Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
General safety requirements for active implantable medical devices, covering electrical, mechanical, thermal and biocompatibility hazards. It also applies to some non-implantable parts and accessories.
The text of this standard is sold by ISO 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 |
|---|---|---|---|---|
| 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: GB 9706.1-2020, IEC 60601-1, JIS T 0601-1, IEC 60601-2-83, IEC 60601-1-8, IEC 60601-1-11, AS/NZS 3820, AS/NZS 3112, AS/NZS 4417.1, IEC 62133-2. See .
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.