DIN ISO 8536-6:2017
医用输液设备 第6部分：输液瓶冷冻干燥瓶盖（ISO 8536-6:2016）
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)
- 标准号
- DIN ISO 8536-6:2017
- 发布
- 2017年
- 发布单位
- 德国标准化学会
- 替代标准
- DIN ISO 8536-6 E:2017-04
- 当前最新
- DIN ISO 8536-6:2017-09
- 引用标准
- DIN EN ISO 15378:2016 DIN EN ISO 8536-1:2011 DIN EN ISO 8536-3:2009 DIN EN ISO 8871-1:2004 DIN EN ISO 8871-4:2006 DIN EN ISO 8871-5:2017 DIN ISO 3302-1:1999 DIN ISO 48:2016 DIN ISO 7619-1:2012 ISO ISO 2230:2002 ISO 3302-1:2014 ISO 3302-2:2008 ISO 48:2010
- 被代替标准
- DIN ISO 8536-6:2012
- 适用范围
- This part of ISO 8536 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. Freeze drying closures can pick up water during shipping, storage, washing and steam sterilization cycles, which is difficult to remove in a subsequent drying cycle. As a consequence, the freeze drying closures are usually loaded with residual moisture. Depending upon the mass of the freeze-dried product and the degree of its sensitivity to water, the residual moisture in the rubber material can spoil the freeze-dried preparation during storage. These specific process requirements have been addressed in this part of ISO 8536 by specifying relevant requirements for freeze drying closures including a test method on determination of residual moisture.