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sklademVydáno: 2016-03-31
BS EN ISO 8362-5:2016
Injection containers and accessories Freeze drying closures for injection vials
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| Označení normy: | BS EN ISO 8362-5:2016 |
| Počet stran: | 20 |
| Vydáno: | 2016-03-31 |
| ISBN: | 978 0 580 87254 9 |
| Status: | Standard |
Popis
BS EN ISO 8362-5:2016
This standard BS EN ISO 8362-5:2016 Injection containers and accessories is classified in these ICS categories:
- 11.040.20 Transfusion, infusion and injection equipment
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which 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 part of ISO 8362 are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.