ISO 13485
Quality systems - Medical devices - Particular requirements for the application of ISO 9001
Qualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die Anwendung von ISO 9001
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible international committee
ISO/TC 210/WG 1 - Application of quality systems to medical devices