BS EN 62304:2006+A1:2015 Medical device software. Software life-cycle processes

BS EN 62304:2006+A1:2015

Medical device software. Software life-cycle processes

Status : Current, Work in hand   Published : November 2006



What is this standard about?

It deals with medical device software. The amendment adds requirements for legacy software which will help manufacturers demonstrate compliance with the relevant European Directives.

Who is this standard for?

The standard is relevant to manufacturers of:

  • Medical electrical equipment
  • Medical devices incorporating software
  • Software that is itself a medical device

Why should you use this standard? 

The amended standard applies to the development and maintenance of medical device software when the software is itself a medical device or when software is embedded or an integral part of the final medical device.

What’s changed since the last update?

Amendment 1 adds requirements to deal with legacy software, where the software design is prior to the existence of the current version. It will help manufacturers show compliance with the standard in order to meet European Directives. Software safety classification changes needed for this amendment include clarification of requirements and updating of the software safety classification to include a risk-based approach. 

Standard NumberBS EN 62304:2006+A1:2015
TitleMedical device software. Software life-cycle processes
StatusCurrent, Work in hand
Publication Date30 November 2006
Normative References(Required to achieve compliance to this standard)EN ISO 14971:2000, ISO 14971
Informative References(Provided for Information)ISO/IEC 33004, IEC 60601-1-4:1996, EN ISO 13485:2003, EN ISO 9000:2005, IEC 82304-1, IEC 60601-1:2005, ISO/IEC 25010:2011, IEC 61010-1:2010, IEC 62366-1:2015, ISO 9000:2005, ISO 9001:2008, EN 60601-1:2006/A1:2013, EN ISO 9001:2008, IEC 60601-1-6, EN 62366-1:2015, IEC 61508-3, IEEE 610.12:1990, EN 60601-1:2006, ISO/IEC 15504-5:2012, IEC 60601-1:2005/A1:2012, EN 60601-1-6, 98/79/EC, ISO/IEC 14764:1999, EN 82304-1:2017, ISO/IEC Guide 51:2014, IEEE 1044:2009, EN 61010-1:2010, EN 60601-1-4:1996/A1:1999, ISO 13485:2003, 90/385/EC, IEC 60601-1-4:1996/A1:1999, EN 61508-3, ISO/IEC 33001, EN 60601-1-4:1996, ISO/IEC 90003:2014, ISO/IEC 12207:2008, 93/42/EEC
International RelationshipsIEC 62304:2006/AMD1:2015,EN 62304:2006/A1:2015,EN 60335-2-26:2003/A1:2008
Amended ByAmendment, November 2015; Corrigendum, May 2011
Draft Superseded By14/30287753 DC
DescriptorsIdentification methods, Maintenance, Risk assessment, Electrical equipment, Electrical medical equipment, Safety measures, Equipment safety, Life (durability), Quality management, Computer technology, Software engineering techniques, Life cycle, Medical equipment, Computer software, Design, Quality assurance systems, Hazards
Title in FrenchLogiciels de dispositifs médicaux. Processus du cycle de vie du logiciel
Title in GermanMedizingeräte-Software. Software-Lebenszyklus-Prozesse
ISBN978 0 580 83868 2
File Size3.473 MB

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