IEC 81001-5-1:2021

Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle IEC 81001-5-1:2021

Publication date:   Dec 21, 2021

General information

60.60 Standard published   Dec 21, 2021

IEC

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology | 35.080   Software

Buying

Published

Language in which you want to receive the document.

Scope

This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 – taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES.The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves.It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1.This document excludes specification of ACCOMPANYING DOCUMENTATION contents.

Life cycle

NOW

PUBLISHED
IEC 81001-5-1:2021
60.60 Standard published
Dec 21, 2021