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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.20 Transfusion, infusion and injection equipment>BS ISO 8536-6:2016 Infusion equipment for medical use Freeze drying closures for infusion bottles
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immediate downloadReleased: 2017-01-31
BS ISO 8536-6:2016 Infusion equipment for medical use Freeze drying closures for infusion bottles

BS ISO 8536-6:2016

Infusion equipment for medical use Freeze drying closures for infusion bottles

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Standard number:BS ISO 8536-6:2016
Pages:26
Released:2017-01-31
ISBN:978 0 580 91221 4
Status:Standard
DESCRIPTION

BS ISO 8536-6:2016


This standard BS ISO 8536-6:2016 Infusion equipment for medical use is classified in these ICS categories:
  • 11.040.20 Transfusion, infusion and injection equipment

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.

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.