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sklademVydáno: 2017-01-31
BS ISO 8536-6:2016
Infusion equipment for medical use Freeze drying closures for infusion bottles
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| Označení normy: | BS ISO 8536-6:2016 |
| Počet stran: | 26 |
| Vydáno: | 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.