Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
Covers single-use gravity feed transfusion sets.
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 |
|---|---|---|---|---|
| European Union | Harmonized | EN ISO 1135-4:2025 (ISO 1135-4:2025) | - | Recognition number MDR entry 52. Effective June 17, 2026. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 60118-0, ISO 80369-2, EN 455-1, EN 455-2, EN 13795-1, EN 13795-2, EN 14683, ISO 7197, ISO 14630, ISO 21535, ISO 21536, ISO 14607. 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.