ISO 13485:1996 PDF
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
Title (English):
ISO 13485:1996
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 10
- Publication date:
- December 26, 1996
- Edition:
- ISO IS 13485 edition 1 version 1
- ICS:
- 03.100.70
Description (English):
Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of medical devices.
Technical details
- Technical committee
- ISO/TC 210 - Quality management and corresponding general aspects for medical devices
- SKU
- ISO 13485:1996
