Стандарты BSI

PD ISO/TR 27809:2007

Действует

Health informatics. Measures for ensuring patient safety of health software — 48 стр.

Описание Изменения Ссылки Версии

Ссылочные документы

BS EN 1041:1998

Заменен

Information supplied by the manufacturer with medical devices — 20 стр.

ISO/TS 25238:2007

Действует

Health informatics -- Classification of safety risks from health software — 34 стр.

IEC 61508-5:1998/COR1:1999 ed1.0

Заменен

Corrigendum 1 - Functional safety of electrical/electronic/programmable electronic safety related systems - Part 5: Examples of methods for the determination of safety integrity levels — 1 стр.

IEC 61508-3:1998/COR1:1999 ed1.0

Заменен

Corrigendum 1 - Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements — 1 стр.

ISO 14971:2007

Действует

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

BS ISO 31000:2009

Заменен

Risk management. Principles and guidelines — 38 стр.

BS ISO/IEC TR 15271:1998

Заменен

Information technology. Guide for ISO/IEC 12207. (Software life cycle processes) — 58 стр.

ISO/IEC 90003:2004

Заменен

Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software — 62 стр.

ISO 13485:2003

Заменен

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

ISO/TR 14969:2004

Заменен

Medical devices -- Quality mangement systems -- Guidance on the application of ISO 13485: 2003 — 84 стр.

ISO/TS 22224:2009

Действует

Health informatics -- Electronic reporting of adverse drug reactions — 18 стр.