ISO 8536-8:2015

Overview

ISO 8536-8:2015 - Infusion sets for single use with pressure infusion apparatus - provides requirements and guidance for sterilized, single‑use infusion sets intended for use with pressure infusion equipment up to 200 kPa (2 bar). The standard covers product designation, materials, physical, chemical and biological requirements, packaging, labelling and disposal, plus normative test methods in annexes. It is part of the ISO 8536 series on infusion equipment for medical use.

Key Topics and Requirements

• Scope and definitions
  • Covers infusion sets used with pressure infusion apparatus; defines terms such as filling volume (VF), storage volume (VS) and bolus volume (VB) (VS = VF + VB).
• Design and components
  • Nomenclature and example configurations for vented and non‑vented infusion sets and separate air‑inlet devices.
  • Typical components: closure‑piercing device, air‑inlet with air filter, drip chamber and drip tube, fluid filter (commonly nominal pore size ~15 µm), tubing, flow regulators and male conical fittings.
• Materials and sterility
  • Materials must be suitable for sterilization and single use; protective caps required to maintain sterility until use.
• Physical requirements and tests
  • Requirements and test methods for particulate contamination, tensile strength, leakage, male conical fitting integrity, injection sites, fluid filters, flow rate, closure‑piercing devices, tubing, flow regulators, protective caps and storage volume.
• Chemical and biological safety
  • Chemical and biological testing requirements are specified in normative annexes to ensure biocompatibility and cleanliness.
• Packaging, labelling and disposal
  • Labelling requirements (unit and shelf labels), graphical symbols and disposal instructions are covered to support safe use and regulatory compliance.

Practical Applications and Users

ISO 8536-8 is used by:

• Medical device manufacturers designing and producing single‑use infusion sets for pressure infusion.
• Quality and regulatory affairs teams for product conformity, technical files and CE/market clearance support.
• Test laboratories implementing the physical, chemical and biological test methods in the annexes.
• Procurement and clinical engineering in hospitals to evaluate device specifications and compatibility with pressure infusion apparatus.
• Design engineers ensuring correct component selection (filters, fittings, tubing) and safe performance under pressurization.

Related Standards

• ISO 8536-4 (gravity‑feed infusion sets)
• ISO 594-2 (Luer lock fittings)
• ISO 15223-1 (symbols for medical device labelling)
• ISO 7000 (graphical symbols)
• IEC 60601-2-24 (safety of infusion pumps)
• Note: ISO 80369-7 is referenced as a replacement for certain connectors.

ISO 8536-8:2015 is essential for ensuring the safety, performance and regulatory compliance of single‑use infusion sets used with pressure infusion equipment.