DIN EN ISO 11608-4:2007
医用笔式注射器.第4部分:电子和电动笔式注射器的要求和试验方法

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006); English version of DIN EN ISO 11608-4:2007-11

被代替

标准号

DIN EN ISO 11608-4:2007

发布

2007年

发布单位

德国标准化学会

替代标准

DIN EN ISO 11608-4:2016

当前最新

DIN EN ISO 11608-4:2016

 

 

引用标准

IEC 60068-2-27:1987 IEC 60529:2001 IEC 60601-1-1:2000 IEC 60601-1-2:2001 IEC 60601-1:1988 IEC60068-2-30:1980 ISO 11608-1:2000

适用范围

This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.The injector may be for single-use or multiple-use.The injector system is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors(as covered in ISO 21649)nor infusion pumps(as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.

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