標(biāo)準(zhǔn)號(hào)：BS EN 60601-1-6-2010
中文標(biāo)準(zhǔn)名稱：醫(yī)用電氣設(shè)備.基本安全性和基本性能的一般要求.并列標(biāo)準(zhǔn).可用性
英文標(biāo)準(zhǔn)名稱：Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard - Usability
標(biāo)準(zhǔn)類型：C37
發(fā)布日期：2010/5/31 12:00:00
實(shí)施日期：2010/5/31 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C37
國際標(biāo)準(zhǔn)分類號(hào)：11.040.01
適用范圍：This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify,design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIALPERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITYproblems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used toidentify but does not assess or mitigate RISKS associated with ABNORMAL USE.If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been compliedwith 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, associatedwith USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVEEVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).