標(biāo)準(zhǔn)號(hào)：BS EN 60601-1-11-2010
中文標(biāo)準(zhǔn)名稱：醫(yī)療電氣設(shè)備.基本安全性和必要性能的一般要求.附屬標(biāo)準(zhǔn).家庭保健環(huán)境中使用的醫(yī)療電氣設(shè)備和醫(yī)療電氣系統(tǒng)要求
英文標(biāo)準(zhǔn)名稱：Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
標(biāo)準(zhǔn)類型：C37
發(fā)布日期：2010/7/31 12:00:00
實(shí)施日期：2010/7/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C37
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.040.10
適用范圍：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofMEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to asME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.