Technical management programs for medical devices
A technical management program standard for medical devices. It asks for a transparent plug cover when plugs are re-wireable.
The text of this standard is sold by Standards Australia and Standards NZ 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 | - | - | Named in the TGA guidance for electromedical devices. |
Related standards: Q5A(R2), Q5B, Q5D, Q5E, Q8(R2), Q11, Q12, Q13, ISO/IEC 17050-1, UN Manual of Tests and Criteria, section 38.3. 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.