Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
用于医疗用途的输液设备 - 第6部分:用于输液瓶的冷冻干燥器
发布日期:
2016-11-21
ISO 8536-6:2016规定了与药物和生物材料冷冻干燥(或冻干)相关的输液瓶封口类型的形状、尺寸、材料、性能要求和标签,如ISO 8536-1所述。
尺寸要求不适用于涂有屏障的封闭件。
本文件中规定的封盖仅供一次性使用。
ISO 8536-6:2016 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.