ISO 13485:1996

Issue date: 1996 12 26

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

Specifies, in conjunction with the application of ISO 9001, the quality system requirements for the design/development and, when relevant, installation and servicing of m...

Withdrawn: 2006 09 18

Publisher:

International Organization for Standardization

Format:

Digital | 10 Pages

Language:

English

Currently valid:

ISO 13485:2016:2016 02 25

ICS

03.100.70

11.040.01

Topics

Healthcare, Medical equipment, Medical equipment in general

Services & management, Company organization and management. Quality, Management systems

Summary

Norm timeline

Normative References

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.

ISO 13485:2016

2016 02 25

Medical devices — Quality management systems — Requirements for regulatory purposes

Norm

ISO 13485:2003

2003 07 03

Medical devices — Quality management systems — Requirements for regulatory purposes

Norm

ISO 13485:1996

1996 12 26

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

Norm

↖

Norm

ISO 13485:2003

Issue date : 2003 07 03

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:1996

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