BAS EN ISO 13485:2002

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001(revision of EN 46001:1996)

General Information
Status: Withdrawn
No. of pages: 11
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 08.10.2002
Technical committee:
BAS/TC 25, Healthcare
Directive:
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
...
Abstract
Upravljanje kvalitetom i osiguravanje kvaliteta
Lifecycle
...
Original document and degree of correspondence
  • EN ISO 13485:2000, identical
  • ISO 13485:1996, identical
Relation to BAS standards
BAS EN ISO 13485:2004
replaces
BAS EN ISO 13485:2002