ISO 13485:1996

Quality systems — Medical devices — Particular requirements for the application of ISO 9001

WITHDRAWN

About this standard

Languages
English and French
Type
International Organization for Standardization (ISO)
Standards committee
ISO/TC 210 (Quality management and corresponding general aspects for products with a health purpose including medical devices)
Status
WITHDRAWN
Publication date
26 December 1996
Replaced by
ISO 13485:2003
ICS Code
03.100.70 (Management systems)
11.040.01 (Medical equipment in general)
Withdrawn Date
Price
€ 70,35

About this training

Summary

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.