• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
1001 to 1500 of 1711 Results
 < 
 1 
 2 
 3 
 4 
 > 
Results per Page
New Search export reports to excelExport to Excel HelpStandards Search Assistance
Date of
Entry
Sort by Date [Old to new]
Sort by Date [New to old]
Specialty Task
Group Area
Sort by Specialty Task Group Area [A-Z]
Sort by Specialty Task Group Area [Z-A]
Recognition
Number
Sort by Recognition Number [0-9]
Sort by Recognition Number [9-0]
Extent of
Recognition
Sort by Extent of Recognition [A-Z]
Sort by Extent of Recognition [Z-A]
Standards
Developing
Organization

Standard Designation
Number and Date
 

Standard Title
(click for recognition information)
 
08/06/2013 InVitro Diagnostics 7-243 Partial CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
06/27/2016 InVitro Diagnostics 7-264 Partial CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
06/07/2021 InVitro Diagnostics 7-262 Partial CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
06/07/2021 InVitro Diagnostics 7-236 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
05/26/2025 InVitro Diagnostics 7-330 Partial CLSI M38M51S 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi
07/15/2019 InVitro Diagnostics 7-290 Partial CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
05/29/2024 InVitro Diagnostics 7-321 Partial CLSI MM24 1st Edition Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
04/04/2016 InVitro Diagnostics 7-259 Partial CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing
12/23/2024 InVitro Diagnostics 7-327 Partial CLSI M100 34th Edition Performance Standards for Antimicrobial Susceptibility Testing
01/14/2019 InVitro Diagnostics 7-269 Partial CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
12/23/2016 InVitro Diagnostics 7-268 Partial CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
01/30/2014 InVitro Diagnostics 7-220 Partial CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
08/14/2015 InVitro Diagnostics 7-257 Complete CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
01/30/2014 InVitro Diagnostics 7-223 Complete CLSI QMS06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline - Third Edition
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
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.
07/09/2014 InVitro Diagnostics 7-213 Complete CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
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.
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
05/26/2025 InVitro Diagnostics 7-335 Complete CLSI POCT01-A2 Point-of-Care Connectivity - Second Edition
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
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
12/23/2016 InVitro Diagnostics 7-267 Complete CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
08/20/2012 InVitro Diagnostics 7-76 Complete CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
07/09/2014 InVitro Diagnostics 7-175 Complete CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
01/14/2019 InVitro Diagnostics 7-178 Complete CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
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
03/16/2012 InVitro Diagnostics 7-227 Complete CLSI M53-A (Replaces M53-P) Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
01/15/2013 InVitro Diagnostics 7-233 Complete CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-237 Complete CLSI MM01-A3 (Replaces MM01-A2) Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013 InVitro Diagnostics 7-238 Complete CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-150 Complete CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
08/20/2012 InVitro Diagnostics 7-197 Complete CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
12/22/2025 InVitro Diagnostics 7-346 Complete CLSI EP32 2nd Edition Implementation of Metrological Traceability in Laboratory Medicine
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 7-331 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
05/26/2025 InVitro Diagnostics 7-332 Complete CLSI AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
09/17/2018 InVitro Diagnostics 7-277 Complete CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
09/17/2018 InVitro Diagnostics 7-278 Complete CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
12/22/2025 InVitro Diagnostics 7-348 Complete CLSI EP37 2nd Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-284 Complete CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
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 7-342 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
05/26/2025 InVitro Diagnostics 7-337 Complete CLSI AUTO08-A Managing and Validating Laboratory Information Systems; Approved Guideline
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
12/22/2025 InVitro Diagnostics 7-347 Complete CLSI EP21 3rd Edition Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
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 7-345 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
12/23/2019 InVitro Diagnostics 7-295 Complete CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
12/22/2025 InVitro Diagnostics 7-349 Complete CLSI EP35 2nd Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
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
07/09/2014 InVitro Diagnostics 7-48 Complete CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
03/18/2009 InVitro Diagnostics 7-192 Complete CLSI MM18-A (Replaces MM18-P) Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
03/18/2009 InVitro Diagnostics 7-71 Complete CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009 InVitro Diagnostics 7-145 Complete CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
12/22/2025 InVitro Diagnostics 7-351 Complete CLSI EP46 1st Edition Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
03/08/2004 InVitro Diagnostics 7-86 Complete CLSI C29-A2 (Replaces C29-A) Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004 InVitro Diagnostics 7-87 Complete CLSI C31-A2 (Replaces C31-A) Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004 InVitro Diagnostics 7-88 Complete CLSI C37-A Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004 InVitro Diagnostics 7-89 Complete CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004 InVitro Diagnostics 7-105 Complete CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
06/07/2021 InVitro Diagnostics 7-306 Complete CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
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
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
04/04/2016 InVitro Diagnostics 7-260 Complete CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
01/14/2019 InVitro Diagnostics 7-286 Complete CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
01/30/2014 InVitro Diagnostics 7-239 Complete CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
06/07/2021 InVitro Diagnostics 7-307 Complete CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
05/26/2025 InVitro Diagnostics 7-329 Complete CLSI EP06-EG 2nd Edition Developer Validation of Linearity, Establishment Guide
05/29/2023 InVitro Diagnostics 7-315 Complete CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance
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
08/20/2012 InVitro Diagnostics 7-148 Complete CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
07/06/2020 InVitro Diagnostics 7-297 Complete ISO TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
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
01/14/2019 InVitro Diagnostics 7-285 Complete CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
08/14/2015 InVitro Diagnostics 7-252 Complete CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
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
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
07/09/2014 InVitro Diagnostics 7-221 Complete CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
08/14/2015 InVitro Diagnostics 7-253 Complete CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
12/18/2023 InVitro Diagnostics 7-319 Complete CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters
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
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
03/18/2009 InVitro Diagnostics 7-170 Complete CLSI I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
03/18/2009 InVitro Diagnostics 7-176 Complete CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 Complete CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 Complete CLSI M41-A Viral Culture; Approved Guideline.
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
03/18/2009 InVitro Diagnostics 7-190 Complete CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; 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
08/21/2017 InVitro Diagnostics 7-270 Complete CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/21/2017 InVitro Diagnostics 7-273 Complete CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
07/15/2019 InVitro Diagnostics 7-288 Complete CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
12/20/2021 InVitro Diagnostics 7-309 Complete ISO 17099 First edition 2014-11-15 Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/23/2024 InVitro Diagnostics 7-322 Complete CLSI M47 2nd Edition Principles and Procedures for Blood Cultures
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 7-324 Complete CLSI M07 12th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
12/23/2024 InVitro Diagnostics 7-323 Complete CLSI EP19 3rd Edition A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
05/26/2025 InVitro Diagnostics 7-334 Complete CLSI AUTO05-A Laboratory Automation: Electromechanical Interfaces; Approved Standard
12/21/2020 InVitro Diagnostics 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
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.
09/17/2018 InVitro Diagnostics 7-279 Complete CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 Complete CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
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)
06/07/2018 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
07/06/2020 General Plastic Surgery/
General Hospital
6-444 Complete ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
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
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
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
6-477 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
12/22/2025 General Plastic Surgery/
General Hospital
6-517 Complete ASTM F3502-25 Standard Specification for Barrier Face Coverings
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
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
09/21/2016 General Plastic Surgery/
General Hospital
6-381 Complete ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
06/07/2018 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)
05/30/2022 General Plastic Surgery/
General Hospital
6-480 Complete ISO 11608-6:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022 General Plastic Surgery/
General Hospital
6-481 Complete ANSI AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022 General Plastic Surgery/
General Hospital
6-482 Complete AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
12/22/2025 General Plastic Surgery/
General Hospital
6-518 Complete ASTM F1670/F1670M-24a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2023 General Plastic Surgery/
General Hospital
6-491 Complete ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
04/04/2016 General Plastic Surgery/
General Hospital
6-355 Complete ASTM D3772-15(2021) Standard Specification for Industrial Rubber Finger Cots
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
08/14/2015 General Plastic Surgery/
General Hospital
6-353 Complete ASTM F2051-00 (Reapproved 2022) Standard Specification for Implantable Saline Filled Breast Prosthesis
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
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
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
12/20/2021 General Plastic Surgery/
General Hospital
6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital
6-466 Complete USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital
6-467 Complete USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-468 Complete USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital
6-469 Complete USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital
6-470 Complete USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/23/2019 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.
08/14/2015 General Plastic Surgery/
General Hospital
6-110 Complete ASTM F1441-03 (Reapproved 2022) Standard Specification for Soft-Tissue Expander Devices
12/20/2021 General Plastic Surgery/
General Hospital
6-472 Complete USP-NF M36660_04_01 Heparin Lock Flush Solution
09/17/2018 General Plastic Surgery/
General Hospital
6-409 Complete ASTM F703-18 (Reapproved 2022) Standard Specification for Implantable Breast Prostheses
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
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
6-493 Complete ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
12/22/2025 General Plastic Surgery/
General Hospital
6-520 Complete ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
05/29/2023 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
05/29/2023 General Plastic Surgery/
General Hospital
6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
12/19/2022 General Plastic Surgery/
General Hospital
6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
05/29/2023 General Plastic Surgery/
General Hospital
6-494 Complete ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/22/2025 General Plastic Surgery/
General Hospital
6-519 Complete ASTM F2101-25 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
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
6-269 Complete ASTM F1078-10 (Reapproved 2024) Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
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
12/22/2025 General Plastic Surgery/
General Hospital
6-515 Complete ASTM D6499-24 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
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
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
6-185 Complete ASTM F881-94 (Reapproved 2022) Standard Specification for Silicone Elastomer Facial Implants
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
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
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
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
07/15/2019 General Plastic Surgery/
General Hospital
6-422 Complete AAMI TIR38:2019 Medical device safety assurance case guidance
12/20/2021 General Plastic Surgery/
General Hospital
6-473 Complete USP-NF M80190_04_01 Absorbable Surgical Suture
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
12/23/2019 General Plastic Surgery/
General Hospital
6-426 Complete ISO 23907-1 First edition 2019-01 Sharps injury protection - Requirements and test methods - Sharps containers
06/07/2021 General Plastic Surgery/
General Hospital
6-461 Complete IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
12/19/2022 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
05/29/2024 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
05/26/2025 General Plastic Surgery/
General Hospital
6-509 Complete ASTM F3186-24 Standard Specification for Adult Portable Bed Rails and Related Products
05/29/2023 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
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
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
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
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
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
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
6-179 Complete ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods
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
6-505 Complete ISO 21649 Second Edition 2023-01 Needle-free injectors for medical use -- Requirements and test methods
06/07/2018 General Plastic Surgery/
General Hospital
6-407 Complete ASTM F3186-17 Standard Specification for Adult Portable Bed Rails and Related Products
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
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
04/04/2016 General Plastic Surgery/
General Hospital
6-356 Complete ASTM D5712-15(2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
12/22/2025 General Plastic Surgery/
General Hospital
6-514 Complete ISO 1135-4 Seventh edition 2025-05 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
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
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
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)].
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)]
01/15/2013 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
08/20/2012 General Plastic Surgery/
General Hospital
6-278 Complete ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
12/20/2021 General Plastic Surgery/
General Hospital
6-471 Complete USP-NF M88880_05_01 Sterile Water for Irrigation
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
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
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
05/30/2022 General Plastic Surgery/
General Hospital
6-476 Complete ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
01/14/2019 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
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
6-117 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
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
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
06/07/2018 General Plastic Surgery/
General Hospital
6-270 Complete ASTM F1840-10 (Reapproved 2023) Standard Terminology for Surgical Suture Needles
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
12/23/2024 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
6-492 Complete ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks
07/06/2020 General Plastic Surgery/
General Hospital
6-442 Partial ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital
6-446 Partial ASTM D6319-19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application
07/06/2020 General Plastic Surgery/
General Hospital
6-178 Partial ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves
12/18/2023 General Plastic Surgery/
General Hospital
6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
06/27/2016 General Plastic Surgery/
General Hospital
6-364 Partial ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
09/17/2018 General Plastic Surgery/
General Hospital
6-408 Partial ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
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
6-445 Partial ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
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
12/21/2020 General Plastic Surgery/
General Hospital
6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
04/04/2016 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
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
ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/21/2020 General Plastic Surgery/
General Hospital
6-448 Partial ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
07/06/2020 General Plastic Surgery/
General Hospital
6-440 Partial ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
05/29/2023 General Plastic Surgery/
General Hospital
6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
07/06/2020 General Plastic Surgery/
General Hospital
6-443 Partial ASTM D3577-19 (Reapproved 2023) Standard Specification for Rubber Surgical Gloves
12/22/2025 General Plastic Surgery/
General Hospital
6-439 Partial ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
12/22/2025 General Plastic Surgery/
General Hospital
6-516 Partial ASTM F2407/F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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
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
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
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
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)
19-38 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
12/21/2020 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
ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
05/29/2024 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
12/23/2016 General II (ES/
EMC)
19-20 Complete IEEE ANSI C63.16-2016 (Revision of ANSI C63.16-1993) American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
08/21/2017 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.
07/15/2019 General II (ES/
EMC)
19-35 Complete UL Standard for Standby Batteries 1989 Edition 5, 2013-10-02, ANSI November 2018
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
04/03/2023 General II (ES/
EMC)
19-49 Complete IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
12/19/2022 General II (ES/
EMC)
19-48 Complete IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
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.
04/04/2016 General II (ES/
EMC)
19-17 Complete IEEE ANSI C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
12/21/2020 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
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)]
07/09/2014 General II (ES/
EMC)
19-10 Complete UL 1642 5th Edition Lithium Batteries
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
12/23/2019 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
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
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)]
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
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)]
05/26/2025 General II (ES/
EMC)
19-55 Complete IEC 62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
12/20/2021 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
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
07/09/2014 General II (ES/
EMC)
19-11 Complete UL 2054 2nd Edition Household and Commercial Batteries
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
04/03/2023 General II (ES/
EMC)
19-34 Complete IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
12/20/2021 General II (ES/
EMC)
19-41 Complete ANSI UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
05/26/2025 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
05/30/2022 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)]
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
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)]
12/23/2024 General II (ES/
EMC)
19-51 Complete UL 1642 Sixth Edition September 29, 2020 Standard For Safety Lithium Batteries
02/07/2022 General II (ES/
EMC)
19-45 Complete AIM Standard 7351731 Rev. 3.00 2021-06-04 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
12/21/2020 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
07/06/2020 General I (QS/
RM)
5-126 Complete ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
12/23/2024 General I (QS/
RM)
5-143 Complete ISO 14630 Fffth edition 2024-09 Non-active surgical implants -- General requirements
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)
5-139 Complete ISO 18250-3 First edition 2018-06 Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
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)
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
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)
5-140 Complete ASME V&V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022 General I (QS/
RM)
5-137 Complete IEC TR 60878 Ed. 4.0 2022-11 Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)]
12/19/2022 General I (QS/
RM)
5-136 Complete ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
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)
05/26/2025 General I (QS/
RM)
5-145 Complete IEC 60417:2025 DB Graphical symbols for use on equipment
05/26/2025 General I (QS/
RM)
5-144 Complete ISO 80369-20 Second edition 2024-11 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015 General I (QS/
RM)
5-97 Complete ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ANSI AAMI ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
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
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
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
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
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)].
12/22/2025 General I (QS/
RM)
5-147 Complete ISO 80369-1 Third edition 2025-10 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
01/14/2019 General I (QS/
RM)
5-121 Complete ISO 80369-1 Second edition 2018-11 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
12/22/2025 General I (QS/
RM)
5-148 Complete ISO 15223-1 Fourth edition 2021-07 [Including AMD1: 2025] Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)]
12/20/2021 General I (QS/
RM)
5-134 Complete ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/21/2020 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
ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020 General I (QS/
RM)
5-132 Complete IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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
ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
12/23/2016 General I (QS/
RM)
5-113 Complete ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
12/23/2019 General I (QS/
RM)
5-124 Complete ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols
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)]
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)]
ANSI AAMI ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
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
12/19/2022 General I (QS/
RM)
5-135 Complete ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices - Information to be supplied by the manufacturer
05/29/2024 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
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
ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
01/27/2015 General I (QS/
RM)
5-62 Complete ANSI ASQ Z1.4-2003 (R2018) Sampling Procedures and Tables for Inspection by Attributes
12/22/2025 General I (QS/
RM)
5-146 Complete ISO 80369-6 Second edition 2025-05 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
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.
01/27/2015 General I (QS/
RM)
5-48 Complete ANSI Z1.9-2003 (R2018) Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
06/27/2016 General I (QS/
RM)
5-57 Partial ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices
05/29/2023 Dental/
ENT
4-306 Partial ISO 22052 First edition 2020-06 Dentistry - Compressed air source equipment
ANSI ADA Standard No. 94-2021 Central Compressed Air Source Equipment
05/29/2023 Dental/
ENT
4-305 Partial ISO 10637 Second edition 2018-05 Dentistry - Central suction source equipment
ANSI ADA Standard No. 177-2020 Central Suction Source Equipment
12/22/2025 Dental/
ENT
4-354 Partial ISO 17730 Third edition 2025-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
12/18/2023 Dental/
ENT
4-319 Partial ISO 17730 Second edition 2020-09 Dentistry - Fluoride varnishes
ANSI ADA Standard No. 117-2022 Dentistry - Fluoride Varnishes
06/07/2021 Dental/
ENT
4-276 Partial ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
07/15/2019 Dental/
ENT
4-259 Partial ISO 14801 Third edition 2016-11-01 Dentistry - Implants - Dynamic loading test for endosseous dental implants
ANSI ADA Standard No. 127-2018 Dynamic Loading Test for Endosseous Dental Implants
12/20/2021 Dental/
ENT
4-291 Complete ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
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
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
09/17/2018 Dental/
ENT
4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
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
12/22/2025 Dental/
ENT
4-350 Complete ANSI ASA S3.6-2025 American National Standard Specification for Audiometers
12/21/2020 Dental/
ENT
4-271 Complete ANSI ADA Standard No. 34-2013 Dental Cartridge Syringes
12/23/2024 Dental/
ENT
4-335 Complete ISO 11499 Third edition 2014-06 Dentistry - Single-use cartridges for local anaesthetics
ANSI ADA Standard No. 190-2020 Single-Use Dental Cartridges for Local Anesthetics
12/23/2024 Dental/
ENT
4-337 Complete ISO 20608 First edition 2018-04 Dentistry - Powder jet handpieces and powders
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
4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
12/23/2024 Dental/
ENT
4-328 Complete ANSI ADA Standard No. 57-2021 Endodontic Sealing Materials
12/18/2023 Dental/
ENT
4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
05/26/2025 Dental/
ENT
4-347 Complete ISO 22254 First edition 2005-08 Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection
05/26/2025 Dental/
ENT
4-344 Complete ANSI ADA Standard No. 186-2024 Dentistry - Polymer-based Machinable Blanks
05/26/2025 Dental/
ENT
4-345 Complete ANSI ADA Standard No. 187-2024 Dentistry - Dental CAD/CAM Machinable Ceramic Blanks
05/26/2025 Dental/
ENT
4-346 Complete ISO 9680 Fourth edition 2021-11 Dentistry - Operating lights
ANSI ADA Standard No. 89-2023 Dentistry - Dental Operating Lights
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
04/04/2016 Dental/
ENT
4-222 Complete ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
ANSI ADA Standard No. 39-2020 Pit and Fissure Sealants
12/18/2023 Dental/
ENT
4-318 Complete ISO 20749 Second edition 2023-06 Dentistry - Pre-capsulated dental amalgam
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)
01/30/2014 Dental/
ENT
4-180 Complete ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
12/18/2023 Dental/
ENT
4-310 Complete ISO 22112 Second edition 2017-08 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2021 Artificial Teeth for Dental Prostheses
05/26/2025 Dental/
ENT
4-340 Complete ANSI ADA Standard No. 46-2016 Dental Patient Chair
12/22/2025 Dental/
ENT
4-362 Complete ISO 3630-3 Third edition 2021-06 Corrected version 2023-05 Dentistry - Endodontic instruments - Part 3: Compactors
ANSI ADA Standard No. 71-2022 Dentistry - Endodontic Instruments: Compactors
01/30/2014 Dental/
ENT
4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
12/23/2024 Dental/
ENT
4-336 Complete ISO 18397 First edition 2016-01 Dentistry - Powered scaler
ANSI ADA Standard No. 157-2020 Powered Dental Scaler Handpieces and Tips
06/27/2016 Dental/
ENT
4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
06/27/2016 Dental/
ENT
4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2025) American National Standard Bioacoustical Terminology
01/14/2019 Dental/
ENT
4-251 Complete ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials
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
06/07/2018 Dental/
ENT
4-241 Complete ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
12/23/2024 Dental/
ENT
4-331 Complete ISO 28399 Third edition 2021-03 Dentistry - External tooth bleaching products
ANSI ADA Standard No. 136-2022 Dentistry - External Tooth Bleaching Products
07/06/2020 Dental/
ENT
4-263 Complete ISO 9693 Third edition 2019-10 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
ANSI ADA Standard No. 38-2020 Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
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
12/21/2020 Dental/
ENT
4-266 Complete ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
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)]
ANSI ADA Standard No. 32-2017 Orthodontic Wires
12/22/2025 Dental/
ENT
4-364 Complete ISO 3990 First edition 2023-07 Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials
12/18/2023 Dental/
ENT
4-313 Complete ISO 27020 Second edition 2019-06 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2020 Orthodontic Brackets and Tubes
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
05/29/2023 Dental/
ENT
4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
05/29/2023 Dental/
ENT
4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
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
12/21/2020 Dental/
ENT
4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
12/21/2020 Dental/
ENT
4-272 Complete ANSI ADA Standard No. 63-2013 Root Canal Barbed Broaches and Rasps
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
05/29/2023 Dental/
ENT
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
08/21/2017 Dental/
ENT
4-232 Complete ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
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)
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
07/09/2014 Dental/
ENT
4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
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
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
08/14/2015 Dental/
ENT
4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
08/14/2015 Dental/
ENT
4-184 Complete ANSI ASA S3.25-2009 (Reaffirmed 2024) American National Standard For an Occluded Ear Simulator
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
08/21/2017 Dental/
ENT
4-233 Complete ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
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
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
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
12/23/2024 Dental/
ENT
4-333 Complete ISO 3630-4 Second edition 2023-08 Dentistry - Endodontic instruments - Part 4: Auxiliary instruments
12/23/2024 Dental/
ENT
4-334 Complete ISO 11143 Second edition 2008-07 Dentistry - Amalgam separators
ANSI ADA Standard No. 108-2009, Addendum (R2022) Amalgam Separators
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
ANSI ADA Standard No. 48-2020 Curing Lights (Powered Polymerization Activators)
01/14/2019 Dental/
ENT
4-256 Complete ANSI ADA Standard No. 132-2015 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
06/07/2021 Dental/
ENT
4-274 Complete ANSI ASA S3.2-2020 (Reaffirmed 2025) American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
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
01/27/2015 Dental/
ENT
4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
05/29/2023 Dental/
ENT
4-299 Complete ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
ANSI ADA Standard No. 30-2023 Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
05/29/2023 Dental/
ENT
4-300 Complete ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
ANSI ADA Standard No. 134-2023 Dentistry - Metallic Materials for Fixed and Removable Restorations and Appliances
05/29/2023 Dental/
ENT
4-301 Complete ISO 21563 Second edition 2021-08 Dentistry - Hydrocolloid impression materials
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
ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
12/18/2023 Dental/
ENT
4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
12/18/2023 Dental/
ENT
4-322 Complete ISO 18675 First edition 2022-05 Dentistry - Machinable ceramic blanks
12/18/2023 Dental/
ENT
4-323 Complete ISO 5139 First edition 2023-05 Dentistry - Polymer-based composite machinable blanks
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
12/22/2025 Dental/
ENT
4-353 Complete ISO 20127 Third edition 2025-05 Dentistry - Physical properties of powered toothbrushes
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
12/22/2025 Dental/
ENT
4-363 Complete ISO 3630-5 Second edition 2020-08 Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments
ANSI ADA Standard No. 28-2021 Endodontic Instruments - Shaping and Cleaning Instruments
12/22/2025 Dental/
ENT
4-365 Complete ISO 6873 Third edition 2013-04 Dentistry - Gypsum products
ANSI ADA Standards No. 25-2015 (R2021) Dental Gypsum Products
12/22/2025 Dental/
ENT
4-366 Complete ISO 7551 Second edition 2023-05 Dentistry - Endodontic absorbent points
ANSI ADA Standard No. 73-2024 Dentistry - Endodontic Absorbent Points
12/22/2025 Dental/
ENT
4-367 Complete ISO 9997 Third edition 2020-01 Dentistry - Cartridge Syringes
08/21/2017 Dental/
ENT
4-215 Complete ANSI ADA Standard No. 96-2012 Dental Water-based Cements
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
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
05/29/2024 Dental/
ENT
4-325 Complete ANSI ADA Standard No. 96-2020 Dental Water-based Cements
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
12/22/2025 Dental/
ENT
4-349 Complete ANSI ADA Standard No. 34-2025 Dental Cartridge Syringes
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
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
12/18/2023 Dental/
ENT
4-317 Complete ISO 8325 Third edition 2023-03 Dentistry - Test methods for rotary 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
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
01/14/2019 Dental/
ENT
4-255 Complete ANSI ADA Standard No. 131-2015 (R2020) Dental CAD/CAM Machinable Zirconia Blanks
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
ANSI ADA Standard No. 160-2020 Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
12/20/2021 Dental/
ENT
4-288 Complete ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
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
ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
12/20/2021 Dental/
ENT
4-285 Complete ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
12/23/2019 Dental/
ENT
4-260 Complete ANSI ASA S12.2-2019 (Reaffirmed 2023) American National Standard for Criteria for Evaluating Room Noise
12/23/2019 Dental/
ENT
4-261 Complete ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
12/20/2021 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
ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
12/20/2021 Dental/
ENT
4-289 Complete ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 Complete ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
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
ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
05/26/2025 Dental/
ENT
4-343 Complete ANSI ADA Standard No. 105-2024 Elastomeric Auxiliaries for Use in Orthodontics
12/18/2023 Dental/
ENT
4-316 Complete ISO 20127 Second edition 2020-08 Dentistry - Physical properties of powered toothbrushes
ANSI ADA Standard No.120-2022 Dentistry - Physical Properties of Powered Toothbrushes
12/22/2025 Dental/
ENT
4-356 Complete ANSI ADA Standard No. 32-2024 Dentistry - Orthodontic Wires
12/22/2025 Dental/
ENT
4-357 Complete ANSI ADA Standard No. 54-1986 (R2024) Double-Pointed, Parenteral, Single Use Needles for Dentistry
12/22/2025 Dental/
ENT
4-358 Complete ANSI ADA Standard No. 95-2020 Endodontics Instruments - Enlargers
12/22/2025 Dental/
ENT
4-359 Complete ANSI ADA Standard No. 159-2024 Dentistry - Coiled Springs for Use in Orthodontics
12/22/2025 Dental/
ENT
4-360 Complete ISO 3630-1 Third edition 2019-08 Dentistry - Endodontic instruments - Part 1: General requirements
ANSI ADA Standard No. 101-2021 Endodontic Instruments - General Requirements
12/22/2025 Dental/
ENT
4-361 Complete ISO 3630-2 Fourth edition 2023-02 Dentistry - Endodontic instruments - Part 2: Enlargers
12/21/2020 Dental/
ENT
4-265 Complete ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
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
12/21/2020 Dental/
ENT
4-269 Complete ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
ANSI ADA Standard No. 158-2020 Coupling Dimensions for Dental Handpiece Connectors
01/14/2019 Dental/
ENT
4-254 Complete ANSI ADA Standard No. 99-2001 (R2023) Athletic Mouth Protectors and Materials
06/07/2021 Dental/
ENT
4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2025) American National Standard Method for Coupler Calibration of Earphones
12/22/2025 Dental/
ENT
4-355 Complete ISO 18397 Second edition 2025-07 Dentistry - Powered scaler
12/19/2022 Dental/
ENT
4-297 Complete ISO 20126 Third edition 2022-03 Dentistry - Manual toothbrushes - General requirements and test methods
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
12/22/2025 Dental/
ENT
4-352 Complete ANSI ASA S3.35-2025 American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
06/07/2021 Dental/
ENT
4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
06/07/2021 Dental/
ENT
4-283 Complete ISO 16409 Second edition 2016-10 Dentistry - Oral care products - Manual interdental brushes
ANSI ADA Standard No. 125-2018 Manual Interdental Brushes
06/07/2021 Dental/
ENT
4-278 Complete ISO 4823 Fifth edition 2021-02 Dentistry - Elastomeric impression and bite registration materials
ANSI ADA Standard No. 19-2022 Elastomeric Impression and Bite Registration
12/20/2021 Dental/
ENT
4-286 Complete ANSI ADA Standard No. 87-1995 (R2024) Dental Impression Trays
12/20/2021 Dental/
ENT
4-287 Complete ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
12/22/2025 Dental/
ENT
4-348 Complete ISO 9917-1 Third Edition 2025-05 Dentistry - Water-based cements - Part 1: Acid-base cements
06/07/2021 Dental/
ENT
4-275 Complete ANSI ASA S3.6-2018 (Reaffirmed 2023) American National Standard Specification for Audiometers
12/22/2025 Dental/
ENT
4-351 Complete ISO 6877 Fourth edition 2025-08 Dentistry - Endodontic obturating materials
12/18/2023 Dental/
ENT
4-309 Complete ISO 6877 Third edition 2021-09 Dentistry - Endodontic obturating materials
ANSI ADA Standard No. 78-2022 Dentistry - Endodontic Obturating Materials
05/30/2022 Cardiovascular 3-181 Complete ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
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
01/30/2014 Cardiovascular 3-118 Complete ANSI AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
12/22/2025 Cardiovascular 3-201 Complete IEC 60601-2-31 Edition 3.0 2020-01 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 3-102 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
12/20/2021 Cardiovascular 3-176 Complete ISO 18193 First edition 2021-08 Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021 Cardiovascular 3-177 Complete ASTM F2606-08 (Reapproved 2021) Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
12/20/2021 Cardiovascular 3-173 Complete ISO 5840-3 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
05/26/2025 Cardiovascular 3-198 Complete ISO 25539-3 Second edition 2024-10 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
01/14/2019 Cardiovascular 3-44 Complete ANSI AAMI BP22:1994 (R2016) Blood pressure transducers
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
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 3-175 Complete ISO 5840-2 Second edition 2021-01 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021 Cardiovascular 3-171 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
12/20/2021 Cardiovascular 3-180 Complete ASTM F3505-21 Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
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
 
 < 
 1 
 2 
 3 
 4 
 > 
 
-
-