Overview
EN ISO 8536-2:2023 - Infusion equipment for medical use - Part 2: Closures for infusion bottles - specifies the shape, dimensions, materials, performance requirements and labelling for elastomeric closures used on infusion glass bottles (as referenced in ISO 8536-1). The standard applies to single‑use closures (note: dimensional requirements do not apply to barrier‑coated closures) and replaces the 2010 edition, adding a 29 mm size to align with ISO 8536-1.
Key topics and technical requirements
- Shape & dimensions: Prescribed geometries for two typical closure designs (type A and B) with dimensional tolerances; flange conicity and allowable indentations are covered.
- Designation: Naming convention (e.g., Infusion closure ISO 8536-2 - 32 - A) to ensure clear identification and compatibility.
- Material & sterilization: Elastomeric formulations must meet performance requirements and withstand two autoclave cycles at (121 ± 2) °C for 30 min without functional impairment; suitability for other sterilization methods (e.g., irradiation) must be demonstrated.
- Performance tests (normative annexes):
- Hardness (Shore)
- Fragmentation (annex A) - limits on particulates released on piercing
- Spike penetration force (annex B) - controlled piercing characteristics for access devices
- Spike retention / sealability (annex C) - leakage and reseal performance after piercing
- Resistance to ageing, chemical and biological requirements (including extractables and biocompatibility tests per referenced documents)
- Closure piercing device specification (annex D) used for testing
- Labelling: Requirements to support traceability and correct use.
- Quality context: Recognizes that primary packaging affects potency, purity and stability; principles of cGMP apply to manufacturing.
Practical applications and users
Who uses EN ISO 8536-2:2023:
- Closure and elastomeric component manufacturers - to design and validate infusion bottle closures.
- Pharmaceutical and medical device manufacturers - to select compliant primary packaging for parenteral products.
- Quality, regulatory and procurement teams - to specify requirements in supplier contracts and technical files.
- Test laboratories and conformity assessors - to perform standardized performance and biological tests.
Practical benefits:
- Ensures mechanical compatibility with infusion bottles and predictable piercing behavior.
- Reduces fragmentation and contamination risk at point of access.
- Supports regulatory compliance, consistent supplier qualification and safe parenteral product packaging.
Related standards
Keywords: EN ISO 8536-2:2023, closures for infusion bottles, infusion equipment standard, elastomeric closures, spike penetration force, sealability, primary packaging, cGMP.
