標準號：BS EN 60601-2-39-2008
中文標準名稱：醫療電氣設備.腹膜透析設備的基本安全和重要性能的特殊要求
英文標準名稱：Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
標準類型：C37
發布日期：2009/3/31 12:00:00
實施日期：2009/3/31 12:00:00
中國標準分類號：C37
國際標準分類號：11.040.99
引用標準：IEC 60601-1-9-2007;IEC 60601-1-10-2007
適用范圍：This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofPERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to asPD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under thesupervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless ofwhether the PD EQUIPMENT is used in a hospital or domestic environment.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS withinthe scope of this standard are not covered by specific requirements in this standard except in7.2.13 and 8.4.1 of the general standard.