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现行 BS EN ISO 80601-2-61:2019
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Medical electrical equipment-Particular requirements for basic safety and essential performance of pulse oximeter equipment 医用电气设备
发布日期: 2019-03-14
BS EN ISO 80601-2-61:2019适用于以下用途的脉搏血氧仪设备的基本安全和基本性能: 用于人体,以下简称医用电气设备。这包括正常使用所需的任何部件, 包括脉搏血氧仪监护仪、脉搏血氧仪探头和探头电缆延长器。交叉引用:IEC 60825-2:2004/AMD1:2006IEC 60825-2:2004IEC 60601-1-11:2015IEC 60601-1:2005ISO 14937:2009IEC 60601-1-12:2014IEC 60601-1-8:2006/AMD1:2012IEC 60068-2-27:2008+AMD1:2013ISO 7010ISO 7000IEC 60529:2013IEC 60417IEC 60601-1-8:2006ISO 15223-1:2016IEC 60825-2:2004/AMD2:2010IEC 60601- 6.6.6)6.6 6.6.6)6.6.6.6:2010年3年3年3年3年3年6年6月6年6年6年6月6年6.6)6 6.6)6 6.6)6 6.6)6.6.6)6.6.6)6.6.6)6.6年6年6.6.6年6.6.6.6)6 6.6)6.6.6.6-6 6 6 6 6 6 6 6 6 6 6 6 6)6)6 6.6.6 6 6 6 6 6 6)6 6 6 6 6 6.6.6.6.6.8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8)IEC IEC指南99:2007IEC60601-1-10:2007ISO 80601-2-61:2011ISO 16142-1:2016IEC 62366:2007IEC TR 60721-4-7:2001/AMD1:2003ASTM E456-13AE3ISO 11073-10404:2010IEC 60721-3-7:2002CLSI C46-A2:2009 GUM:1995ASTM F2761-14VIMCLSI/NCCLS H1-A3:2000ISO/IEC指南98- 3:2008购买本文件时可获得的所有现行修订均包含在购买本文件中。
BS EN ISO 80601-2-61:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.Cross References:IEC 60825-2:2004/AMD1:2006IEC 60825-2:2004IEC 60601-1-11:2015IEC 60601-1:2005ISO 14937:2009IEC 60601-1-12:2014IEC 60601-1-8:2006/AMD1:2012IEC 60068-2-27:2008+AMD1:2013ISO 7010ISO 7000IEC 60529:2013IEC 60417IEC 60601-1-8:2006ISO 15223-1:2016IEC 60825-2:2004/AMD2:2010IEC 60601-1:2005/AMD1:2012IEC 62366-1:2015IEC 60601-1-6:2010IEC 60068-2-64:2008IEC 60068-2-27:2008ISO 4135:2001ISO 3744:2010IEC 60825-1:2014IEC 60601-1-2:2014ISO 14155:2011IEC 60601-1-6:2010/AMD1:2013IEC 60068-2-31:2008ISO 9000:2015ISO 3534-2:2006IEC TR 60878:2015IEC 60601-1-3:2008/AMD1:2013IEC TR 60721-4-7:2001IEC 62366:2007/AMD1:2014IEC 60601-1-3:2008ISO 13732-1:2006ISO/IEC Guide 99:2007IEC 60601-1-10:2007ISO 80601-2-61:2011ISO 16142-1:2016IEC 62366:2007IEC TR 60721-4-7:2001/AMD1:2003ASTM E456 - 13AE3ISO 11073-10404:2010IEC 60721-3-7:2002CLSI C46-A2:2009GUM:1995ASTM F2761-14VIMCLSI/NCCLS H1-A3:2000ISO/IEC Guide 98-3:2008All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
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