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)
09/17/2018	Materials	8-470	Complete	ASTM	F2102-17	Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
12/19/2022	Orthopedic	11-395	Complete	ASTM	F1814-22	Standard Guide for Evaluating Modular Hip and Knee Joint Components
04/04/2016	Materials	8-408	Complete	ASTM	F3122-14	Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
09/09/2008	Software/ Informatics	13-19	Complete	CLSI	LIS04-A	Standard Guide for Documentation of Clinical Laboratory Computer Systems
12/23/2019	Sterility	14-538	Complete	ASTM	F3357-19	Standard Guide for Designing Reusable Medical Devices for Cleanability
12/20/2021	Cardiovascular	3-179	Complete	ASTM	F3172-15 (Reapproved 2021)	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
12/21/2020	Sterility	14-553	Complete	ASTM	F2097-20	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
09/09/2008	Software/ Informatics	13-24	Complete	CLSI	LIS09-A	Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
09/17/2018	Cardiovascular	3-153	Complete	ASTM	F2743-11	Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
06/07/2021	Orthopedic	11-380	Complete	ASTM	F2979-20	Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
06/07/2021	Tissue Engineering	15-67	Complete	ASTM	F2212-20	Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
12/23/2016	Orthopedic	11-317	Complete	ASTM	F3129-16	Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
08/21/2017	Tissue Engineering	15-49	Complete	ASTM	F2027-16	Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
06/07/2018	Tissue Engineering	15-51	Complete	ASTM	F2347-15	Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
07/15/2019	Tissue Engineering	15-58	Complete	ASTM	F2103-18	Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
07/06/2020	Tissue Engineering	15-61	Complete	ASTM	F2150-19	Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
06/07/2018	Tissue Engineering	15-52	Complete	ASTM	F2064-17	Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
01/14/2019	Cardiovascular	3-66	Complete	ASTM	F2081-06 (Reapproved 2017)	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
07/06/2020	Sterility	14-539	Complete	ASTM	F2475-20	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
12/21/2020	Materials	8-538	Complete	ASTM	F2759-19	Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
04/04/2016	Tissue Engineering	15-43	Complete	ASTM	F2791-15	Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
07/06/2020	General Plastic Surgery/ General Hospital	6-444	Complete	ASTM	D7103-19(2023)	Standard Guide for Assessment of Medical Gloves
09/17/2018	Orthopedic	11-340	Complete	ASTM	F3018-17	Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
08/21/2017	Materials	8-455	Complete	ASTM	F2902-16	Standard Guide for Assessment of Absorbable Polymeric Implants
07/06/2020	Materials	8-532	Complete	ASTM	F3335-20	Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion
07/06/2020	Tissue Engineering	15-59	Complete	ASTM	F2450-18	Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
06/07/2018	Tissue Engineering	15-53	Complete	ASTM	F3206-17	Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
09/17/2018	Sterility	14-517	Complete	ASTM	F3293-18	Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
06/07/2018	Materials	8-463	Complete	ISO ASTM	52901 First edition 2017-08	Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts
12/23/2019	Cardiovascular	3-162	Complete	ASTM	F3374-19	Standard Guide for Active Fixation Durability of Endovascular Prostheses
12/23/2016	Sterility	14-497	Complete	ASTM	F1980-16	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
02/20/2023	Sterility	14-575	Complete	ASTM	F1980-21	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
12/19/2022	Software/ Informatics	13-128	Complete	IEEE UL	Std 2621.2-2022	Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
06/07/2021	Cardiovascular	3-168	Partial	IEEE	Std 1708-2014	Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
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	General I (QS/ RM)	5-141	Complete	ASME	V&V 20-2009 (R2021)	Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
04/04/2016	General I (QS/ RM)	5-98	Complete	ANSI ESD	S20.20-2014	Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
08/21/2017	Software/ Informatics	13-96	Complete	UL ANSI	2900-1 First Edition 2017	Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
06/07/2018	Software/ Informatics	13-104	Complete	UL ANSI	2900-2-1 First Edition 2017	Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
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
12/19/2022	Software/ Informatics	13-125	Complete	ANSI AAMI UL	2800-1-1:2022	Standard for Risk Concerns for Interoperable Medical Products
03/16/2012	Radiology	12-177	Complete	UL	122-2007 (R2011)	Standard for Photographic Equipment - Ed. 5.0
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	Software/ Informatics	13-121	Complete	ANSI AAMI UL	2800-1:2022	Standard for Medical Device Interoperability
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	Software/ Informatics	13-126	Complete	ANSI AAMI UL	2800-1-2:2022	Standard for Interoperable Item Development Life Cycle
07/09/2014	Anesthesiology	1-100	Complete	CGA	V-1:2013	Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
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
01/14/2019	Materials	8-489	Complete	ASTM	F3302-18	Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
07/09/2014	Anesthesiology	1-101	Complete	CGA	C-9:2013	Standard Color Marking of Compressed Gas Containers for Medical Use
07/09/2014	Tissue Engineering	15-40	Complete	ASTM	F2211-13	Standard Classification for Tissue Engineered Medical Products (TEMPs)
09/09/2008	Software/ Informatics	13-20	Complete	CLSI	LIS05-A	Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
09/21/2016	General Plastic Surgery/ General Hospital	6-380	Complete	ISO	9626 Second edition 2016-08-01	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
08/20/2012	Software/ Informatics	13-31	Complete	CLSI	AUTO12-A	Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
12/21/2020	Materials	8-548	Complete	ISO ASTM	52915 Third edition 2020-03	Specification for additive manufacturing file format (AMF) Version 1.2
10/09/2023	Software/ Informatics	13-129	Complete	ISO IEC IEEE	29119-1 Second edition 2022-01	Software and systems engineering - Software testing - Part 1: General concepts
07/06/2020	Software/ Informatics	13-115	Complete	ISO IEC IEEE	29119-1 First edition 2013-09-01	Software and systems engineering - Software testing - Part 1: Concepts and definitions
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
12/21/2020	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
08/21/2017	General I (QS/ RM)	5-107	Complete	IEC	80369-5: Edition 1.0 2016-03	Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
08/21/2017	General I (QS/ RM)	5-107	Complete	ANSI AAMI ISO	80369-5:2016	Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
07/15/2019	General I (QS/ RM)	5-123	Complete	ISO	80369-3 First Edition 2016-07-01	Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
08/14/2015	General I (QS/ RM)	5-97	Complete	ISO	80369-20 First edition 2015-05-15	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015	General I (QS/ RM)	5-97	Complete	ANSI AAMI ISO	80369-20:2015	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
01/14/2019	General I (QS/ RM)	5-121	Complete	ISO	80369-1 Second edition 2018-11	Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
06/27/2016	General I (QS/ RM)	5-108	Complete	ISO	80369-6 First Edition 2016-03-15	Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
12/18/2023	Cardiovascular	3-190	Complete	ISO	PAS 7020 First edition 2023-05	Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
07/06/2020	General I (QS/ RM)	5-128	Complete	ISTA	3E 2017	Similar Packaged-Products in Unitized Loads of Truckload Shipment
01/30/2014	General Plastic Surgery/ General Hospital	6-273	Complete	ISO	23908 First edition 2011-06-11	Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
12/23/2019	General Plastic Surgery/ General Hospital	6-426	Complete	ISO	23907-1 First edition 2019-01	Sharps injury protection - Requirements and test methods - Sharps containers
12/23/2019	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.
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.
12/23/2019	General II (ES/ EMC)	19-13	Complete	IEC	62133 Edition 2.0 2012-12	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 [Including: Corrigendum 1 (2013)]
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	General II (ES/ EMC)	19-32	Complete	IEC	62133-1 Edition 1.0 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 1: Nickel systems
07/09/2014	Radiology	12-194	Complete	ANSI HPS	N43.6-2007 (R2013)	Sealed Radioactive Sources - Classification
01/14/2019	Dental/ ENT	4-256	Complete	ANSI ADA	Standard No. 132-2015	Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
07/09/2014	General I (QS/ RM)	5-88	Complete	ISO	2859-1 Second edition 1999-11-15	Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
01/27/2015	General I (QS/ RM)	5-48	Complete	ANSI	Z1.9-2003 (R2018)	Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
01/27/2015	General I (QS/ RM)	5-62	Complete	ANSI ASQ	Z1.4-2003 (R2018)	Sampling Procedures and Tables for Inspection by Attributes
12/19/2022	Anesthesiology	1-154	Complete	ASME	PVHO-1-2019	Safety Standard for Pressure Vessels for Human Occupancy
09/17/2018	Physical Medicine	16-203	Complete	ASME	A18.1-2017	Safety Standard for Platform Lifts and Stairway Chairlifts
08/21/2017	General II (ES/ EMC)	19-28	Complete	IEC	62485-4 Edition 1.0 2015-01	Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
08/21/2017	General II (ES/ EMC)	19-27	Complete	IEC	62485-3 Edition 2.0 2014-07	Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
08/21/2017	General II (ES/ EMC)	19-26	Complete	IEC	62485-2 Edition 1.0 2010-06	Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
08/21/2017	General II (ES/ EMC)	19-25	Complete	IEC	62485-1 Edition 1.0 2015-04	Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
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
07/09/2014	Radiology	12-273	Complete	IEC	60825-1 Edition 2.0 2007-03	Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-86	Complete	ISO	16037 First edition 2002-05-15 (Amendment 1 2011-02-15)	Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
06/27/2016	Dental/ ENT	4-202	Complete	ANSI ADA	Standard No. 58-2010 (R2015)	Root Canal Files, Type H (Hedstrom)
12/21/2020	Dental/ ENT	4-272	Complete	ANSI ADA	Standard No. 63-2013	Root Canal Barbed Broaches and Rasps
10/04/2010	InVitro Diagnostics	7-212	Complete	CLSI	EP18-A2	Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
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
03/18/2009	Software/ Informatics	13-28	Complete	CLSI	AUTO9-A	Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
09/17/2018	InVitro Diagnostics	7-278	Complete	CLSI	M27 4th Edition	Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018	InVitro Diagnostics	7-276	Complete	CLSI	M38 3rd Edition	Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
03/16/2012	InVitro Diagnostics	7-165	Complete	CLSI	H20-A2 (Replaces H20-A)	Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/18/2009	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
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
06/27/2016	Radiology	12-297	Complete	ANSI IES	RP-27.1-2015	Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
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
01/27/2015	Neurology	17-13	Complete	IEEE	Std 2010-2012	Recommended Practice for Neurofeedback Systems
01/30/2014	Radiology	12-59	Complete	IEC	61168:1993	Radiotherapy simulators - Functional performance characteristics
01/30/2014	Radiology	12-267	Complete	IEC	61217 Edition 2.0 2011-12	Radiotherapy equipment - Coordinates, movements, and scales
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	7-309	Complete	ISO	17099 First edition 2014-11-15	Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/04/2017	Radiology	12-307	Complete	AAMI	RT2:2017	Radiation therapy readiness check
07/06/2020	Radiology	12-334	Complete	AAMI	RT3:2020	Radiation therapy machine characterization
01/15/2013	InVitro Diagnostics	7-238	Complete	CLSI	MM06-A2 (Replaces MM06-A)	Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
01/30/2014	InVitro Diagnostics	7-220	Partial	CLSI	H59-A (Replaces H59-P)	Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
08/21/2017	Radiology	12-306	Complete	NEMA	MS 12-2016	Quantification and Mapping of Geometric Distortion for Special Applications
01/30/2014	InVitro Diagnostics	7-223	Complete	CLSI	QMS06-A3 (Formerly GP22-A3)	Quality Management System: Continual Improvement; Approved Guideline - Third Edition
01/27/2015	InVitro Diagnostics	7-250	Partial	CLSI	M40-A2 (Reaffirmed: September 2019)	Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
01/14/2019	InVitro Diagnostics	7-178	Complete	CLSI	M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16	Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
03/18/2009	InVitro Diagnostics	7-190	Complete	CLSI	M50-A (Replaces M50-P)	Quality Control for Commercial Microbial Identification Systems; Approved Guideline
09/09/2008	InVitro Diagnostics	7-136	Complete	CLSI	I/LA2-A2 (Replaces I/LA2-A)	Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
08/02/2011	InVitro Diagnostics	7-219	Complete	CLSI	I/LA28-A2	Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/21/2017	Materials	8-459	Complete	SAE	AMS2750 Rev. E 2012-07	Pyrometry
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
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-88	Complete	ISO	29942 First edition 2011-07-01	Prophylatic dams -- Requirements and test methods
07/09/2014	Sterility	14-286	Complete	ANSI AAMI	ST65:2008/(R)2018	Processing of reusable surgical textiles for use in health care facilities
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	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
08/20/2012	InVitro Diagnostics	7-148	Complete	CLSI	M28-A2 (Replaces M28-A)	Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
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
10/04/2004	InVitro Diagnostics	7-105	Complete	CLSI	H30-A2	Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
10/04/2004	InVitro Diagnostics	7-104	Complete	CLSI	H7-A3	Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
06/27/2016	Software/ Informatics	13-83	Complete	AAMI	TIR57:2016	Principles for medical device security - Risk management.
12/23/2019	Software/ Informatics	13-112	Complete	AAMI	TIR97:2019	Principles for medical device security - Postmarket risk management for device manufacturers
08/14/2015	InVitro Diagnostics	7-257	Complete	CLSI	M56-A	Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
03/18/2009	InVitro Diagnostics	7-189	Complete	CLSI	M47-A (Replaces M47-P)	Principles and Procedures for Blood Cultures; Approved Guideline
01/27/2015	Radiology	12-230	Complete	NEMA	XR 24-2008 (R2014)	Primary user controls for interventional angiography x-ray equipment
08/21/2017	General II (ES/ EMC)	19-24	Complete	IEC	60086-5 Edition 4.0 2016-07	Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
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)]
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
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-137	Complete	ISO	23500-5 First edition 2019-02	Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-137	Complete	ANSI AAMI ISO	23500-5:2019	Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-136	Complete	ISO	23500-4 First edition 2019-02	Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-136	Complete	ANSI AAMI ISO	23500-4:2019	Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-135	Complete	ISO	23500-3 First edition 2019-02	Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-135	Complete	ANSI AAMI ISO	23500-3:2019	Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-134	Complete	ISO	23500-2 First edition 2019-02	Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-134	Complete	ANSI AAMI ISO	23500-2:2019	Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies
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
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
12/20/2021	General Plastic Surgery/ General Hospital	6-464	Complete	ISO	11040-4 Third edition 2015-04-01	Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
01/30/2014	Sterility	14-430	Complete	ISO ASTM	51607 Third edition 2013-06-01	Practice for use of an alanine-EPR dosimery system
01/30/2014	Sterility	14-429	Complete	ISO ASTM	51275 Third edition 2013-06-01	Practice for use of a radiochromic film dosimetry system
07/06/2020	Sterility	14-545	Complete	ISO ASTM	51276 Fourth edition 2019-08	Practice for use of a polymethylmethacrylate dosimetry system
08/14/2015	Sterility	14-463	Complete	ISO ASTM	51608 Second edition 2015-03-15	Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
12/21/2020	Sterility	14-552	Complete	ISO ASTM	51818 Fourth edition 2020-06	Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
08/14/2015	Sterility	14-464	Complete	ISO ASTM	51649 Third edition 2015-03-15	Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/06/2013	Sterility	14-383	Complete	ISO ASTM	51702 Third edition 2013-04-15	Practice for dosimetry in a gamma facility for radiation processing
08/06/2013	Sterility	14-381	Complete	ISO ASTM	51261 Second edition 2013-04-15	Practice for calibration of routine dosimetry systems for radiation processing
09/09/2008	Software/ Informatics	13-14	Complete	CLSI	POCT1-A2	Point-of-Care Connectivity
12/21/2020	InVitro Diagnostics	7-299	Complete	CLSI	POCT14 2nd Edition	Point-of-Care Coagulation Testing and Anticoagulation Monitoring
07/09/2014	Materials	8-379	Complete	ISO	11542-2 First edition 1998-11-15	Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
07/09/2014	Dental/ ENT	4-149	Complete	ANSI ADA	Standard No. 39-2006 (R2011)	Pit and Fissure Sealants
03/31/2006	Radiology	12-138	Complete	ISO	5799 Second edition 1991-08-01	Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
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
03/31/2006	Radiology	12-137	Complete	ISO	4090 Third eidition 2001-08-15	Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
08/20/2012	Radiology	12-249	Complete	IEC	62471 First edition 2006-07	Photobiological safety of lamps and lamp systems
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
05/29/2023	InVitro Diagnostics	7-317	Partial	CLSI	M100, 33rd Edition	Performance Standards for Antimicrobial Susceptibility Testing
09/17/2018	InVitro Diagnostics	7-280	Complete	CLSI	M02 13th Edition	Performance Standards for Antimicrobial Disk Susceptibility Tests
12/19/2022	InVitro Diagnostics	7-314	Partial	CLSI	M27M44S, 3rd Edition	Performance Standards for Antifungal Susceptibility Testing of Yeasts
06/07/2021	InVitro Diagnostics	7-307	Complete	CLSI	POCT05 2nd Edition	Performance Metrics for Continuous Interstitial Glucose Monitoring
07/15/2019	Radiology	12-326	Complete	NEMA	NU 2-2018	Performance Measurements of Positron Emission Tomographs
06/07/2021	Radiology	12-337	Complete	NEMA	NU 1-2018	Performance Measurements of Gamma Cameras
06/07/2021	Dental/ ENT	4-279	Complete	ANSI ADA	Standard No. 85-2004 (R2009)	Part 1: Disposable Prophy Angles
12/18/2023	Sterility	14-595	Complete	ISO	11607-2 Second edition 2019-02 [Including AMD1:2023]	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
07/15/2019	Sterility	14-531	Complete	ISO	11607-2 Second edition 2019-02	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
07/15/2019	Sterility	14-531	Complete	ANSI AAMI ISO	11607-2:2019	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
12/18/2023	Sterility	14-594	Complete	ISO	11607-1 Second edition 2019-02 [Including AMD1:2023]	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
07/15/2019	Sterility	14-530	Complete	ISO	11607-1 Second edition 2019-02	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
07/15/2019	Sterility	14-530	Complete	ANSI AAMI ISO	11607-1:2019	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
05/29/2023	Sterility	14-585	Complete	AAMI ISO	TIR16775:2023	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
05/29/2023	Sterility	14-585	Complete	ISO	TS 16775 Second edition 2021-11	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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
07/06/2020	General I (QS/ RM)	5-126	Complete	ISTA	3A 2018	Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
07/06/2020	General I (QS/ RM)	5-127	Complete	ISTA	3B 2017	Packaged-Products for Less-Than-Truckload (LTL) Shipment
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)
12/19/2007	Radiology	12-173	Complete	ISO	14880-4:2006	Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007	Radiology	12-172	Complete	ISO	14880-3:2006	Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007	Radiology	12-171	Complete	ISO	14880-2:2006	Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
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
08/02/2011	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
06/07/2021	ObGyn/ Gastroenterology/ Urology	9-131	Complete	ISO	8600-5 Second Edition 2020-10	Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
03/16/2012	Radiology	12-115	Complete	ISO	13695:2004	Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
06/07/2018	Radiology	12-314	Complete	ISO	11554 Fourth edition 2017-07	Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, energy and temporal characteristics
01/14/2019	Radiology	12-324	Complete	ISO	13694 Third edition 2018-11	Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (energy) density distribution
10/04/2004	Radiology	12-116	Complete	ISO	13696:2002	Optics and optical instruments -- Test methods for radiation scattered by optical components
12/23/2019	Radiology	12-327	Complete	ISO	11551 Third eidtion 2019-10	Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptance of optical laser components
03/16/2012	Radiology	12-106	Complete	ISO	17526 First edition 2003-06-15	Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
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
09/17/2018	Ophthalmic	10-112	Complete	ISO	11986 Third edition 2017-11	Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
09/17/2018	Ophthalmic	10-111	Complete	ISO	11981 Third edition 2017-11	Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
08/06/2013	Ophthalmic	10-77	Complete	ISO	9394 Third edition 2012-10-01	Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
09/21/2016	Ophthalmic	10-101	Complete	ISO	18189 First edition 2016-06-01	Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
06/07/2018	Ophthalmic	10-107	Complete	ISO	18369-4 Second edition 2017-08	Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
06/07/2018	Ophthalmic	10-106	Complete	ISO	18369-3 Second edition 2017-08	Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
01/14/2019	Ophthalmic	10-108	Partial	ISO	18369-2 Third edition 2017-08	Ophthalmic optics - Contact lenses - Part 2: Tolerances
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
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]
04/04/2016	Ophthalmic	10-100	Complete	ISO	18259 First Edition 2014-10-01	Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
08/14/2015	Ophthalmic	10-97	Complete	ISO	13212 Third edition 2014-09-01	Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
08/14/2015	Ophthalmic	10-94	Complete	ISO	14730 Second edition 2014-10-01	Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
06/07/2021	Ophthalmic	10-122	Partial	ISO	10939 Third edition 2017-05	Ophthalmic instruments - Slit-lamp microscopes
12/19/2007	Ophthalmic	10-39	Complete	ISO	12865 Second edition 2006-07-01	Ophthalmic instruments - Retinoscopes
03/16/2012	Ophthalmic	10-70	Complete	ISO	10943 Third edition 2011-08-15	Ophthalmic instruments - Indirect ophthalmoscopes
01/14/2019	Ophthalmic	10-74	Partial	ISO	10940 Second edition 2009-08-01	Ophthalmic instruments - Fundus cameras
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
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
12/19/2022	Ophthalmic	10-132	Partial	ISO	10942 Third edition 2022-01	Ophthalmic instruments - Direct ophthalmoscopes
05/30/2022	Ophthalmic	10-131	Complete	ISO	15798 Fourth edition 2022-01	Ophthalmic implants - Ophthalmic viscosurgical devices
12/21/2020	Ophthalmic	10-121	Complete	ISO	16672 Third edition 2020-06	Ophthalmic implants - Ocular endotamponades
06/07/2018	Ophthalmic	10-105	Complete	ISO	11979-8 Third edition 2017-04	Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
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
08/14/2015	Ophthalmic	10-95	Complete	ISO	11979-6 Third edition 2014-10-01	Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
12/21/2020	Ophthalmic	10-119	Complete	ISO	11979-5 Third edition 2020-09	Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
08/06/2013	Ophthalmic	10-78	Complete	ISO	11979-3 Third edition 2012-12-01	Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
08/14/2015	Ophthalmic	10-98	Complete	ISO	11979-2 Second edition 2014-08-15	Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
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.
06/07/2021	Ophthalmic	10-124	Complete	ISO	11979-1 Fourth edition 2018-11	Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
12/21/2020	Ophthalmic	10-120	Complete	ISO	TR 22979 Second Edition 2017-05	Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
05/05/2010	InVitro Diagnostics	7-205	Complete	CLSI	H47-A2	One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
01/15/2013	Sterility	14-215	Complete	AOAC	6.2.05:2006	Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013	Sterility	14-213	Complete	AOAC	6.2.03:2006	Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013	Sterility	14-212	Complete	AOAC	6.2.02:2006	Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test 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
01/30/2014	Sterility	14-413	Complete	AOAC	6.2.06:2013	Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
01/15/2013	Sterility	14-217	Complete	AOAC	6.3.02:2006	Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
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	14-412	Complete	AOAC	6.2.01:2013	Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
08/14/2015	InVitro Diagnostics	7-255	Partial	CLSI	MM09-A2 (Replaces MM09-A)	Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
01/14/2019	InVitro Diagnostics	7-232	Complete	CLSI	MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17	Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition
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
12/20/2021	General Plastic Surgery/ General Hospital	6-467	Complete	USP-NF	M80200_04_01	Nonabsorbable Surgical Suture
07/06/2020	Cardiovascular	3-167	Complete	ISO	TS 81060-5 First edition 2020-02	Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
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
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)]
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
08/06/2013	Orthopedic	11-254	Complete	ISO	14630 Fourth edition 2012-12-01	Non-active surgical implants -- General requirements
09/11/2023	Orthopedic	11-400	Complete	ISO	21536 Third edition 2023-07	Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
09/11/2023	Orthopedic	11-401	Complete	ISO	21535 Third edition 2023-07	Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
07/15/2019	Materials	8-517	Complete	ISO	17327-1 First edition 2018-02	Non-active surgical implants - Implant coating - Part 1: General requirements
01/30/2014	Neurology	17-12	Complete	ISO	7197 Third edition 2006-06-01	Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
08/06/2013	General Plastic Surgery/ General Hospital	6-179	Complete	ISO	21649 First edition 2006-06-01	Needle-free injectors for medical use -- Requirements and test methods
09/21/2016	General Plastic Surgery/ General Hospital	6-382	Complete	ISO	11608-7 First edition 2016-08-01	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
05/30/2022	General Plastic Surgery/ General Hospital	6-480	Complete	ISO	11608-6:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022	General Plastic Surgery/ General Hospital	6-479	Complete	ISO	11608-5:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
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
05/30/2022	General Plastic Surgery/ General Hospital	6-477	Complete	ISO	11608-3:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022	General Plastic Surgery/ General Hospital	6-476	Complete	ISO	11608-2:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
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
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-111	Complete	ISO	4074 Third edition 2015-10-15	Natural latex rubber condoms - Requirements and test methods
12/19/2022	Nanotechnology	18-22	Complete	ISO	17200 First edition 2020-09	Nanotechnology - Nanoparticles in powder form - Characteristics and measurements
12/19/2022	Nanotechnology	18-21	Complete	ISO	TS 80004-6 Second edition 2021-03	Nanotechnologies - Vocabulary - Part 6: Nano-object characterization
01/14/2019	Nanotechnology	18-11	Complete	ISO	TR 13121 First edition 2011-05-15	Nanotechnologies - Nanomaterial risk evaluation
07/15/2019	Nanotechnology	18-14	Partial	ISO	TR 11360 First edition 2010-07-15	Nanotechnologies - Methodology for the classification and categorization of nanomaterials
12/21/2020	Nanotechnology	18-17	Complete	ISO	21363 First edition 2020-06	Nanotechnologies - Measurements of particle size and shape distributions by transmission electron microscopy
12/20/2021	Nanotechnology	18-19	Complete	ISO	19749 First edition 2021-07	Nanotechnologies - Measurements of particle size and shape distributions by scanning electron microscopy
06/07/2018	Nanotechnology	18-9	Complete	ISO	TR 13014 First edition 2012-05-15	Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].
06/07/2018	Nanotechnology	18-10	Complete	ISO	29701 First edition 2010-09-15	Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test.
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
07/06/2020	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	ObGyn/ Gastroenterology/ Urology	9-129	Complete	ISO CIE	61966-2-1 First edition 1999-10	Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
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
01/14/2019	InVitro Diagnostics	7-269	Partial	CLSI	MM23-1st Edition	Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
04/04/2016	InVitro Diagnostics	7-260	Complete	CLSI	MM03-3rd Edition (Replaces MM03-A2)	Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
01/30/2014	InVitro Diagnostics	7-239	Complete	CLSI	EP32-R (Formerly X05-R)	Metrological Traceability and Its Implementation; A Report
08/21/2017	InVitro Diagnostics	7-273	Complete	CLSI	M58 1st Edition	Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
09/17/2018	InVitro Diagnostics	7-279	Complete	CLSI	M07 11th Edition	Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
01/14/2019	InVitro Diagnostics	7-286	Complete	CLSI	M11 9th Edition	Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
06/07/2021	InVitro Diagnostics	7-236	Partial	CLSI	M43-A October 2011	Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
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
08/06/2013	InVitro Diagnostics	7-243	Partial	CLSI	M51-A (Replaces M51-P)	Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
12/19/2022	Anesthesiology	1-158	Complete	ISO	10079-4 First edition 2021-08	Medical suction equipment - Part 4: General requirements
12/19/2022	Anesthesiology	1-156	Complete	ISO	10079-3 Fourth edition 2022-03	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/19/2022	Anesthesiology	1-155	Complete	ISO	10079-2 Fourth edition 2022-03	Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022	Anesthesiology	1-157	Complete	ISO	10079-1 Fourth edition 2022-03	Medical suction equipment - Part 1: Electrically powered suction equipment
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
08/14/2015	Radiology	12-289	Complete	IEC	62220-1-1 Edition 1.0 2015-03	Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
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
05/29/2023	ObGyn/ Gastroenterology/ Urology	9-149	Complete	IEC	60601-2-39 Edition 3.0 2018-04	Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
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
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)]
01/30/2014	Radiology	12-259	Complete	IEC	61674 Edition 2.0 2012-11	Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
06/07/2021	Radiology	12-335	Complete	IEC	60336 Edition 5.0 2020-12	Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
03/16/2012	Radiology	12-241	Complete	IEC	62274 First Edition 2005-05	Medical electrical equipment - Safety of radiotherapy record and verify systems
03/14/2011	Radiology	12-217	Complete	IEC	62083 Edition 2.0 2009-09	Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
12/23/2016	Radiology	12-303	Complete	IEC	61303 Edition 1.0 1994-09	Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]
08/14/2015	Radiology	12-290	Complete	IEC	61910-1 Edition 1.0 2014-09	Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
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
05/30/2022	Anesthesiology	1-152	Complete	ISO	80601-2-87 First edition 2021-04	Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
12/19/2022	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
07/15/2019	Anesthesiology	1-144	Complete	ISO	80601-2-80 First edition 2018-07	Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
06/27/2016	Radiology	12-301	Complete	IEC	60601-2-8 Edition 2.1 b:2015	Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
07/15/2019	Anesthesiology	1-143	Complete	ISO	80601-2-79 First edition 2018-07	Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
12/20/2021	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
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	IEC	80601-2-77 Edition 1.0 2019-07	Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	ANSI AAMI IEC	80601-2-77:2020	Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
01/14/2019	Anesthesiology	1-138	Complete	ISO	80601-2-74 First edition 2017-05	Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
12/18/2023	Anesthesiology	1-163	Complete	ISO	80601-2-72 Second edition 2023-06	Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/14/2015	Anesthesiology	1-105	Complete	ISO	80601-2-72 First edition 2015-04-11	Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
04/04/2016	Anesthesiology	1-115	Complete	ISO	80601-2-70 First Edition 2015-01-15	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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
12/21/2020	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
09/17/2018	Radiology	12-319	Complete	IEC	60601-2-68 Edition 1.0 2014-09	Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
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
09/17/2018	Radiology	12-318	Complete	IEC	60601-2-64 Edition 1.0 2014-09	Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
06/07/2021	Radiology	12-339	Complete	IEC	60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
07/09/2014	Radiology	12-281	Complete	IEC	60601-2-62 Edition 1.0 2013-07	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
09/17/2018	Anesthesiology	1-139	Partial	ISO	80601-2-61 Second edition 2017-12 (Corrected version 2018-02)	Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
12/23/2019	Dental/ ENT	4-262	Complete	IEC	80601-2-60 Edition 2.0 2019-06	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
06/07/2018	General Plastic Surgery/ General Hospital	6-405	Complete	IEC	80601-2-59 Edition 2.0 2017-09	Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
06/07/2021	Ophthalmic	10-126	Complete	IEC	80601-2-58 Edition 2.0 2014-09	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
06/07/2021	Ophthalmic	10-126	Complete	ANSI AAMI IEC	80601-2-58:2014	Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
03/16/2012	Radiology	12-242	Complete	IEC	60601-2-57 Edition 1.0 2011-01	Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
07/15/2019	General Plastic Surgery/ General Hospital	6-421	Complete	ISO	80601-2-56 Second edition 2017-03	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
12/18/2023	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
05/29/2023	General Plastic Surgery/ General Hospital	6-489	Complete	IEC	60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
01/30/2014	General Plastic Surgery/ General Hospital	6-321	Complete	IEC	60601-2-52 Edition 1.0 2009-12	Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
12/21/2020	General Plastic Surgery/ General Hospital	6-450	Complete	IEC	60601-2-50 Edition 3.0 2020-09	Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
08/06/2013	Radiology	12-205	Complete	IEC	60601-2-5: Edition 3.0 2009-07	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
07/06/2020	Cardiovascular	3-155	Complete	IEC	60601-2-47 Edition 2.0 2012-02	Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
07/06/2020	Cardiovascular	3-155	Complete	ANSI AAMI IEC	60601-2-47:2012/(R)2016	Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
06/27/2016	Radiology	12-294	Complete	IEC	60601-2-45 Edition 3.1 2015	Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
06/27/2016	Radiology	12-302	Partial	IEC	60601-2-44 Edition 3.2: 2016	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
05/29/2023	Radiology	12-351	Complete	IEC	60601-2-43 Edition 3.0 2022-12	Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/23/2019	Radiology	12-329	Complete	IEC	60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
12/21/2020	Cardiovascular	3-169	Partial	IEC	60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
12/21/2020	Cardiovascular	3-169	Partial	ANSI AAMI IEC	60601-2-4:2010/A1:2018 (Consolidated Text)	Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
06/27/2016	Radiology	12-293	Complete	IEC	60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-119	Complete	IEC	60601-2-36 Edition 2.0 2014-04	Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
12/19/2022	General Plastic Surgery/ General Hospital	6-483	Complete	IEC	60601-2-35 Edition 2.0 2020-09	Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
08/06/2013	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
05/29/2023	Radiology	12-347	Complete	IEC	60601-2-33 Edition 4.0 2022-08	Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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
07/06/2020	Cardiovascular	3-123	Partial	IEC	80601-2-30: Edition 2.0 2018-03	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
07/06/2020	Cardiovascular	3-123	Partial	ANSI AAMI IEC	80601-2-30:2018	Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
08/06/2013	Radiology	12-211	Complete	IEC	60601-2-29 Edition 3.0 2008-06	Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
12/23/2019	Radiology	12-309	Complete	IEC	60601-2-28 Edition 3.0 2017-06	Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12/18/2023	Cardiovascular	3-126	Partial	IEC	60601-2-27 Edition 3.0 2011-03	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
12/18/2023	Cardiovascular	3-126	Partial	ANSI AAMI IEC	60601-2-27:2011(R)2016	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
12/18/2023	Cardiovascular	3-105	Partial	IEC	60601-2-25 Edition 2.0 2011-10	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
12/18/2023	Cardiovascular	3-105	Partial	ANSI AAMI IEC	60601-2-25:2011/(R)2016	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
08/20/2012	Anesthesiology	1-87	Complete	IEC	60601-2-23 Edition 3.0 2011-02	Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
01/14/2014	Radiology	12-268	Complete	IEC	60601-2-22 Edition 3.1 2012-10	Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
06/07/2021	General Plastic Surgery/ General Hospital	6-463	Complete	IEC	60601-2-21 Edition 3.0 2020-09	Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	IEC	60601-2-2 Edition 6.0 2017-03	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	ANSI AAMI IEC	60601-2-2:2017	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021	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
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
07/09/2014	Radiology	12-272	Complete	IEC	60601-2-17 Edition 3.0 2013-11	Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-121	Complete	IEC	60601-2-16 Edition 5.0 2018-4	Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-121	Complete	ANSI AAMI IEC	60601-2-16:2018	Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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	1-165	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
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
08/06/2013	Radiology	12-255	Complete	IEC	60601-2-11 Edition 3.0 2013-01	Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
06/07/2018	Neurology	17-16	Complete	IEC	60601-2-10 Edition 2.1 2016-04	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
06/07/2021	Radiology	12-338	Complete	IEC	60601-2-1 Edition 4.0 2020-10	Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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)]
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.
12/21/2020	General I (QS/ RM)	5-131	Complete	IEC	60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
12/21/2020	General I (QS/ RM)	5-131	Complete	ANSI AAMI IEC	60601-1-8:2006 and A1:2012 [Including AMD 2:2021]	Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
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	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
12/21/2020	General II (ES/ EMC)	19-36	Partial	IEC	60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
12/21/2020	General II (ES/ EMC)	19-36	Partial	ANSI AAMI IEC	60601-1-2:2014 [Including AMD 1:2021]	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
12/21/2020	General II (ES/ EMC)	19-39	Complete	IEC	60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
12/21/2020	General II (ES/ EMC)	19-39	Complete	ANSI AAMI IEC	60601-1-12:2016 [Including AMD 1:2021]	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]
12/21/2020	General II (ES/ EMC)	19-38	Partial	IEC	60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
12/21/2020	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
09/17/2018	Radiology	12-320	Complete	IEC	62667 Edition 1.0 2017-08	Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
05/30/2022	Radiology	12-344	Complete	IEC	62563-2 Edition 1.0 2021-11	Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
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
08/06/2013	Radiology	12-253	Complete	IEC	60976 Edition 2.0 2007-10	Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
10/04/2010	Radiology	12-215	Complete	IEC	62494-1 Edition 1.0 (2008-08)	Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
10/04/2010	Radiology	12-214	Complete	IEC	62220-1-3 Edition 1.0 2008-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
10/04/2010	Radiology	12-213	Complete	IEC	62220-1-2 Edition 1.0 2007-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
09/17/2018	Anesthesiology	1-140	Complete	ISO	80601-2-55 Second edition 2018-02	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
06/07/2021	General Plastic Surgery/ General Hospital	6-462	Complete	IEC	60601-2-20 Edition 3.0 2020-09	Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
01/14/2019	Tissue Engineering	15-47	Complete	ISO	22442-3 First edition 2007-12-15	Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) Agents.
12/21/2020	Tissue Engineering	15-65	Complete	ISO	22442-2 Third edition 2020-09	Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
12/21/2020	Tissue Engineering	15-64	Partial	ISO	22442-1 Third edition 2020-09	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
12/20/2021	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
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
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
12/20/2021	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
07/06/2020	General I (QS/ RM)	5-129	Complete	IEC	62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION	Medical devices - Part 1: Application of usability engineering to medical devices
07/06/2020	General I (QS/ RM)	5-129	Complete	ANSI AAMI IEC	62366-1:2015+AMD1:2020 (Consolidated Text)	Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
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
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
12/23/2019	General I (QS/ RM)	5-125	Complete	ISO	14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices
12/23/2019	General I (QS/ RM)	5-125	Complete	ANSI AAMI ISO	14971: 2019	Medical devices - Applications of risk management to medical devices
01/14/2019	Software/ Informatics	13-79	Complete	IEC	62304 Edition 1.1 2015-06 CONSOLIDATED VERSION	Medical device software - Software life cycle processes
01/14/2019	Software/ Informatics	13-79	Complete	ANSI AAMI IEC	62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
01/15/2013	Software/ Informatics	13-34	Complete	ANSI AAMI IEC	TIR80002-1:2009	Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
01/15/2013	Software/ Informatics	13-34	Complete	IEC	TR 80002-1 Edition 1.0 2009-09	Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
07/15/2019	General Plastic Surgery/ General Hospital	6-422	Complete	AAMI	TIR38:2019	Medical device safety assurance case guidance
08/14/2015	ObGyn/ Gastroenterology/ Urology	9-108	Complete	ISO	8009 Second edition 2014-11-15	Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
07/06/2020	InVitro Diagnostics	7-296	Partial	CLSI	EP09c 3rd Edition	Measurement Procedure Comparison and Bias Estimation Using Patient Samples
01/30/2014	General I (QS/ RM)	5-47	Complete	ISO	10012 First edition 2003-01-15	Measurement management systems - Requirements for measurement processes and measuring equipment
08/21/2017	InVitro Diagnostics	7-272	Partial	CLSI	C57 1st Edition (Reaffirmed: January 2020)	Mass Spectrometry for Androgen and Estrogen Measurements in Serum
05/30/2022	Dental/ ENT	4-293	Complete	ANSI ADA	Standard No. 119-2021	Manual Toothbrushes
03/18/2009	Software/ Informatics	13-25	Complete	CLSI	AUTO8-A	Managing and Validating Laboratory Information Systems; Approved Guideline
01/14/2019	ObGyn/ Gastroenterology/ Urology	9-68	Complete	ISO	23409 First edition 2011-02-15	Male Condoms - Requirements and test methods for condoms made from synthetic materials
09/17/2018	ObGyn/ Gastroenterology/ Urology	9-117	Complete	ISO	16038 Second edition 2017-11	Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
07/06/2020	Radiology	12-332	Complete	IEC	62464-1 Edition 2.0 2018-12	Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
03/16/2012	Anesthesiology	1-72	Complete	ISO	10651-5 First edition 2006-02-01	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
12/23/2019	Anesthesiology	1-145	Complete	ISO	19223 First edition 2019-07	Lung ventilators and related equipment - Vocabulary and semantics.
12/18/2023	Anesthesiology	1-162	Complete	ISO	10651-4 Second edition 2023-03	Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
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
01/27/2015	Software/ Informatics	13-71	Partial	RII	Version 2.48	Logical Observation Identifiers Names and Codes (LOINC)
07/09/2014	General II (ES/ EMC)	19-10	Complete	UL	1642 5th Edition	Lithium Batteries
09/21/2016	InVitro Diagnostics	7-265	Partial	CLSI	C62-A	Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
05/29/2023	General Plastic Surgery/ General Hospital	6-487	Partial	ANSI AAMI	PB70:2022	Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
08/06/2013	General Plastic Surgery/ General Hospital	6-296	Complete	ANSI AAMI	PB70:2012	Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
03/16/2012	Radiology	12-248	Complete	ISO	21254-3 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012	Radiology	12-246	Complete	ISO	21254-2 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012	Radiology	12-245	Complete	ISO	21254-1 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
03/16/2012	Radiology	12-142	Complete	ISO	11146-2 First edition 2005-02-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
03/16/2012	Radiology	12-134	Complete	ISO	11146-1 First edition 2005-01-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
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
01/30/2014	Radiology	12-262	Complete	ISO	11670 Second edition 2003-04-01	Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
03/16/2012	Radiology	12-143	Complete	ISO	15367-2 First edition 2005-03-15	Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012	Radiology	12-117	Complete	ISO	15367-1 First edition 2003-09-15	Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
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
01/14/2019	Radiology	12-323	Complete	ISO	11990 Third edition 2018-08	Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs
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
08/20/2012	InVitro Diagnostics	7-76	Complete	CLSI	M15-A (Replaces M15-T)	Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
01/14/2019	InVitro Diagnostics	7-285	Complete	CLSI	M48-A 2nd Edition	Laboratory Detection and Identification of Mycobacteria
09/09/2008	Software/ Informatics	13-12	Complete	CLSI	AUTO4-A	Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
09/09/2008	Software/ Informatics	13-13	Complete	CLSI	AUTO5-A	Laboratory Automation: Electromechanical Interfaces; Approved Standard
08/06/2013	Software/ Informatics	13-37	Complete	CLSI	AUTO7-A	Laboratory Automation: Data Content for Specimen Identification; Approved Standard
09/09/2008	Software/ Informatics	13-10	Complete	CLSI	AUTO1-A	Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
03/16/2012	Software/ Informatics	13-30	Complete	CLSI	AUTO3-A2	Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
09/09/2008	Software/ Informatics	13-9	Complete	CLSI	AUTO2-A2	Laboratory Automation: Bar Codes for Specimen Container Identification
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.
01/30/2014	General Plastic Surgery/ General Hospital	6-303	Complete	ISO	10555-5 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/30/2014	General Plastic Surgery/ General Hospital	6-322	Complete	ISO	10555-4 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
01/30/2014	General Plastic Surgery/ General Hospital	6-305	Complete	ISO	10555-3 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
09/17/2018	General Plastic Surgery/ General Hospital	6-408	Partial	ISO	10555-1 Second edition 2013-06-15	Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
05/29/2023	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
06/07/2018	Neurology	17-1	Partial	AAMI	NS28:1988/(R) 2015	Intracranial pressure monitoring devices
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
09/17/2018	InVitro Diagnostics	7-275	Complete	CLSI	EP07 3rd Edition	Interference Testing in Clinical Chemistry.
08/21/2017	Anesthesiology	1-124	Complete	ISO	8835-7 First edition 2011-11-01	Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
01/14/2019	Anesthesiology	1-114	Complete	ISO	18835 First Edition 2015-04-01	Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
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	6-358	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
08/06/2013	General Plastic Surgery/ General Hospital	6-216	Complete	ISO	8536-7 Third edition 2009-01-15	Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
01/14/2019	General Plastic Surgery/ General Hospital	6-410	Complete	ISO	8536-6 Third edition 2016-12-01	Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
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
07/06/2020	General Plastic Surgery/ General Hospital	6-447	Complete	ISO	8536-4 Sixth edition 2019-09	Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
08/06/2013	General Plastic Surgery/ General Hospital	6-240	Complete	ISO	8536-3 Third edition 2009-06-01	Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
08/20/2012	General Plastic Surgery/ General Hospital	6-242	Complete	ISO	8536-2 Third edition 2010-03-15	Infusion equipment for medical use - Part 2: Closures for infusion bottles
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
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
08/06/2013	General Plastic Surgery/ General Hospital	6-276	Complete	ISO	8536-1 Fourth edition 2011-09-01	Infusion equipment for medical use - Part 1: Infusion glass bottles
12/23/2016	Software/ Informatics	13-85	Complete	CLSI	AUTO11-A2	Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
08/14/2015	Software/ Informatics	13-78	Complete	INCITS ISO IEC	30111 First edition 2013-11-01 (R2019)	Information technology - Security techniques - Vulnerability handling processes
08/14/2015	Software/ Informatics	13-77	Complete	ISO IEC	29147 First edition 2014-02-15	Information technology - Security techniques - Vulnerability disclosure
12/04/2017	Software/ Informatics	13-98	Complete	ISO IEC	646 Third edition 1991-12-15 (R2018)	Information technology - ISO 7-bit coded character set for information interchange
12/04/2017	Software/ Informatics	13-98	Complete	INCITS ISO IEC	646:1991 (R2018)	Information technology - ISO 7-bit coded character set for information interchange
01/30/2014	Radiology	12-261	Complete	ISO IEC	10918-1 First edition 1994-02-15	Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
12/04/2017	Software/ Informatics	13-101	Complete	ISO IEC	15459-6 Second edition 2014 Corrected 2016	Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
12/04/2017	Software/ Informatics	13-100	Complete	ISO IEC	15459-4 Third edition 2014 Corrected 2016	Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
12/04/2017	Software/ Informatics	13-99	Complete	ISO IEC	15459-2 Third edition 2015-03-01	Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures
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
08/06/2013	Software/ Informatics	13-61	Complete	IEC	62443-2-1 Edition 1.0 2010-11	Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
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
12/21/2020	InVitro Diagnostics	7-305	Complete	ISO	17511 Second edition 2020-04	In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
01/30/2014	Orthopedic	11-75	Complete	ISO	5838-3 First edition 1993-09-15	Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
01/30/2014	Orthopedic	11-74	Complete	ISO	5838-2 First edition 1991-01-15	Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
01/30/2014	Materials	8-159	Complete	ISO	9584 First edition 1993-10-15	Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
01/30/2014	Materials	8-157	Complete	ISO	9583 First edition 1993-10-15	Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
08/06/2013	Orthopedic	11-252	Complete	ISO	5838-1 Third edition 2013-03-01	Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
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	Materials	8-595	Complete	ISO	5832-5 Fourth Edition 2022-03	Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
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
04/04/2016	Materials	8-406	Complete	ISO	5832-11 Second edition 2014-09-15	Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
12/20/2021	Materials	8-579	Complete	ISO	13779-3 Second Edition 2018-12	Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
08/14/2015	Orthopedic	11-290	Complete	ISO	8828 Second edition 2014-11-15	Implants for surgery -- Guidance on care and handling of orthopaedic implants
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
06/27/2016	Materials	8-430	Complete	ISO	13356:2015 Third Edition 2015-09-15	Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
08/21/2017	Materials	8-457	Complete	ISO	13175-3 First edition 2012-10-01	Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
09/17/2018	Cardiovascular	3-156	Complete	ISO	14708-1 Second edition 2014-08-15	Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018	Cardiovascular	3-156	Complete	ANSI AAMI ISO	14708-1:2014	Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
07/06/2020	Orthopedic	11-367	Complete	ISO	14243-3 Second edition 2014-11-01	Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
12/23/2016	Orthopedic	11-311	Complete	ISO	14243-2 Third edition 2016-09-01	Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
07/06/2020	Orthopedic	11-364	Complete	ISO	14243-1 Second edition 2009-11-15	Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
12/23/2019	Orthopedic	11-361	Complete	ISO	14243-5 First edition 2019-05	Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
07/15/2019	Orthopedic	11-353	Complete	ISO	18192-3 First edition 2017-06	Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
01/30/2014	Orthopedic	11-274	Complete	ISO	18192-2 First edition 2010-06-15	Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
07/15/2019	Orthopedic	11-351	Complete	ISO	18192-1 Second edition 2011-03-01	Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
07/15/2019	Orthopedic	11-349	Complete	ISO	14242-3 First edition 2009-03-15	Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
12/23/2016	Orthopedic	11-314	Complete	ISO	14242-2 Second edition 2016-09-15	Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
07/15/2019	Orthopedic	11-352	Complete	ISO	14242-1 Third edition 2014-10-15	Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
07/15/2019	Orthopedic	11-358	Complete	ISO	14242-4 First edition 2018-05	Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
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
07/15/2019	Materials	8-497	Complete	ISO	5834-5 Second edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment 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
07/15/2019	Materials	8-495	Complete	ISO	5834-3 Second edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
07/15/2019	Materials	8-514	Complete	ISO	5834-2 Fifth edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
12/23/2019	Materials	8-501	Complete	ISO	5834-1 Fourth edition 2019-02	Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
12/21/2020	Orthopedic	11-370	Complete	ISO	14879-1 Second edition 2020-07	Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
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
09/17/2018	Orthopedic	11-337	Complete	ISO	16087 First edition 2013-10-01	Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
12/20/2021	Orthopedic	11-390	Complete	ISO	23089-2 First edition 2021-05	Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
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)]
07/09/2014	Orthopedic	11-277	Complete	ISO	7206-6 Second edition 2013-11-15	Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
12/23/2016	Orthopedic	11-312	Complete	ISO	7206-4 Third edition 2010-06-15	Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
09/17/2018	Orthopedic	11-339	Complete	ISO	7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15	Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
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)]
12/23/2016	Orthopedic	11-319	Complete	ISO	7206-12 First edition 2016-10-01	Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
12/23/2019	Materials	8-519	Complete	ISO	13782 Second edition 2019-04	Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
12/23/2019	Materials	8-492	Complete	ISO	5832-9 Third edition 2019-02	Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
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
09/17/2018	Materials	8-465	Complete	ISO	5832-2 Fourth edition 2018-03	Implants for surgery - Metallic materials - Part 2: Unalloyed titanium

Recognized Consensus Standards: Medical Devices

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