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EN 60601-1-6:2010 Standard

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  Keywords:

#use #usability #associated #risks #equipment

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityIEC 60601-1-6:2010

  Purpose

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 13408-6:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN 60601-1:2006/A1:2013

Active implantable medical devices Directive (90/385/EEC)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN 1041:2008

Active implantable medical devices Directive (90/385/EEC)

Information supplied by the manufacturer of medical devices

EN ISO 10993-4:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-6:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 10993-9:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

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