	Sterility	14-336	Partial	ANSI AAMI ISO	14161-2009/(R)2014	Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
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
09/17/2018	Materials	8-473	Partial	ASTM	F2885-17	Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
06/07/2018	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
06/07/2021	Dental/ ENT	4-280	Partial	ANSI ADA	Standard No. 117-2018	Fluoride varnishes
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
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
01/14/2019	Dental/ ENT	4-257	Partial	ISO	17730 First edition 2014-11-01	Dentistry - Fluoride varnishes
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
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
06/27/2016	Cardiovascular	3-143	Partial	ISO	12417 First edition 2015-10-01	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
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
08/14/2015	Software/ Informatics	13-73	Partial	IHTSDO	SNOMED-CT RF2 Release 2015	Systematized Nomenclature of Medicine - Clinical Terms
01/27/2015	InVitro Diagnostics	7-250	Partial	CLSI	M40-A2 (Reaffirmed: September 2019)	Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
12/18/2023	General Plastic Surgery/ General Hospital	6-497	Partial	ASTM	D7866-23	Standard Specification for Radiation Attenuating Protective Gloves
06/07/2018	Neurology	17-1	Partial	AAMI	NS28:1988/(R) 2015	Intracranial pressure monitoring devices
12/18/2023	InVitro Diagnostics	7-320	Partial	CLSI	H62 1st Edition	Validation of Assays Performed by Flow Cytometry
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
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
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)]
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-143	Partial	ISO	20696 First edition 2018-06; Corrected 2019-12	Sterile urethral catheters for single use
04/04/2016	Materials	8-409	Partial	ASTM	F2924-14	Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
08/14/2015	Neurology	17-4	Partial	ASTM	F647-94 (Reapproved 2014)	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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
08/21/2017	InVitro Diagnostics	7-272	Partial	CLSI	C57 1st Edition (Reaffirmed: January 2020)	Mass Spectrometry for Androgen and Estrogen Measurements in Serum
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
06/27/2016	InVitro Diagnostics	7-264	Partial	CLSI	MM21-1st Edition (Reaffirmed: January 2020)	Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
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
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	InVitro Diagnostics	7-317	Partial	CLSI	M100, 33rd Edition	Performance Standards for Antimicrobial Susceptibility Testing
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
01/14/2019	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
08/14/2015	Sterility	14-460	Partial	ISO	11140-1 Third edition 2014-11-01	Sterilization of health care products - Chemical indicators - Part 1: General requirements
08/14/2015	Sterility	14-460	Partial	ANSI AAMI ISO	11140-1:2014	Sterilization of health care products - Chemical indicators - Part 1: General requirements
12/19/2022	Biocompatibility	2-296	Partial	ISO	10993-10 Fourth edition 2021-11	Biological evaluation of medical devices - Part 10: Tests for skin sensitization
12/19/2022	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
01/27/2015	Software/ Informatics	13-71	Partial	RII	Version 2.48	Logical Observation Identifiers Names and Codes (LOINC)
07/15/2019	InVitro Diagnostics	7-291	Partial	CLSI	EP27-A	How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/26/2016	Biocompatibility	2-191	Partial	ISO	10993-12 Fourth edition 2012-07-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016	Biocompatibility	2-191	Partial	ANSI AAMI ISO	10993-12:2012	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/20/2021	Biocompatibility	2-294	Partial	USP-NF	M98834_01_01	<88> Biological Reactivity Tests, In Vivo
07/06/2020	Biocompatibility	2-276	Partial	ISO	10993-18 Second edition 2020-01	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
07/06/2020	General Plastic Surgery/ General Hospital	6-440	Partial	ASTM	D3578-19(2023)	Standard Specification for Rubber Examination Gloves
12/19/2022	InVitro Diagnostics	7-314	Partial	CLSI	M27M44S, 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/20/2021	General II (ES/ EMC)	19-42	Partial	IEC	61326-1 Edition 3.0 2020-10	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/20/2021	Cardiovascular	3-174	Partial	ISO	5840-1 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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
07/26/2016	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
12/20/2021	General Plastic Surgery/ General Hospital	6-474	Partial	ASTM	F3352-19	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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
12/19/2022	Ophthalmic	10-132	Partial	ISO	10942 Third edition 2022-01	Ophthalmic instruments - Direct ophthalmoscopes
06/07/2021	Software/ Informatics	13-117	Partial	IEEE	Std 11073-40101-2020	Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment.
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	IEC	60601-2-2 Edition 6.0 2017-03	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	ANSI AAMI IEC	60601-2-2:2017	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/20/2021	Biocompatibility	2-295	Partial	USP-NF	M98900_01_01	<151> Pyrogen Test (USP Rabbit Test)
12/21/2020	General II (ES/ EMC)	19-38	Partial	IEC	60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
05/30/2022	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
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
12/21/2020	Orthopedic	11-330	Partial	ASTM	F2028-17	Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
12/21/2020	Tissue Engineering	15-64	Partial	ISO	22442-1 Third edition 2020-09	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
09/17/2018	Ophthalmic	10-56	Partial	ANSI	Z80.12-2007 (R2022)	American National Standard for Ophthalmics - Multifocal Intraocular Lenses
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
09/21/2016	InVitro Diagnostics	7-265	Partial	CLSI	C62-A	Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
10/17/2014	ObGyn/ Gastroenterology/ Urology	9-95	Partial	CEN	EN 1615:2000	Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
07/15/2019	Nanotechnology	18-14	Partial	ISO	TR 11360 First edition 2010-07-15	Nanotechnologies - Methodology for the classification and categorization of nanomaterials
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
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
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
07/15/2019	Ophthalmic	10-116	Partial	ANSI	Z80.35-2018 (R2023)	American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
06/07/2021	Cardiovascular	3-168	Partial	IEEE	Std 1708-2014	Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
07/15/2019	Nanotechnology	18-13	Partial	ISO	TS 18827 First edition 2017-06	Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials
06/07/2021	InVitro Diagnostics	7-292	Partial	CLSI	M62 1st Edition	Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
01/14/2019	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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
05/30/2022	Sterility	14-572	Partial	ANSI AAMI	ST91:2021	Flexible and semi-rigid endoscope processing in health care facilities
08/14/2015	Anesthesiology	1-103	Partial	ISO	5367 Fifth edition 2014-10-15	Anaesthetic and respiratory equipment - Breathing sets and connectors
06/07/2021	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
06/07/2021	Ophthalmic	10-122	Partial	ISO	10939 Third edition 2017-05	Ophthalmic instruments - Slit-lamp microscopes
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	Biocompatibility	2-290	Partial	ISO	TS 37137-1 First edition 2021-03	Biological evaluation of absorbable medical devices - Part 1: General requirements.
06/07/2021	InVitro Diagnostics	7-236	Partial	CLSI	M43-A October 2011	Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
12/21/2020	General II (ES/ EMC)	19-36	Partial	IEC	60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
12/21/2020	General II (ES/ EMC)	19-36	Partial	ANSI AAMI IEC	60601-1-2:2014 [Including AMD 1:2021]	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
12/21/2020	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	Ophthalmic	10-125	Partial	ISO	11979-7 Fourth edition 2018-03	Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
07/06/2020	InVitro Diagnostics	7-296	Partial	CLSI	EP09c 3rd Edition	Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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
12/21/2020	ObGyn/ Gastroenterology/ Urology	9-130	Complete	ISO	8600-6 Second edition 2020-09	Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
12/23/2019	General I (QS/ RM)	5-124	Complete	ISO	7000 Sixth edition 2019-07	Graphical symbols for use on equipment - Registered symbols
12/23/2019	Radiology	12-328	Complete	IEC	61223-3-5 Edition 2.0 2019-09	Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
01/14/2019	Radiology	12-102	Complete	ANSI IES	RP-27.2-00/R17	Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
01/14/2019	Radiology	12-321	Complete	ANSI IES	RP-27.3-17	Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
07/06/2020	InVitro Diagnostics	7-298	Complete	CLSI	EP35, 1st Edition	Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
01/14/2019	General I (QS/ RM)	5-122	Complete	ASME	V&V 40-2018	Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
01/14/2019	Cardiovascular	3-158	Complete	ASTM	F3320-18	Standard Guide forCoating Characterization of Drug Coated Balloons
01/14/2019	Dental/ ENT	4-255	Complete	ANSI ADA	Standard No. 131-2015 (R2020)	Dental CAD/CAM Machinable Zirconia Blanks
07/15/2019	Orthopedic	11-355	Complete	ISO	15142-1 First edition 2003-08-01	Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
07/06/2020	Cardiovascular	3-164	Complete	ASTM	F1830-19	Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
03/16/2012	Radiology	12-115	Complete	ISO	13695:2004	Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
12/23/2016	Radiology	12-303	Complete	IEC	61303 Edition 1.0 1994-09	Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
12/23/2016	Radiology	12-304	Complete	IEC	60731 Edition 3.1 2016-04	Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
09/09/2008	Software/ Informatics	13-18	Complete	CLSI	LIS03-A	Standard Guide for Selection of a Clinical Laboratory Information Management System
12/23/2019	Materials	8-492	Complete	ISO	5832-9 Third edition 2019-02	Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
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)]
07/06/2020	General Plastic Surgery/ General Hospital	6-444	Complete	ASTM	D7103-19(2023)	Standard Guide for Assessment of Medical Gloves
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
12/21/2020	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
07/09/2014	Software/ Informatics	13-68	Complete	ISO	11073-90101 First edition 2008-01-15	Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
04/04/2016	Software/ Informatics	13-81	Complete	IEEE	Std 11073-10419:2015	Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
07/15/2019	Materials	8-510	Complete	ASTM	F997-18	Standard Specification for Polycarbonate Resin for Medical Applications
12/23/2019	Materials	8-505	Complete	ISO	6474-2 Second edition 2019-03	Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
12/23/2019	Materials	8-507	Complete	ASTM	F688-19	Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
08/14/2015	Software/ Informatics	13-76	Complete	ISO	11073-91064 First edition 2009-05-01	Health informatics - Standard communication protocol - Computer-assisted electrocardiography
07/06/2020	ObGyn/ Gastroenterology/ Urology	9-124	Complete	CIE ISO	11664-1:2019	Colorimetry - Part 1: CIE standard colorimetric observers
08/21/2017	Software/ Informatics	13-94	Complete	ISO IEEE	11073-10424 First edition 2016-06-15	Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)]
08/06/2013	Software/ Informatics	13-49	Complete	ISO IEEE	11073-20101 First edition 2004-12-15	Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
07/09/2014	Radiology	12-275	Complete	IEC	61161 Edition 3.0 2013-01	Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014	Radiology	12-280	Complete	IEC	62555 Edition 1.0 2013-11	Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
07/09/2014	Radiology	12-281	Complete	IEC	60601-2-62 Edition 1.0 2013-07	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/06/2020	ObGyn/ Gastroenterology/ Urology	9-129	Complete	ISO CIE	61966-2-1 First edition 1999-10	Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
12/23/2019	Materials	8-520	Complete	ASTM	F799-19	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
12/21/2020	Sterility	14-554	Complete	ASTM	F17-20	Standard Terminology Relating to Flexible Barrier Packaging
12/23/2019	General Plastic Surgery/ General Hospital	6-424	Complete	ASTM	D5151-19(2023)	Standard Test Method for Detection of Holes in Medical Gloves
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.
03/18/2009	InVitro Diagnostics	7-180	Complete	CLSI	M34-A (Replaces M24-P)	Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
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
03/16/2012	Radiology	12-134	Complete	ISO	11146-1 First edition 2005-01-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
07/09/2014	Sterility	14-282	Complete	ASTM	F2338-09 (Reapproved 2020)	Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
08/06/2013	Ophthalmic	10-78	Complete	ISO	11979-3 Third edition 2012-12-01	Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
01/30/2014	General Plastic Surgery/ General Hospital	6-305	Complete	ISO	10555-3 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014	Sterility	14-405	Complete	ASTM	F2252/F2252M-13 (Reapproved 2018)	Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
08/14/2015	ObGyn/ Gastroenterology/ Urology	9-108	Complete	ISO	8009 Second edition 2014-11-15	Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
09/17/2018	Orthopedic	11-337	Complete	ISO	16087 First edition 2013-10-01	Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
09/09/2008	Radiology	12-166	Complete	NEMA	XR 23-2006 (R2020)	"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
10/04/2010	Radiology	12-213	Complete	IEC	62220-1-2 Edition 1.0 2007-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
10/04/2010	Radiology	12-214	Complete	IEC	62220-1-3 Edition 1.0 2008-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
07/09/2014	Radiology	12-283	Complete	ISO	12609-2 First edition 2013-07-15	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
07/09/2014	Tissue Engineering	15-40	Complete	ASTM	F2211-13	Standard Classification for Tissue Engineered Medical Products (TEMPs)
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
01/14/2019	Materials	8-488	Complete	ASTM	F3301-18a	Standard for Additive Manufacturing - Post Processing Methods - Standard Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion
12/23/2019	Materials	8-519	Complete	ISO	13782 Second edition 2019-04	Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
07/15/2019	InVitro Diagnostics	7-288	Complete	CLSI	M24 3rd Edition	Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
08/14/2015	Radiology	12-290	Complete	IEC	61910-1 Edition 1.0 2014-09	Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
07/15/2019	Materials	8-493	Complete	ISO	13779-2 Third edition 2018-12	Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
12/23/2019	Cardiovascular	3-162	Complete	ASTM	F3374-19	Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2019	InVitro Diagnostics	7-295	Complete	CLSI	M52, 1st ed. August 2015 (Reaffirmed: January 2020)	Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
12/21/2020	General I (QS/ RM)	5-132	Complete	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
07/06/2020	Sterility	14-549	Complete	ASTM	F3004-13 (Reapproved 2020)	Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound
07/15/2019	Sterility	14-528	Complete	ISO	11137-1 First edition 2006-04-15	Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
07/15/2019	Sterility	14-528	Complete	ANSI AAMI ISO	11137-1:2006/(R)2015	Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
12/23/2019	General I (QS/ RM)	5-125	Complete	ISO	14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices
12/23/2019	General I (QS/ RM)	5-125	Complete	ANSI AAMI ISO	14971: 2019	Medical devices - Applications of risk management to medical devices
01/14/2019	Ophthalmic	10-114	Complete	ANSI	Z80.28-2017	American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
01/14/2019	Ophthalmic	10-115	Complete	ANSI	Z80.29-2015 (R2020)	American National Standard for Ophthalmics - Accomodative Intraocular Lenses
01/14/2019	Software/ Informatics	13-106	Complete	IEEE	Std 11073-10207-2017	Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/14/2019	Software/ Informatics	13-107	Complete	ISO	11073-20702 First edition 2018-09	Health informatics - Point-of-care medical device communication - Part 20702: Medical devices communication profile for web services
01/14/2019	Software/ Informatics	13-107	Complete	IEEE	Std 11073-20702-2016	Health informatics - Point-of-care medical device communication Part 20702: Medical Devices
07/15/2019	Biocompatibility	2-265	Complete	ASTM	F2901-19	Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
12/23/2019	Dental/ ENT	4-260	Complete	ANSI ASA	S12.2-2019	American National Standard for Criteria for Evaluating Room Noise
07/06/2020	Cardiovascular	3-165	Complete	ASTM	F1841-19	Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
12/23/2019	Dental/ ENT	4-261	Complete	ISO	7405 Third edition 2018-10 Corrected version 2018-12	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
12/23/2019	Dental/ ENT	4-262	Complete	IEC	80601-2-60 Edition 2.0 2019-06	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
07/15/2019	Ophthalmic	10-118	Complete	ANSI	Z80.38-2017 (R2021)	American National Standard for Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery
07/15/2019	Dental/ ENT	4-258	Complete	ISO	10139-2 Third edition 2016-06-15	Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
07/15/2019	Dental/ ENT	4-258	Complete	ANSI ADA	Standard No. 160-2020	Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
07/06/2020	Radiology	12-332	Complete	IEC	62464-1 Edition 2.0 2018-12	Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
07/06/2020	Cardiovascular	3-155	Complete	IEC	60601-2-47 Edition 2.0 2012-02	Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
07/06/2020	Cardiovascular	3-155	Complete	ANSI AAMI IEC	60601-2-47:2012/(R)2016	Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
08/06/2013	Software/ Informatics	13-55	Complete	IEEE	Std 11073-10421-2010	Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
12/23/2019	Materials	8-501	Complete	ISO	5834-1 Fourth edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
06/07/2021	Orthopedic	11-382	Complete	ASTM	F3090-20	Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
06/07/2021	Radiology	12-335	Complete	IEC	60336 Edition 5.0 2020-12	Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
12/21/2020	Materials	8-540	Complete	ASTM	F1091-20	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/21/2020	Materials	8-541	Complete	ASTM	F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
12/21/2020	Materials	8-542	Complete	ASTM	F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
12/23/2016	Software/ Informatics	13-87	Complete	ISO IEC	15026-2 First edition 2011-02-15	Systems and software engineering - Systems and software assurance - Part 2: Assurance case
07/09/2014	Software/ Informatics	13-65	Complete	UL ANSI	1998 Third Edition 2013	Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
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	Orthopedic	11-394	Complete	ASTM	F1820-22	Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
12/23/2019	InVitro Diagnostics	7-293	Complete	CLSI	QMS01, 5th ed. June 2019 (Replaces QMS01-A4)	A Quality Management System Model for Laboratory Services.
01/14/2019	InVitro Diagnostics	7-232	Complete	CLSI	MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17	Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
07/15/2019	Sterility	14-529	Complete	ISO	11135 Second edition 2014-07-15	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
07/15/2019	Sterility	14-529	Complete	ANSI AAMI ISO	11135:2014/A1:2018	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
07/06/2020	Software/ Informatics	13-113	Complete	IEEE	Std 11073-20601-2019	Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol.
12/23/2016	General I (QS/ RM)	5-113	Complete	ASTM	D7386-16	Standard Practice for Performance Testing of Packages for Single Delivery Systems
01/27/2015	Sterility	14-165	Complete	ISO	14644-5 First edition 2004-08-15	Cleanrooms and associated controlled environments - Part 5: Operations
07/09/2014	Sterility	14-257	Complete	ASTM	D3078-02 (Reapproved 2021)e1	Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
08/06/2013	Sterility	14-383	Complete	ISO ASTM	51702 Third edition 2013-04-15	Practice for dosimetry in a gamma facility for radiation processing
12/21/2020	Biocompatibility	2-280	Complete	ASTM	F1408-20a	Standard Practice for Subcutaneous Screening Test for Implant Materials
01/14/2019	General Plastic Surgery/ General Hospital	6-338	Complete	ASTM	D7866-14	Standard Specification for Radiation Attenuating Protective Gloves
12/18/2023	ObGyn/ Gastroenterology/ Urology	9-150	Complete	ISO	7439 Fourth edition 2023-04	Copper-bearing contraceptive intrauterine devices - Requirements and tests
01/14/2019	Orthopedic	11-347	Complete	ASTM	F2077-18	Test Methods for Intervertebral Body Fusion Devices
04/04/2016	Tissue Engineering	15-24	Complete	ASTM	F2721-09 (Reapproved 2014)	Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
12/23/2019	Materials	8-521	Complete	ASTM	F2313-18	Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
07/15/2019	Biocompatibility	2-263	Complete	ASTM	F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
12/21/2020	Dental/ ENT	4-264	Complete	ISO	9333 Second edition 2006-07	Dentistry - Brazing materials
12/21/2020	Dental/ ENT	4-264	Complete	ANSI ADA	Standard No. 88-2019	Dental Brazing Alloys
06/07/2021	Orthopedic	11-379	Complete	ASTM	F2978-20	Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
07/06/2020	Sterility	14-540	Complete	ISO	11737-2 Third edition 2019-12	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020	Sterility	14-540	Complete	ANSI AAMI ISO	11737-2:2019	Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
07/06/2020	Sterility	14-545	Complete	ISO ASTM	51276 Fourth edition 2019-08	Practice for use of a polymethylmethacrylate dosimetry system
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-121	Complete	IEC	60601-2-16 Edition 5.0 2018-4	Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-121	Complete	ANSI AAMI IEC	60601-2-16:2018	Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
08/06/2013	Software/ Informatics	13-38	Complete	IEC	80001-1 Edition 1.0 2010-10	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
08/06/2013	Software/ Informatics	13-38	Complete	ANSI AAMI IEC	80001-1:2010	Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
01/30/2014	Software/ Informatics	13-63	Complete	ANSI AAMI IEC	TIR 80001-2-4:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
01/30/2014	Software/ Informatics	13-63	Complete	IEC	TR 80001-2-4 Edition 1.0 2012-11	Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
07/06/2020	Sterility	14-542	Complete	ISO ASTM	52628 Second edition 2020-04	Standard practice for dosimetry in radiation processing
12/23/2019	Orthopedic	11-360	Complete	ASTM	F1378-18e1	Standard Specification for Shoulder Prostheses
12/21/2020	Biocompatibility	2-282	Complete	ISO	14155 Third edition 2020-07	Clinical investigation of medical devices for human subjects - Good clinical practice
04/04/2016	General II (ES/ EMC)	19-17	Complete	IEEE ANSI	C63.18-2014	American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
12/23/2019	Materials	8-502	Complete	ASTM	F2038-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
01/14/2019	Radiology	12-323	Complete	ISO	11990 Third edition 2018-08	Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
01/14/2019	Radiology	12-324	Complete	ISO	13694 Third edition 2018-11	Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
12/23/2019	Materials	8-480	Complete	ASTM	F2063-18	Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
12/23/2019	Materials	8-481	Complete	ASTM	F1314-18	Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
12/23/2019	Materials	8-484	Complete	ASTM	F2066-18	Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
08/21/2017	Software/ Informatics	13-91	Complete	ISO IEEE	11073-10419 First edition 2016-06-15	Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
01/30/2014	Radiology	12-228	Complete	IEC	61391-2 Edition 1.0 2010-01	Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
03/14/2011	Radiology	12-226	Complete	IEC	61223-2-6 Second Edition 2006-11	Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
12/23/2019	Materials	8-522	Complete	ASTM	F2129-19a	Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
07/06/2020	Materials	8-534	Complete	ISO ASTM	52911-1: First Edition 2019-07	Additive Manufacturing - Design - Part 1: Laser-based powder bed fusion of metals
07/06/2020	Materials	8-535	Complete	ISO ASTM	52911-2: First Edition 2019-09	Additive Manufacturing - Design - Part 2: Laser-based powder bed fusion of polymers
07/06/2020	Radiology	12-334	Complete	AAMI	RT3:2020	Radiation therapy machine characterization
12/23/2019	Physical Medicine	16-226	Complete	RESNA ANSI	WC-4:2017 Section 10	American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transporation Section 10 Wheelchair and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers.
06/27/2016	Materials	8-429	Complete	ASTM	F2224-09 (Reapproved 2020)	Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
07/15/2019	Materials	8-503	Complete	ASTM	F2042-18	Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/15/2019	Materials	8-509	Complete	ASTM	F702-18	Standard Specification for Polysulfone Resin for Medical Applications
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-138	Complete	ISO	20695 First edition 2020-03	Enteral feeding systems - Design and testing
07/15/2019	Physical Medicine	16-206	Complete	ISO	7176 - 30 First edition 2018-12	Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
01/14/2019	General I (QS/ RM)	5-121	Complete	ISO	80369-1 Second edition 2018-11	Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
12/21/2020	Anesthesiology	1-148	Complete	ISO	80601-2-69 Second edition 2020-11	Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
07/06/2020	Orthopedic	11-367	Complete	ISO	14243-3 Second edition 2014-11-01	Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
07/06/2020	Orthopedic	11-368	Complete	ASTM	F3334-19	Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
07/06/2020	Orthopedic	11-369	Complete	ASTM	F3292-19	Standard Practice for Inspection of Spinal Implants Undergoing Testing
06/07/2021	General Plastic Surgery/ General Hospital	6-463	Complete	IEC	60601-2-21 Edition 3.0 2020-09	Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
07/06/2020	General I (QS/ RM)	5-127	Complete	ISTA	3B 2017	Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020	General I (QS/ RM)	5-128	Complete	ISTA	3E 2017	Similar Packaged-Products in Unitized Loads of Truckload Shipment
06/07/2021	InVitro Diagnostics	7-307	Complete	CLSI	POCT05 2nd Edition	Performance Metrics for Continuous Interstitial Glucose Monitoring
06/07/2021	Orthopedic	11-380	Complete	ASTM	F2979-20	Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
07/06/2020	Sterility	14-539	Complete	ASTM	F2475-20	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
07/06/2020	Materials	8-529	Complete	ASTM	F2633-19	Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
07/15/2019	Tissue Engineering	15-57	Complete	ASTM	F2315-18	Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
07/15/2019	Tissue Engineering	15-58	Complete	ASTM	F2103-18	Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
12/21/2020	Sterility	14-550	Complete	ANSI AAMI	ST67:2019	Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
12/21/2020	Sterility	14-552	Complete	ISO ASTM	51818 Fourth edition 2020-06	Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
12/23/2019	Physical Medicine	16-228	Complete	RESNA ANSI	WC-4:2017 Section 19	American National Standard for Wheelchairs - Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles.
07/15/2019	Materials	8-504	Complete	ASTM	F561-19	Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
12/21/2020	Neurology	17-17	Complete	ASTM	F3395/F3395M-19	Standard Specification for Neurosurgical Head Holder Devices
07/06/2020	Biocompatibility	2-275	Complete	ISO	10993-7 Second edition 2008-10-15	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
06/07/2018	ObGyn/ Gastroenterology/ Urology	9-114	Complete	IEC	60601-2-18: Edition 3.0 2009-08	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
01/14/2019	Software/ Informatics	13-79	Complete	IEC	62304 Edition 1.1 2015-06 CONSOLIDATED VERSION	Medical device software - Software life cycle processes
01/14/2019	Software/ Informatics	13-79	Complete	ANSI AAMI IEC	62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
07/15/2019	Sterility	14-532	Complete	ASTM	F3287-17e1	Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
12/21/2020	Biocompatibility	2-281	Complete	ISO	TS 10993-19 Second edition 2020-03	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
07/06/2020	Software/ Informatics	13-114	Complete	IEEE	Std 11073-10101-2019	Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020	Software/ Informatics	13-115	Complete	ISO IEC IEEE	29119-1 First edition 2013-09-01	Software and systems engineering - Software testing - Part 1: Concepts and definitions
07/15/2019	Sterility	14-533	Complete	ISO	TS 19930 First edition 2017-12	Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
07/06/2020	Materials	8-531	Complete	ASTM	F3321-19	Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
07/15/2019	General I (QS/ RM)	5-123	Complete	ISO	80369-3 First Edition 2016-07-01	Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
12/21/2020	Dental/ ENT	4-270	Complete	ANSI ADA	Technical Report No. 146-2018	CAD/CAM Abutments in Dentistry
07/06/2020	Radiology	12-333	Complete	IEC	TR 63183 Edition 1.0 2019-12	Guidance on error and warning messages for software used in radiotherapy
06/07/2021	Materials	8-558	Complete	ASTM	F3333-20	Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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
08/21/2017	Dental/ ENT	4-239	Complete	ANSI AAMI	CI86:2017	Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
01/14/2019	Biocompatibility	2-141	Complete	ASTM	F1984-99 (Reapproved 2018)	Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
01/14/2019	Neurology	17-14	Complete	ANSI AAMI	NS4:2013(R)2017	Transcutaneous Electrical Nerve Stimulators
04/04/2016	Anesthesiology	1-115	Complete	ISO	80601-2-70 First Edition 2015-01-15	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
05/30/2022	Radiology	12-344	Complete	IEC	62563-2 Edition 1.0 2021-11	Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
01/14/2019	Physical Medicine	16-204	Complete	ISO	7176-6 Third edition 2018-06	Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
01/14/2019	Cardiovascular	3-79	Complete	ASTM	F2079-09 (Reapproved 2017)	Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
01/14/2019	InVitro Diagnostics	7-139	Complete	CLSI	QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2	Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
05/30/2022	General Plastic Surgery/ General Hospital	6-479	Complete	ISO	11608-5:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
01/30/2014	Cardiovascular	3-54	Complete	ANSI AAMI ISO	7198:2016 Second edition	Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
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
12/20/2021	Cardiovascular	3-172	Complete	AAMI	TIR42:2021	Evaluation of Particulates Associated with Vascular Medical Devices
05/30/2022	InVitro Diagnostics	7-312	Complete	CLSI	M39 5th Edition	Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
07/06/2020	Sterility	14-541	Complete	ANSI AAMI	ST72:2019	Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
07/15/2019	Anesthesiology	1-116	Complete	ISO	5360 Fourth edition 2016-02-15	Anaesthetic vaporizers - Agent specific filling systems
07/15/2019	Anesthesiology	1-122	Complete	ISO	5364 Fifth edition 2016-09-01	Anaesthetic and respiratory equipment-Oropharyngeal airways
03/16/2012	Cardiovascular	3-96	Complete	ISO	81060-1 First edition 2007-12-01	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
03/16/2012	Cardiovascular	3-96	Complete	ANSI AAMI ISO	81060-1:2007/(R)2013	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
07/12/1999	Radiology	12-51	Complete	IEC	61145 (1992-05)	Calibration and usage of ionization chamber systems for assay of radionuclides
03/08/2004	InVitro Diagnostics	7-86	Complete	CLSI	C29-A2 (Replaces C29-A)	Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004	InVitro Diagnostics	7-87	Complete	CLSI	C31-A2 (Replaces C31-A)	Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004	InVitro Diagnostics	7-88	Complete	CLSI	C37-A	Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004	InVitro Diagnostics	7-89	Complete	CLSI	C39-A (Replaces C39-P)	A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004	InVitro Diagnostics	7-105	Complete	CLSI	H30-A2	Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
07/15/2019	Biocompatibility	2-264	Complete	ASTM	F2148-18	Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
07/15/2019	Materials	8-518	Complete	ASTM	F3306-19	Standard Test Method for Ion Release Evaluation of Medical Implants
05/30/2022	Anesthesiology	1-152	Complete	ISO	80601-2-87 First edition 2021-04	Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
12/20/2021	Ophthalmic	10-128	Complete	ASTM	D882-18	Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
07/26/2016	Biocompatibility	2-170	Complete	ISO	10993-14 First edition 2001-11-15	Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
07/26/2016	Biocompatibility	2-170	Complete	ANSI AAMI ISO	10993-14:2001/(R) 2011	Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
07/06/2020	Materials	8-536	Complete	ISO ASTM	52902:First Edition 2019-07	Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
05/30/2022	General II (ES/ EMC)	19-47	Complete	ANSI AAMI	HA60601-1-11:2015 [Including AMD1:2021]	Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
12/20/2021	Materials	8-575	Complete	ASTM	F3160-21	Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
08/21/2017	Biocompatibility	2-247	Complete	ISO	10993-6 Third edition 2016-12-01	Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
08/21/2017	Software/ Informatics	13-97	Complete	IEC	82304-1 Edition 1.0 2016-10	Health software - Part 1: General requirements for product safety
05/30/2022	Sterility	14-577	Complete	ISO	11737-1 Third edition 2018-01 [Including AMD1:2021]	Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
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
12/19/2022	Orthopedic	11-397	Complete	ASTM	F3210-22e1	Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
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
01/14/2019	General Plastic Surgery/ General Hospital	6-410	Complete	ISO	8536-6 Third edition 2016-12-01	Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
07/06/2020	Materials	8-533	Complete	ISO ASTM	52907: First Edition 2019-11	Additive Manufacturing - Feedstock materials - Methods to characterize metal powders
08/21/2017	Software/ Informatics	13-96	Complete	UL ANSI	2900-1 First Edition 2017	Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/14/2015	Software/ Informatics	13-77	Complete	ISO IEC	29147 First edition 2014-02-15	Information technology - Security techniques - Vulnerability disclosure
01/14/2019	Anesthesiology	1-114	Complete	ISO	18835 First Edition 2015-04-01	Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
12/20/2021	Radiology	12-341	Complete	IEC	62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION	Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods
12/19/2022	General I (QS/ RM)	5-135	Complete	ISO	20417 First edition 2021-04 Corrected version 2021-12	Medical devices - Information to be supplied by the manufacturer
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
07/06/2020	Tissue Engineering	15-61	Complete	ASTM	F2150-19	Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
12/23/2019	Materials	8-523	Complete	ASTM	F3275-19	Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
12/23/2019	Materials	8-524	Complete	ASTM	F3276-19	Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
12/23/2019	Radiology	12-309	Complete	IEC	60601-2-28 Edition 3.0 2017-06	Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12/19/2022	General I (QS/ RM)	5-140	Complete	ASME	V&V 10-2019	Standard for Verification and Validation in Computational Solid Mechanics
05/29/2023	Materials	8-598	Complete	ASTM	F3109-22	Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/23/2019	Materials	8-508	Complete	ASTM	F2579-18	Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
12/23/2019	Sterility	14-538	Complete	ASTM	F3357-19	Standard Guide for Designing Reusable Medical Devices for Cleanability
07/15/2019	Ophthalmic	10-117	Complete	ANSI	Z80.37-2017 (R2021)	American National Standard for Ophthalmics - Slit-Lamp Microscopes
07/15/2019	InVitro Diagnostics	7-287	Complete	CLSI	M44-S3 (2018)	Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
12/23/2016	Materials	8-441	Complete	ASTM	F3109-16	Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/21/2020	Sterility	14-553	Complete	ASTM	F2097-20	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
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
07/15/2019	General Plastic Surgery/ General Hospital	6-422	Complete	AAMI	TIR38:2019	Medical device safety assurance case guidance
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
07/06/2020	Sterility	14-544	Complete	ISO	18472 Second edition 2018-08	Sterilization of health care products - Biological and chemical indicators - Test equipment
12/23/2016	Biocompatibility	2-93	Complete	ASTM	F763-04 (Reapproved 2016)	Standard Practice for Short-Term Screening of Implant Materials
12/19/2022	General Plastic Surgery/ General Hospital	6-484	Complete	ASTM	F3502-22a	Standard Specification for Barrier Face Coverings
07/15/2019	General Plastic Surgery/ General Hospital	6-421	Complete	ISO	80601-2-56 Second edition 2017-03	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
12/21/2020	Dental/ ENT	4-266	Complete	ISO	19023 First edition 2018-02	Dentistry - Orthodontic anchor screws
12/21/2020	Dental/ ENT	4-266	Complete	ANSI ADA	Standard No. 178-2019	Orthodontic Anchor Screws
07/06/2020	Orthopedic	11-363	Complete	ASTM	F897-19	Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
12/23/2019	Radiology	12-327	Complete	ISO	11551 Third eidtion 2019-10	Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
07/26/2016	Biocompatibility	2-174	Complete	ISO	10993-10 Third Edition 2010-08-01	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
07/26/2016	Biocompatibility	2-174	Complete	ANSI AAMI ISO	10993-10:2010/(R)2014	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
01/14/2019	Dental/ ENT	4-217	Complete	ANSI ASA	S3.36-2012 (Reaffirmed 2022)	American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
01/14/2019	Dental/ ENT	4-163	Complete	ANSI ASA	S3.5-1997 (Reaffirmed 2020)	American National Standard Methods for Calculation of the Speech Intelligibility Index
03/16/2012	Anesthesiology	1-73	Complete	ISO	10651-4 First edition 2002-03-01	Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
12/18/2023	Dental/ ENT	4-321	Complete	ISO	23450 First edition 2021-03	Dentistry - Intraoral camera
05/29/2023	Cardiovascular	3-187	Complete	ISO	14708-6 Second edition 2019-09	Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
09/17/2018	Orthopedic	11-339	Complete	ISO	7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15	Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
09/17/2018	Orthopedic	11-340	Complete	ASTM	F3018-17	Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
09/17/2018	Ophthalmic	10-112	Complete	ISO	11986 Third edition 2017-11	Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
01/27/2015	Materials	8-171	Complete	ASTM	F1609-08 (Reapproved 2014)	Standard Specification for Calcium Phosphate Coatings for Implantable Materials
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	7-284	Complete	CLSI	EP37 1st Edition	Supplemental Tables for Interference Testing in Clinical Chemistry
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
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	General I (QS/ RM)	5-42	Complete	ASTM	D903-98 (Reapproved 2017)	Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
09/17/2018	Ophthalmic	10-57	Complete	ANSI	Z80.13-2007 (R2022)	American National Standard for Ophthalmics - Phakic Intraocular Lenses
09/17/2018	Ophthalmic	10-111	Complete	ISO	11981 Third edition 2017-11	Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
09/17/2018	Sterility	14-293	Complete	ANSI AAMI	ST50:2004/(R)2018	Dry heat (heated air) sterilizers
09/17/2018	Sterility	14-516	Complete	ASTM	F3039-15	Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
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)].
08/06/2013	Software/ Informatics	13-56	Complete	IEEE	Std 11073-10406-2011	Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/21/2017	Software/ Informatics	13-67	Complete	ISO IEEE	11073-10418 First edition 2014-03-01	Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
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
09/17/2018	Dental/ ENT	4-246	Complete	ISO	20749 First edition 2017-03	Dentistry - Pre-capsulated dental amalgam
09/17/2018	Dental/ ENT	4-246	Complete	ANSI ADA	Standard No. 144-2018	Alloy for Dental Amalgam
06/27/2016	Materials	8-426	Complete	ASTM	F3087-15	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
07/09/2014	Anesthesiology	1-100	Complete	CGA	V-1:2013	Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
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
04/04/2016	Orthopedic	11-303	Complete	ASTM	F3047M-15	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
01/30/2014	General I (QS/ RM)	5-84	Complete	AAMI	TIR 49:2013/(R)2020	Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
04/04/2016	Materials	8-116	Complete	ASTM	F2258-05 (Reapproved 2015)	Standard Test Method for Strength Properties of Tissue Adhesives in Tension
01/27/2015	Orthopedic	11-283	Complete	ASTM	F2943-14 (Reapproved 2019)	Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
09/17/2018	Orthopedic	11-334	Complete	ASTM	F1829-17	Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
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
12/23/2016	Biocompatibility	2-189	Complete	ASTM	F895-11 (Reapproved 2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-68	Complete	ISO	23409 First edition 2011-02-15	Male Condoms - Requirements and test methods for condoms made from synthetic materials
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-111	Complete	ISO	4074 Third edition 2015-10-15	Natural latex rubber condoms - Requirements and test methods
12/18/2023	Orthopedic	11-406	Complete	ASTM	F3141-23	Standard Guide for Total Knee Replacement Loading Profiles
01/14/2019	Nanotechnology	18-5	Complete	ASTM	E2859-11 (Reapproved 2017)	Standard Guide for Size Measurement of Nanoparticles Using Atomic Force Microscopy
07/09/2014	Dental/ ENT	4-160	Complete	ANSI ASA	S3.1-1999 (Reaffirmed 2023)	American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
12/18/2023	Anesthesiology	1-163	Complete	ISO	80601-2-72 Second edition 2023-06	Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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
08/14/2015	Dental/ ENT	4-220	Complete	ANSI ASA	S3.22-2014 (Reaffirmed 2020)	American National Standard Specification of Hearing Aid Characteristics
08/14/2015	Dental/ ENT	4-184	Complete	ANSI ASA	S3.25-2009 (Reaffirmed 2019)	American National Standard For an Occluded Ear Simulator
09/09/2008	Dental/ ENT	4-145	Complete	ISO	22803 First edition 2004-09-01	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
08/14/2015	Ophthalmic	10-98	Complete	ISO	11979-2 Second edition 2014-08-15	Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015	Ophthalmic	10-97	Complete	ISO	13212 Third edition 2014-09-01	Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
12/18/2023	Orthopedic	11-402	Complete	ASTM	F1798-21	Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
12/18/2023	Dental/ ENT	4-309	Complete	ISO	6877 Third edition 2021-09	Dentistry - Endodontic obturating materials
12/18/2023	Dental/ ENT	4-309	Complete	ANSI ADA	Standard No. 78-2021	Dentistry - Endodontic Obturating Materials
01/14/2019	Nanotechnology	18-8	Complete	ASTM	E2578-07 (Reapproved 2022)	Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions
01/14/2019	Nanotechnology	18-11	Complete	ISO	TR 13121 First edition 2011-05-15	Nanotechnologies - Nanomaterial risk evaluation
12/18/2023	Dental/ ENT	4-311	Complete	ISO	9917-2 Third edition 2017-09	Dentistry - Water-based cements - Part 2: Resin-modified cements
07/26/2016	Biocompatibility	2-227	Complete	ASTM	F1983-14	Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
09/17/2018	General Plastic Surgery/ General Hospital	6-123	Complete	ASTM	E667-98 (Reapproved 2017)	Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
09/17/2018	Orthopedic	11-336	Complete	ISO	17853 Third edition 2011-03-01	Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
04/04/2016	Materials	8-413	Complete	ASTM	F2819-10 (Reapproved 2015)	Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
05/29/2023	Radiology	12-347	Complete	IEC	60601-2-33 Edition 4.0 2022-08	Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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
12/18/2023	Radiology	12-352	Complete	NEMA	PS 3.1 - 3.20 2023e	Digital Imaging and Communications in Medicine (DICOM) Set
08/14/2015	Orthopedic	11-183	Complete	ASTM	F1875-98 (Reapproved 2022)	Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
12/23/2016	Orthopedic	11-319	Complete	ISO	7206-12 First edition 2016-10-01	Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
01/14/2019	Tissue Engineering	15-56	Complete	ASTM	F3224-17	Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
08/21/2017	Biocompatibility	2-246	Complete	ASTM	F1877-16	Standard Practice for Characterization of Particles
05/29/2023	Dental/ ENT	4-308	Complete	ISO	14708-7 Second edition 2019-12	Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
12/18/2023	Biocompatibility	2-302	Complete	ASTM	F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
04/04/2016	Materials	8-403	Complete	ASTM	D638-14	Standard Test Method for Tensile Properties of Plastics
08/21/2017	Materials	8-457	Complete	ISO	13175-3 First edition 2012-10-01	Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
06/07/2018	Biocompatibility	2-250	Complete	ASTM	F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
06/27/2016	Radiology	12-293	Complete	IEC	60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
09/17/2018	Physical Medicine	16-203	Complete	ASME	A18.1-2017	Safety Standard for Platform Lifts and Stairway Chairlifts
01/27/2015	Dental/ ENT	4-185	Complete	ANSI ASA	S3.45-2009 (Reaffirmed 2019)	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
01/14/2019	Biocompatibility	2-136	Complete	ASTM	E1262-88 (Reapproved 2018)	Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019	Biocompatibility	2-145	Complete	ASTM	F1439-03 (Reapproved 2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
05/27/2005	Radiology	12-121	Complete	IEC	61847: 1998	Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
01/14/2019	Cardiovascular	3-66	Complete	ASTM	F2081-06 (Reapproved 2017)	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
01/14/2019	Sterility	14-518	Complete	AAMI ANSI	ST55:2016/(R)2023	Table-top steam sterilizers
07/06/2020	General Plastic Surgery/ General Hospital	6-439	Complete	ISO	7886-2 Second edition 2020-04	Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
07/06/2020	General Plastic Surgery/ General Hospital	6-441	Complete	ISO	7886-3 Second edition 2020-05	Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
07/06/2020	Orthopedic	11-364	Complete	ISO	14243-1 Second edition 2009-11-15	Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
01/14/2019	Radiology	12-322	Complete	NEMA	MS 5-2018	Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
12/23/2016	Biocompatibility	2-94	Complete	ASTM	F981-04 (Reapproved 2016)	Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
07/06/2020	Tissue Engineering	15-63	Complete	ASTM	F2739-19	Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
07/06/2020	Orthopedic	11-365	Complete	ASTM	F1800-19 e1	Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
07/06/2020	Orthopedic	11-366	Complete	ASTM	F2381-19	Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
07/06/2020	Materials	8-527	Complete	ASTM	F899-20	Standard Specification for Wrought Stainless Steels for Surgical Instruments
01/14/2019	General I (QS/ RM)	5-120	Complete	IEC	60812 Edition 3.0 2018-08	Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
12/18/2023	Orthopedic	11-404	Complete	ASTM	F2887-23	Standard Specification for Total Elbow Prostheses
08/21/2017	Orthopedic	11-321	Complete	ASTM	F2887-17	Standard Specification for Total Elbow Prostheses
08/21/2017	Orthopedic	11-242	Complete	ASTM	F1839-08 (Reapproved 2016)	Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
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)]
12/18/2023	Orthopedic	11-405	Complete	ASTM	F1829-23	Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
05/29/2023	InVitro Diagnostics	7-316	Complete	CLSI	NBS01 7th Edition	Dried Blood Spot Specimen Collection for Newborn Screening
01/30/2014	Materials	8-358	Complete	ASTM	F1855-00 (Reapproved 2019)	Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
06/27/2015	Sterility	14-484	Complete	ASTM	F1929-15	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
07/09/2014	Materials	8-378	Complete	ASTM	D792-13	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
09/17/2018	Orthopedic	11-335	Complete	ASTM	F3141-17a	Standard Guide for Total Knee Replacement Loading Profiles
04/04/2016	Cardiovascular	3-125	Complete	ISO	5841-3 Third edition 2013-04-15	Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
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	Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
05/29/2023	Radiology	12-350	Complete	IEC	60806 Edition 2.0 2022-11	Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
05/29/2023	Sterility	14-588	Complete	AAMI	TIR17:2017/(R)2020	Compatibility of materials subjected to sterilization
12/23/2016	General II (ES/ EMC)	19-20	Complete	IEEE ANSI	C63.16-2016 (Revision of ANSI C63.16-1993)	American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
08/06/2013	Software/ Informatics	13-59	Complete	ISO IEC IEEE	15026-4 First edition 2021-10-01	Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
12/04/2017	Software/ Informatics	13-99	Complete	ISO IEC	15459-2 Third edition 2015-03-01	Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
12/23/2016	Orthopedic	11-312	Complete	ISO	7206-4 Third edition 2010-06-15	Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
12/23/2016	Sterility	14-500	Complete	ISO	14644-1 Second edition 2015-12-15	Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
01/14/2019	Orthopedic	11-342	Complete	ASTM	F732-17	Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
12/23/2016	Sterility	14-169	Complete	ASTM	F2391-05 (Reapproved 2016)	Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
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
08/21/2017	Orthopedic	11-269	Complete	ASTM	F2423-11 (Reapproved 2020)	Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
06/27/2016	Orthopedic	11-307	Complete	ASTM	F2385-15 (Reapproved 2019)	Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs

Recognized Consensus Standards: Medical Devices

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