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)
04/04/2016	Materials	8-405	Complete	ISO	5832-4 Third edition 2014-09-15	Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
12/23/2016	Materials	8-435	Complete	ISO	5832-1 Fifth edition 2016-07-15	Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
12/23/2016	Materials	8-368	Complete	ASTM	F2625-10 (Reapproved 2016)	Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
01/30/2014	Sterility	14-395	Complete	ISO	14698-2 First edition 2003-09-15	Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014	Sterility	14-397	Complete	AOAC	6.2.04:2013	Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014	Sterility	14-398	Complete	AOAC	6.3.05:2013	Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014	Sterility	14-399	Complete	AOAC	6.3.06:2012	Official Method 965.12 Tuberculocidal Activity of Disinfectants
05/29/2023	Biocompatibility	2-300	Complete	ISO	10993-2 Third edition 2022-11	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
09/17/2018	Dental/ ENT	4-244	Complete	ISO	8325 Second edition 2004-09-15	Dentistry - Test methods for rotary instruments
04/04/2016	Materials	8-135	Complete	ASTM	F2392-04 (Reapproved 2015)	Standard Test Method for Burst Strength of Surgical Sealants
01/27/2015	Materials	8-383	Complete	ASTM	F1926/F1926M-14	Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
07/09/2014	Software/ Informatics	13-69	Complete	ISO IEEE	11073-10472 First edition 2012-11-01	Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor
07/09/2014	Sterility	14-434	Complete	ASTM	F2228-13 (Reapproved 2021)	Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/15/2019	Materials	8-496	Complete	ISO	5834-4 Second edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
12/23/2019	General Plastic Surgery/ General Hospital	6-427	Complete	ASTM	F2101-19	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/18/2023	Materials	8-605	Complete	ASTM	F1609-23	Standard Specification for Calcium Phosphate Coatings for Implantable Materials
09/17/2018	Tissue Engineering	15-55	Complete	ASTM	F3259-17	Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
06/07/2018	Materials	8-113	Complete	ASTM	F1147-05 (Reapproved 2017)e1	Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
01/25/2013	Cardiovascular	3-89	Complete	ISO	27186 First edition 2010-03-15	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/25/2013	Cardiovascular	3-89	Complete	ANSI AAMI ISO	27186:2010	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
08/20/2012	Cardiovascular	3-103	Complete	ISO	25539-3 First edition 2011-12-01	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ANSI AAMI ISO	25539-3:2011	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
06/15/2016	Cardiovascular	3-132	Complete	ISO	27185 First edition 2012-02-15	Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
06/15/2016	Cardiovascular	3-132	Complete	ANSI AAMI ISO	27185:2012	Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
12/18/2023	Orthopedic	11-409	Complete	ASTM	F3495-23	Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
12/18/2023	Anesthesiology	1-164	Complete	ISO	5361 Fourth edition 2023-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
01/30/2014	General Plastic Surgery/ General Hospital	6-253	Complete	ISO	10535 Second edition 2006-12-15	Hoists for the transfer of disabled persons - Requirements and test methods
05/29/2023	General Plastic Surgery/ General Hospital	6-493	Complete	ASTM	F2101-23	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/18/2023	Materials	8-606	Complete	ASTM	F2537-23	Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion
01/27/2015	Sterility	14-141	Complete	ISO	14644-4 First edition 2001-04-01	Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
12/18/2023	Sterility	14-590	Complete	ISO	14644-8 Third edition 2022-06	Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
01/27/2015	Sterility	14-379	Complete	ISO	14644-8 Second edition 2013-02-15	Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
12/18/2023	Sterility	14-591	Complete	ISO	14644-10 Second edition 2022-05	Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination
01/27/2015	Sterility	14-390	Complete	ISO	14644-10 First edition 2013-03-01	Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
12/18/2023	Sterility	14-592	Complete	ISO	13408-1 Third edition 2023-08	Aseptic processing of health care products - Part 1: General requirements
05/29/2024	Software/ Informatics	13-135	Complete	ISO IEEE	11073-10407 Second edition 2022-12	Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
04/04/2016	Orthopedic	11-301	Complete	ASTM	F2091-15	Standard Specification for Acetabular Prostheses
05/29/2023	General Plastic Surgery/ General Hospital	6-494	Complete	ASTM	F3352/F3352M-23a	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
08/21/2017	Dental/ ENT	4-215	Complete	ANSI ADA	Standard No. 96-2012	Dental Water-based Cements
05/29/2024	Sterility	14-602	Complete	AAMI	TIR12:2020/(R)2023	Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
11/08/2005	Radiology	12-6	Complete	IEC	60806 First edition 1984-01	Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
01/30/2014	InVitro Diagnostics	7-152	Complete	CLSI	EP12-A2	User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
01/30/2014	InVitro Diagnostics	7-244	Complete	CLSI	NBS01-A6 (Replaces LA04-A5)	Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
10/09/2023	Software/ Informatics	13-131	Complete	ANSI AAMI	SW96:2023	Standard for medical device security - Security risk management for device manufacturers
12/19/2022	Anesthesiology	1-157	Complete	ISO	10079-1 Fourth edition 2022-03	Medical suction equipment - Part 1: Electrically powered suction equipment
12/19/2022	Anesthesiology	1-158	Complete	ISO	10079-4 First edition 2021-08	Medical suction equipment - Part 4: General requirements
12/23/2016	Biocompatibility	2-93	Complete	ASTM	F763-04 (Reapproved 2016)	Standard Practice for Short-Term Screening of Implant Materials
08/06/2013	Cardiovascular	3-87	Complete	ASTM	F2477-07 (Reapproved 2013)	Standard Test Methods for in vitro Pulsatile Durability
12/19/2022	Cardiovascular	3-183	Complete	ISO	11658 First edition 2012-05-15	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022	Cardiovascular	3-183	Complete	ANSI AAMI ISO	11658: 2012	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022	Orthopedic	11-394	Complete	ASTM	F1820-22	Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
05/30/2022	Radiology	12-345	Complete	IEC	61223-3-7 Edition 1.0 2021-12	Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
08/14/2015	General Plastic Surgery/ General Hospital	6-185	Complete	ASTM	F881-94 (Reapproved 2014)	Standard Specification for Silicone Elastomer Facial Implants
01/14/2019	Materials	8-482	Complete	ASTM	D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
05/29/2023	Biocompatibility	2-299	Complete	ASTM	F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
12/23/2016	Anesthesiology	1-118	Complete	ISO	5361 Third edition 2016-09-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
01/27/2015	Dental/ ENT	4-219	Complete	ISO	29022 First edition 2013-06-01	Dentistry - Adhesive - Notched-edge sheer bond strength test
01/30/2014	Materials	8-344	Complete	ISO	7153-1 Second edition 1991-04-01	Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
01/30/2014	Sterility	14-401	Complete	ASTM	F2217/F2217M-13 (Reapproved 2023)	Standard Practice for Coating/Adhesive Weight Determination
07/26/2016	Biocompatibility	2-213	Complete	ASTM	F1904-14	Standard Practice for Testing the Biological Responses to Particles In Vivo
05/29/2024	Sterility	14-598	Complete	ISO	14644-3 Second edition 2020-06	Cleanrooms and associated controlled environments - Part 3: Test methods
05/29/2023	Orthopedic	11-399	Complete	ASTM	F1357-23	Standard Specification for Articulating Total Wrist Implants
08/14/2015	Orthopedic	11-294	Complete	ASTM	F1357-14 (Reapproved 2019)	Standard Specification for Articulating Total Wrist Implants
12/18/2023	Anesthesiology	1-165	Complete	ISO	80601-2-13 Second edition 2022-04	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
05/29/2023	General Plastic Surgery/ General Hospital	6-490	Complete	ISO	10555-6 First edition 2015-04-15 [Including AMD1:2019]	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
04/04/2016	General Plastic Surgery/ General Hospital	6-357	Complete	ISO	10555-6 First edition 2015-04-15	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
05/29/2023	General Plastic Surgery/ General Hospital	6-495	Complete	ISO	20698 First Edition 2018-07	Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
08/06/2013	Software/ Informatics	13-57	Complete	ISO IEEE	11073-10407 First edition 2010-05-01	Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-145	Complete	ASTM	D7661-18	Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
07/09/2014	ObGyn/ Gastroenterology/ Urology	9-94	Complete	ISO	8600-4 Second Edition 2014-03-15	Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
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
10/09/2023	Software/ Informatics	13-129	Complete	ISO IEC IEEE	29119-1 Second edition 2022-01	Software and systems engineering - Software testing - Part 1: General concepts
01/27/2015	Sterility	14-456	Complete	ANSI AAMI ISO	TIR16775:2014	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
01/27/2015	Sterility	14-456	Complete	ISO	TS 16775 First edition 2014-05-15	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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	Orthopedic	11-406	Complete	ASTM	F3141-23	Standard Guide for Total Knee Replacement Loading Profiles
05/29/2023	Sterility	14-586	Complete	ISO	22441 First edition 2022-08	Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
12/20/2021	Dental/ ENT	4-292	Complete	ISO	28888 First edition 2013-10	Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
12/20/2021	Dental/ ENT	4-292	Complete	ANSI ADA	Standard No. 151-2015 (R2020)	Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
05/30/2022	Materials	8-592	Complete	ASTM	F3384-21	Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
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
12/19/2022	General Plastic Surgery/ General Hospital	6-483	Complete	IEC	60601-2-35 Edition 2.0 2020-09	Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
05/30/2022	Materials	8-593	Complete	ISO	13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15	Implants for surgery - Hydroxyapatite - Part 6: Powders
01/27/2015	Software/ Informatics	13-72	Complete	IEEE	Std 11073-10425-2014	Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
07/09/2014	InVitro Diagnostics	7-213	Complete	CLSI	GP44-A4 (Formerly H18-A4)	Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
07/09/2014	Radiology	12-282	Complete	ISO	12609-1 First edition 2013-07-15	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
03/18/2009	InVitro Diagnostics	7-180	Complete	CLSI	M34-A (Replaces M24-P)	Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-182	Complete	CLSI	M36-A	Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-185	Complete	CLSI	M41-A	Viral Culture; Approved Guideline.
03/18/2009	General Plastic Surgery/ General Hospital	6-215	Complete	ASTM	F2132-01 (Reapproved 2008)e1	Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
03/18/2009	InVitro Diagnostics	7-189	Complete	CLSI	M47-A (Replaces M47-P)	Principles and Procedures for Blood Cultures; Approved Guideline
03/18/2009	InVitro Diagnostics	7-190	Complete	CLSI	M50-A (Replaces M50-P)	Quality Control for Commercial Microbial Identification Systems; Approved Guideline
03/18/2009	InVitro Diagnostics	7-192	Complete	CLSI	MM18-A (Replaces MM18-P)	Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
03/18/2009	InVitro Diagnostics	7-71	Complete	CLSI	H15-A3 (Replaces H15-A2)	Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009	Software/ Informatics	13-25	Complete	CLSI	AUTO8-A	Managing and Validating Laboratory Information Systems; Approved Guideline
04/04/2016	Materials	8-200	Complete	ASTM	F2003-02 (Reapproved 2015)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
12/20/2021	Materials	8-563	Complete	ASTM	F1801-20	Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
03/16/2012	Radiology	12-174	Complete	ISO	13697 First edition 2006-05-15	Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
03/16/2012	Radiology	12-175	Complete	ISO	24013 First edition 2006-11-15	Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
08/20/2012	Software/ Informatics	13-31	Complete	CLSI	AUTO12-A	Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
08/20/2012	Cardiovascular	3-102	Complete	IEC	60601-2-31 Edition 2.1 2011-09	Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/20/2012	Cardiovascular	3-104	Complete	ASTM	F2914-12 (Reapproved 2018)	Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
08/20/2012	General Plastic Surgery/ General Hospital	6-278	Complete	ISO	11040-5 Third edition 2012-02-15	Prefilled syringes - Part 5: Plunger stoppers for injectables
08/20/2012	InVitro Diagnostics	7-76	Complete	CLSI	M15-A (Replaces M15-T)	Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
10/09/2023	Software/ Informatics	13-130	Complete	ANSI AAMI	2700-2-1:2022	Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
05/29/2024	Sterility	14-599	Complete	ISO	14644-9 Second edition 2022-05	Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
08/02/2011	Ophthalmic	10-65	Complete	ISO	15752 Second edition 2010-01-15	Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
01/15/2013	Software/ Informatics	13-33	Complete	AAMI	TIR 36:2007	Validation of software for regulated processes
01/15/2013	General Plastic Surgery/ General Hospital	6-122	Complete	ISO	8536-5 Second edition 2004-02-01	Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
03/16/2012	InVitro Diagnostics	7-227	Complete	CLSI	M53-A (Replaces M53-P)	Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/15/2013	InVitro Diagnostics	7-233	Complete	CLSI	EP17-A2	Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013	InVitro Diagnostics	7-237	Complete	CLSI	MM01-A3 (Replaces MM01-A2)	Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013	InVitro Diagnostics	7-238	Complete	CLSI	MM06-A2 (Replaces MM06-A)	Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
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	Anesthesiology	1-153	Complete	NFPA	99:2021	Health Care Facilities Code
12/19/2022	Anesthesiology	1-154	Complete	ASME	PVHO-1-2019	Safety Standard for Pressure Vessels for Human Occupancy
12/20/2021	Materials	8-569	Complete	ASTM	F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
12/20/2021	General Plastic Surgery/ General Hospital	6-471	Complete	USP-NF	M88880_05_01	Sterile Water for Irrigation
01/30/2014	Dental/ ENT	4-153	Complete	ISO	9917-1 Second edition 2007-10-01	Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014	Dental/ ENT	4-180	Complete	ISO	9168 Third edition 2009-07-15	Dentistry - Hose connectors for air driven dental handpieces
08/06/2013	Software/ Informatics	13-60	Complete	IEC	TS 62443-1-1 Edition 1.0 2009-07	Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013	Software/ Informatics	13-62	Complete	IEC	TR 62443-3-1 Edition 1.0 2009-07	Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
01/30/2014	Dental/ ENT	4-199	Complete	ISO	6876 Third edition 2012-06-01	Dentistry -- Root canal sealing materials
01/30/2014	Physical Medicine	16-27	Complete	ISO	7176-15 First edition 1996-11-15	Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
12/20/2021	Sterility	14-571	Complete	ISO	11138-8 First edition 2021-07	Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
12/19/2022	Biocompatibility	2-289	Complete	ISO	10993-12 Fifth edition 2021-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
08/14/2015	General Plastic Surgery/ General Hospital	6-354	Complete	ASTM	D7907-14 (Reapproved 2019)	Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
08/14/2015	Materials	8-389	Complete	ISO	15309 First edition 2013-12-01	Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015	Radiology	12-292	Complete	IEEE	Std 3333.2.1-2015	IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
06/07/2018	Ophthalmic	10-109	Complete	ISO	18369-1 Second edition 2017-08	Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
07/09/2014	Radiology	12-194	Complete	ANSI HPS	N43.6-2007 (R2013)	Sealed Radioactive Sources - Classification
05/30/2022	Materials	8-589	Complete	ASTM	F1925-22	Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
12/20/2021	Materials	8-573	Complete	ASTM	F2695-12(2020)	Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
12/19/2022	General I (QS/ RM)	5-137	Complete	IEC	TR 60878 Ed. 4.0 2022-11	Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022	General I (QS/ RM)	5-136	Complete	ASTM	D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
07/09/2014	Software/ Informatics	13-15	Complete	CLSI	AUTO13-A2 (Formerly GP19-A2)	Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
08/14/2015	Dental/ ENT	4-130	Complete	ANSI ADA	Standard No. 17-1983 (R2014)	Denture Base Temporary Relining Resins
04/04/2016	Materials	8-415	Complete	ASTM	F2778-09 (Reapproved 2020)	Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
09/09/2008	Sterility	14-239	Complete	ISO	13408-3 First edition 2006-09-15	Aseptic processing of health care products - Part 3: Lyophilization
09/09/2008	Sterility	14-239	Complete	ANSI AAMI ISO	13408-3:2006/(R)2015	Aseptic processing of health care products - Part 3: Lyophilization
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-142	Complete	ASTM	D1894-14	Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
07/09/2014	Anesthesiology	1-99	Complete	ASTM	G175-13 (Reapproved 2021)	Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
07/09/2014	Dental/ ENT	4-165	Complete	ANSI ASA	S3.13-1987 (Reaffirmed 2020)	American National Standard Mechanical Coupler for Measurement of Bone Vibrators
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-88	Complete	ISO	29942 First edition 2011-07-01	Prophylatic dams -- Requirements and test methods
04/04/2016	Radiology	12-196	Complete	NEMA	MS 2-2008 (R2020)	Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
03/16/2012	General Plastic Surgery/ General Hospital	6-272	Complete	ASTM	F2062-00 (Reapproved 2018)	Standard Specification for Square Drive Interconnections on Surgical Instruments
12/23/2019	General II (ES/ EMC)	19-33	Complete	IEC	62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2019	Orthopedic	11-362	Complete	ISO	22622 First edition 2019-07	Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
05/29/2023	InVitro Diagnostics	7-315	Complete	CLSI	EP12 3rd Edition	Evaluation of Qualitative, Binary Output Examination Performance
05/29/2024	Software/ Informatics	13-134	Complete	ISO IEEE	11073-10404 Second edition 2022-12	Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
12/23/2016	Cardiovascular	3-144	Complete	ISO	7198 Second edition 2016-08-01	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
08/14/2015	General Plastic Surgery/ General Hospital	6-110	Complete	ASTM	F1441-03 (Reapproved 2014)	Standard Specification for Soft-Tissue Expander Devices
08/06/2013	Cardiovascular	3-115	Complete	IEC	60601-2-34 Edition 3.0 2011-05	Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
07/09/2014	Radiology	12-279	Complete	IEC	62127-03 Edition 1.1 2013-05	Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
08/14/2015	InVitro Diagnostics	7-251	Complete	CLSI	EP05-A3 (Reaffirmed: September 2019)	Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
03/31/2006	Radiology	12-136	Complete	ISO	9236-1 Second edition 2004-02-01	Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
08/02/2011	Ophthalmic	10-66	Complete	ISO	10936-2 Second edition 2010-01-15	Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
01/30/2014	Sterility	14-429	Complete	ISO ASTM	51275 Third edition 2013-06-01	Practice for use of a radiochromic film dosimetry system
05/29/2023	Sterility	14-587	Complete	AAMI	TIR104:2022	Guidance on transferring health care products between radiation sterilization sources
05/29/2023	General Plastic Surgery/ General Hospital	6-486	Complete	ISO	10535 Third edition 2021-10	Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
12/19/2022	Materials	8-595	Complete	ISO	5832-5 Fourth Edition 2022-03	Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
12/20/2021	Cardiovascular	3-175	Complete	ISO	5840-2 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021	Cardiovascular	3-180	Complete	ASTM	F3505-21	Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/19/2022	Orthopedic	11-397	Complete	ASTM	F3210-22e1	Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
12/19/2022	Orthopedic	11-398	Complete	ASTM	F3574-22	Standard Test Methods for Sacroiliac Joint Fusion Devices
12/20/2021	General II (ES/ EMC)	19-44	Complete	IEEE ANSI	C63.24-2021	American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
12/20/2021	General I (QS/ RM)	5-134	Complete	ISO	15223-1 Fourth edition 2021-07	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/18/2023	Dental/ ENT	4-322	Complete	ISO	18675 First edition 2022-05	Dentistry - Machinable ceramic blanks
12/18/2023	Dental/ ENT	4-323	Complete	ISO	5139 First edition 2023-05	Dentistry - Polymer-based composite machinable blanks
12/18/2023	Dental/ ENT	4-324	Complete	ISO	TS 16506 First edition 2018-03	Dentistry - Polymer-based luting materials containing adhesive components
01/14/2019	Anesthesiology	1-141	Complete	ISO	80601-2-13 First edition 2011-08-11	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
12/18/2023	Anesthesiology	1-166	Complete	ISO	11195 Second edition 2018-01	Gas mixers for medical use - Stand-alone gas mixers
12/18/2023	Sterility	14-589	Complete	ISO	14644-4 Second edition 2022-11	Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
05/29/2023	Cardiovascular	3-186	Complete	ISO	14708-2 Third edition 2019-09	Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
12/23/2016	Materials	8-441	Complete	ASTM	F3109-16	Standard Test Method for Verification of Multi-Axis Force Measuring Platforms
12/20/2021	Software/ Informatics	13-120	Complete	ANSI AAMI	2700-1:2019	Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
12/23/2016	InVitro Diagnostics	7-267	Complete	CLSI	C24 4th Edition (Replaces C24-A3)	Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
05/30/2022	Materials	8-584	Complete	ASTM	F2146-22	Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
05/30/2022	Materials	8-585	Complete	ASTM	F1377-21	Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
05/30/2022	Materials	8-586	Complete	ASTM	F2989-21	Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
12/20/2021	Materials	8-570	Complete	ASTM	F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021	Materials	8-571	Complete	ASTM	F2052-21	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
12/19/2022	Anesthesiology	1-155	Complete	ISO	10079-2 Fourth edition 2022-03	Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022	Biocompatibility	2-297	Complete	ASTM	F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
05/29/2023	Materials	8-599	Complete	ASTM	F1295-22	Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
05/29/2023	Dental/ ENT	4-298	Complete	ISO	4049 Fifth edition 2019-05	Dentistry - Polymer-based restorative materials
05/29/2023	Dental/ ENT	4-298	Complete	ANSI ADA	Standard No. 27-2022	Polymer-based Restorative Materials
12/19/2022	General I (QS/ RM)	5-140	Complete	ASME	V&V 10-2019	Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022	Nanotechnology	18-21	Complete	ISO	TS 80004-6 Second edition 2021-03	Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
05/30/2022	General Plastic Surgery/ General Hospital	6-475	Complete	ISO	11608-4:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
01/14/2019	Dental/ ENT	4-254	Complete	ANSI ADA	Standard No. 99-2001 (R2013)	Athletic Mouth Protectors and Materials
12/23/2019	Physical Medicine	16-225	Complete	RESNA ANSI	WC-1:2019 Section 26	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
12/19/2022	Anesthesiology	1-156	Complete	ISO	10079-3 Fourth edition 2022-03	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
04/03/2023	General II (ES/ EMC)	19-34	Complete	IEC	61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
12/19/2022	Radiology	12-346	Complete	ISO	12005 Third edition 2022-05	Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization
12/20/2021	InVitro Diagnostics	7-310	Complete	ISO	19238 Second edition 2014-02-01	Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021	InVitro Diagnostics	7-311	Complete	CLSI	EP39, 1st Edition	A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
12/19/2022	Software/ Informatics	13-122	Complete	IEC	81001-5-1 Edition 1.0 2021-12	Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022	Software/ Informatics	13-123	Complete	ANSI NEMA	HN 1-2019	American National Standard Manufacturer Disclosure Statement for Medical Device Security
01/30/2014	Dental/ ENT	4-181	Complete	ISO	4049 Fourth edition 2009-10-01	Dentistry - Polymer-based restorative materials
01/30/2014	Dental/ ENT	4-198	Complete	ISO	3107 Fourth edition 2011-03-01	Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
01/30/2014	Dental/ ENT	4-198	Complete	ANSI ADA	Standard No. 30-2013 (R2018)	Dental Zinc Oxide-Eugenol and Zinc Oxide
05/29/2023	Dental/ ENT	4-300	Complete	ISO	22674 Third edition 2022-08	Dentistry - Metallic materials for fixed and removable restorations and appliances
12/20/2021	Sterility	14-564	Complete	USP-NF	M98910_01_01	<161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
12/20/2021	Sterility	14-565	Complete	USP-NF	M98802_01_01	<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
12/20/2021	Sterility	14-566	Complete	USP-NF	M98795_02_01	<55> Biological Indicators -- Resistance Performance Tests
12/20/2021	Sterility	14-567	Complete	USP-NF	M7414_01_01	<1229.5> Biological Indicators for Sterilization
12/20/2021	Sterility	14-568	Complete	USP-NF	M98800_01_01	<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
12/20/2021	Sterility	14-569	Complete	USP-NF	M98810_01_01	<71> Sterility Tests
12/20/2021	Sterility	14-570	Complete	USP-NF	M98830_02_01	<85> Bacterial Endotoxins Test
05/29/2023	Dental/ ENT	4-299	Complete	ISO	3107 Fifth edition 2022-09	Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
05/29/2023	Dental/ ENT	4-299	Complete	ANSI ADA	Standard No. 30-2023	Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
12/20/2021	Physical Medicine	16-232	Complete	IEC	80601-2-78 Edition 1.0 2019-07	Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
12/20/2021	Orthopedic	11-389	Complete	ISO	7206-10 Second edition 2018-08	Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
05/29/2023	Materials	8-597	Complete	ASTM	F2003-02(2022)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
05/30/2022	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)]
05/30/2022	Sterility	14-574	Complete	ASTM	F1608-21	Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/19/2022	Software/ Informatics	13-124	Complete	AAMI	CR34971:2022	Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
12/20/2021	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
12/19/2022	Software/ Informatics	13-125	Complete	ANSI AAMI UL	2800-1-1:2022	Standard for Risk Concerns for Interoperable Medical Products
12/20/2021	Sterility	14-563	Complete	ISO	13408-6 Second edition 2021-04	Aseptic processing of health care products - Part 6: Isolator systems
12/20/2021	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	Software/ Informatics	13-126	Complete	ANSI AAMI UL	2800-1-2:2022	Standard for Interoperable Item Development Life Cycle
12/19/2022	Software/ Informatics	13-127	Complete	ANSI AAMI UL	2800-1-3:2022	Standard for Interoperable Item Integration Life Cycle
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
05/30/2022	General Plastic Surgery/ General Hospital	6-480	Complete	ISO	11608-6:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
04/03/2023	General II (ES/ EMC)	19-49	Complete	IEC	60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
05/30/2022	General Plastic Surgery/ General Hospital	6-481	Complete	ANSI AAMI	CN27:2021	General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022	General Plastic Surgery/ General Hospital	6-482	Complete	AAMI	TIR101:2021	Fluid delivery performance testing for infusion pumps
05/30/2022	General Plastic Surgery/ General Hospital	6-478	Complete	ISO	11608-1:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
12/20/2021	Orthopedic	11-392	Complete	ASTM	F2723-21	Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
12/20/2021	Nanotechnology	18-19	Complete	ISO	19749 First edition 2021-07	Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
12/19/2022	Sterility	14-580	Complete	ISO	11137-2 Third edition 2013-06 [Including AMD1:2022]	Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]
12/19/2022	Materials	8-594	Complete	ISO	5832-6 Third Edition 2022-03	Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
12/19/2022	Software/ Informatics	13-121	Complete	ANSI AAMI UL	2800-1:2022	Standard for Medical Device Interoperability
12/19/2022	Ophthalmic	10-133	Complete	ISO	11979-10 Second edition 2018-03	Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
12/20/2021	Cardiovascular	3-176	Complete	ISO	18193 First edition 2021-08	Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021	Cardiovascular	3-177	Complete	ASTM	F2606-08 (Reapproved 2021)	Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021	Dental/ ENT	4-286	Complete	ANSI ADA	Standard No. 87-1995 (R2014)	Dental Impression Trays
12/19/2022	Sterility	14-581	Complete	ASTM	F2638-22	Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/19/2022	Sterility	14-582	Complete	AAMI ISO	TIR11137-4:2022	Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022	Sterility	14-582	Complete	ISO	TS 11137-4 First edition 2020-06	Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022	Sterility	14-583	Complete	ANSI AAMI	ST98:2022	Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
12/20/2021	Dental/ ENT	4-287	Complete	ANSI ADA	Standard No. 116-2020	Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
05/30/2022	ObGyn/ Gastroenterology/ Urology	9-139	Complete	CIE ISO	11664-5:2016	Colorimetry - Part 5: CIE 1976 Luv* colour space and u',v' uniform chromaticity scale diagram
05/30/2022	Sterility	14-579	Complete	ISO	17664-2 First edition 2021-02	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
05/30/2022	Cardiovascular	3-181	Complete	ISO	25539-2 Third edition 2020-09	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021	General Plastic Surgery/ General Hospital	6-472	Complete	USP-NF	M36660_04_01	Heparin Lock Flush Solution
06/07/2021	Materials	8-555	Complete	ASTM	F1472-20a	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
05/29/2023	Materials	8-604	Complete	ASTM	F2257-22	Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
12/20/2021	General Plastic Surgery/ General Hospital	6-465	Complete	USP-NF	M76090_03_01	Sodium Chloride Irrigation
12/20/2021	General Plastic Surgery/ General Hospital	6-466	Complete	USP-NF	M76070_03_01	Sodium Chloride Injection
12/20/2021	General Plastic Surgery/ General Hospital	6-467	Complete	USP-NF	M80200_04_01	Nonabsorbable Surgical Suture
12/20/2021	General Plastic Surgery/ General Hospital	6-468	Complete	USP-NF	M99670_02_01	<881> Tensile Strength
12/20/2021	General Plastic Surgery/ General Hospital	6-469	Complete	USP-NF	M99650_02_01	<861> Sutures - Diameter
12/20/2021	General Plastic Surgery/ General Hospital	6-470	Complete	USP-NF	M99660_03_01	<871> Sutures - Needle Attachment
12/20/2021	Dental/ ENT	4-288	Complete	ISO	7488 Second edition 2018-04	Dentistry - Mixing machines for dental amalgam
12/20/2021	Dental/ ENT	4-288	Complete	ANSI ADA	Standard No. 43-2020	Electrically Powered Dental Amalgamators
12/20/2021	Dental/ ENT	4-289	Complete	ISO	18556 Frist edition 2016-04	Dentistry - Intraoral spatulas
12/20/2021	Dental/ ENT	4-290	Complete	ISO	28158 Second edition 2018-09	Dentistry - Integrated dental floss and handles
12/20/2021	Dental/ ENT	4-290	Complete	ANSI ADA	Standard No. 185-2020	Integrated Dental Floss and Handles
12/20/2021	Dental/ ENT	4-291	Complete	ISO	28399 First edition 2011-01	Dentistry - Products for external tooth bleaching
12/20/2021	Dental/ ENT	4-291	Complete	ANSI ADA	Standard No. 136-2015 (R2020)	Products for External Tooth Bleaching
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-144	Complete	ISO	20697 First edition 2018-06; Corrected 2018-09	Sterile drainage catheters and accessory devices for single use
12/19/2022	Orthopedic	11-395	Complete	ASTM	F1814-22	Standard Guide for Evaluating Modular Hip and Knee Joint Components
01/14/2019	InVitro Diagnostics	7-285	Complete	CLSI	M48-A 2nd Edition	Laboratory Detection and Identification of Mycobacteria
07/06/2020	InVitro Diagnostics	7-297	Complete	ISO	TS 20914 First edition 2019-07	Medical laboratories - Practical guidance for the estimation of measurement uncertainty
05/30/2022	Materials	8-591	Complete	ASTM	F2229-21	Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
12/20/2021	Orthopedic	11-391	Complete	ASTM	F2722-21	Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
05/30/2022	Materials	8-587	Complete	ISO	5832-3 Fifth Edition 2021-11	Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
08/21/2017	Materials	8-453	Complete	ASTM	F1295-16	Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
12/19/2022	General Plastic Surgery/ General Hospital	6-485	Complete	ISO	7886-4 Second Edition 2018-11	Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
12/20/2021	Biocompatibility	2-292	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Direct Contact Test
12/20/2021	Biocompatibility	2-293	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Elution Test
12/19/2022	General II (ES/ EMC)	19-48	Complete	IEEE ANSI	USEMCSC C63.27-2021	American National Standard for Evaluation of Wireless Coexistence
12/21/2020	General I (QS/ RM)	5-133	Complete	ISO	80369-7 Second edition 2021-05	Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
06/07/2021	General II (ES/ EMC)	19-40	Complete	IEC	60086-4 Edition 5.0 2019-04	Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
12/23/2019	Physical Medicine	16-219	Complete	RESNA ANSI	WC-2:2019 Section 14	American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
12/20/2021	Ophthalmic	10-130	Complete	ANSI	Z80.36-2021	American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
12/19/2022	InVitro Diagnostics	7-313	Complete	CLSI	EP27 2nd Edition	Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
06/27/2016	Dental/ ENT	4-227	Complete	ISO	22674 Second edition 2016-01-15	Dentistry - Metallic materials for fixed and removable restorations and appliances
06/27/2016	Dental/ ENT	4-227	Complete	ANSI ADA	Standard No. 134-2018	Metallic Materials for Fixed and Removable Restorations and Appliances
05/29/2023	Dental/ ENT	4-301	Complete	ISO	21563 Second edition 2021-08	Dentistry - Hydrocolloid impression materials
05/29/2023	Dental/ ENT	4-301	Complete	ANSI ADA	Standard No. 128-2022	Hydrocolloid Impression Materials
06/07/2018	Dental/ ENT	4-240	Complete	ISO	21563 First edition 2013-08-15	Dentistry - Hydrocolloid impression materials
06/07/2018	Dental/ ENT	4-240	Complete	ANSI ADA	Standard No. 128-2015	Hydrocolloid Impression Materials
05/29/2023	Dental/ ENT	4-302	Complete	ISO	10477 Fourth edition 2020-10	Dentistry - Polymer-based crown and veneering materials
05/29/2023	Dental/ ENT	4-302	Complete	ANSI ADA	Standard No. 53-2022	Polymer-Based Crown and Veneering Materials
05/30/2022	Radiology	12-343	Complete	IEC	62127-1 Edition 2.0 2022-03	Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
06/27/2016	General Plastic Surgery/ General Hospital	6-363	Complete	ISO	11810 Second edition 2015-12-15	Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
05/29/2023	Cardiovascular	3-184	Complete	ASTM	F2477-23	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
07/15/2019	Orthopedic	11-354	Complete	ASTM	F3295-18	Standard Guide for Impingement Testing of Total Disc Prostheses
12/21/2020	Orthopedic	11-374	Complete	ISO	7207-2 Second edition 2011-07-01	Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
05/30/2022	General Plastic Surgery/ General Hospital	6-476	Complete	ISO	11608-2:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
01/14/2019	Materials	8-485	Complete	ASTM	F3260-18	Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
05/30/2022	General II (ES/ EMC)	19-46	Complete	ANSI AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
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
02/20/2023	Sterility	14-575	Complete	ASTM	F1980-21	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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
12/23/2019	Anesthesiology	1-145	Complete	ISO	19223 First edition 2019-07	Lung ventilators and related equipment - Vocabulary and semantics.
12/23/2019	General Plastic Surgery/ General Hospital	6-437	Complete	ISO	23907-2 First edition 2019-11	Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
05/30/2022	Materials	8-590	Complete	ISO	TS 17137 Third edition 2021-09	Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
12/20/2021	Materials	8-564	Complete	ASTM	F2005-21	Standard Terminology for Nickel-Titanium Shape Memory Alloys
12/20/2021	Materials	8-565	Complete	ASTM	F2754/F2754M-21	Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
12/21/2020	Sterility	14-553	Complete	ASTM	F2097-20	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/23/2019	Cardiovascular	3-161	Complete	ISO	14117 Second edition 2019-09	Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
12/20/2021	Materials	8-566	Complete	ASTM	F1813-21	Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
12/19/2022	Materials	8-596	Complete	ASTM	D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
12/19/2022	Anesthesiology	1-159	Complete	ISO	18778 Second edition 2022-06	Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
12/19/2022	Anesthesiology	1-160	Complete	ISO	80601-2-84 First edition 2020-07	Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
12/20/2021	General II (ES/ EMC)	19-41	Complete	ANSI UL	61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019	Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
02/07/2022	General II (ES/ EMC)	19-45	Complete	AIM	Standard 7351731 Rev. 3.00 2021-06-04	Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
12/19/2022	General I (QS/ RM)	5-139	Complete	ISO	18250-3 First edition 2018-06	Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/20/2021	Cardiovascular	3-173	Complete	ISO	5840-3 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
05/30/2022	Sterility	14-576	Complete	ASTM	D4169-22	Standard Practice for Performance Testing of Shipping Containers and Systems
12/20/2021	Cardiovascular	3-179	Complete	ASTM	F3172-15 (Reapproved 2021)	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
06/07/2021	Anesthesiology	1-151	Complete	ISO	80601-2-70 Second edition 2020-11	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/23/2019	Physical Medicine	16-217	Complete	RESNA ANSI	WC-1:2019 Section 11	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins
12/23/2019	Physical Medicine	16-220	Complete	RESNA ANSI	WC-1:2019 Section 15	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling
12/23/2019	Physical Medicine	16-221	Complete	RESNA ANSI	WC-1:2019 Section 16	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods
12/21/2020	Nanotechnology	18-17	Complete	ISO	21363 First edition 2020-06	Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
01/30/2014	Cardiovascular	3-118	Complete	ANSI AAMI	EC57:2012	Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
06/07/2018	ObGyn/ Gastroenterology/ Urology	9-114	Complete	IEC	60601-2-18: Edition 3.0 2009-08	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
12/21/2020	Biocompatibility	2-278	Complete	ASTM	F719-20 e1	Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
06/07/2018	General Plastic Surgery/ General Hospital	6-270	Complete	ASTM	F1840-10 (Reapproved 2016)	Standard Terminology for Surgical Suture Needles
09/17/2018	Orthopedic	11-333	Complete	ASTM	F382-17	Standard Specification and Test Method for Metallic Bone Plates
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
12/21/2020	Materials	8-549	Complete	ASTM	F3208-20	Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
12/21/2020	Biocompatibility	2-283	Complete	ASTM	F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
07/06/2020	Biocompatibility	2-274	Complete	ASTM	F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
07/15/2019	Sterility	14-532	Complete	ASTM	F3287-17e1	Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
08/06/2013	General Plastic Surgery/ General Hospital	6-147	Complete	ASTM	D6978-05(2023)	Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
06/07/2018	ObGyn/ Gastroenterology/ Urology	9-115	Complete	ISO	29943-1 First edition 2017-07.	Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports
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
12/23/2019	Materials	8-519	Complete	ISO	13782 Second edition 2019-04	Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
01/14/2019	Ophthalmic	10-114	Complete	ANSI	Z80.28-2017	American National Standard for Ophthalmics - Methods of Reporting Optical Aberrations of Eyes
12/21/2020	Materials	8-539	Complete	ASTM	F139-19	Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
07/06/2020	Nanotechnology	18-16	Complete	ISO	TS 21362 First edition 2018-06	Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation
07/06/2020	Radiology	12-330	Complete	NEMA	Standards Publication XR 28-2018	Supplemental Requirements for User Information and System Function Related to Dose in CT
12/23/2019	Physical Medicine	16-222	Complete	RESNA ANSI	WC-1:2019 Section 20	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs
12/23/2019	Physical Medicine	16-223	Complete	RESNA ANSI	WC-1:2019 Section 22	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
12/23/2019	Physical Medicine	16-224	Complete	RESNA ANSI	WC-2:2019 Section 21	American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
04/04/2016	General Plastic Surgery/ General Hospital	6-356	Complete	ASTM	D5712-15(2020)	Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
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
12/23/2019	Physical Medicine	16-216	Complete	RESNA ANSI	WC-2:2019 Section 10	American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
12/21/2020	Dental/ ENT	4-271	Complete	ANSI ADA	Standard No. 34-2013	Dental Cartridge Syringes
12/21/2020	Dental/ ENT	4-272	Complete	ANSI ADA	Standard No. 63-2013	Root Canal Barbed Broaches and Rasps
12/23/2019	Physical Medicine	16-213	Complete	RESNA ANSI	WC-1:2019 Section 7	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions
12/23/2019	Physical Medicine	16-214	Complete	RESNA ANSI	WC-1:2019 Section 8	American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
08/21/2017	Dental/ ENT	4-239	Complete	ANSI AAMI	CI86:2017	Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
07/09/2014	General II (ES/ EMC)	19-10	Complete	UL	1642 5th Edition	Lithium Batteries
12/20/2021	Cardiovascular	3-171	Complete	ASTM	F2514-21	Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/19/2022	Orthopedic	11-396	Complete	ISO	7206-13 First edition 2016-07-01 [Including AMD1:2022]	Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
12/23/2019	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
07/09/2014	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]
01/14/2019	Anesthesiology	1-117	Complete	ISO	5366 First edition 2016-10-01	Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-122	Complete	ISO	25841 Third edition 2017-08	Female condoms -- Requirements and test methods
12/20/2021	Materials	8-567	Complete	ASTM	F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021	Materials	8-575	Complete	ASTM	F3160-21	Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
12/20/2021	Materials	8-576	Complete	ASTM	F451-21	Standard Specification for Acrylic Bone Cement
12/20/2021	Ophthalmic	10-127	Complete	ANSI	Z80.21-2020	American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts
12/20/2021	Ophthalmic	10-128	Complete	ASTM	D882-18	Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
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
12/21/2020	Biocompatibility	2-277	Complete	ASTM	F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
12/23/2016	Sterility	14-497	Complete	ASTM	F1980-16	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
04/04/2016	Materials	8-394	Complete	ASTM	F1472-14	Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
08/14/2015	Radiology	12-291	Complete	IEC	62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION	Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
06/07/2021	Radiology	12-340	Complete	IEC	60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
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
05/30/2022	Ophthalmic	10-131	Complete	ISO	15798 Fourth edition 2022-01	Ophthalmic implants - Ophthalmic viscosurgical devices
04/04/2016	Sterility	14-340	Complete	ISO	20857 First edition 2010-08-15	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-340	Complete	ANSI AAMI ISO	20857:2010/(R)2015	(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
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
12/21/2020	Anesthesiology	1-149	Complete	ISO	7376 Third edition 2020-08	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
12/21/2020	Dental/ ENT	4-269	Complete	ISO	3964 Third edition 11-2016	Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
12/21/2020	Dental/ ENT	4-269	Complete	ANSI ADA	Standard No. 158-2020	Coupling Dimensions for Dental Handpiece Connectors
07/15/2019	Materials	8-517	Complete	ISO	17327-1 First edition 2018-02	Non-active surgical implants - Implant coating - Part 1: General requirements
12/19/2022	Dental/ ENT	4-295	Complete	ANSI ADA	Standard No. 41-2020	Evaluation of Biocompatibility of Medical Devices Used in Dentistry
12/19/2022	ObGyn/ Gastroenterology/ Urology	9-141	Complete	ISO	8637-3 First Edition 2018-07	Extracorporeal systems for blood purification - Part 3: Plasmafilters
12/20/2021	Materials	8-577	Complete	ISO	13179-1 Second Edition 2021-09	Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
12/20/2021	Materials	8-578	Complete	ASTM	F2848-21	Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
09/21/2016	General Plastic Surgery/ General Hospital	6-381	Complete	ISO	6009 Fourth edition 2016-08-01	Hypodermic needles for single use - Colour coding for identification.
06/07/2021	Dental/ ENT	4-279	Complete	ANSI ADA	Standard No. 85-2004 (R2009)	Part 1: Disposable Prophy Angles
06/07/2021	Dental/ ENT	4-283	Complete	ISO	16409 Second edition 2016-10	Dentistry - Oral care products - Manual interdental brushes
06/07/2021	Dental/ ENT	4-283	Complete	ANSI ADA	Standard No. 125-2018	Manual Interdental Brushes
10/19/2020	Software/ Informatics	13-116	Complete	FIRST	CVSS v3.0	Common Vulnerability Scoring System version 3.0
12/21/2020	Orthopedic	11-371	Complete	ASTM	F2009-20	Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
12/21/2020	InVitro Diagnostics	7-299	Complete	CLSI	POCT14 2nd Edition	Point-of-Care Coagulation Testing and Anticoagulation Monitoring
12/21/2020	Materials	8-548	Complete	ISO ASTM	52915 Third edition 2020-03	Specification for additive manufacturing file format (AMF) Version 1.2
06/07/2021	Software/ Informatics	13-118	Complete	IEEE	Std 11073-40102:2020	Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
12/21/2020	Neurology	17-17	Complete	ASTM	F3395/F3395M-19	Standard Specification for Neurosurgical Head Holder Devices
06/07/2021	General Plastic Surgery/ General Hospital	6-461	Complete	IEC	60601-2-19 Edition 3.0 2020-09	Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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
06/07/2021	Materials	8-562	Complete	ISO ASTM	52904 First edition 2019-08	Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications
06/07/2021	Software/ Informatics	13-119	Complete	ANSI ISA	62443-4-1-2018	Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
06/07/2021	Tissue Engineering	15-66	Complete	ASTM	F2260-18	Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy
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)]
12/21/2020	General II (ES/ EMC)	19-37	Complete	IEC	60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
12/21/2020	Materials	8-550	Complete	ASTM	F2181-20	Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
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
06/07/2021	Dental/ ENT	4-273	Complete	ANSI ASA	S3.7-2016 (Reaffirmed 2023)	American National Standard Method for Coupler Calibration of Earphones
06/07/2021	Dental/ ENT	4-275	Complete	ANSI ASA	S3.6-2018	American National Standard for Specification for Audiometers
01/14/2019	Cardiovascular	3-44	Complete	ANSI AAMI	BP22:1994 (R2016)	Blood pressure transducers
06/07/2021	Physical Medicine	16-231	Complete	ISO	10328 Second edition 2016-06-01	Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
12/23/2019	Materials	8-491	Complete	ASTM	F1088-18	Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
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
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)
07/15/2019	Biocompatibility	2-265	Complete	ASTM	F2901-19	Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
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
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
06/07/2021	Orthopedic	11-384	Complete	ASTM	F3446-20	Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
06/07/2021	Radiology	12-336	Complete	IEC	60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
06/07/2021	Radiology	12-337	Complete	NEMA	NU 1-2018	Performance Measurements of Gamma Cameras
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
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
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
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
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)]
12/21/2020	Materials	8-543	Partial	ASTM	F755-19	Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
06/07/2021	InVitro Diagnostics	7-262	Partial	CLSI	M45 3rd Edition	Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
06/07/2021	InVitro Diagnostics	7-292	Partial	CLSI	M62 1st Edition	Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
06/07/2021	Ophthalmic	10-123	Partial	ISO	15004-1 Second edition 2020-5	Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
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
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
12/21/2020	General Plastic Surgery/ General Hospital	6-448	Partial	ASTM	F2407-20	Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
07/06/2020	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	10-85	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
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
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	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
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
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	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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	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.
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)]
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
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	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
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	InVitro Diagnostics	7-296	Partial	CLSI	EP09c 3rd Edition	Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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
01/14/2019	Ophthalmic	10-86	Partial	ISO	14729 First edition 2001-04-15	Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
01/14/2019	Ophthalmic	10-93	Partial	ANSI	Z80.27-2014 (R2019)	American National Standard for Ophthalmics - Implantable Glaucoma Devices
07/15/2019	InVitro Diagnostics	7-289	Partial	CLSI	MM17 2nd Edition	Verification and Validation of Multiplex Nucleic Acid Assays
05/29/2023	Cardiovascular	3-188	Partial	ISO	81060-3 First edition 2022-12	Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
12/18/2023	InVitro Diagnostics	7-320	Partial	CLSI	H62 1st Edition	Validation of Assays Performed by Flow Cytometry
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	Sterility	14-396	Partial	ANSI AAMI	ST77:2013/(R)2018	Containment devices for reusable medical device sterilization
07/15/2019	Ophthalmic	10-89	Partial	ANSI	Z80.7-2013 (R2023)	American National Standard for Ophthalmic Optics - Intraocular Lenses
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
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
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
12/18/2023	Nanotechnology	18-24	Partial	ASTM	E2524-22	Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
07/06/2020	General Plastic Surgery/ General Hospital	6-446	Partial	ASTM	D6319-19(2023)	Standard Specification for Nitrile Examination Gloves for Medical Application
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
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
07/26/2016	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	3-86	Partial	ASTM	F2394-07 (Reapproved 2017)	Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
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
05/29/2024	Ophthalmic	10-135	Partial	ISO	11979-7 Fifth edition 2024-01	Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
01/14/2019	Biocompatibility	2-258	Partial	ISO	10993-1 Fifth edition 2018-08	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/14/2019	Biocompatibility	2-258	Partial	ANSI AAMI ISO	10993-1: 2018	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
05/29/2024	InVitro Diagnostics	7-321	Partial	CLSI	MM24 1st Edition	Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
12/23/2019	Cardiovascular	3-163	Partial	ISO	18242 First edition 2016-09-01	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
12/18/2023	Radiology	12-348	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
05/29/2024	Anesthesiology	1-173	Partial	ISO	18562-1 Second edition 2024-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
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
07/26/2016	Biocompatibility	2-169	Partial	ISO	10993-13 Second edition 2010-06-15	Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016	Biocompatibility	2-169	Partial	ANSI AAMI ISO	10993-13:2010/(R)2014	Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
01/14/2019	InVitro Diagnostics	7-269	Partial	CLSI	MM23-1st Edition	Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
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
05/29/2023	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
05/29/2024	Ophthalmic	10-134	Partial	ISO	10943 Fourth edition 2023-01	Ophthalmic instruments - Indirect ophthalmoscopes
12/18/2023	Biocompatibility	2-303	Partial	ISO	10993-17 Second edition 2023-09	Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
04/04/2016	Tissue Engineering	15-44	Partial	ASTM	F2529-13	Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
01/14/2019	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
01/14/2019	Ophthalmic	10-74	Partial	ISO	10940 Second edition 2009-08-01	Ophthalmic instruments - Fundus cameras
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
05/29/2024	General II (ES/ EMC)	19-50	Partial	IEC	TS 60601-4-2 Edition 1.0 2024-03	Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
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
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-143	Partial	ISO	20696 First edition 2018-06; Corrected 2019-12	Sterile urethral catheters for single use
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
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
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
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
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
05/29/2024	Anesthesiology	1-179	Partial	ISO	26782 First edition 2009-07	Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]
08/14/2015	Neurology	17-4	Partial	ASTM	F647-94 (Reapproved 2014)	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
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
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
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
04/04/2016	General Plastic Surgery/ General Hospital	6-359	Partial	ISO	8536-9 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016	General Plastic Surgery/ General Hospital	6-361	Partial	ISO	8536-11 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
12/18/2023	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
05/29/2023	InVitro Diagnostics	7-317	Partial	CLSI	M100, 33rd Edition	Performance Standards for Antimicrobial Susceptibility Testing
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
09/17/2018	General Plastic Surgery/ General Hospital	6-408	Partial	ISO	10555-1 Second edition 2013-06-15	Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
01/30/2014	InVitro Diagnostics	7-210	Partial	CLSI	H26-A2	Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
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
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	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
08/14/2015	Ophthalmic	10-96	Partial	ANSI	Z80.10-2014	American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
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

Recognized Consensus Standards: Medical Devices

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