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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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08/20/2012 Cardiovascular 3-103 Complete ISO 25539-3 First edition 2011-12-01 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
ANSI AAMI ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012 Cardiovascular 3-104 Complete ASTM F2914-12 (Reapproved 2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
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
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
08/20/2012 InVitro Diagnostics 7-76 Complete CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
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.
08/20/2012 InVitro Diagnostics 7-197 Complete CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
08/20/2012 Radiology 12-249 Complete IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
08/20/2012 Software/
Informatics
13-31 Complete CLSI AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
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
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