ISO 10985:2009 输液瓶和注射瓶用铝塑组合盖 要求和试验方法

标准编号：ISO 10985:2009

中文名称：输液瓶和注射瓶用铝塑组合盖 要求和试验方法

英文名称：Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods

发布日期：2009-02

标准范围

ISO 10985:2009规定了根据ISO 8536-7或ISO 8362-6分别用于ISO 8536-1规定的输液瓶和/或ISO 8362-1和ISO 8362-4规定的注射瓶的铝-塑料组合瓶盖的一般要求和测试方法。ISO 10985:2009的目的是规定提供以下条件的CAP:在管理之前保证封闭的原创性；将密封元件(橡胶封闭件)压缩到输液瓶和/或注射瓶的密封表面上；保护密封元件免受污染和机械损坏；简单且无损伤地打开封闭件，以暴露橡胶封闭件的穿透区域和/或允许完全移除盖子。

ISO 10985:2009 specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.The purpose of ISO 10985:2009 is to specify caps that provide:

• guarantee of originality of the closure up to the point of administration;
• compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles;
• protection of the sealing element against soiling and mechanical damage;
• simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.

标准预览图