Overview
EN ISO 8536-13:2024 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies safety, performance and test requirements for non‑sterile, single‑use graduated flow regulators (GFRs) used as subcomponents in sterilized infusion sets. The standard applies to GFRs that control intravenous infusion flow under gravity feed conditions and was prepared jointly by ISO TC 76 and CEN TC 205. EN ISO 8536-13:2024 supersedes the earlier edition and aligns physical, chemical and design expectations for manufacturers and test laboratories.
Key topics and technical requirements
- Scope & definition
- GFR = subcomponent with graduation and fluid contact for setting liquid flow.
- Covers GFRs intended for single use in infusion sets (gravity feed).
- Design and markings
- Must be designed for constant flow regulation and to avoid accidental flow change.
- Scale must clearly indicate open and closed positions and manufacturer‑defined scale positions.
- Flow performance
- Stability requirement: when tested, flow stability shall be at least within ±10% during the test time.
- GFRs must deliver flow rates according to the manufacturer’s scale and tolerances (test methods in Annex A).
- Physical requirements and tests
- Particulate contamination: inner surface smooth/clean; testing per ISO 8536-4 with limits on particle counts.
- Tensile strength: withstand a static longitudinal tensile force of ≥15 N for 15 s after pre‑conditioning.
- Leakage: must be leak‑tight in open, closed and intermediate positions; no leakage under specified air/water test conditions.
- Preconditioning: tests consider sterilization, transport, ageing and number of activations.
- Materials and biocompatibility
- Materials must meet chemical requirements and be evaluated per ISO 10993-1.
- Normative references
Applications and who uses it
- Medical device manufacturers designing and producing infusion sets and GFR subcomponents.
- Quality assurance and regulatory affairs teams ensuring product compliance with EU/CEN and international requirements.
- Test laboratories performing physical, particulate, tensile and leakage tests according to Annex A.
- Purchasing and procurement professionals specifying compliant infusion components.
- Healthcare facilities and clinical engineers evaluating device safety and compatibility for gravity‑fed IV therapy.
Related standards
- ISO 8536-4 - Infusion sets for single use, gravity feed (test methods referenced)
- ISO 10993-1 - Biological evaluation of medical devices (biocompatibility)
- ISO 80000-4 - Quantities and units - mechanics
EN ISO 8536-13:2024 is essential for ensuring safe, reliable graduated flow regulators in infusion equipment, supporting regulatory compliance, consistent flow control, and reduced particulate and leakage risks in single‑use infusion systems.