Cover DIN EN IEC 81001-5-1 VDE 0750-103-5-1:2023-07

DIN EN IEC 81001-5-1 VDE 0750-103-5-1:2023-07

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); German version EN IEC 81001-5-1:2022
Class/Status: Standard, valid
Released: 2023-07
VDE Art. No.: 0701470

This document defines the Life Cycle requirements for development and maintenance of Health Software needed to support conformity 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.