BS EN 60601-1-6:2010+A1:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability

BS EN 60601-1-6:2010+A1:2015

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability

Status : Current, Work in hand   Published : May 2010



What is this standard about? 

BS EN 60601-1-6 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.It is a collateral standard – its objective is to specify requirements that are in addition to those of the general standard. BS EN 60601-1-6 looks specifically at the usability of medical electrical equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers, suppliers and users of medical electronic equipment and components
  • All healthcare facilities/hospitals/intensive care units
  • Health and safety professionals• Regulatory bodies and technical committees

Why should you use this standard?

This collateral standard specifies a process for a manufacturer to analyse, specify, design, verify and validate the usability of equipment, relating to safety and performance. As medical equipment develops, it is also increasingly being used by patients and non-specialist health care professionals, so improvements to usability are needed. It outlines a usability engineering process which assesses and mitigates risks caused by usability problems associated with normal use.

NOTE: The standard can be used to identify but does not assess or mitigate risks associated with abnormal use.

What’s changed since the last update?

The third edition of this standard has been systematically reviewed by experts to ensure its continued market relevance and to take into consideration technological developments. Changes include:

  • Revisions to align with the usability engineering process in IEC 62366
  • Table B-1 has been developed to map the clauses and sub-clauses relevant to IEC 62366
  • The reference to the complete life cycle process (including post production monitoring and surveillance) has been removed

Standard NumberBS EN 60601-1-6:2010+A1:2015
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
StatusCurrent, Work in hand
Publication Date31 May 2010
Normative References(Required to achieve compliance to this standard)EN 60601-1-8:2007/A1:2013/Corrigendum 1:2014, EN 62366:2008/A1:2015, EN 60601-1:2006/A1:2013/Corrigendum 1:2014, EN 62366:2008, ISO 14971:2007, IEC 62366:2007, IEC 60601-1-8:2006/A1:2012, EN 60601-1:2006/A12:2014, EN 60601-1-8:2007, IEC 60601-1:2005/A1:2012, IEC 60601-1-8:2006, EN 60601-1:2006/Corrigendum 1:2010, EN 60601-1-8:2007/A1:2013, EN 60601-1:2006, IEC 62366:2007/A1:2014, EN 60601-1:2006/A1:2013, IEC 60601-1:2005, EN ISO 14971:2009
Informative References(Provided for Information)ISO/IEC 25062:2006, EN ISO 9241-20:2009, ISO 9241-410:2008, ISO/IEC 18019:2004, ISO 9241-300:2008, ISO/IEC 14598-6:2001, EN ISO 9241-400:2007, 90/385/EEC, EN ISO 9241-307:2008, ISO 9241-20:2008, EN ISO 9241-303:2008, EN ISO 9241-110:2006, ISO 9241-305:2008, EN ISO 13407:1999, ISO 9241-304:2008, EN ISO 9241-304:2008, EN ISO 9241-300:2008, EN 29241:1993, ISO 9241-210, ISO 9241-303:2008, ANSI/AAMI HE 74:2001, EN ISO 9241-410:2008, ISO 9241-920:2009, ISO 9241-110:2006, EN ISO 9241-171:2008, ISO 9241-302:2008, ISO/TR 16982:2002, ISO 9241-307:2008, ISO 9241-171:2008, EN ISO 9241-11:1998, ISO 9241-400:2007, EN ISO 9241-302:2008, EN ISO 9241-305:2008, ISO/IEC 14598-3:2000, ISO/IEC 14598-1:1999, ISO 9241-2:1992, ISO/IEC 15910:1999, ISO/IEC 14598-4:1999, ISO/IEC 14598-5:1998, ISO 13407:1999, ISO/IEC 14598-2:2000, ISO 9241-11:1998
International RelationshipsEN 60601-1-6:2010/A1:2015,IEC 60601-1-6:2010/AMD1:2013
Amended ByAmendment, July 2015
Draft Superseded By12/30258857 DC
DescriptorsMedical equipment, Instructions for use, Equipment safety, Electrical safety, Ergonomics, Risk assessment, Electrical equipment, Design, Electrical medical equipment, Electronic equipment and components
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale. Aptitude à l'utilisation
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm. Gebrauchstauglichkeit
ISBN978 0 580 77963 3
File Size1.991 MB

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