Overview
ISO 8536-13:2016 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies requirements for non-sterile, single‑use graduated flow regulators (GFRs) used as subcomponents in sterilized, gravity‑feed infusion sets. The standard covers design, materials, physical, chemical and biological requirements, packaging and labelling, and normative test methods to demonstrate performance and safety. Note: national pharmacopoeia or regulations may take legal precedence in some countries.
Key topics and requirements
- Scope and purpose
- Applies to gravity‑feed GFRs that have direct fluid contact and regulate intravenous infusion flow.
- Design
- GFRs shall provide constant flow regulation, prevent accidental flow changes, and clearly indicate open and off (closed) positions.
- Materials and biological safety
- Materials must meet chemical/biological requirements and be evaluated per ISO 10993‑1 (biological evaluation of medical devices).
- Physical performance
- Graduated scale: must show at minimum open/closed and manufacturer‑defined scale positions.
- Particulate contamination: inner surfaces must be smooth; particle counts must not exceed the contamination index (see Annex A.1).
- Tensile strength: withstand a static longitudinal tensile force of ≥15 N for 15 s (Annex A.2).
- Leakage: impermeable to microorganisms/fluids; no air leakage when tested at 50 kPa excess pressure and 40 ±1 °C (Annex A.3).
- Flow rates and stability: measured with NaCl 9 g/L at 23 ±2 °C, hydrostatic head 1 m; accuracy per manufacturer and stability within ±10% over a 6‑hour test after 15 min stabilization (Annex A.4).
- Packaging and labelling
- Referenced to ISO 8536‑4 requirements; labelling must additionally reference GFR.
Applications and users
- Who uses this standard
- Medical device designers and manufacturers of infusion sets and GFR components
- Quality assurance / regulatory teams validating product design and batch release
- Test laboratories performing physical and performance testing
- Procurement and clinical engineering evaluating device compliance
- Practical applications
- Design validation and type testing for single‑use GFRs
- Production control specifications (material selection, particulate limits, tensile/ leak targets)
- Regulatory submissions and conformity assessments where ISO 8536 series is referenced
- Supplier contracts and acceptance criteria for infusion set subcomponents
Related standards
- ISO 8536 family (Parts 1–12, 14) - infusion equipment series
- ISO 8536‑4 - infusion sets for single use, gravity feed (normative references for packaging, labelling, tests)
- ISO 10993‑1 - biological evaluation of medical devices
- ISO 15223‑1 (symbols for labelling) - referenced for label content
Keywords: ISO 8536-13, graduated flow regulators, infusion equipment, single‑use GFR, gravity feed, medical device standard, flow rate testing, leakage test, particulate contamination, ISO 10993-1.
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