ISO 8536-16:2025

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

• IEC 60601-2-24 (volumetric infusion controllers)
• ISO 8536-4 (infusion sets for single use, gravity feed)
• ISO 15223-1 (medical device symbols)
• ISO 7000 (graphical symbols)
• ISO 3696 (water quality), ISO 14644-1 (cleanrooms)

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.