EN ISO 15747-2019

Plastic containers for intravenous injections

EN ISO 15747-2019 发布历史

This document specifies requirements to the safe handling and the physical@ chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries@ national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

EN ISO 15747-2019由CEN - European Committee for Standardization 发布于 2019-03-01，并于 2019-03-13 实施。

EN ISO 15747-2019的历代版本如下：

• 2005年03月01日 EN ISO 15747-2005 静脉注射用塑料容器
• 2010年04月01日 EN ISO 15747-2010 静脉注射用塑料容器
• 2011年 EN ISO 15747-2011 静脉注射用塑料容器
• 2019年03月01日 EN ISO 15747-2019

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标准号

EN ISO 15747-2019

发布日期

2019年03月01日

实施日期

2019年03月13日

废止日期

无

中国标准分类号

/

国际标准分类号

/

发布单位

CEN - European Committee for Standardization

引用标准

26

适用范围

This document specifies requirements to the safe handling and the physical@ chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries@ national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.