ISO 8536-2:2023 PDF

Overview

ISO 8536-2:2023 - "Infusion equipment for medical use - Part 2: Closures for infusion bottles" specifies the shape, dimensions, materials, performance requirements and labelling of elastomeric closures used on infusion bottles. The standard applies to single‑use infusion closures (types A and B) and complements ISO 8536-1 (infusion glass bottles). Dimensional rules exclude barrier‑coated closures. The document also includes normative test methods (Annexes A–D) for fragmentation, spike penetration, spike retention/sealability and the test spike design.

Key topics and technical requirements

• Geometry and sizing: Defines closure shapes (types A and B) and nominal bottle sizes (examples include 28, 29 and 32 mm) with tolerances; general dimensional tolerances per ISO 3302 series.
• Material and sterilization: Elastomeric formulations are specified; closures shall withstand two autoclave cycles at (121 ± 2) °C for 30 min (unless terminal sterilization applies). Manufacturers must ensure batch conformance to type samples.
• Performance tests:
  • Hardness: agreed nominal value ±5 IRHD (tested per ISO 48-4).
  • Fragmentation: ≤20 fragments per ten piercings (Annex A).
  • Spike penetration force: individual ≤80 N and average