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

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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Status : Revised, Superseded, Withdrawn   Published : March 2012 Replaced By : BS EN ISO 13485:2016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StatusRevised, Superseded, Withdrawn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Withdrawn Date29 February 2016
Cross References90/385/EEC, 93/42/EEC, 98/79/EC, ISO 9000:2000, ISO 9001:2000, ISO 10012, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13683:1997, ISO 14155-1:2003, ISO 14155-2:2003, ISO 14160:1998, ISO 14937:2000, ISO/TR 14969, ISO 14971:2000, ISO 19011:2002
Replaced ByBS EN ISO 13485:2016
ReplacesBS EN ISO 13485:2003
International RelationshipsEN ISO 13485 Corr 2 (07/12)
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£264.00


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