標準號：ISO 11608-4-2006
中文標準名稱：醫用筆式注射器.第4部分:電子和電動筆式注射器的要求和試驗方法
英文標準名稱：Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
標準類型：C31
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.25
引用標準：ISO 11608-1-2000;IEC 60068-2-27-1987;IEC 60068-2-30-1980;IEC 60068-2-64-1993;IEC 60529-2001
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.