19/30401042 DC - BS EN ISO 13485 AMD1. Medical devices. Quality management systems. Requirements for regulatory purposes

19/30401042 DC

BS EN ISO 13485 AMD1. Medical devices. Quality management systems. Requirements for regulatory purposes

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

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Standard Number19/30401042 DC
TitleBS EN ISO 13485 AMD1. Medical devices. Quality management systems. Requirements for regulatory purposes
StatusCurrent, Draft for public comment
Publication Date07 November 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
International RelationshipsEN ISO 13485:2016/prA1:2019
Draft Expiry Date24 December 2019
DescriptorsManagement, Quality management, Medical equipment, Medical technology, Medical instruments, Quality assurance systems, Acceptance (approval)
ICS03.100.70
11.040.01
CommitteeCH/210
PublisherBSI
FormatA4
DeliveryYes
Pages54
File Size562 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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