BS EN ISO 8536-2:2010

Foreword
Introduction
1 Scope
2 Normative references
3 Shape and dimensions
4 Designation
5 Material
6 Requirements
7 Labelling
Annex A (normative) - Determination of fragments
Annex B (normative) - Determination of spike penetration
        force
Annex C (normative) - Spike retention/sealability
Annex D (normative) - Closure piercing device

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

This part of ISO8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO8536-1.

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

Closures specified in this part of ISO8536 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.