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Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 |
35.240.80 : 건강 관리 기술에서의 IT 응용
11.040.01 : 일반 의료장비 |
| 페이지수 | 114 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | 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 | 2021-12-16 | 표준 |
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 상세보기
IEC TR 60601-4-5:2021 - Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications 상세보기
ISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts 상세보기
IEC TR 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 상세보기
IEC 82304-1:2016 - Health software - Part 1: General requirements for product safety 상세보기
IEC 62443-4-2:2019 - Security for industrial automation and control systems - Part 4-2: Technical security requirements for IACS components 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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