BAS EN ISO 13485/Cor2:2011
Medical devices - Quality management systems - Requirements for regulatory purposes
General Information
Status: Withdrawn
No. of pages: 7
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 12.05.2011
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
Lifecycle
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Original document and degree of correspondence
- EN ISO 13485:2003/AC:2009, identical
- ISO 13485:2003/Cor 1:2009, identical