Needles & Syringes - Related International Standards
The following non-harmonised international standards are related to Needles & Syringes for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods | active | 10, 11, 14 | Link |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | active | 10, 11, 14, 21 | Link |
| ISO 8536-16:2025 | Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers | active | 10, 11, 14 | Link |
| ISO 1135-4:2025 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed | active | 10, 11, 14 | Link |
| ISO 1135-5:2025 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus | active | 10, 11, 14 | Link |
| ISO 80369-1:2025 | Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements | active | 3, 5, 9, 14 | Link |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers | active | 1, 3, 5, 9, 14 | Link |
| ISO 23908:2025 | Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods (ISO 23908:2024) | active | 1, 3, 9, 14, 14.1 | Link |