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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
12/19/2022 General Plastic Surgery/
General Hospital		 6-484 Complete ASTM F3502-22a Standard Specification for Barrier Face Coverings
12/20/2021 General Plastic Surgery/
General Hospital		 6-466 Complete USP-NF M76070_03_01 Sodium Chloride Injection
05/30/2022 General Plastic Surgery/
General Hospital		 6-477 Complete ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022 General Plastic Surgery/
General Hospital		 6-475 Complete ISO 11608-4:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
12/20/2021 General Plastic Surgery/
General Hospital		 6-467 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
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
05/30/2022 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		 6-480 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		 6-479 Complete ISO 11608-5:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
12/20/2021 General Plastic Surgery/
General Hospital		 6-465 Complete USP-NF M76090_03_01 Sodium Chloride Irrigation
09/21/2016 General Plastic Surgery/
General Hospital		 6-381 Complete ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification.
12/21/2020 General Plastic Surgery/
General Hospital		 6-450 Complete IEC 60601-2-50 Edition 3.0 2020-09 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
12/20/2021 General Plastic Surgery/
General Hospital		 6-472 Complete USP-NF M36660_04_01 Heparin Lock Flush Solution
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.
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
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
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
05/30/2022 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
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)]
12/21/2020 General Plastic Surgery/
General Hospital		 6-448 Partial ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
06/27/2016 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
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
07/06/2020 General Plastic Surgery/
General Hospital		 6-440 Partial ASTM D3578-19(2023) Standard Specification for Rubber Examination Gloves
12/21/2020 General Plastic Surgery/
General Hospital		 6-449 Partial ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs
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
12/18/2023 General Plastic Surgery/
General Hospital		 6-497 Partial ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves
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
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
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		 6-442 Partial ASTM D6977-19(2023) Standard Specification for Polychloroprene Examination Gloves for Medical Application
12/20/2021 General Plastic Surgery/
General Hospital		 6-474 Partial ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
07/06/2020 General Plastic Surgery/
General Hospital		 6-443 Partial ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
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		 6-445 Partial ASTM D5250-19(2023) Standard Specification for Poly(vinyl chloride) 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
07/06/2020 General Plastic Surgery/
General Hospital		 6-444 Complete ASTM D7103-19(2023) Standard Guide for Assessment of Medical Gloves
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
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
07/15/2019 InVitro Diagnostics 7-288 Complete CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
05/30/2022 InVitro Diagnostics 7-312 Complete CLSI M39 5th Edition Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
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
12/20/2021 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
 
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