Overview
EN ISO 8536-8:2015 - Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus - defines requirements and tests for sterilized single‑use infusion sets intended to be used with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). Published in 2015 and adopted by CEN, this standard supersedes the 2004 edition and supports conformity with relevant EU medical device requirements.
Key topics and requirements
The standard covers practical and technical aspects relevant to safe design, manufacture and labelling of infusion sets used under pressure. Major topics include:
- Scope and terms - definitions for infusion sets used with pressure infusion apparatus.
- Materials - selection of biocompatible materials and references to biological evaluation (ISO 10993 series).
- Physical requirements - tests and acceptance criteria for:
- particulate contamination,
- tensile strength,
- leakage,
- male conical fittings,
- injection sites and closure‑piercing devices,
- fluid filters and flow rate performance,
- air‑inlet devices, drip chamber, tubing and flow regulators,
- protective caps and storage volume (Annex B).
- Chemical and biological requirements - chemical safety and biological evaluation expectations for sterilized medical devices.
- Packaging, labelling and disposal - unit and multi‑unit labelling, essential label information (manufacturer, LOT/batch, single‑use indication), packaging for sterility and guidance for disposal.
- Normative tests and annexes - physical test methods (Annex A) and storage volume determination (Annex B).
- Regulatory alignment - informative Annex ZA maps clauses to Essential Requirements of EC Directive 93/42/EEC for medical devices.
Applications and users
EN ISO 8536-8:2015 is practical for professionals involved in the lifecycle of infusion sets and pressure infusion systems:
- Medical device manufacturers - product design, testing and technical files for CE marking.
- Quality and regulatory teams - conformity assessment, risk management and documentation.
- Test laboratories - executing the physical, chemical and biological tests referenced.
- Procurement/specification writers - defining supplier requirements and purchase specifications for sterile single‑use infusion sets.
- Clinicians and biomedical engineers - understanding device limitations (pressure rating) and correct usage, labelling and disposal requirements.
Related standards
Relevant cross‑references in the document include ISO 594‑2, ISO 7000, ISO 8536‑4, ISO 15223‑1 and the ISO 10993 series for biological evaluation.
Keywords: EN ISO 8536-8:2015, infusion sets, pressure infusion apparatus, single‑use, sterile infusion equipment, medical device standard, ISO 8536.