ISO 13485:1996Withdrawn

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

Systèmes qualité — Dispositifs médicaux — Exigences particulières relatives à l'application de l'ISO 9001

Need ISO 13485 certification?

We handle documents, training and the accredited audit — fixed price.

See our ISO 13485 service Get a free quote

Abstract / scope

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.

Life cycle

Replaced by

ISO 13485:2003WithdrawnMedical devices — Quality management systems — Requirements for regulatory purposesInternational Standard · Published 3 Jul 2003 · ISO/TC 210