SIST EN ISO 8536-2:2023 PDF

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

• ISO 8536-1 (Infusion glass bottles)
• ISO 8536-3, ISO 8536-7 (caps and aluminium/plastic caps)
• ISO 8871 series (elastomeric parts - extractables/biological)
• ISO 15378 / GMP guidelines (cGMP for primary packaging)

Keywords: EN ISO 8536-2:2023, closures for infusion bottles, infusion equipment standard, elastomeric closures, spike penetration force, sealability, primary packaging, cGMP.