DIN EN ISO 11608-5-2013 医用笔式注射器.要求和试验方法.第5部分:自动功能(ISO 11608-5-2012).德文版本EN ISO 11608-5-2012

标准号：DIN EN ISO 11608-5-2013
中文标准名称：医用笔式注射器.要求和试验方法.第5部分:自动功能(ISO 11608-5-2012).德文版本EN ISO 11608-5-2012
英文标准名称：Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012
标准类型：C31
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C31
国际标准分类号：11.040.25
引用标准：ISO 11608-1;ISO 14971;IEC 62366
适用范围：This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO),for the administration of medicinal products in humans,including but not limited to:a)drug product preparation (e.g. reconstitution);b)needle preparation;c)air removal;d)priming;e)dose setting;f)actuation;g)needle insertion;h)injection of the medicinal product;i)disabling the NIS-AUTO;j)needle retraction;k)needle shielding;l)needle hiding;m)sharps injury protection;n)needle removal.