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

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标准号

DIN EN ISO 11608-4-2007

发布日期

2007年11月01日

实施日期

废止日期

无

中国标准分类号

C31

国际标准分类号

11.040.25

发布单位

德国标准化学会

引用标准

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

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.

DIN EN ISO 11608-4-2007系列标准