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sklademVydáno: 2010-08-31
BS EN ISO 8536-2:2010
Infusion equipment for medical use Closures for infusion bottles
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Označení normy: | BS EN ISO 8536-2:2010 |
Počet stran: | 18 |
Vydáno: | 2010-08-31 |
ISBN: | 978 0 580 71529 7 |
Status: | Standard |
Popis
BS EN ISO 8536-2:2010
This standard BS EN ISO 8536-2:2010 Infusion equipment for medical use is classified in these ICS categories:
- 11.040.20 Transfusion, infusion and injection equipment
This part of ISO 8536 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 part of ISO 8536 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.