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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/15/2019 InVitro Diagnostics 7-288 Complete CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
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.
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
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 7-299 Complete CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring
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.
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
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
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
08/06/2013 InVitro Diagnostics 7-234 Partial CLSI EP24-A2 (Replaces GP 10-A) Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
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
07/15/2019 InVitro Diagnostics 7-291 Partial CLSI EP27-A How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
01/27/2015 InVitro Diagnostics 7-250 Partial CLSI M40-A2 (Reaffirmed: September 2019) Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
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
06/07/2021 InVitro Diagnostics 7-292 Partial CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
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
01/30/2014 InVitro Diagnostics 7-220 Partial CLSI H59-A (Replaces H59-P) Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
08/14/2015 InVitro Diagnostics 7-255 Partial CLSI MM09-A2 (Replaces MM09-A) Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
05/29/2024 InVitro Diagnostics 7-321 Partial CLSI MM24 1st Edition Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
07/15/2019 InVitro Diagnostics 7-289 Partial CLSI MM17 2nd Edition Verification and Validation of Multiplex Nucleic Acid Assays
07/15/2019 InVitro Diagnostics 7-290 Partial CLSI EP34 1st Edition Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
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
06/07/2021 InVitro Diagnostics 7-307 Complete CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring
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
09/21/2016 InVitro Diagnostics 7-265 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
01/30/2014 InVitro Diagnostics 7-210 Partial CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
01/14/2019 InVitro Diagnostics 7-269 Partial CLSI MM23-1st Edition Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
06/07/2021 InVitro Diagnostics 7-236 Partial CLSI M43-A October 2011 Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
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.
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
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		 6-480 Complete ISO 11608-6:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
05/30/2022 General Plastic Surgery/
General Hospital		 6-481 Complete ANSI AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022 General Plastic Surgery/
General Hospital		 6-482 Complete AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps
05/29/2023 General Plastic Surgery/
General Hospital		 6-494 Complete ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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
03/16/2012 General Plastic Surgery/
General Hospital		 6-177 Complete ASTM E1112-00(2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
05/30/2022 General Plastic Surgery/
General Hospital		 6-479 Complete ISO 11608-5:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
05/30/2022 General Plastic Surgery/
General Hospital		 6-476 Complete ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen 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
12/21/2020 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
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
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
12/23/2019 General Plastic Surgery/
General Hospital		 6-424 Complete ASTM D5151-19(2023) Standard Test Method for Detection of Holes in Medical Gloves
08/06/2013 General Plastic Surgery/
General Hospital		 6-240 Complete ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
08/06/2013 General Plastic Surgery/
General Hospital		 6-276 Complete ISO 8536-1 Fourth edition 2011-09-01 Infusion equipment for medical use - Part 1: Infusion glass bottles
08/06/2013 General Plastic Surgery/
General Hospital		 6-295 Complete AAMI ANSI BF7:2012 Blood transfusion microfilters
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
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
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
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
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 Complete IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
06/07/2018 General Plastic Surgery/
General Hospital		 6-406 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)
09/17/2018 General Plastic Surgery/
General Hospital		 6-409 Complete ASTM F703-18 Standard Specification for Implantable Breast Prostheses
12/20/2021 General Plastic Surgery/
General Hospital		 6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
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
07/06/2020 General Plastic Surgery/
General Hospital		 6-439 Complete ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
01/30/2014 General Plastic Surgery/
General Hospital		 6-306 Complete ASTM F1671/F1671M-13 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
05/29/2023 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
05/29/2023 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
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
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
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
06/07/2018 General Plastic Surgery/
General Hospital		 6-402 Complete ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
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
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
08/14/2015 General Plastic Surgery/
General Hospital		 6-200 Complete ASTM E1061-01(2022) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
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
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
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
08/06/2013 General Plastic Surgery/
General Hospital		 6-296 Complete ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
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
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 Complete IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
01/14/2019 General Plastic Surgery/
General Hospital		 6-410 Complete ISO 8536-6 Third edition 2016-12-01 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
07/15/2019 General Plastic Surgery/
General Hospital		 6-421 Complete ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
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
07/15/2019 General Plastic Surgery/
General Hospital		 6-422 Complete AAMI TIR38:2019 Medical device safety assurance case guidance
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
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
06/07/2018 General Plastic Surgery/
General Hospital		 6-270 Complete ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles
08/21/2017 General Plastic Surgery/
General Hospital		 6-70 Complete ASTM E825-98 (Reapproved 2016) 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 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017 General Plastic Surgery/
General Hospital		 6-384 Complete ISO 1135-4 Sixth edition 2015-12-01 Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017 General Plastic Surgery/
General Hospital		 6-125 Complete ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017 General Plastic Surgery/
General Hospital		 6-400 Complete ASTM F3212-16(2023) Standard Test Method for Coring Testing of Huber Needles
08/14/2015 General Plastic Surgery/
General Hospital		 6-353 Complete ASTM F2051-00 (Reapproved 2014) Standard Specification for Implantable Saline Filled Breast Prosthesis
 
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