Project
Interpretation Sheet 1 - Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Abstract
This interpretation sheet clarifies the requirements for providing essential accompanying documentation to operators of health software products regarding the transfer of risk related to software items from manufacturers to responsible organizations or operators. It also clarifies the requirements needed to maintain the security of the health software product.
Begin
2025-10-10
Planned document number
DIN EN IEC 81001-5-1 Beiblatt 1
Project number
02233436
