Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Edition 1.0 2021-12 | - | Recognition number 13-122. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| United Kingdom | Not recognized | - | - | A device that conforms to this standard does not get the statutory presumption of conformity, because the standard is not designated.. The complete list of designated standards published in January 2026 does not name this standard. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: YY/T 1843-2022, JIS T 81001-5-1, ISO/IEC 29147, ISO/IEC 30111, ISO/IEC 27001, IEC 80001-5-1, AAMI TIR57, ANSI/CAN/UL 2900-1, ANSI/CAN/UL 2900-2-1, IEC 80001-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Japan | Adopted | IEC 81001-5-1:2021, identical JIS version | JIS T 81001-5-1:2023ヘルスソフトウェア及びヘルスＩＴシステムの安全，有効性及びセキュリティ―第５－１部：セキュリティ―製品ライフサイクルにおけるアクティビティ | Effective April 1, 2023. Transition until March 31, 2024. For software devices connected to other devices or networks, conformity with JIS T 81001-5-1 or similar standards is checked, and documents are attached for approval or certification of controlled and higher class devices. |
| Canada | Not recognized | - | - | The standard does not appear on the list of recognized standards. A manufacturer may still give other evidence of safety or effectiveness. |
| Australia | Referenced | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. |