Overview
ISO 8536-7:2009, "Infusion equipment for medical use - Part 7: Caps made of aluminium‑plastics combinations for infusion bottles", defines requirements for aluminium‑plastics caps used on infusion glass bottles (per ISO 8536‑1). This international standard addresses design, dimensions, tolerances, functional tests and labelling to ensure safe, consistent closures for infusion bottles in clinical and pharmaceutical settings.
Key Topics and Requirements
- Scope and purpose: Specifies caps made of aluminium‑plastics combinations intended for infusion glass bottles; these caps are not considered primary packaging in direct contact with solutions.
- Classification: Two cap types are defined:
- Type ZB: aluminium cap with central opening and plastics component
- Type ZD: aluminium cap with complete tear‑off tab and plastics component
- Dimensions and tolerances: Cap geometry and nominal sizes (examples include 28 and 32) follow the dimensions in the standard and general tolerances in ISO 2768‑1/‑2.
- Construction and materials:
- Aluminium cap requirements reference ISO 8536‑3.
- Plastics component and the aluminium‑plastic interface reference ISO 10985.
- Construction elements must not interfere with the sealing process.
- Functional performance:
- Specified removal forces for plastics component and tear‑off tab (example values: for nominal size 28 - plastics removal max 40 N, tear‑off max 30 N; for size 32 - plastics 60 N, tear‑off 40 N).
- Caps must withstand sterilization per ISO 8872 (see Clause 5.1).
- Packaging and marking: Packaging and marking requirements align with ISO 8872; designation format example: “Cap ISO 8536‑7 - ZD - 32”.
Applications and Who Uses This Standard
ISO 8536‑7:2009 is used by:
- Medical device and closure manufacturers designing aluminium‑plastic caps for infusion bottles.
- Quality assurance and testing labs performing incoming inspection, dimensional checks and removal‑force testing.
- Regulatory and compliance teams ensuring infusion equipment meets international medical device standards.
- Procurement specialists specifying compatible caps for infusion glass bottles.
- Hospital pharmacy and clinical engineering personnel verifying compatibility with infusion bottles and sterilization procedures.
Practical uses include product design validation, supplier qualification, incoming quality control, and ensuring compatibility with sterilization and packaging workflows.
Related Standards
- ISO 8536‑1 (Infusion glass bottles)
- ISO 8536‑3 (Aluminium caps for infusion bottles)
- ISO 10985 (Aluminium‑plastics caps - requirements and test methods)
- ISO 8872 (Aluminium caps - general requirements, packaging, sterilization)
- ISO 2768‑1/‑2 (General tolerances)
Keywords: ISO 8536‑7:2009, infusion equipment, aluminium‑plastics caps, infusion bottles, medical device standards, closure specifications, sterilization, packaging, marking, dimensions and tolerances.
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