Overview - ISO 8536-10:2015 (Infusion equipment | Accessories for fluid lines with pressure infusion equipment)
ISO 8536-10:2015 specifies requirements for sterilized, single‑use accessories used in fluid lines with pressure infusion equipment. The standard covers common components such as two‑way, three‑way and four‑way stopcocks (including manifolds), units with injection sites or check valves, and stoppers/adapters. It complements other parts of ISO 8536 (notably Parts 4, 8, 9 and 12) and applies where national regulations do not take precedence.
Keywords: ISO 8536-10, infusion equipment, pressure infusion equipment, stopcocks, single-use accessories, medical device standard.
Key topics and technical requirements
- Scope of devices: Stopcocks (2/3/4‑way and manifolds), injection‑site or check‑valve units, stoppers and adapters for single use.
- Physical requirements
- Avoidance of air bubbles: flow channels must show no detectable bubbles (Annex A.1).
- Particulate contamination: manufacturing and fluid pathways must minimize particles; rinse tests use ≥50× inner volume (A.2).
- Tensile strength: devices and connections must withstand 15 N static tensile force for 15 s (A.3).
- Leakage: impermeable to air, fluids and microorganisms; stopcocks must be tight in any position (A.4).
- Adapters: conical fittings shall comply with ISO 594‑2 (Luer lock).
- Manipulation: stopcocks/manifolds must operate without impairing adjacent components (A.5).
- Injection site loss limits: max 10 drops per batch and 2 drops per unit (A.6).
- Check valves: must close tightly per ISO 8536‑12 test methods.
- Chemical and biological: chemical tests in Annex B; sterility, freedom from pyrogens and haemolysis per ISO 8536‑4 and ISO 10993‑4.
- Packaging & labelling
- Unit and shelf/multi‑unit labels must include manufacturer, contents description, lot, expiry (year/month), sterile symbol, single‑use symbol, the letter “P” (pressure), instructions and storage notes.
- Use of graphical symbols per ISO 15223‑1 and ISO 7000 is specified.
- Disposal: guidance for safe, environmentally sound disposal (e.g., biohazard procedures).
Applications and who uses this standard
- Medical device manufacturers of infusion accessories and pressure infusion systems (design, production, testing).
- Quality assurance, regulatory affairs, and conformity assessment teams preparing technical documentation and labels.
- Hospital procurement, biomedical engineering and clinical staff selecting compatible single‑use fluid line accessories.
- Test laboratories performing physical, chemical and biological verification against ISO requirements.
Related standards
This concise reference helps manufacturers, clinicians and regulators ensure safety, compatibility and regulatory compliance for single‑use infusion accessories used with pressure infusion equipment.
Open preview (PDF)Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment