Standard Swedish standard · SS-EN ISO 13485/AC:2007

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

Status: Withdrawn · Replaced by: SS-EN ISO 13485:2012 Corrected by: SS-EN ISO 13485/AC:2009


Quality management and quality assurance (03.120.10) General (11.040.01) Quality management and corresponding general aspects for medical devices (11.110.10)

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-63098

Edition: 1

Approved: 9/7/2007

No of pages: 12

Correction: SS-EN ISO 13485 , SS-EN ISO 13485

Replaced by: SS-EN ISO 13485:2012