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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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03/16/2012 Cardiovascular 3-96 Complete ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
ANSI AAMI ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
04/04/2016 Dental/
ENT		 4-222 Complete ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
09/09/2008 Software/
Informatics		 13-19 Complete CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer Systems
08/20/2012 InVitro Diagnostics 7-76 Complete CLSI M15-A (Replaces M15-T) Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
01/27/2015 ObGyn/
Gastroenterology/
Urology		 9-45 Complete ASTM F2528-06(2023) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
08/02/2011 InVitro Diagnostics 7-219 Complete CLSI I/LA28-A2 Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/21/2017 General II (ES/
EMC)		 19-22 Complete AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
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
01/30/2014 Sterility 14-395 Complete ISO 14698-2 First edition 2003-09-15 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
08/06/2013 Orthopedic 11-252 Complete ISO 5838-1 Third edition 2013-03-01 Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
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