DIN ISO 8536-6-2017 发布历史

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.

DIN ISO 8536-6-2017由德国标准化学会 DE-DIN 发布于 2017-09-00。

DIN ISO 8536-6-2017在国际标准分类中归属于: 11.040.20 输血、输液和注射设备。

DIN ISO 8536-6-2017 发布之时，引用了标准

DIN EN ISO 8536-1-2011 医疗用输液设备.第1部分:玻璃输液瓶(ISO 8536-1-2011).德文版 EN ISO 8536-1-2011
DIN EN ISO 8536-3-2009 医用输液器具.第3部分:输液瓶铝盖(ISO 8536-3-2009).英文版本DIN EN ISO 8536-3-2009-09
DIN EN ISO 8871-1-2004 非肠道及制药设备用弹性件.第1部分:水蒸汽中的提取物
DIN EN ISO 8871-4-2006 非肠道及制药设备用弹性件.第4部分:生物学要求和试验方法
DIN EN ISO 8871-5-2017 非肠道和制药设备用弹性件.第5部分:功能要求和试验(ISO 8871-5-2016);德文版本EN ISO 8871-5-2016
DIN ISO 3302-1-1999 橡胶.产品公差.第1部分:尺寸公差(ISO 3302-1-1996)
DIN ISO 7619-1-2012 硫化橡胶或热塑性橡胶.压痕硬度的测定.第1部分:硬度计法(肖氏硬度)(ISO 7619-1-2010)
ISO 48-2010 硫化或热塑性橡胶.硬度的测定(硬度10 IRHD和100 IRHD之间)
ISO 2230-2002 橡胶产品.贮存导则
ISO 3302-1-2014 橡胶产品公差第1部分:尺寸公差
ISO 3302-2-2008 橡胶.产品公差.第2部分:几何公差
ISO 7619-1-2010 硫化或热塑性橡胶.压痕硬度的测定.第1部分:硬度计法(肖氏硬度)
ISO 8536-1-2011 医用输液设备.第1部分:输液玻璃瓶
ISO 8536-3-2009 医用输液设备.第3部分:输液瓶铝帽
ISO 8871-1-2003 非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物
ISO 8871-4-2006 非肠道及制药设备用弹性件.第4部分:生物学要求和试验方法
ISO 8871-5-2016 非肠道及制药设备用弹性件.第5部分:功能要求和试验
ISO 15378-2015 医用制品的包装原材料.根据良好加工规范(GMP)应用ISO 9001-2008的特殊要求
ISO 15510-2014 不锈钢.化学成分

DIN ISO 8536-6-2017的历代版本如下：

2012年09月 DIN ISO 8536-6-2012 输液用医疗器械. 第6部分: 输液瓶用冷冻干燥瓶塞(ISO 8536-6-2009)
2017年09月 DIN ISO 8536-6-2017 输液用医疗器械.第6部分:输液瓶用冷冻干燥瓶塞(ISO 8536-6-2016)

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标准号: DIN ISO 8536-6-2017
发布日期: 2017年09月
实施日期
废止日期: 无
国际标准分类号: 11.040.20
发布单位: DE-DIN
引用标准: 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 EN ISO 15378-2016 DIN ISO 48-2016 DIN ISO 3302-1-1999 DIN ISO 7619-1-2012 ISO 48-2010 ISO 2230-2002 ISO 3302-1-2014 ISO 3302-2-2008 ISO
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.

DIN ISO 8536-6-2017

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)