BAS EN ISO 13485/Cor1:2008

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

General Information
Status: Withdrawn
No. of pages: 10
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 21.07.2008
Technical committee:
BAS/TC 25, Healthcare
Directive:
93/42/EEC, Medical devices;
ICS:
03.120.10, Quality management and quality assurance;
11.040.01, Medical equipment in general
...
Abstract
Upravljanje kvalitetom i osiguravanje kvaliteta
Lifecycle
...
Original document and degree of correspondence
  • EN ISO 13485:2003/AC:2007, identical
Relation to BAS standards
BAS EN ISO 13485/Cor2:2011
replaces
BAS EN ISO 13485/Cor1:2008