標準號：DIN ISO 8536-6-2017
中文標準名稱：輸液用醫(yī)療器械.第6部分:輸液瓶用冷凍干燥瓶塞(ISO 8536-6-2016)
英文標準名稱：Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)
標準類型：C31
發(fā)布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.20
引用標準：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
適用范圍：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.