ISO 8536-2:2023

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 <75 N; closures must not be pushed into the bottle (Annex B).
  • Spike retention/sealability: no leakage between spike and closure for 4 h and no complete pull‑out (Annex C).
• Chemical and biological safety: Requirements reference ISO 8871-1 (extractables) and ISO 8871-4 (biological tests).
• Labelling: Packed closures should show manufacturer, article description, quantity, manufacture date, batch number and ISO designation.

Applications and practical value

• Ensures compatibility and safety of primary packaging for parenteral infusion solutions-critical to potency, purity and stability of medicinal products.
• Guides manufacturers of elastomeric closures on design, materials and validation testing.
• Supports pharmaceutical producers, quality control and procurement teams when specifying closures for infusion bottles to meet regulatory and cGMP expectations.
• Used by testing laboratories to perform standardized fragmentation, penetration and sealability tests for product release and supplier qualification.

Who should use this standard

• Medical device and pharmaceutical packaging engineers
• Closure manufacturers and suppliers
• Quality assurance/quality control professionals in pharma
• Regulatory and procurement teams specifying primary packaging for infusions

Related standards

• ISO 8536-1 (infusion glass bottles)
• ISO 8536-3 / ISO 8536-7 (aluminium and aluminium‑plastic caps)
• ISO 8871-1 and ISO 8871-4 (chemical and biological requirements)
• ISO 48-4, ISO 3302 series, ISO 2230 (testing and storage guidance)

Keywords: ISO 8536-2, infusion closures, infusion bottles, elastomeric closures, spike penetration, fragmentation, medical infusion equipment, primary packaging, sterilization, cGMP.