标准号：ISO 14155-1-2003
实施状态：作废
中文名称：人用医疗设备的临床调查.第1部分:一般要求
英文名称：Clinical investigation of medical devices for human subjects - Part 1: General requirements
发布日期：2003-02
被替代标准：ISO 14155-2011
代替标准：ISO 14155-1996;ISO/FDIS 14155-1-2002
采用标准：DIN EN ISO 14155-1-2003,IDT;DIN EN ISO 14155-1-2009,IDT;ANSI/AAMI/ISO 14155-1-2003,IDT;BS EN ISO 14155-1-2003,IDT;BS EN ISO 14155-1-2010,IDT;EN ISO 14155-1-2003,IDT;EN ISO 14155-1-2009,IDT;FprEN ISO 14155-1-2009,IDT;NF S99-201-1-2003,IDT;NF S99-201-1-2009,IDT;S99-201-1PR,IDT;SN EN ISO 14155-1-2003,IDT;SN EN ISO 14155-1-2010,IDT;OENORM EN ISO 14155-1-2003,IDT;OENORM EN ISO 14155-1-2009,IDT;OENORM EN ISO 14155-1-2009,IDT;PN-EN ISO 14155-1-2006,IDT;PN-EN ISO 14155-1-2010,IDT;UNE-EN ISO 14155-1-2003,IDT;UNE-EN ISO 14155-1-2009,IDT;GOST R ISO 14155-1-2008,IDT
起草单位：ISO/TC 194
标准简介：This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to
— protect human subjects,
— ensure the scientific conduct of the clinical investigation,
— assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
This part of ISO 14155
a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,
b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,
c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.
文件格式：PDF
文件大小：237.46KB
文件页数：28
（以上信息更新时间为：2019-11-23）
ISO 14155-1-2003 人用医疗设备的临床调查.第1部分_一般要求.pdf
(237.46 KB)
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