PD ISO/TS 20405:2018

Действует

Health informatics. Framework of event data and reporting definitions for the safety of health software — 24 стр.

Ссылочные документы

Действует

Health software - Part 1: General requirements for product safety — 55 стр.

Заменен

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

Действует

Health informatics -- Measures for ensuring patient safety of health software — 46 стр.

Действует

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

Действует

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

Заменен

Information technology. Security techniques. Information security risk management — 80 стр.

Действует

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

Действует

Risk management -- Guidelines — 24 стр.

Действует

Health informatics -- Guidance on standards for enabling safety in health software — 56 стр.