ISO 8536-13:2024

Overview

ISO 8536-13:2024 - Infusion equipment for medical use - Part 13 specifies requirements for graduated flow regulators (GFRs) that are non‑sterile, single‑use subcomponents intended for inclusion in sterilized infusion sets. The standard covers devices with fluid contact used to control intravenous infusion flow under gravity feed conditions. It defines design, material assessment, physical and chemical requirements, and normative test methods to ensure safe, accurate and reliable flow regulation.

Key topics and technical requirements

• Scope and purpose: Applies to single‑use, non‑sterile GFRs integrated into sterilized infusion sets to control IV flow rates under gravity feed.
• Design: GFRs must provide constant flow regulation, clearly indicate open and closed positions, resist accidental adjustment, and include a visible scale and pointer for settings (activation defined as open→closed→open).
• Materials and biocompatibility: Materials are assessed per ISO 10993‑1 for biological evaluation; chemical requirements reference ISO 8536‑4.
• Physical requirements:
  • Flow stability: When tested (Annex A.5), flow must remain within ±10% during the 6‑hour stability test after a 15‑minute stabilization period.
  • Flow accuracy: Flow rates must match manufacturer specifications across low, medium and high scale positions.
  • Particulate contamination: Inner surfaces must be smooth and clean; particulate limits tested as specified in ISO 8536‑4.
  • Tensile strength: GFRs shall withstand a static longitudinal force of 15 N for 15 s.
  • Leakage: No leakage permitted in open, closed or intermediate positions; leakage tests use positive pressure (50 kPa) and negative internal excess pressure (−20 kPa) protocols (Annex A.4).
• Test methods (Annex A): Detailed physical tests include particulate, tensile, leakage and flow‑rate determination (e.g., NaCl 9 g/L solution, 1 000 ml test reservoir, 1 000 mm drip chamber height).

Applications and practical value

• Ensures safety and performance of infusion sets used in hospitals, ambulatory care and emergency settings.
• Guides design and verification for manufacturers developing single‑use GFRs to meet regulatory and quality requirements.
• Provides standardized test methods for quality control, bench testing, and type testing by laboratories and notified bodies.
• Reduces risk of infusion errors by specifying readable scales, secure activation and leakproof construction.

Who should use this standard

• Medical device manufacturers (design, R&D, quality)
• Test laboratories and conformity assessment bodies
• Regulatory affairs and procurement teams specifying infusion components
• Clinical engineering and hospital supply managers assessing device compatibility

Related standards

• ISO 8536‑4 (Infusion sets for single use, gravity feed)
• ISO 10993‑1 (Biological evaluation of medical devices)
• ISO 80000‑4 (Quantities and units - Mechanics)

Keywords: ISO 8536-13:2024, graduated flow regulators, infusion equipment, single-use GFR, gravity feed, flow rate stability, leakage test, particulate contamination, medical device standard.