Overview
ISO 8536-16:2025 specifies requirements for sterilized, single‑use, gravity‑feed infusion sets designed to be used with volumetric infusion controllers (as defined in IEC 60601-2-24). The standard covers design, materials, physical performance, labelling, packaging and disposal for infusion sets that incorporate a flow element to enable accurate volumetric control. It is part of the ISO 8536 series for infusion equipment for medical use.
Keywords: ISO 8536-16, infusion sets, volumetric infusion controllers, single‑use, gravity feed, IEC 60601-2-24.
Key topics and technical requirements
- Scope and compatibility
- Applies to gravity‑feed, single‑use infusion sets intended for use with volumetric infusion controllers (positive gauge pressure driven by gravity).
- Design and components
- Typical components include closure‑piercing device, drip chamber, drip tube, fluid filter, tubing, flow regulator/flow element, injection site and male conical fitting. Protective caps are required.
- Physical performance
- Particulate contamination: manufacturing and testing minimize particles; limits defined by the contamination index test (Annex A).
- Leakage: no signs of leakage under specified test conditions.
- Tensile resistance: must withstand a static longitudinal tensile force of ≥ 15 N for 15 s.
- Flow rate: when tested with the dedicated volumetric controller and fully open flow path, the set shall deliver ≥ 1 000 ml of 9 g/l NaCl in 10 min.
- Flow regulator/element: must allow volumetric controllers to regulate flow and must prevent free flow.
- Drip chamber: must permit drop‑count measurement by a drop sensor.
- Materials, chemical and biological requirements
- Materials in contact with solutions must meet clauses referenced to ISO 8536-4 and applicable chemical/biological tests.
- Labelling and packaging
- Unit container labelling must include manufacturer, content description, sterility and single‑use statements, lot number and expiry, and symbols per ISO 15223-1 and ISO 7000.
- Testing
- Physical tests are detailed in Annex A; cleanroom and water quality references include ISO 14644-1 and ISO 3696.
Applications and users
Who uses ISO 8536-16:
- Medical device manufacturers designing disposable infusion sets and flow elements compatible with volumetric controllers.
- R&D and design engineers implementing safety features (anti‑free‑flow, drip sensing).
- Quality, regulatory and compliance teams preparing technical documentation and CE/FDA submissions.
- Test laboratories performing performance and sterility/biocompatibility testing.
- Hospital procurement and biomedical engineering teams assessing device compatibility with existing volumetric infusion controllers.
Related standards
This standard ensures safe, compatible and verifiable performance of infusion sets used with volumetric infusion controllers, helping manufacturers and healthcare providers meet regulatory and clinical requirements.
Open preview (PDF)Infusion equipment for medical use — Part 16: Infusion sets for single use with volumetric infusion controllers