BS EN ISO 13485:2012 - Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN ISO 13485:2012

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Revised, Superseded, Withdrawn   Published : March 2012 Replaced By : BS EN ISO 13485:2016

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Standard NumberBS EN ISO 13485:2012
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
StatusRevised, Superseded, Withdrawn
Publication Date31 March 2012
Withdrawn Date29 February 2016
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
Replaced ByBS EN ISO 13485:2016
ReplacesBS EN ISO 13485:2003
International RelationshipsEN ISO 13485:2012/AC:2012
Amended ByCorrigendum, September 2012
DescriptorsMedical technology, Acceptance (approval), Quality assurance systems, Medical instruments, Quality management, Management, Medical equipment
ICS03.100.70
03.120.10
11.040.01
Title in FrenchDispositifs médicaux. Systèmes de manegement de la qualité. Exigences à des fins réglementaires
Title in GermanMedizinprodukte. Qualitätsmanagementsysteme. Anforderungen für regulatorische Zwecke
CommitteeCH/210/1
ISBN978 0 580 79953 2
PublisherBSI
FormatA4
DeliveryNo
Pages86
File Size1.687 MB
Price£280.00


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