BAS EN ISO 13485/Cor1:2013

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1

General Information
Status: Withdrawn
No. of pages: 5
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 21.11.2013
Technical committee:
BAS/TC 25, Healthcare
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
ICS:
03.120.10, Quality management and quality assurance;
11.040.01, Medical equipment in general
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Abstract
Lifecycle
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Original document and degree of correspondence
  • EN ISO 13485:2012/AC:2012, identical
  • ISO 13485:2003/Cor 1:2009, identical
Relation to BAS standards
BAS EN ISO 13485:2017
replaces
BAS EN ISO 13485/Cor1:2013