BS EN IEC 81001-5-1:2022
Health software and health IT systems safety, effectiveness and security - Security. Activities in the product life cycle
Health software and health IT systems safety, effectiveness and security - Security. Activities in the product life cycle
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Дата публикации:
- 28 февраля 2026 г.
- ICS:
- 11.040.01
- Технический комитет:
- CENELEC
- SKU:
- BS EN IEC 81001-5-1:2022
Abstract
1 Scope This document defines the life cycle requirements for development and maintenance of health software needed to support conformance to IEC 62443‑4‑1 [11] – 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 . An informal overview of activities for health software is shown in Figure 2. 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 [17]. This document excludes specification of accompanying documentation contents.<...
Похожие стандарты
Упомянутые в описании и другие стандарты BS
IEC 62443-4-1:2018
ДействующийSecurity for industrial automation and control systems - Part 4-1: Secure product development lifecycle requi…
Overview IEC 62443-4-1:2018, published by the International Electrotechnical Commission (IEC), establishes process requirements for the secure development of products used in industrial automation an…
ISO 81001-1:2021
ДействующийHealth software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
Overview ISO 81001-1:2021 - "Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts" - defines the core principles, concepts, terms and definitions…
BS ISO 10835:2007
ДействующийDirect reduced iron and hot briquetted iron. Sampling and sample preparation.
1 Scope This International Standard gives a) the underlying theory, b) the basic principles for sampling and preparation of samples , and c) the basic requirements for the design, installation and op…