CAN/CSA-C22.2 No.60601-1-6-2011(R2021)

Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability

CAN/CSA-C22.2 No.60601-1-6-2011(R2021) 发布历史

CAN/CSA-C22.2 No.60601-1-6-2011(R2021)由SCC 发布于 2011-12-01。

CAN/CSA-C22.2 No.60601-1-6-2011(R2021)在国际标准分类中归属于: 11.040 医疗设备。

CAN/CSA-C22.2 No.60601-1-6-2011(R2021) 的最新版本是哪一版？

最新版本是 CAN/CSA-C22.2 No.60601-1-6-2011(R2021) 。

CAN/CSA-C22.2 No.60601-1-6-2011(R2021)的历代版本如下：

• 0000年 CAN/CSA-C22.2 No.60601-1-6-2011(R2021)

1.1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. 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. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

标准号

CAN/CSA-C22.2 No.60601-1-6-2011(R2021)

发布

2011年

发布单位

SCC

当前最新

CAN/CSA-C22.2 No.60601-1-6-2011(R2021)

 

 

代替标准

2021-01-01

被代替标准

CAN/CSA-C22.2 No. 60601-1-6:08

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