IEC/TR 80002-1
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
Software für Medizinprodukte - Teil 1: Anleitung zur Anwendung der ISO 14971 auf Software für Medizinprodukte
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible international committee
IEC/SC 62A - Common aspects of electrical equipment used in medical practice