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EN 60601-1:2006/A1:2013 Standard

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  Keywords:

#medical #publications #european #eu #directive

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. EN 60601-1:2006/A1:2013+A12:2014 modifies the European standard EN 60601-1:2006. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. In this amendment you can find: — the relationship between EN 60601-1 and the essential requirements of EU Directive 90/385/EEC on active implantable medical devices, — normative references to international publications with their corresponding European publications, — the relationship between EN 60601-1 and the essential requirements of EU Directive 93/42/EEC on medical devices.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 60601-1:2006"

  Reference

This standard supersedes the "18/01/2011"

Anyway is still possible use the "18/01/2011" until December 31st, 2017

  Related Standards

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...

EN ISO 14155:2011/AC:2011

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

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

EN ISO 11607-1:2020

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 14155:2020

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

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 11607-2:2020

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

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 11137-2:2015

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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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