Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
文件核验信息(付费前可核对)
标准范围(官方英文摘要)
IEC 81001-5-1:2021 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.
标准信息
- 标准号
- IEC 81001-5-1:2021
- 英文标题
- Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
- 发布单位
- —
- 技术委员会
- TC 62/SC 62A
- 版本 / 版次
- 1.0
- 状态
- 现行
- 发布日期
- 2021
- ICS 分类
- 35.240.80 信息技术在医药卫生技术中的应用
- 页数
- 114 页
- 官方定价
- CHF 300
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