19/30370858 DC - BS EN ISO 20417. Medical devices. Information to be provided by the manufacturer

19/30370858 DC

BS EN ISO 20417. Medical devices. Information to be provided by the manufacturer

Status : Current, Draft for public comment   Published : March 2019

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Format
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Standard Number19/30370858 DC
TitleBS EN ISO 20417. Medical devices. Information to be provided by the manufacturer
StatusCurrent, Draft for public comment
Publication Date25 March 2019
Normative References(Required to achieve compliance to this standard)ISO 15459-4, ISO 15459-6, ISO 15459-2, ISO 14971, ISO/IEC 646, IEC 62366-1:2015+AMD1, IEC 60417 (database), ISO 16142-2:2017, ISO 639-3:2007, ISO 3864-1:2011, ISO 13485:2016, ISO 16142-1:2016, ISO 8601:2004, ISO 7000:2014, ISO 22742:2010, ISO 15223-1:2016, ISO 639-2:1998 (R10), ISO 80000-1:2009, ISO 3166-1:2013, ISO 7010:2011, ISO 639-1:2002
Informative References(Provided for Information)ISO 16142-2:2017, ISO 13485:2016, ISO 11607-1:2006, ISO 780:2015, IEC 60601-1-11:2015, EN 1041:2008+A1:2013, ISO 18113-1:2009, ISO 11139:2018, ISO 16142-1:2016, IEC 60601-1:2005, ISO 14708-2:2012, IEC 60601-1:2005/AMD1:2012, IEC 80001-1:2010, ISO 17664 (series)
International RelationshipsEN ISO 20417,ISO 20417
Draft Expiry Date12 May 2019
DescriptorsDiagnosis (medical), Medical instruments, Clinical investigation instruments, Risk analysis, Risk assessment, Medical equipment, Management, Hazards, Safety measures
ICS11.040.01
Title in FrenchDispositifs médicaux -- Informations à fournir par le fabricant
CommitteeCH/210
PublisherBSI
FormatA4
DeliveryYes
Pages84
File Size1.327 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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