BS EN ISO 8536-2:2010 PDF
Infusion equipment for medical use - Closures for infusion bottles
Infusion equipment for medical use - Closures for infusion bottles
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 апреля 2010 г.
- ICS:
- 11.040.20
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 8536-2:2010
Abstract
1 Scope 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.
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ДействующийInfusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1
Overview ISO 8536-15:2022/Amd 1:2023 is an important amendment to the international standard for infusion equipment used in medical settings. Specifically, it addresses light-protective infusion sets…