PD IEC/TR 80002-1:2009

Действует

Medical device software. Guidance on the application of ISO 14971 to medical device software — 66 стр.

Ссылочные документы

Заменен

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities — 86 стр.

Заменен

Medical devices - Application of usability engineering to medical devices — 209 стр.

Заменен

Hazard and operability studies (HAZOP studies) - Application guide — 113 стр.

Заменен

Fault tree analysis (FTA) — 39 стр.

Заменен

Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) — 21 стр.

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

Действует

Medical device software - Software life cycle processes — 78 стр.