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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
03/16/2012 General Plastic Surgery/
General Hospital
6-272 ASTM F2062-00 (Reapproved 2018) Standard Specification for Square Drive Interconnections on Surgical Instruments
08/14/2015 General Plastic Surgery/
General Hospital
6-353 ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
08/21/2017 General Plastic Surgery/
General Hospital
6-384 ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017 General Plastic Surgery/
General Hospital
6-125 ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017 General Plastic Surgery/
General Hospital
6-400 ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
08/21/2017 General Plastic Surgery/
General Hospital
6-124 ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 General Plastic Surgery/
General Hospital
6-70 ASTM E825-98 (Reapproved 2016) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
03/18/2009 General Plastic Surgery/
General Hospital
6-215 ASTM F2132 -01 (Reapproved 2008)e1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
12/20/2021 General Plastic Surgery/
General Hospital
6-464 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)]
06/27/2016 General Plastic Surgery/
General Hospital
6-365 ISO 11040-4 Third edition 2015-04-01 Prefilled syringes - Part 4: Glass barrels for injectables
08/06/2013 General Plastic Surgery/
General Hospital
6-240 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 ISO 8536-1 Fourth edition 2011-09-01 Infusion equipment for medical use - Part 1: Infusion glass bottles
06/27/2016 General Plastic Surgery/
General Hospital
6-363 ISO 11810 Second edition 2015-12-15 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
01/15/2013 General Plastic Surgery/
General Hospital
6-122 ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
05/30/2022 General Plastic Surgery/
General Hospital
6-477 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 ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
05/30/2022 General Plastic Surgery/
General Hospital
6-480 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 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 AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
12/20/2021 General Plastic Surgery/
General Hospital
6-471 USP-NF M88880_05_01 Sterile Water for Irrigation
08/06/2013 General Plastic Surgery/
General Hospital
6-275 ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
08/06/2013 General Plastic Surgery/
General Hospital
6-294 ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
09/21/2016 General Plastic Surgery/
General Hospital
6-381 ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
12/20/2021 General Plastic Surgery/
General Hospital
6-465 USP-NF M76090_03_01 Sodium Chloride Irrigation
12/20/2021 General Plastic Surgery/
General Hospital
6-466 USP-NF M76070_03_01 Sodium Chloride Injection
12/20/2021 General Plastic Surgery/
General Hospital
6-467 USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital
6-468 USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital
6-469 USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital
6-470 USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 General Plastic Surgery/
General Hospital
6-472 USP-NF M36660_04_01 Heparin Lock Flush Solution
12/20/2021 General Plastic Surgery/
General Hospital
6-473 USP-NF M80190_04_01 Absorbable Surgical Suture
04/04/2016 General Plastic Surgery/
General Hospital
6-355 ASTM D3772-15 Standard Specification for Industrial Rubber Finger Cots
07/15/2019 General Plastic Surgery/
General Hospital
6-423 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
12/23/2019 General Plastic Surgery/
General Hospital
6-437 ISO 23907-2 First edition 2019-11 Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
05/30/2022 General Plastic Surgery/
General Hospital
6-476 ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
06/27/2016 General Plastic Surgery/
General Hospital
6-377 ISO 11608-5 First edition 2012-10-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated function.
08/06/2013 General Plastic Surgery/
General Hospital
6-174 ISO 11608-4 First edition 2006-03-15 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
08/14/2015 General Plastic Surgery/
General Hospital
6-341 ISO 11608-1 Third edition 2014-12-15 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
08/21/2017 General Plastic Surgery/
General Hospital
6-390 ANSI AAMI IEC 80601-2-35:2009/A1:2016 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
03/16/2012 General Plastic Surgery/
General Hospital
6-271 ASTM F1874-98 (Reapproved 2011) Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
03/16/2012 General Plastic Surgery/
General Hospital
6-268 ASTM F921-10 (Reapproved 2018) Standard Terminology Relating to Hemostatic Forceps
12/21/2020 General Plastic Surgery/
General Hospital
6-450 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
06/07/2018 General Plastic Surgery/
General Hospital
6-402 ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
01/30/2014 General Plastic Surgery/
General Hospital
6-117 ASTM F2172-02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/30/2014 General Plastic Surgery/
General Hospital
6-303 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 ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
03/01/2021 General Plastic Surgery/
General Hospital
6-460 ASTM F3502-21 Standard Specification for Barrier Face Coverings
06/07/2021 General Plastic Surgery/
General Hospital
6-389 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
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
12/20/2021 General Plastic Surgery/
General Hospital
6-474 ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
09/17/2018 General Plastic Surgery/
General Hospital
6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
12/21/2020 General Plastic Surgery/
General Hospital
6-449 ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
06/27/2016 General Plastic Surgery/
General Hospital
6-364 ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
07/06/2020 General Plastic Surgery/
General Hospital
6-440 ASTM D3578-19 Standard Specification for Rubber Examination Gloves
12/21/2020 General Plastic Surgery/
General Hospital
6-448 ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
07/06/2020 General Plastic Surgery/
General Hospital
6-442 ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
04/04/2016 General Plastic Surgery/
General Hospital
6-358 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 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
07/06/2020 General Plastic Surgery/
General Hospital
6-443 ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
07/06/2020 General Plastic Surgery/
General Hospital
6-446 ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
04/04/2016 General Plastic Surgery/
General Hospital
6-359 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 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 ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
08/21/2017 General Plastic Surgery/
General Hospital
6-386 ANSI AAMI IEC 60601-2-20:2009/A1:2016 Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)]
IEC 60601-2-20 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)]
12/23/2019 General Plastic Surgery/
General Hospital
6-438 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
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
05/30/2022 General Plastic Surgery/
General Hospital
6-478 ISO 11608-1:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
08/21/2017 General Plastic Surgery/
General Hospital
6-385 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
IEC 60601-2-19 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
08/06/2013 General Plastic Surgery/
General Hospital
6-147 ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
06/07/2021 General Plastic Surgery/
General Hospital
6-461 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
01/30/2014 General Plastic Surgery/
General Hospital
6-321 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)]
07/06/2020 General Plastic Surgery/
General Hospital
6-178 ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
07/06/2020 General Plastic Surgery/
General Hospital
6-444 ASTM D7103-19 Standard Guide for Assessment of Medical Gloves
12/21/2020 InVitro Diagnostics 7-300 CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
06/07/2021 InVitro Diagnostics 7-262 CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
06/07/2021 InVitro Diagnostics 7-292 CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
07/06/2020 InVitro Diagnostics 7-296 CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
06/07/2021 InVitro Diagnostics 7-236 CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
06/07/2021 InVitro Diagnostics 7-308 CLSI M100, 31st Edition Performance Standards for Antimicrobial Susceptibility Testing
12/23/2019 InVitro Diagnostics 7-295 CLSI M52, 1st ed. August 2015 (Reaffirmed: January 2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
12/21/2020 InVitro Diagnostics 7-299 CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
06/07/2021 InVitro Diagnostics 7-307 CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
04/04/2016 InVitro Diagnostics 7-259 CLSI GP23-A2 (Replaces GP23-A) Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
07/15/2019 InVitro Diagnostics 7-291 CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
07/15/2019 InVitro Diagnostics 7-289 CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-290 CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
12/23/2016 InVitro Diagnostics 7-268 CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
08/14/2015 InVitro Diagnostics 7-255 CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
01/30/2014 InVitro Diagnostics 7-210 CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
01/27/2015 InVitro Diagnostics 7-250 CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
06/27/2016 InVitro Diagnostics 7-264 CLSI MM21-1st Edition (Reaffirmed: January 2020) Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
08/06/2013 InVitro Diagnostics 7-234 CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
01/30/2014 InVitro Diagnostics 7-220 CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
01/14/2019 InVitro Diagnostics 7-269 CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
08/06/2013 InVitro Diagnostics 7-243 CLSI M51-A (Replaces M51-P) Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
05/30/2022 InVitro Diagnostics 7-303 CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of Yeast
08/21/2017 InVitro Diagnostics 7-272 CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
09/21/2016 InVitro Diagnostics 7-265 CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
08/20/2012 InVitro Diagnostics 7-148 CLSI M28-A2 (Replaces M28-A) Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
09/09/2008 InVitro Diagnostics 7-21 CLSI C42-A Erythrocyte Protoporphyrin Testing; Approved Guideline
09/09/2008 InVitro Diagnostics 7-136 CLSI I/LA2-A2 (Replaces I/LA2-A) Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
08/20/2012 InVitro Diagnostics 7-197 CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
 
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