GSO IEC 62366:2014

Medical devices - Application of usability engineering to medical devices

GSO IEC 62366:2014 发布历史

GSO IEC 62366:2014由GSO 发布于 2014-12-25。

GSO IEC 62366:2014在国际标准分类中归属于: 11.040 医疗设备。

GSO IEC 62366:2014 的最新版本是哪一版？

最新版本是 GSO IEC 62366:2014 。

GSO IEC 62366:2014的历代版本如下：

• 2014年 GSO IEC 62366:2014

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

标准号

GSO IEC 62366:2014

发布

2014年

发布单位

GSO

当前最新

GSO IEC 62366:2014

 

 

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