標(biāo)準(zhǔn)號(hào)：DIN EN ISO 11608-4-2007
中文標(biāo)準(zhǔn)名稱：醫(yī)用筆式注射器.第4部分:電子和電動(dòng)筆式注射器的要求和試驗(yàn)方法
英文標(biāo)準(zhǔn)名稱：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
標(biāo)準(zhǔn)類型：C31
發(fā)布日期：2007/11/1 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C31
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.040.25
引用標(biāo)準(zhǔn)：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
適用范圍：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.