18/30344861 DC - BS EN 62304. Health software. Software life cycle processes

18/30344861 DC

BS EN 62304. Health software. Software life cycle processes

Status : Draft for public comment, Current   Published : March 2018



Standard Number18/30344861 DC
TitleBS EN 62304. Health software. Software life cycle processes
StatusDraft for public comment, Current
Publication Date14 March 2018
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)ISO/IEC 27000, ISA/IEC 62443, IEC 80001-2-8:2016, IEC 60601-1-6, ISO/IEC Guide 73:2009, IEC 61508-3, ISO/IEC Guide 63, ISO 9000:2015, ISO 13485:2016, ISO/IEC 27002:2013, ISO/IEC 90003:2014, ISO/IEC 25010:2011, IEC 61010-1:2010, ISO 14708-1:2014, ISO/IEC Guide 51:2014, IEC 82304-1:2016, ISO 27799:2008, IEC 80001-1:2010, IEC 60601-1:2005/AMD1:2012, AAMI TIR57:2016, ISO 9001:2015, EN 45502-1:2015, ISO/IEC 12207:2008, ISO/IEC 14764:1999, IEC 62366-1:2015, IEC 60601-1:2005, IEC TR 80001-2-2:2012, ISO 31000:2009
International RelationshipsprEN 62304:2018
Draft Expiry Date11 April 2018
DescriptorsLife cycle, Safety measures, Equipment safety, Life (durability), Risk assessment, Software engineering techniques, Hazards, Computer software, Electrical medical equipment, Computer technology, Design, Electrical equipment, Quality management, Identification methods, Quality assurance systems, Maintenance, Medical equipment
File Size1.184 MB
NotesWarning: this draft is not current beyond its expiry date for comments.

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