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)
03/16/2012	InVitro Diagnostics	7-150	Complete	CLSI	H43-A2	Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
03/18/2009	InVitro Diagnostics	7-190	Complete	CLSI	M50-A (Replaces M50-P)	Quality Control for Commercial Microbial Identification Systems; Approved Guideline
01/15/2013	InVitro Diagnostics	7-237	Complete	CLSI	MM01-A3 (Replaces MM01-A2)	Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013	InVitro Diagnostics	7-238	Complete	CLSI	MM06-A2 (Replaces MM06-A)	Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
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
11/08/2005	InVitro Diagnostics	7-113	Complete	CLSI	I/LA23-A (Replaces I/LA23-P)	Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
07/15/2019	InVitro Diagnostics	7-287	Complete	CLSI	M44-S3 (2018)	Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
03/18/2009	InVitro Diagnostics	7-189	Complete	CLSI	M47-A (Replaces M47-P)	Principles and Procedures for Blood Cultures; Approved Guideline
12/23/2024	InVitro Diagnostics	7-322	Complete	CLSI	M47 2nd Edition	Principles and Procedures for Blood Cultures
12/23/2019	InVitro Diagnostics	7-293	Complete	CLSI	QMS01, 5th ed. June 2019 (Replaces QMS01-A4)	A Quality Management System Model for Laboratory Services.
06/07/2021	InVitro Diagnostics	7-307	Complete	CLSI	POCT05 2nd Edition	Performance Metrics for Continuous Interstitial Glucose Monitoring
09/17/2018	InVitro Diagnostics	7-280	Complete	CLSI	M02 13th Edition	Performance Standards for Antimicrobial Disk Susceptibility Tests
09/17/2018	InVitro Diagnostics	7-279	Complete	CLSI	M07 11th Edition	Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
05/26/2025	InVitro Diagnostics	7-342	Complete	CLSI	AUTO12-A	Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025	InVitro Diagnostics	7-334	Complete	CLSI	AUTO05-A	Laboratory Automation: Electromechanical Interfaces; Approved Standard
05/26/2025	InVitro Diagnostics	7-335	Complete	CLSI	POCT01-A2	Point-of-Care Connectivity - Second Edition
05/26/2025	InVitro Diagnostics	7-336	Complete	CLSI	LIS02-A2	Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition.
05/26/2025	InVitro Diagnostics	7-340	Complete	CLSI	LIS01-A2	Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems - Second Edition.
05/26/2025	InVitro Diagnostics	7-338	Complete	CLSI	AUTO10-A	Autoverification of Clinical Laboratory Test Results; Approved Guideline
12/23/2024	InVitro Diagnostics	7-323	Complete	CLSI	EP19 3rd Edition	A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
12/21/2020	InVitro Diagnostics	7-300	Complete	CLSI	MM13 2nd Edition	Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020	InVitro Diagnostics	7-302	Complete	CLSI	C34 4th Edition	Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
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
06/07/2021	InVitro Diagnostics	7-306	Complete	CLSI	EP06 2nd Edition	Evaluation of the Linearity of Quantitative Measurement Procedures
12/21/2020	InVitro Diagnostics	7-301	Complete	CLSI	GP42 7th Edition	Collection of Capillary Blood Specimens
05/26/2025	InVitro Diagnostics	7-329	Complete	CLSI	EP06-EG 2nd Edition	Developer Validation of Linearity, Establishment Guide
05/26/2025	InVitro Diagnostics	7-339	Complete	CLSI	AUTO09-A	Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
05/26/2025	InVitro Diagnostics	7-341	Complete	CLSI	AUTO03-A2	Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard - Second Edition
05/26/2025	InVitro Diagnostics	7-343	Complete	CLSI	AUTO07-A	Laboratory Automation: Data Content for Specimen Identification; Approved Standard
05/26/2025	InVitro Diagnostics	7-344	Complete	CLSI	AUTO11-A2	Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition.
05/26/2025	InVitro Diagnostics	7-345	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
05/26/2025	InVitro Diagnostics	7-332	Complete	CLSI	AUTO01-A	Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
12/20/2021	InVitro Diagnostics	7-310	Complete	ISO	19238 Second edition 2014-02-01	Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021	InVitro Diagnostics	7-311	Complete	CLSI	EP39, 1st Edition	A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
07/06/2020	InVitro Diagnostics	7-298	Complete	CLSI	EP35, 1st Edition	Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
12/23/2024	InVitro Diagnostics	7-324	Complete	CLSI	M07 12th Edition	Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
08/14/2015	InVitro Diagnostics	7-251	Complete	CLSI	EP05-A3 (Reaffirmed: September 2019)	Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015	InVitro Diagnostics	7-252	Complete	CLSI	EP14-A3	Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
08/20/2012	InVitro Diagnostics	7-76	Complete	CLSI	M15-A (Replaces M15-T)	Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
05/26/2025	InVitro Diagnostics	7-331	Complete	CLSI	AUTO02-A2	Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition
05/26/2025	InVitro Diagnostics	7-333	Complete	CLSI	AUTO04-A	Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
07/09/2014	InVitro Diagnostics	7-175	Complete	CLSI	C59-A	Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
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.
08/06/2013	InVitro Diagnostics	7-242	Complete	CLSI	C56-A	Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
01/30/2014	InVitro Diagnostics	7-224	Complete	CLSI	EP28-A3c (Formerly C28-A3c)	Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
01/30/2014	InVitro Diagnostics	7-223	Complete	CLSI	QMS06-A3 (Formerly GP22-A3)	Quality Management System: Continual Improvement; Approved Guideline - Third Edition
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.
05/05/2010	InVitro Diagnostics	7-207	Complete	CLSI	GP16-A3 (Replaces GP16-A2)	Urinalysis; Approved Guideline - Third Edition
05/30/2022	InVitro Diagnostics	7-312	Complete	CLSI	M39 5th Edition	Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
03/18/2009	InVitro Diagnostics	7-71	Complete	CLSI	H15-A3 (Replaces H15-A2)	Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009	InVitro Diagnostics	7-145	Complete	CLSI	H42-A2 (Replaces H42-A)	Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
04/04/2016	InVitro Diagnostics	7-260	Complete	CLSI	MM03-3rd Edition (Replaces MM03-A2)	Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
12/23/2016	InVitro Diagnostics	7-267	Complete	CLSI	C24 4th Edition (Replaces C24-A3)	Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
01/14/2019	InVitro Diagnostics	7-286	Complete	CLSI	M11 9th Edition	Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/14/2019	InVitro Diagnostics	7-139	Complete	CLSI	QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2	Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
01/15/2013	InVitro Diagnostics	7-233	Complete	CLSI	EP17-A2	Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
09/21/2016	InVitro Diagnostics	7-266	Complete	CLSI	EP19 2nd Edition (Replaces EP19-R)	A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
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
01/15/2013	InVitro Diagnostics	7-235	Complete	CLSI	EP25-A (Replaces EP25-P)	Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
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
08/14/2015	InVitro Diagnostics	7-257	Complete	CLSI	M56-A	Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
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
03/16/2012	InVitro Diagnostics	7-227	Complete	CLSI	M53-A (Replaces M53-P)	Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
09/17/2018	InVitro Diagnostics	7-283	Complete	CLSI	POCT04 3rd Edition	Essential Tools for Implementation and Management of a Point-of-Care Testing Program
09/17/2018	InVitro Diagnostics	7-275	Complete	CLSI	EP07 3rd Edition	Interference Testing in Clinical Chemistry.
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	7-166	Complete	CLSI	GP20-A2 (Replaces GP20-A)	Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012	InVitro Diagnostics	7-225	Complete	CLSI	GP34-A (Replaces GP34-P)	Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
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.
01/14/2019	InVitro Diagnostics	7-285	Complete	CLSI	M48-A 2nd Edition	Laboratory Detection and Identification of Mycobacteria
03/08/2004	InVitro Diagnostics	7-86	Complete	CLSI	C29-A2 (Replaces C29-A)	Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004	InVitro Diagnostics	7-87	Complete	CLSI	C31-A2 (Replaces C31-A)	Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004	InVitro Diagnostics	7-88	Complete	CLSI	C37-A	Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004	InVitro Diagnostics	7-89	Complete	CLSI	C39-A (Replaces C39-P)	A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004	InVitro Diagnostics	7-105	Complete	CLSI	H30-A2	Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
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.
09/09/2008	InVitro Diagnostics	7-21	Complete	CLSI	C42-A	Erythrocyte Protoporphyrin Testing; 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.
09/09/2008	InVitro Diagnostics	7-159	Complete	CLSI	H21-A5	Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
09/09/2008	InVitro Diagnostics	7-163	Complete	CLSI	H56-A (Replaces H56-P)	Body Fluid Analysis for Cellular Composition; Approved Guideline.
09/21/2016	General Plastic Surgery/ General Hospital	6-379	Complete	ISO	7864 Fourth edition 2016-08-01	Sterile hypodermic needles for single use - Requirements and test methods
07/15/2019	General Plastic Surgery/ General Hospital	6-423	Complete	IEC	60601-2-6 Edition 2.1 2016-04	CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
09/17/2018	General Plastic Surgery/ General Hospital	6-123	Complete	ASTM	E667-98 (Reapproved 2017)	Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
09/17/2018	General Plastic Surgery/ General Hospital	6-409	Complete	ASTM	F703-18 (Reapproved 2022)	Standard Specification for Implantable Breast Prostheses
05/29/2024	General Plastic Surgery/ General Hospital	6-499	Complete	ISO	10555-1 Third edition 2023-11	Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
03/16/2012	General Plastic Surgery/ General Hospital	6-269	Complete	ASTM	F1078-10 (Reapproved 2024)	Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
05/29/2023	General Plastic Surgery/ General Hospital	6-494	Complete	ASTM	F3352/F3352M-23a	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
06/07/2018	General Plastic Surgery/ General Hospital	6-214	Complete	ASTM	D6355-07(2022)	Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
12/23/2019	General Plastic Surgery/ General Hospital	6-424	Complete	ASTM	D5151-19(2023)	Standard Test Method for Detection of Holes in Medical Gloves
01/14/2019	General Plastic Surgery/ General Hospital	6-411	Complete	ASTM	D6499-18	Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
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
07/06/2020	General Plastic Surgery/ General Hospital	6-440	Partial	ASTM	D3578-19(2023)	Standard Specification for Rubber Examination Gloves
04/04/2016	General Plastic Surgery/ General Hospital	6-359	Partial	ISO	8536-9 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016	General Plastic Surgery/ General Hospital	6-361	Partial	ISO	8536-11 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
07/06/2020	General Plastic Surgery/ General Hospital	6-178	Partial	ASTM	D6124-06(2022)	Standard Test Method for Residual Powder on Medical Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-443	Partial	ASTM	D3577-19 (Reapproved 2023)	Standard Specification for Rubber Surgical Gloves
12/18/2023	General Plastic Surgery/ General Hospital	6-497	Partial	ASTM	D7866-23	Standard Specification for Radiation Attenuating Protective Gloves
08/21/2017	General Plastic Surgery/ General Hospital	6-384	Complete	ISO	1135-4 Sixth edition 2015-12-01	Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017	General Plastic Surgery/ General Hospital	6-125	Complete	ASTM	E1965-98 (Reapproved 2023)	Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017	General Plastic Surgery/ General Hospital	6-400	Complete	ASTM	F3212-16(2023)	Standard Test Method for Coring Testing of Huber Needles
08/21/2017	General Plastic Surgery/ General Hospital	6-70	Complete	ASTM	E825-98 (Reapproved 2023)	Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/21/2017	General Plastic Surgery/ General Hospital	6-124	Complete	ASTM	E1104-98 (Reapproved 2023)	Standard Specification for Clinical Thermometer Probe Covers and Sheaths
07/06/2020	General Plastic Surgery/ General Hospital	6-445	Partial	ASTM	D5250-19(2023)	Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
04/04/2016	General Plastic Surgery/ General Hospital	6-358	Partial	ISO	8536-8 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
04/04/2016	General Plastic Surgery/ General Hospital	6-360	Partial	ISO	8536-10 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
07/06/2020	General Plastic Surgery/ General Hospital	6-446	Partial	ASTM	D6319-19(2023)	Standard Specification for Nitrile Examination Gloves for Medical Application
12/21/2020	General Plastic Surgery/ General Hospital	6-448	Partial	ASTM	F2407-20	Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
05/26/2025	General Plastic Surgery/ General Hospital	6-513	Partial	ISO	14607 Fourth edition 2024-12	Non-active surgical implants - Mammary implants - Specific requirements
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
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	6-496	Partial	ASTM	F739-20	Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
06/27/2016	General Plastic Surgery/ General Hospital	6-364	Partial	ISO	8537 Third edition 2016-03-15	Sterile single-use syringes, with or without needle, for insulin
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
08/14/2015	General Plastic Surgery/ General Hospital	6-185	Complete	ASTM	F881-94 (Reapproved 2022)	Standard Specification for Silicone Elastomer Facial Implants
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
05/30/2022	General Plastic Surgery/ General Hospital	6-479	Complete	ISO	11608-5:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
01/15/2013	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
01/30/2014	General Plastic Surgery/ General Hospital	6-117	Complete	ASTM	F2172-02 (Reapproved 2011)	Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
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	6-305	Complete	ISO	10555-3 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
08/14/2015	General Plastic Surgery/ General Hospital	6-353	Complete	ASTM	F2051-00 (Reapproved 2022)	Standard Specification for Implantable Saline Filled Breast Prosthesis
06/07/2018	General Plastic Surgery/ General Hospital	6-404	Complete	ISO	7886-1 Second edition 2017-05	Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
01/14/2019	General Plastic Surgery/ General Hospital	6-338	Complete	ASTM	D7866-14	Standard Specification for Radiation Attenuating Protective Gloves
08/14/2015	General Plastic Surgery/ General Hospital	6-200	Complete	ASTM	E1061-01(2022)	Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
03/16/2012	General Plastic Surgery/ General Hospital	6-272	Complete	ASTM	F2062-00 (Reapproved 2018)	Standard Specification for Square Drive Interconnections on Surgical Instruments
07/15/2019	General Plastic Surgery/ General Hospital	6-421	Complete	ISO	80601-2-56 Second edition 2017-03 [Including AMD1:2018]	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
07/06/2020	General Plastic Surgery/ General Hospital	6-441	Complete	ISO	7886-3 Second edition 2020-05	Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
12/19/2022	General Plastic Surgery/ General Hospital	6-484	Complete	ASTM	F3502-22a	Standard Specification for Barrier Face Coverings
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.
05/29/2023	General Plastic Surgery/ General Hospital	6-493	Complete	ASTM	F2101-23	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
05/29/2023	General Plastic Surgery/ General Hospital	6-486	Complete	ISO	10535 Third edition 2021-10	Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
05/29/2023	General Plastic Surgery/ General Hospital	6-490	Complete	ISO	10555-6 First edition 2015-04-15 [Including AMD1:2019]	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
05/29/2023	General Plastic Surgery/ General Hospital	6-495	Complete	ISO	20698 First Edition 2018-07	Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
12/20/2021	General Plastic Surgery/ General Hospital	6-471	Complete	USP-NF	M88880_05_01	Sterile Water for Irrigation
05/30/2022	General Plastic Surgery/ General Hospital	6-480	Complete	ISO	11608-6:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022	General Plastic Surgery/ General Hospital	6-481	Complete	ANSI AAMI	CN27:2021	General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022	General Plastic Surgery/ General Hospital	6-482	Complete	AAMI	TIR101:2021	Fluid delivery performance testing for infusion pumps
05/29/2023	General Plastic Surgery/ General Hospital	6-492	Complete	ASTM	F2100-23	Standard Specification for Performance of Materials Used in Medical Face Masks
04/04/2016	General Plastic Surgery/ General Hospital	6-355	Complete	ASTM	D3772-15(2021)	Standard Specification for Industrial Rubber Finger Cots
05/29/2024	General Plastic Surgery/ General Hospital	6-501	Complete	ISO	15747 Third edition 2018-09	Plastic containers for intravenous injections
05/29/2024	General Plastic Surgery/ General Hospital	6-500	Complete	IEC	63045 Edition 1.0 2020-05	Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields
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
08/06/2013	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
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
03/16/2012	General Plastic Surgery/ General Hospital	6-268	Complete	ASTM	F921-10 (Reapproved 2024)	Standard Terminology Relating to Hemostatic Forceps
03/16/2012	General Plastic Surgery/ General Hospital	6-271	Complete	ASTM	F1874-98 (Reapproved 2011)	Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
12/20/2021	General Plastic Surgery/ General Hospital	6-465	Complete	USP-NF	M76090_03_01	Sodium Chloride Irrigation
12/20/2021	General Plastic Surgery/ General Hospital	6-466	Complete	USP-NF	M76070_03_01	Sodium Chloride Injection
12/20/2021	General Plastic Surgery/ General Hospital	6-467	Complete	USP-NF	M80200_04_01	Nonabsorbable Surgical Suture
12/20/2021	General Plastic Surgery/ General Hospital	6-468	Complete	USP-NF	M99670_02_01	<881> Tensile Strength
05/30/2022	General Plastic Surgery/ General Hospital	6-477	Complete	ISO	11608-3:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022	General Plastic Surgery/ General Hospital	6-475	Complete	ISO	11608-4:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
12/20/2021	General Plastic Surgery/ General Hospital	6-469	Complete	USP-NF	M99650_02_01	<861> Sutures - Diameter
07/15/2019	General Plastic Surgery/ General Hospital	6-422	Complete	AAMI	TIR38:2019	Medical device safety assurance case guidance
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
09/21/2016	General Plastic Surgery/ General Hospital	6-381	Complete	ISO	6009 Fourth edition 2016-08-01	Hypodermic needles for single use - Colour coding for identification.
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	General Plastic Surgery/ General Hospital	6-147	Complete	ASTM	D6978-05(2023)	Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
05/26/2025	General Plastic Surgery/ General Hospital	6-505	Complete	ISO	21649 Second Edition 2023-01	Needle-free injectors for medical use -- Requirements and test methods
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
03/16/2012	General Plastic Surgery/ General Hospital	6-177	Complete	ASTM	E1112-00 (Reapproved 2018)	Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
05/29/2023	General Plastic Surgery/ General Hospital	6-488	Complete	ASTM	F1671/F1671M-22	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
05/26/2025	General Plastic Surgery/ General Hospital	6-509	Complete	ASTM	F3186-24	Standard Specification for Adult Portable Bed Rails and Related Products
05/26/2025	General Plastic Surgery/ General Hospital	6-512	Complete	IEC	60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION	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
08/14/2015	General Plastic Surgery/ General Hospital	6-110	Complete	ASTM	F1441-03 (Reapproved 2022)	Standard Specification for Soft-Tissue Expander Devices
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
07/06/2020	General Plastic Surgery/ General Hospital	6-444	Complete	ASTM	D7103-19(2023)	Standard Guide for Assessment of Medical Gloves
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
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
12/19/2022	General Plastic Surgery/ General Hospital	6-483	Complete	IEC	60601-2-35 Edition 2.0 2020-09	Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
05/26/2025	General Plastic Surgery/ General Hospital	6-510	Complete	IEC	80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	IEC	80601-2-77 Edition 1.0 2019-07	Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	ANSI AAMI IEC	80601-2-77:2020	Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
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
12/23/2024	General Plastic Surgery/ General Hospital	6-504	Complete	ASTM	F1862/F1862M-24	Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
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	General Plastic Surgery/ General Hospital	6-406	Complete	ASTM	F1862/F1862M-17	Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
06/07/2018	General Plastic Surgery/ General Hospital	6-407	Complete	ASTM	F3186-17	Standard Specification for Adult Portable Bed Rails and Related Products
05/26/2025	General Plastic Surgery/ General Hospital	6-508	Complete	IEC	80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
09/21/2016	General Plastic Surgery/ General Hospital	6-382	Complete	ISO	11608-7 First edition 2016-08-01	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
12/20/2021	General Plastic Surgery/ General Hospital	6-470	Complete	USP-NF	M99660_03_01	<871> Sutures - Needle Attachment
12/20/2021	General Plastic Surgery/ General Hospital	6-472	Complete	USP-NF	M36660_04_01	Heparin Lock Flush Solution
12/20/2021	General Plastic Surgery/ General Hospital	6-473	Complete	USP-NF	M80190_04_01	Absorbable Surgical Suture
12/19/2022	General Plastic Surgery/ General Hospital	6-485	Complete	ISO	7886-4 Second Edition 2018-11	Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
09/21/2016	General Plastic Surgery/ General Hospital	6-380	Complete	ISO	9626 Second edition 2016-08-01	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
05/29/2024	General Plastic Surgery/ General Hospital	6-498	Complete	ISO	10555-4 Third edition 2023-11	Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation 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
03/18/2009	General Plastic Surgery/ General Hospital	6-215	Complete	ASTM	F2132-01 (Reapproved 2008)e1	Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
06/07/2018	General Plastic Surgery/ General Hospital	6-270	Complete	ASTM	F1840-10 (Reapproved 2023)	Standard Terminology for Surgical Suture Needles
08/14/2015	General Plastic Surgery/ General Hospital	6-354	Complete	ASTM	D7907-14 (Reapproved 2019)	Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
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)]
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
04/04/2016	General Plastic Surgery/ General Hospital	6-356	Complete	ASTM	D5712-15(2020)	Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
05/26/2025	General Plastic Surgery/ General Hospital	6-506	Complete	ISO	8536-2 Fourth edition 2023-01	Infusion equipment for medical use - Part 2: Closures 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
05/26/2025	General Plastic Surgery/ General Hospital	6-511	Complete	ISO	11040-4 Fourth edition 2024-06	Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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
06/07/2018	General Plastic Surgery/ General Hospital	6-401	Complete	ASTM	D7160-16 (Reapproved 2023)	Standard Practice for Determination of Expiration Dating for Medical Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-439	Complete	ISO	7886-2 Second edition 2020-04	Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
05/29/2024	General Plastic Surgery/ General Hospital	6-502	Complete	ISO	23217 First Edition 2024-02	Injection systems for self-administration by paediatric patients - Requirements and guidelines for design
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
12/20/2021	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)]
05/26/2025	General Plastic Surgery/ General Hospital	6-507	Complete	ISO	23908 Second Edition 2024-12	Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods
12/23/2024	General Plastic Surgery/ General Hospital	6-503	Complete	ISO	16571 Second edition 2024-03	Systems for evacuation of plume generated by medical device
05/29/2023	General Plastic Surgery/ General Hospital	6-491	Complete	ASTM	F1670/F1670M-17a	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2024	General II (ES/ EMC)	19-50	Partial	IEC	TS 60601-4-2 Edition 1.0 2024-03	Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
09/17/2018	General II (ES/ EMC)	19-19	Partial	IEC	TR 60601-4-2 Edition 1.0 2016-05	Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
12/20/2021	General II (ES/ EMC)	19-43	Partial	IEC	61326-2-6 Edition 3.0 2020-10	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
12/21/2020	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)	19-38	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
12/20/2021	General II (ES/ EMC)	19-42	Partial	IEC	61326-1 Edition 3.0 2020-10	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/19/2022	General II (ES/ EMC)	19-48	Complete	IEEE ANSI	USEMCSC C63.27-2021	American National Standard for Evaluation of Wireless Coexistence
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
08/21/2017	General II (ES/ EMC)	19-25	Complete	IEC	62485-1 Edition 1.0 2015-04	Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
08/21/2017	General II (ES/ EMC)	19-27	Complete	IEC	62485-3 Edition 2.0 2014-07	Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
07/15/2019	General II (ES/ EMC)	19-35	Complete	UL	Standard for Standby Batteries	1989 Edition 5, 2013-10-02, ANSI November 2018
07/09/2014	General II (ES/ EMC)	19-10	Complete	UL	1642 5th Edition	Lithium 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)	19-28	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
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
07/28/2025	General II (ES/ EMC)	19-57	Complete	IEC	61326-2-6 Edition 4.0 2025-06	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
05/26/2025	General II (ES/ EMC)	19-56	Complete	IEC	60086-4 Edition 6.0 2025-01	Primary batteries - Part 4: Safety of lithium batteries
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
05/26/2025	General II (ES/ EMC)	19-54	Complete	IEC	60086-5 Edition 5.0 2021-09	Primary batteries - Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)]
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
05/26/2025	General II (ES/ EMC)	19-55	Complete	IEC	62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/23/2016	General II (ES/ EMC)	19-20	Complete	IEEE ANSI	C63.16-2016 (Revision of ANSI C63.16-1993)	American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
12/23/2024	General II (ES/ EMC)	19-51	Complete	UL	1642 Sixth Edition September 29, 2020	Standard For Safety Lithium Batteries
07/09/2014	General II (ES/ EMC)	19-11	Complete	UL	2054 2nd Edition	Household and Commercial Batteries
12/20/2021	General II (ES/ EMC)	19-44	Complete	IEEE ANSI	C63.24-2021	American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
12/21/2020	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)]
06/07/2021	General II (ES/ EMC)	19-40	Complete	IEC	60086-4 Edition 5.0 2019-04	Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
12/23/2024	General II (ES/ EMC)	19-52	Complete	UL	2054 Third Edition November 17, 2021	Standard For Safety Household and Commercial Batteries
12/23/2024	General II (ES/ EMC)	19-53	Complete	IEC	TS 60601-4-6 Edition 1.0 2024-04	Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
12/20/2021	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
09/17/2018	General II (ES/ EMC)	19-31	Complete	IEEE ANSI	C63.15-2017 (Revision of ANSI C63.15-2010)	American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
04/04/2016	General II (ES/ EMC)	19-17	Complete	IEEE ANSI	C63.18-2014	American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
08/21/2017	General II (ES/ EMC)	19-22	Complete	AAMI	TIR69:2017/(R2020)	Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
05/30/2022	General II (ES/ EMC)	19-47	Complete	ANSI AAMI	HA60601-1-11:2015 [Including AMD1:2021]	Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
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
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.
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
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)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
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
01/27/2015	General I (QS/ RM)	5-62	Complete	ANSI ASQ	Z1.4-2003 (R2018)	Sampling Procedures and Tables for Inspection by Attributes
07/15/2019	General I (QS/ RM)	5-123	Complete	ISO	80369-3 First Edition 2016-07-01	Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
12/19/2022	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
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
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)	5-141	Complete	ASME	V&V 20-2009 (R2021)	Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
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
01/14/2019	General I (QS/ RM)	5-120	Complete	IEC	60812 Edition 3.0 2018-08	Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
12/19/2022	General I (QS/ RM)	5-138	Complete	AAMI	TIR66: 2017/(R)2025	Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/19/2022	General I (QS/ RM)	5-136	Complete	ASTM	D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
12/19/2022	General I (QS/ RM)	5-137	Complete	IEC	TR 60878 Ed. 4.0 2022-11	Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
09/17/2018	General I (QS/ RM)	5-42	Complete	ASTM	D903-98 (Reapproved 2017)	Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
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)]
12/23/2016	General I (QS/ RM)	5-113	Complete	ASTM	D7386-16	Standard Practice for Performance Testing of Packages for Single Delivery Systems
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)
07/06/2020	General I (QS/ RM)	5-130	Complete	ISO	7010 Third edition 2019-07	Graphical symbols - Safety colours and safety signs - Registered safety signs
12/19/2022	General I (QS/ RM)	5-140	Complete	ASME	V&V 10-2019	Standard for Verification and Validation in Computational Solid Mechanics
07/06/2020	General I (QS/ RM)	5-127	Complete	ISTA	3B 2017	Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020	General I (QS/ RM)	5-128	Complete	ISTA	3E 2017	Similar Packaged-Products in Unitized Loads of Truckload Shipment
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)	5-126	Complete	ISTA	3A 2018	Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
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
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
12/23/2019	General I (QS/ RM)	5-124	Complete	ISO	7000 Sixth edition 2019-07	Graphical symbols for use on equipment - Registered symbols
05/26/2025	General I (QS/ RM)	5-145	Complete	IEC	60417:2025 DB	Graphical symbols for use on equipment
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)]
12/23/2024	General I (QS/ RM)	5-143	Complete	ISO	14630 Fffth edition 2024-09	Non-active surgical implants -- General requirements
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	General I (QS/ RM)	5-122	Complete	ASME	V&V 40-2018	Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
01/30/2014	General I (QS/ RM)	5-47	Complete	ISO	10012 First edition 2003-01-15	Measurement management systems - Requirements for measurement processes and measuring equipment
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.
01/30/2014	General I (QS/ RM)	5-84	Complete	AAMI	TIR 49:2013/(R)2020	Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
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
05/26/2025	General I (QS/ RM)	5-144	Complete	ISO	80369-20 Second edition 2024-11	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
05/29/2024	General I (QS/ RM)	5-142	Complete	ISO	780 Fifth edition 2015-12-01	Packaging - Distribution packaging - Graphical symbols for handling and storage of packages
09/17/2018	Dental/ ENT	4-242	Complete	ISO	10139-1 Third edition 2018-03	Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
09/17/2018	Dental/ ENT	4-242	Complete	ANSI ADA	Standard No. 75-2020	Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
12/20/2021	Dental/ ENT	4-290	Complete	ISO	28158 Second edition 2018-09	Dentistry - Integrated dental floss and handles
12/20/2021	Dental/ ENT	4-290	Complete	ANSI ADA	Standard No. 185-2020	Integrated Dental Floss and Handles
06/07/2021	Dental/ ENT	4-281	Complete	ISO	1797 Third Edition 2017-05	Dentistry - Shanks for rotary and oscillating instruments
06/07/2021	Dental/ ENT	4-281	Complete	ANSI ADA	Standard No. 179-2020	Shanks for Rotary and Oscillating Instruments
12/18/2023	Dental/ ENT	4-314	Complete	ISO	7494-2 Third edition 2022-07	Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
08/21/2017	Dental/ ENT	4-232	Complete	ISO	20795-1 Second edition 2013-03-01	Dentistry - Base polymers - Part 1: Denture base polymers
12/23/2024	Dental/ ENT	4-335	Complete	ISO	11499 Third edition 2014-06	Dentistry - Single-use cartridges for local anaesthetics
12/23/2024	Dental/ ENT	4-335	Complete	ANSI ADA	Standard No. 190-2020	Single-Use Dental Cartridges for Local Anesthetics
12/21/2020	Dental/ ENT	4-265	Complete	ISO	10271 Third edition 2020-08	Dentistry - Corrosion test methods for metallic materials
12/21/2020	Dental/ ENT	4-265	Complete	ANSI ADA	Standard No. 97-2020	Corrosion Test Methods for Metallic Materials
01/30/2014	Dental/ ENT	4-153	Complete	ISO	9917-1 Second edition 2007-10-01	Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
12/18/2023	Dental/ ENT	4-317	Complete	ISO	8325 Third edition 2023-03	Dentistry - Test methods for rotary instruments
08/21/2017	Dental/ ENT	4-238	Complete	ISO	20127 First edition 2005-03-15	Dentistry - Powered toothbrushes - General requirements and test methods
08/21/2017	Dental/ ENT	4-238	Complete	ANSI ADA	Standard No.120-2009 (R2014)	Powered Toothbrushes
01/14/2019	Dental/ ENT	4-217	Complete	ANSI ASA	S3.36-2012 (Reaffirmed 2022)	American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
04/04/2016	Dental/ ENT	4-224	Complete	ISO	24234 Second edition 2015-05-01	Dentistry - Dental Amalgam
12/18/2023	Dental/ ENT	4-316	Complete	ISO	20127 Second edition 2020-08	Dentistry - Physical properties of powered toothbrushes
12/18/2023	Dental/ ENT	4-316	Complete	ANSI ADA	Standard No.120-2022	Dentistry - Physical Properties of Powered Toothbrushes
09/17/2018	Dental/ ENT	4-244	Complete	ISO	8325 Second edition 2004-09-15	Dentistry - Test methods for rotary instruments
12/18/2023	Dental/ ENT	4-318	Complete	ISO	20749 Second edition 2023-06	Dentistry - Pre-capsulated dental amalgam
09/17/2018	Dental/ ENT	4-246	Complete	ISO	20749 First edition 2017-03	Dentistry - Pre-capsulated dental amalgam
09/17/2018	Dental/ ENT	4-246	Complete	ANSI ADA	Standard No. 144-2018	Alloy for Dental Amalgam
12/18/2023	Dental/ ENT	4-312	Complete	ANSI ASA	S3.35-2021	American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
04/04/2016	Dental/ ENT	4-190	Complete	ANSI ASA	S3.35-2010 (Reaffirmed 2020)	American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
06/07/2021	Dental/ ENT	4-276	Partial	ISO	14457 Second edition 2017-10	Dentistry - Handpieces and motors
06/07/2021	Dental/ ENT	4-276	Partial	ANSI ADA	Standard No. 35-2019	Dental Handpieces and Motors
05/29/2023	Dental/ ENT	4-306	Partial	ISO	22052 First edition 2020-06	Dentistry - Compressed air source equipment
05/29/2023	Dental/ ENT	4-306	Partial	ANSI ADA	Standard No. 94-2021	Central Compressed Air Source Equipment
05/26/2025	Dental/ ENT	4-344	Complete	ANSI ADA	Standard No. 186-2024	Dentistry - Polymer-based Machinable Blanks
05/29/2024	Dental/ ENT	4-325	Complete	ANSI ADA	Standard No. 96-2020	Dental Water-based Cements
08/14/2015	Dental/ ENT	4-184	Complete	ANSI ASA	S3.25-2009 (Reaffirmed 2024)	American National Standard For an Occluded Ear Simulator
05/26/2025	Dental/ ENT	4-347	Complete	ISO	22254 First edition 2005-08	Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection
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
05/29/2023	Dental/ ENT	4-305	Partial	ISO	10637 Second edition 2018-05	Dentistry - Central suction source equipment
05/29/2023	Dental/ ENT	4-305	Partial	ANSI ADA	Standard No. 177-2020	Central Suction Source Equipment
12/18/2023	Dental/ ENT	4-319	Partial	ISO	17730 Second edition 2020-09	Dentistry - Fluoride varnishes
12/18/2023	Dental/ ENT	4-319	Partial	ANSI ADA	Standard No. 117-2022	Dentistry - Fluoride Varnishes
01/14/2019	Dental/ ENT	4-257	Partial	ISO	17730 First edition 2014-11-01	Dentistry - Fluoride varnishes
06/07/2021	Dental/ ENT	4-280	Partial	ANSI ADA	Standard No. 117-2018	Fluoride varnishes
07/15/2019	Dental/ ENT	4-259	Partial	ISO	14801 Third edition 2016-11-01	Dentistry - Implants - Dynamic loading test for endosseous dental implants
07/15/2019	Dental/ ENT	4-259	Partial	ANSI ADA	Standard No. 127-2018	Dynamic Loading Test for Endosseous Dental Implants
12/23/2024	Dental/ ENT	4-338	Complete	ISO	22683 First edition 2022-05	Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
12/18/2023	Dental/ ENT	4-313	Complete	ISO	27020 Second edition 2019-06	Dentistry - Brackets and tubes for use in orthodontics
12/18/2023	Dental/ ENT	4-313	Complete	ANSI ADA	Standard No.100-2020	Orthodontic Brackets and Tubes
01/27/2015	Dental/ ENT	4-218	Complete	ISO	27020 First edition 2010-12-15	Dentistry - Brackets and tubes for use in orthodontics
01/27/2015	Dental/ ENT	4-218	Complete	ANSI ADA	Standard No.100-2012	Orthodontic Brackets and Tubes
12/18/2023	Dental/ ENT	4-320	Complete	ISO	13402 First edition 1995-08-01	Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
01/30/2014	Dental/ ENT	4-188	Complete	ISO	9917-2 Second edition 2010-04-15	Dentistry - Water-based cements - Part 2: Resin-modified cements
01/30/2014	Dental/ ENT	4-151	Complete	ISO	22112 First edition 2005-11-01	Dentistry - Artificial teeth for dental prostheses
01/30/2014	Dental/ ENT	4-151	Complete	ANSI ADA	Standard No. 15-2008 (R2013)	Artificial Teeth for Dental Prostheses
08/21/2017	Dental/ ENT	4-215	Complete	ANSI ADA	Standard No. 96-2012	Dental Water-based Cements
12/18/2023	Dental/ ENT	4-315	Complete	ISO	24234 Third edition 2021-08	Dentistry - Dental Amalgam
06/07/2021	Dental/ ENT	4-277	Complete	ANSI IEEE	C63.19-2019	American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
05/29/2023	Dental/ ENT	4-307	Complete	ISO	13504 First edition 2012-07	Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
05/29/2023	Dental/ ENT	4-308	Complete	ISO	14708-7 Second edition 2019-12	Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
12/23/2024	Dental/ ENT	4-329	Complete	ISO	6872 Fifth edition 2024-08	Dentistry - Ceramic materials
05/29/2024	Dental/ ENT	4-326	Complete	ISO	9687 Second edition 2015-02	Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)]
05/29/2024	Dental/ ENT	4-327	Complete	ISO	21531 First edition 2009-02	Dentistry - Graphical symbols for dental instruments
12/21/2020	Dental/ ENT	4-272	Complete	ANSI ADA	Standard No. 63-2013	Root Canal Barbed Broaches and Rasps
01/27/2015	Dental/ ENT	4-136	Complete	ASTM	F2504-05 (Reapproved 2022)	Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/14/2019	Dental/ ENT	4-251	Complete	ISO	6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04]	Dentistry - Ceramic materials
01/14/2019	Dental/ ENT	4-251	Complete	ANSI ADA	Standard No. 69-2020	Dental Ceramic
12/23/2024	Dental/ ENT	4-330	Complete	ANSI ADA	Standard No. 63-2020	Endodontic Instruments - Auxillary
12/23/2024	Dental/ ENT	4-334	Complete	ISO	11143 Second edition 2008-07	Dentistry - Amalgam separators
12/23/2024	Dental/ ENT	4-334	Complete	ANSI ADA	Standard No. 108-2009, Addendum (R2022)	Amalgam Separators
12/23/2024	Dental/ ENT	4-331	Complete	ISO	28399 Third edition 2021-03	Dentistry - External tooth bleaching products
12/23/2024	Dental/ ENT	4-331	Complete	ANSI ADA	Standard No. 136-2022	Dentistry - External Tooth Bleaching Products
12/20/2021	Dental/ ENT	4-291	Complete	ISO	28399 First edition 2011-01	Dentistry - Products for external tooth bleaching
12/20/2021	Dental/ ENT	4-291	Complete	ANSI ADA	Standard No. 136-2015 (R2020)	Products for External Tooth Bleaching
12/23/2024	Dental/ ENT	4-332	Complete	ANSI ADA	Standard No. 206-2024	Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File
08/21/2017	Dental/ ENT	4-239	Complete	ANSI AAMI	CI86:2017/(R)2025	Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
08/14/2015	Dental/ ENT	4-220	Complete	ANSI ASA	S3.22-2014 (Reaffirmed 2020)	American National Standard Specification of Hearing Aid Characteristics
07/06/2020	Dental/ ENT	4-263	Complete	ISO	9693 Third edition 2019-10	Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
07/06/2020	Dental/ ENT	4-263	Complete	ANSI ADA	Standard No. 38-2020	Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
12/18/2023	Dental/ ENT	4-309	Complete	ISO	6877 Third edition 2021-09	Dentistry - Endodontic obturating materials
12/18/2023	Dental/ ENT	4-309	Complete	ANSI ADA	Standard No. 78-2022	Dentistry - Endodontic Obturating Materials
01/30/2014	Dental/ ENT	4-137	Complete	ISO	6877 Second edition 2006-04-01	Dentistry - Root-canal obturating points
01/30/2014	Dental/ ENT	4-137	Complete	ANSI ADA	Standard No. 78-2013	Dental obturating cones
05/29/2023	Dental/ ENT	4-303	Complete	ISO	9333 Third edition 2022-08	Dentistry - Brazing materials
06/07/2018	Dental/ ENT	4-241	Complete	ISO	7491 Second edition 2000-09-01	Dental materials - Determination of colour stability
06/07/2018	Dental/ ENT	4-241	Complete	ANSI ADA	Standard No. 80-2001 (R2020)	Dental Materials-Determination of Color Stability
05/29/2023	Dental/ ENT	4-304	Complete	ISO	21606 Second edition 2022-08	Dentistry - Elastomeric auxiliaries for use in orthodontics
12/23/2024	Dental/ ENT	4-328	Complete	ANSI ADA	Standard No. 57-2021	Endodontic Sealing Materials
12/23/2024	Dental/ ENT	4-333	Complete	ISO	3630-4 Second edition 2023-08	Dentistry - Endodontic instruments - Part 4: Auxiliary instruments
12/18/2023	Dental/ ENT	4-311	Complete	ISO	9917-2 Third edition 2017-09	Dentistry - Water-based cements - Part 2: Resin-modified cements
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	4-270	Complete	ANSI ADA	Technical Report No. 146-2018	CAD/CAM Abutments in Dentistry
08/21/2017	Dental/ ENT	4-233	Complete	ISO	20795-2 Second edition 2013-03-01	Dentistry - Base polymers - Part 2: Orthodontic base polymers
12/18/2023	Dental/ ENT	4-310	Complete	ISO	22112 Second edition 2017-08	Dentistry - Artificial teeth for dental prostheses
12/18/2023	Dental/ ENT	4-310	Complete	ANSI ADA	Standard No. 15-2021	Artificial Teeth for Dental Prostheses
12/20/2021	Dental/ ENT	4-284	Complete	ISO	10873 Second edition 2021-07	Dentistry - Denture adhesives
12/19/2022	Dental/ ENT	4-296	Complete	ISO	9873 Fourth edition 2019-03	Dentistry - Intra-oral mirrors
12/19/2022	Dental/ ENT	4-296	Complete	ANSI ADA	Standard No. 191-2020	Intra-Oral Mirrors
08/06/2013	Dental/ ENT	4-167	Complete	ANSI ASA	S3.21-2004 (Reaffirmed 2023)	American National Standard Methods for Manual Pure-Tone Threshold Audiometry
07/09/2014	Dental/ ENT	4-177	Complete	ANSI ASA	S12.65-2006 (Reaffirmed 2025)	American National Standard For Rating Noise with Respect to Speech Interference
07/09/2014	Dental/ ENT	4-160	Complete	ANSI ASA	S3.1-1999 (Reaffirmed 2023)	American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
01/14/2019	Dental/ ENT	4-255	Complete	ANSI ADA	Standard No. 131-2015 (R2020)	Dental CAD/CAM Machinable Zirconia Blanks
12/21/2020	Dental/ ENT	4-266	Complete	ISO	19023 First edition 2018-02	Dentistry - Orthodontic anchor screws
12/21/2020	Dental/ ENT	4-266	Complete	ANSI ADA	Standard No. 178-2019	Orthodontic Anchor Screws
12/21/2020	Dental/ ENT	4-268	Complete	ISO	15841 Second edition 2014-08	Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
12/21/2020	Dental/ ENT	4-268	Complete	ANSI ADA	Standard No. 32-2017	Orthodontic Wires
12/23/2019	Dental/ ENT	4-260	Complete	ANSI ASA	S12.2-2019 (Reaffirmed 2023)	American National Standard for Criteria for Evaluating Room Noise
01/14/2019	Dental/ ENT	4-162	Complete	ANSI ASA	S3.4-2007 (Reaffirmed 2025)	American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019	Dental/ ENT	4-256	Complete	ANSI ADA	Standard No. 132-2015	Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
01/14/2019	Dental/ ENT	4-163	Complete	ANSI ASA	S3.5-1997 (Reaffirmed 2024)	American National Standard Methods for Calculation of the Speech Intelligibility Index
01/14/2019	Dental/ ENT	4-250	Complete	ISO	7494-1 Third edition 2018-06	Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
01/14/2019	Dental/ ENT	4-252	Complete	ISO	10650 Second edition 2018-08	Dentistry - Powered polymerization activators
01/14/2019	Dental/ ENT	4-252	Complete	ANSI ADA	Standard No. 48-2020	Curing Lights (Powered Polymerization Activators)
05/26/2025	Dental/ ENT	4-343	Complete	ANSI ADA	Standard No. 105-2024	Elastomeric Auxiliaries for Use in Orthodontics
05/26/2025	Dental/ ENT	4-346	Complete	ISO	9680 Fourth edition 2021-11	Dentistry - Operating lights
05/26/2025	Dental/ ENT	4-346	Complete	ANSI ADA	Standard No. 89-2023	Dentistry - Dental Operating Lights
12/21/2020	Dental/ ENT	4-269	Complete	ISO	3964 Third edition 11-2016	Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
12/21/2020	Dental/ ENT	4-269	Complete	ANSI ADA	Standard No. 158-2020	Coupling Dimensions for Dental Handpiece Connectors
05/26/2025	Dental/ ENT	4-339	Complete	ANSI ADA	Standard No. 119-2023	Dentistry-Manual Toothbrushes
05/30/2022	Dental/ ENT	4-293	Complete	ANSI ADA	Standard No. 119-2021	Manual Toothbrushes
05/26/2025	Dental/ ENT	4-340	Complete	ANSI ADA	Standard No. 46-2016	Dental Patient Chair
05/26/2025	Dental/ ENT	4-341	Complete	ANSI ADA	Standard No. 47-1-2021	Stationary Dental Units and Patient Chairs-Part 1: General Requirements
05/26/2025	Dental/ ENT	4-342	Complete	ANSI ADA	Standard No. 47-2-2021	Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems
05/29/2023	Dental/ ENT	4-300	Complete	ISO	22674 Third edition 2022-08	Dentistry - Metallic materials for fixed and removable restorations and appliances
05/29/2023	Dental/ ENT	4-300	Complete	ANSI ADA	Standard No. 134-2023	Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
05/29/2023	Dental/ ENT	4-298	Complete	ISO	4049 Fifth edition 2019-05	Dentistry - Polymer-based restorative materials
05/29/2023	Dental/ ENT	4-298	Complete	ANSI ADA	Standard No. 27-2022	Polymer-based Restorative Materials
12/19/2022	Dental/ ENT	4-297	Complete	ISO	20126 Third edition 2022-03	Dentistry - Manual toothbrushes - General requirements and test methods
06/07/2021	Dental/ ENT	4-278	Complete	ISO	4823 Fifth edition 2021-02	Dentistry - Elastomeric impression and bite registration materials
06/07/2021	Dental/ ENT	4-278	Complete	ANSI ADA	Standard No. 19-2022	Elastomeric Impression and Bite Registration
06/07/2021	Dental/ ENT	4-279	Complete	ANSI ADA	Standard No. 85-2004 (R2009)	Part 1: Disposable Prophy Angles
06/07/2021	Dental/ ENT	4-273	Complete	ANSI ASA	S3.7-2016 (Reaffirmed 2025)	American National Standard Method for Coupler Calibration of Earphones
06/07/2021	Dental/ ENT	4-275	Complete	ANSI ASA	S3.6-2018 (Reaffirmed 2023)	American National Standard Specification for Audiometers
06/07/2021	Dental/ ENT	4-283	Complete	ISO	16409 Second edition 2016-10	Dentistry - Oral care products - Manual interdental brushes
06/07/2021	Dental/ ENT	4-283	Complete	ANSI ADA	Standard No. 125-2018	Manual Interdental Brushes
12/19/2022	Dental/ ENT	4-294	Complete	ANSI ADA	Standard No. 139-2020	Dental Base Polymers
12/19/2022	Dental/ ENT	4-295	Complete	ANSI ADA	Standard No. 41-2020	Evaluation of Biocompatibility of Medical Devices Used in Dentistry
06/07/2021	Dental/ ENT	4-274	Complete	ANSI ASA	S3.2-2020	American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
12/20/2021	Dental/ ENT	4-286	Complete	ANSI ADA	Standard No. 87-1995 (R2014)	Dental Impression Trays
12/21/2020	Dental/ ENT	4-271	Complete	ANSI ADA	Standard No. 34-2013	Dental Cartridge Syringes
03/16/2012	Dental/ ENT	4-173	Complete	ANSI ASA	S3.44-1996 (Reaffirmed 2006)	American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
05/29/2023	Dental/ ENT	4-299	Complete	ISO	3107 Fifth edition 2022-09	Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
05/29/2023	Dental/ ENT	4-299	Complete	ANSI ADA	Standard No. 30-2023	Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
12/20/2021	Dental/ ENT	4-292	Complete	ISO	28888 First edition 2013-10	Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
12/20/2021	Dental/ ENT	4-292	Complete	ANSI ADA	Standard No. 151-2015 (R2020)	Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
01/14/2019	Dental/ ENT	4-254	Complete	ANSI ADA	Standard No. 99-2001 (R2023)	Athletic Mouth Protectors and Materials
08/14/2015	Dental/ ENT	4-130	Complete	ANSI ADA	Standard No. 17-1983 (R2014)	Denture Base Temporary Relining Resins
07/09/2014	Dental/ ENT	4-165	Complete	ANSI ASA	S3.13-1987 (Reaffirmed 2024)	American National Standard Mechanical Coupler for Measurement of Bone Vibrators
12/23/2024	Dental/ ENT	4-336	Complete	ISO	18397 First edition 2016-01	Dentistry - Powered scaler
12/23/2024	Dental/ ENT	4-336	Complete	ANSI ADA	Standard No. 157-2020	Powered Dental Scaler Handpieces and Tips
12/23/2024	Dental/ ENT	4-337	Complete	ISO	20608 First edition 2018-04	Dentistry - Powder jet handpieces and powders
07/09/2014	Dental/ ENT	4-97	Complete	ANSI ADA	Standard No. 57-2000 (R2012)	Endodontic Sealing Material
01/14/2019	Dental/ ENT	4-171	Complete	ANSI ASA	S3.37-1987 (Reaffirmed 2025)	American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
01/27/2015	Dental/ ENT	4-219	Complete	ISO	29022 First edition 2013-06-01	Dentistry - Adhesive - Notched-edge sheer bond strength test
06/27/2016	Dental/ ENT	4-228	Complete	ANSI ASA	S3.20-2015 (Reaffirmed 2025)	American National Standard Bioacoustical Terminology
12/23/2019	Dental/ ENT	4-261	Complete	ISO	7405 Third edition 2018-10 Corrected version 2018-12	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
07/15/2019	Dental/ ENT	4-258	Complete	ISO	10139-2 Third edition 2016-06-15	Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
07/15/2019	Dental/ ENT	4-258	Complete	ANSI ADA	Standard No. 160-2020	Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
12/18/2023	Dental/ ENT	4-322	Complete	ISO	18675 First edition 2022-05	Dentistry - Machinable ceramic blanks
12/18/2023	Dental/ ENT	4-323	Complete	ISO	5139 First edition 2023-05	Dentistry - Polymer-based composite machinable blanks
12/18/2023	Dental/ ENT	4-321	Complete	ISO	23450 First edition 2021-03	Dentistry - Intraoral camera
12/18/2023	Dental/ ENT	4-324	Complete	ISO	TS 16506 First edition 2017-07 Corrected version 2018-03	Dentistry - Polymer-based luting materials containing adhesive components
01/27/2015	Dental/ ENT	4-185	Complete	ANSI ASA	S3.45-2009 (Reaffirmed 2024)	American National Standard Procedures for Testing Basic Vestibular Function
07/09/2014	Dental/ ENT	4-211	Complete	ANSI ASA	S3.46-2013 (Reaffirmed 2023)	American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
08/06/2013	Dental/ ENT	4-204	Complete	ANSI ASA	S3.42-2012/Part 2/ IEC 60118-15:2012 (R2025)	American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
05/29/2023	Dental/ ENT	4-301	Complete	ISO	21563 Second edition 2021-08	Dentistry - Hydrocolloid impression materials
05/29/2023	Dental/ ENT	4-301	Complete	ANSI ADA	Standard No. 128-2022	Hydrocolloid Impression Materials
05/29/2023	Dental/ ENT	4-302	Complete	ISO	10477 Fourth edition 2020-10	Dentistry - Polymer-based crown and veneering materials
05/29/2023	Dental/ ENT	4-302	Complete	ANSI ADA	Standard No. 53-2022	Polymer-Based Crown and Veneering Materials
12/20/2021	Dental/ ENT	4-288	Complete	ISO	7488 Second edition 2018-04	Dentistry - Mixing machines for dental amalgam
12/20/2021	Dental/ ENT	4-288	Complete	ANSI ADA	Standard No. 43-2020	Electrically Powered Dental Amalgamators
12/20/2021	Dental/ ENT	4-289	Complete	ISO	18556 Frist edition 2016-04	Dentistry - Intraoral spatulas
12/20/2021	Dental/ ENT	4-287	Complete	ANSI ADA	Standard No. 116-2020	Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
01/30/2014	Dental/ ENT	4-199	Complete	ISO	6876 Third edition 2012-06-01	Dentistry -- Root canal sealing materials
01/30/2014	Dental/ ENT	4-180	Complete	ISO	9168 Third edition 2009-07-15	Dentistry - Hose connectors for air driven dental handpieces
04/04/2016	Dental/ ENT	4-221	Complete	ISO	7494-2 Second edition 2015-04-01	Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
08/06/2013	Dental/ ENT	4-90	Complete	ANSI ASA	S3.39:1987 (Reaffirmed 2025)	American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
09/17/2018	Dental/ ENT	4-247	Complete	ISO	28319 Second edition 2018-04	Dentistry - Laser welding and filler materials
09/17/2018	Dental/ ENT	4-247	Complete	ANSI ADA	Standard No. 84-2020	Laser Welding and Filler Materials in Dentistry
05/26/2025	Dental/ ENT	4-345	Complete	ANSI ADA	Standard No. 187-2024	Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
09/09/2008	Dental/ ENT	4-145	Complete	ISO	22803 First edition 2004-09-01	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
04/04/2016	Dental/ ENT	4-222	Complete	ISO	6874 Third edition 2015-09-01	Dentistry - Polymer-based pit and fissure sealants
04/04/2016	Dental/ ENT	4-222	Complete	ANSI ADA	Standard No. 39-2020	Pit and Fissure Sealants
12/20/2021	Dental/ ENT	4-285	Complete	ANSI ADA	Standard No. 37-1986 (R2020)	Dental Abrasive Powders
01/14/2019	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
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
07/06/2020	Cardiovascular	3-123	Partial	IEC	80601-2-30: Edition 2.0 2018-03	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
07/06/2020	Cardiovascular	3-123	Partial	ANSI AAMI IEC	80601-2-30:2018	Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
05/29/2023	Cardiovascular	3-185	Partial	ANSI AAMI	PC76:2021	Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
12/23/2019	Cardiovascular	3-163	Partial	ISO	18242 First edition 2016-09-01	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
06/07/2021	Cardiovascular	3-166	Partial	ISO	81060-2 Third edition 2018-11 [Including AMD1:2020]	Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
12/23/2024	Cardiovascular	3-196	Partial	ISO	81060-2 Third edition 2018-11 [Including AMD1:2020 and AMD2:2024]	Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: AMENDMENT 1 (2020) and AMENDMENT 2 (2024)]
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
01/14/2019	Cardiovascular	3-86	Partial	ASTM	F2394-07 (Reapproved 2017)	Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
12/20/2021	Cardiovascular	3-174	Partial	ISO	5840-1 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
12/21/2020	Cardiovascular	3-169	Partial	IEC	60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
12/21/2020	Cardiovascular	3-169	Partial	ANSI AAMI IEC	60601-2-4:2010/A1:2018 (Consolidated Text)	Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
06/07/2021	Cardiovascular	3-168	Partial	IEEE	Std 1708-2014	Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
01/14/2019	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
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
12/23/2024	Cardiovascular	3-195	Partial	ISO	5910 Second edition 2024-07	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
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
06/15/2016	Cardiovascular	3-132	Complete	ISO	27185 First edition 2012-02-15	Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
06/15/2016	Cardiovascular	3-132	Complete	ANSI AAMI ISO	27185:2012	Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
09/17/2018	Cardiovascular	3-110	Complete	AAMI	TIR 41:2011/(R)2017	Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
12/19/2022	Cardiovascular	3-183	Complete	ISO	11658 First edition 2012-05-15	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022	Cardiovascular	3-183	Complete	ANSI AAMI ISO	11658: 2012	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
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
12/23/2019	Cardiovascular	3-161	Complete	ISO	14117 Second edition 2019-09	Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
12/20/2021	Cardiovascular	3-177	Complete	ASTM	F2606-08 (Reapproved 2021)	Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021	Cardiovascular	3-175	Complete	ISO	5840-2 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021	Cardiovascular	3-176	Complete	ISO	18193 First edition 2021-08	Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
05/30/2022	Cardiovascular	3-181	Complete	ISO	25539-2 Third edition 2020-09	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021	Cardiovascular	3-179	Complete	ASTM	F3172-15 (Reapproved 2021)	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
05/29/2023	Cardiovascular	3-186	Complete	ISO	14708-2 Third edition 2019-09	Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023	Cardiovascular	3-187	Complete	ISO	14708-6 Second edition 2019-09	Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
12/20/2021	Cardiovascular	3-171	Complete	ASTM	F2514-21	Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/20/2021	Cardiovascular	3-172	Complete	AAMI	TIR42:2021	Evaluation of Particulates Associated with Vascular Medical Devices
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
01/14/2019	Cardiovascular	3-79	Complete	ASTM	F2079-09 (Reapproved 2017)	Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
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
01/30/2014	Cardiovascular	3-63	Complete	ISO	11318:2002	Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
12/20/2021	Cardiovascular	3-180	Complete	ASTM	F3505-21	Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/20/2021	Cardiovascular	3-173	Complete	ISO	5840-3 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
12/20/2021	Cardiovascular	3-178	Complete	ASTM	F3067-14 (Reapproved 2021)	Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
01/14/2019	Cardiovascular	3-44	Complete	ANSI AAMI	BP22:1994 (R2016)	Blood pressure transducers
08/20/2012	Cardiovascular	3-102	Complete	IEC	60601-2-31 Edition 2.1 2011-09	Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/20/2012	Cardiovascular	3-104	Complete	ASTM	F2914-12 (Reapproved 2018)	Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
08/06/2013	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
12/23/2024	Cardiovascular	3-193	Complete	ISO	12417-1 Second edition 2024-02	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
06/27/2016	Cardiovascular	3-143	Complete	ISO	12417-1 First edition 2015-10-01	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
06/07/2021	Cardiovascular	3-170	Complete	ISO	14708-5 Second edition 2020-05	Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
07/06/2020	Cardiovascular	3-165	Complete	ASTM	F1841-19	Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
05/26/2025	Cardiovascular	3-200	Complete	ASTM	F2477-24	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
08/21/2017	Cardiovascular	3-149	Complete	ISO	25539-1 Second edition 2017-02	Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
08/21/2017	Cardiovascular	3-149	Complete	ANSI AAMI ISO	25539-1:2017	Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
07/06/2020	Cardiovascular	3-164	Complete	ASTM	F1830-19 (Reapproved 2024)	Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps
12/23/2024	Cardiovascular	3-197	Complete	ISO	25539-4 First edition 2021-11	Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices
05/30/2022	Cardiovascular	3-182	Complete	ASTM	F3036-21	Standard Guide for Testing Absorbable Stents
12/23/2019	Cardiovascular	3-162	Complete	ASTM	F3374-19	Standard Guide for Active Fixation Durability of Endovascular Prostheses
05/26/2025	Cardiovascular	3-198	Complete	ISO	25539-3 Second edition 2024-10	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ISO	25539-3 First edition 2011-12-01	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ANSI AAMI ISO	25539-3:2011	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
05/26/2025	Cardiovascular	3-199	Complete	ASTM	F1841-25	Standard Practice for Assessment of Hemolysis in Blood Pumps
05/29/2023	Cardiovascular	3-184	Complete	ASTM	F2477-23	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
01/14/2019	Cardiovascular	3-158	Complete	ASTM	F3320-18	Standard Guide forCoating Characterization of Drug Coated Balloons
12/23/2024	Cardiovascular	3-194	Complete	ISO	7199 Fourth edition 2024-09	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
06/07/2018	Cardiovascular	3-150	Complete	ISO	7199 Third edition 2016-11-15	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
06/07/2018	Cardiovascular	3-150	Complete	ANSI AAMI ISO	7199:2016	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
09/17/2018	Cardiovascular	3-154	Complete	ASTM	F3211-17	Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
01/25/2013	Cardiovascular	3-89	Complete	ISO	27186 First edition 2010-03-15	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/25/2013	Cardiovascular	3-89	Complete	ANSI AAMI ISO	27186:2010	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
12/18/2023	Cardiovascular	3-189	Complete	ASTM	F2942-19	Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
01/14/2019	Cardiovascular	3-138	Complete	ASTM	F2942-13	Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
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
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
12/23/2016	Cardiovascular	3-144	Complete	ISO	7198 Second edition 2016-08-01	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
12/23/2016	Cardiovascular	3-144	Complete	ANSI AAMI ISO	7198:2016	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
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
05/29/2024	Cardiovascular	3-191	Complete	ISO	18242 First edition 2016-09-01 [Including AMD1:2023]	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMENT 1 (2023)]
01/30/2014	Cardiovascular	3-118	Complete	ANSI AAMI	EC57:2012	Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
05/29/2024	Cardiovascular	3-192	Complete	ISO	22679 First edition 2021-11	Cardiovascular implants - Transcatheter cardiac occluders
04/04/2016	Cardiovascular	3-125	Complete	ISO	5841-3 Third edition 2013-04-15	Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
07/15/2019	Biocompatibility	2-263	Complete	ASTM	F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
12/20/2021	Biocompatibility	2-293	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Elution Test
08/21/2017	Biocompatibility	2-155	Complete	ASTM	F2147-01 (Reapproved 2016)	Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
05/29/2023	Biocompatibility	2-300	Complete	ISO	10993-2 Third edition 2022-11	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
06/07/2021	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
12/23/2024	Biocompatibility	2-304	Partial	ASTM	F2382-24	Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
07/26/2016	Biocompatibility	2-237	Partial	ISO	10993-17 First edition 2002-12-01	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016	Biocompatibility	2-237	Partial	ANSI AAMI ISO	10993-17:2002/(R)2012	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

Recognized Consensus Standards: Medical Devices

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