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ISO 8536-2:2023

Infusion equipment for medical use — Part 2: Closures for infusion bottles

Standard Details

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this document are intended for single use only.

NOTE       The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

General Information

Status : Published
Standard Type: Main
Document No: ISO 8536-2:2023
Document Year: 2023
Pages: 12
Edition: 4
  • Section Volume:
  • ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • ICS:
  • 11.040.20 Transfusion, infusion and injection equipment

Life Cycle

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ISO 8536-2:2023
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