IEC 60601的本部分适用于助听器和助听器系统的基本安全， 以下也称为医用电气设备或医用电气系统。 如果某一条款或子条款明确规定仅适用于助听器，或仅适用于助听器系统，则该条款或子条款的标题和内容应如此说明。如果不是这样，本条款或子条款适用于助听器和助听器系统（视情况而定）。交叉引用:IEC 62368-1:2018EN 60950-1:2006IEC 60950-1:2005/AMD2:2013EN 60118-0:2015EN 62368-1:2014/A11:2017IEC 60601-1-11:2015IEC 60118-0:2015EN 60950-1:2006/A2:2013IEC 60601-1-2:2014IEC 60950-1:2005IEC 60601-1:2005IEC 60601-1:2005/AMD1:2012IEC 60950-1:2005/AMD1:2009EN 60950-1:2006/A11:2001EN 60113:2014IEC 60618-2014EN- 1:2006IEC 62489-1:2010/AMD1:2014EN 60318-5:2006IEC 62489-1:2010EN 62366-1:2015EN 60601-1-11:2015ISO/TR 25417:2007IEC 60601-1:2005IEC 60645-1:2017EN 62489-1:2010/A1:2015EN 62489-1:2010/A2:2018IEC 60318-5:2006EN 60118-4:2015IEC 62489-1:2010/AMD2:2017EN 60601-1-1:2006/A12:2012IEC 60601-2IEC 610000EN-2018IEC 2018IEC 2018IEC 6100-2018IEC 6100-2018EC-1:2018IEC 610019CISPR 11EN 55011EN 60601-1-9EN 60601-1-10IEC 61000-4-2IEC 60601-1-9EN 61000-4-8IEC 60601-1-10IEC 60601-1-4FDA指南21 CFR 801.420EN 62489-1:2010IEC 60601-1-11:2015EN 60601-1:2006/A1:2013CIEC 60118-4:2014IEC 60118-0:2015EN 60645-1:2017IEC 62366-1:2015EN 60118-0:2015购买本文件时可提供的所有当前修订版。

This part of IEC 60601 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING AIDS and to HEARING AID SYSTEMS, as relevant.Cross References:IEC 62368-1:2018EN 60950-1:2006IEC 60950-1:2005/AMD2:2013EN 60118-0:2015EN 62368-1:2014/A11:2017IEC 60601-1-11:2015IEC 60118-0:2015EN 60950-1:2006/A2:2013IEC 60601-1-2:2014IEC 60950-1:2005IEC 60601-1:2005IEC 60601-1:2005/AMD1:2012IEC 60950-1:2005/AMD1:2009EN 60950-1:2006/A11:2009EN 62368-1:2014IEC 62304EN 60118-13:2019IEC 60118-13EN 60601-1:2006IEC 62489-1:2010/AMD1:2014EN 60318-5:2006IEC 62489-1:2010EN 62366-1:2015EN 60601-1-11:2015ISO/TR 25417:2007IEC 60601-1:2005IEC 60645-1:2017EN 62489-1:2010/A1:2015EN 62489-1:2010/A2:2018IEC 60318-5:2006EN 60118-4:2015IEC 62489-1:2010/AMD2:2017EN 60601-1:2006/A12:2014IEC 60601-1-2:2014ISO/FDIS 80000-8:2019EN 61000-4-2IEC 61000-4-8ANSI C63.19CISPR 11EN 55011EN 60601-1-9EN 60601-1-10IEC 61000-4-2IEC 60601-1-9EN 61000-4-8IEC 60601-1-10IEC 60601-1-4FDA guidance 21 CFR 801.420EN 62489-1:2010IEC 60601-1-11:2015EN 60601-1:2006/A1:2013IEC 60118-4:2014IEC 60118-0:2015EN 60645-1:2017IEC 62366-1:2015EN 60118-0:2015All current amendments available at time of purchase are included with the purchase of this document.