SR EN ISO 13485:2003

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

Standardul indica cerintele particulare pentru furnizorii de dispozitive medicale, care sunt mai specifice decât cerintele generale specificate în ISO 9001.

General information

Status : Withdrawn
Approval date : 11/20/2003
Publish date : 11/21/2003
Withdrawal date : 7/31/2006
Number of pages : 18
ICS : 03.100.70 Management systems,11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 46001:2000
Replaced by SR EN ISO 13485:2004