中国医疗器械信息
中國醫療器械信息
중국의료기계신식
China Medical Device Information
2015年
11期
32-34,61
,共4页
助听器%电气安全%标准
助聽器%電氣安全%標準
조은기%전기안전%표준
hearing-aid%electric safety%standard
助听器是用来弥补听力障碍者由于听力损伤所造成缺陷的一种医用电气设备。在过去，助听器一直被认为是安全的，所以业内对于助听器安全的重视程度一直不够。本文介绍了国内外助听器行业标准化的状况，阐述了对安全专用标准转化的迫切需要，解读了IEC60601-2-66《助听器及助听器系统基本安全和主要性能专用要求》，并提出了为了促进行业发展，转化该标准的建议方案。
助聽器是用來瀰補聽力障礙者由于聽力損傷所造成缺陷的一種醫用電氣設備。在過去，助聽器一直被認為是安全的，所以業內對于助聽器安全的重視程度一直不夠。本文介紹瞭國內外助聽器行業標準化的狀況，闡述瞭對安全專用標準轉化的迫切需要，解讀瞭IEC60601-2-66《助聽器及助聽器繫統基本安全和主要性能專用要求》，併提齣瞭為瞭促進行業髮展，轉化該標準的建議方案。
조은기시용래미보은력장애자유우은력손상소조성결함적일충의용전기설비。재과거，조은기일직피인위시안전적，소이업내대우조은기안전적중시정도일직불구。본문개소료국내외조은기행업표준화적상황，천술료대안전전용표준전화적박절수요，해독료IEC60601-2-66《조은기급조은기계통기본안전화주요성능전용요구》，병제출료위료촉진행업발전，전화해표준적건의방안。
Hearing aid are used to make up for the hearing impaired due to hearing loss caused by the defect of a kind of medical electrical equipment. In the past, hearing aid has long been regarded as safe, security industry for hearing adi enough emphasis. This paper introduces the status of the hearing aid industry standardization, expounds the transformation of dedicated to safety standards are urgently needed. The author explains the IEC60601-2-66 " Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems ", and put forward in order to promote the development of the industry, transformation of the standard proposal.
