Principles for medical device security - Risk management
Technical report on managing security risk for medical devices, named in the Health Canada cybersecurity guidance.
The text of this standard is sold by AAMI 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 |
|---|---|---|---|---|
| Canada | Referenced | - | - | Recommended in the Health Canada cybersecurity guidance. It is not on the list of recognized standards. |
| Australia | Referenced | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: YY/T 1843-2022, IEC 81001-5-1, JIS T 81001-5-1, ISO/IEC 29147, ISO/IEC 30111, ISO/IEC 27001, IEC 80001-5-1, 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.