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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/20/2012 InVitro Diagnostics 7-76 CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
03/18/2009 InVitro Diagnostics 7-145 CLSI H42-A2 (Replaces H42-A) Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
05/30/2022 InVitro Diagnostics 7-312 CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
08/21/2017 InVitro Diagnostics 7-270 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
12/23/2016 InVitro Diagnostics 7-267 CLSI C24 4th Edition (Replaces C24-A3) Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
09/21/2016 InVitro Diagnostics 7-266 CLSI EP19 2nd Edition (Replaces EP19-R) A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
07/06/2020 InVitro Diagnostics 7-297 ISO /TS 20914 First edition 2019-07 Medical laboratories - Practical guidance for the estimation of measurement uncertainty
12/20/2021 InVitro Diagnostics 7-309 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
03/08/2004 InVitro Diagnostics 7-86 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 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 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 CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
03/16/2012 InVitro Diagnostics 7-227 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 CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013 InVitro Diagnostics 7-235 CLSI EP25-A (Replaces EP25-P) Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
01/15/2013 InVitro Diagnostics 7-237 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 CLSI MM06-A2 (Replaces MM06-A) Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
01/14/2019 InVitro Diagnostics 7-285 CLSI M48-A 2nd Edition Laboratory Detection and Identification of Mycobacteria
01/14/2019 InVitro Diagnostics 7-232 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
10/04/2010 InVitro Diagnostics 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
03/18/2009 InVitro Diagnostics 7-189 CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline
03/18/2009 InVitro Diagnostics 7-190 CLSI M50-A (Replaces M50-P) Quality Control for Commercial Microbial Identification Systems; Approved Guideline
03/18/2009 InVitro Diagnostics 7-192 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 7-176 CLSI I/LA30-A (Replaces I/LA30-P) Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-180 CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-182 CLSI M36-A Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009 InVitro Diagnostics 7-185 CLSI M41-A Viral Culture; Approved Guideline.
08/14/2015 InVitro Diagnostics 7-252 CLSI EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
11/08/2005 InVitro Diagnostics 7-113 CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
03/18/2009 InVitro Diagnostics 7-170 CLSI I/LA21-A2 Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
07/09/2014 InVitro Diagnostics 7-175 CLSI C59-A Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
08/14/2015 InVitro Diagnostics 7-251 CLSI EP05-A3 (Reaffirmed: September 2019) Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015 InVitro Diagnostics 7-257 CLSI M56-A Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
05/05/2010 InVitro Diagnostics 7-207 CLSI GP16-A3 (Replaces GP16-A2) Urinalysis; Approved Guideline - Third Edition
03/18/2009 InVitro Diagnostics 7-71 CLSI H15-A3 (Replaces H15-A2) Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
12/20/2021 InVitro Diagnostics 7-310 ISO 19238 Second edition 2014-02-01 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
12/20/2021 InVitro Diagnostics 7-311 CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
09/09/2008 InVitro Diagnostics 7-163 CLSI H56-A (Replaces H56-P) Body Fluid Analysis for Cellular Composition; Approved Guideline.
12/21/2020 InVitro Diagnostics 7-302 CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
12/21/2020 InVitro Diagnostics 7-304 CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
01/30/2014 InVitro Diagnostics 7-239 CLSI EP32-R (Formerly X05-R) Metrological Traceability and Its Implementation; A Report
01/30/2014 InVitro Diagnostics 7-152 CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
08/14/2015 InVitro Diagnostics 7-253 CLSI EP15-A3 (Reaffirmed: September 2019) User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
10/04/2004 InVitro Diagnostics 7-104 CLSI H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
09/17/2018 InVitro Diagnostics 7-284 CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry
09/17/2018 InVitro Diagnostics 7-277 CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens
05/05/2010 InVitro Diagnostics 7-205 CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
07/09/2014 InVitro Diagnostics 7-221 CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
01/14/2019 InVitro Diagnostics 7-178 CLSI M22-A3 Vol 24 No. 19 Replaces M22-A2 Vol. 16 No. 16 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Third Edition
03/16/2012 InVitro Diagnostics 7-165 CLSI H20-A2 (Replaces H20-A) Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/16/2012 InVitro Diagnostics 7-166 CLSI GP20-A2 (Replaces GP20-A) Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012 InVitro Diagnostics 7-225 CLSI GP34-A (Replaces GP34-P) Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
08/02/2011 InVitro Diagnostics 7-219 CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
07/09/2014 InVitro Diagnostics 7-213 CLSI GP44-A4 (Formerly H18-A4) Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
06/07/2021 InVitro Diagnostics 7-306 CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative Measurement Procedures
07/09/2014 InVitro Diagnostics 7-48 CLSI C60-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
08/21/2017 InVitro Diagnostics 7-273 CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
01/14/2019 InVitro Diagnostics 7-286 CLSI M11 9th Edition Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
09/17/2018 InVitro Diagnostics 7-278 CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
09/17/2018 InVitro Diagnostics 7-279 CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
09/17/2018 InVitro Diagnostics 7-280 CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests
12/21/2020 InVitro Diagnostics 7-301 CLSI GP42 7th Edition Collection of Capillary Blood Specimens
01/30/2014 InVitro Diagnostics 7-244 CLSI NBS01-A6 (Replaces LA04-A5) Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
01/30/2014 InVitro Diagnostics 7-224 CLSI EP28-A3c (Formerly C28-A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
01/30/2014 InVitro Diagnostics 7-223 CLSI QMS06-A3 (Formerly GP22-A3) Quality Management System: Continual Improvement; Approved Guideline - Third Edition
07/06/2020 InVitro Diagnostics 7-298 CLSI EP35, 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
04/04/2016 InVitro Diagnostics 7-260 CLSI MM03-3rd Edition (Replaces MM03-A2) Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
08/06/2013 InVitro Diagnostics 7-242 CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
09/17/2018 InVitro Diagnostics 7-283 CLSI POCT04 3rd Edition Essential Tools for Implementation and Management of a Point-of-Care Testing Program
03/16/2012 InVitro Diagnostics 7-150 CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
01/14/2019 InVitro Diagnostics 7-139 CLSI QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition
09/17/2018 InVitro Diagnostics 7-275 CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry.
09/17/2018 InVitro Diagnostics 7-276 CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
10/04/2004 InVitro Diagnostics 7-105 CLSI H30-A2 Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
09/09/2008 InVitro Diagnostics 7-159 CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
07/15/2019 InVitro Diagnostics 7-287 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
07/15/2019 InVitro Diagnostics 7-288 CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
12/23/2019 InVitro Diagnostics 7-293 CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services.
12/21/2020 InVitro Diagnostics 7-305 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
08/06/2013 Materials 8-338 ASTM F139-12 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
12/21/2020 Materials 8-545 ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
12/23/2019 Materials 8-519 ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
05/21/2007 Materials 8-68 ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
12/23/2019 Materials 8-520 ASTM F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
12/21/2020 Materials 8-540 ASTM F1091-20 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)
08/06/2013 Materials 8-339 ASTM F1091-12 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
12/21/2020 Materials 8-541 ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
08/06/2013 Materials 8-342 ASTM F1537-11 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
12/21/2020 Materials 8-542 ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
07/15/2019 Materials 8-514 ISO 5834-2 Fifth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
12/21/2020 Materials 8-537 ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
06/27/2016 Materials 8-217 ASTM F620-11 (Reapproved 2015) Standard Specification Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
01/30/2014 Materials 8-348 ASTM F138-13 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
07/15/2019 Materials 8-518 ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants
07/15/2019 Materials 8-504 ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
07/15/2019 Materials 8-503 ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part II - Crosslinking and Fabrication
07/15/2019 Materials 8-509 ASTM F702-18 Standard Specification for Polysulfone Resin for Medical Applications
12/23/2019 Materials 8-501 ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
12/23/2019 Materials 8-492 ISO 5832-9 Third edition 2019-02 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
12/23/2019 Materials 8-494 ISO 6474-1 Second edition 2019-03 Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
 
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