BS EN 45502-1:2015规定了通常适用于主动植入式医疗器械的要求 设备。注1:对于特定类型的有源植入式医疗器械，补充或补充了这些一般要求 根据构成本欧洲标准附加部分的特殊标准的要求进行修改。EN 45502中规定的试验为型式试验，将在活性炭样品上进行 植入式医疗设备，以显示合规性。EN 45502的这一部分不仅适用于电驱动的有源植入式医疗设备 但也适用于由其他能源（例如气体压力或弹簧）驱动的设备。EN 45502的这一部分也适用于有源滤波器的一些非植入零件和附件 植入式医疗设备。交叉引用:EN 60068-2-14:2009IEC 60068-2-14:2009EN 60068-2-27:2009IEC 60068-2-27: 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008 2008年6 6 6 6 6 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 6 6 6 6 6 6 6 6 6 6 6 6 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 8601:2004EN 50061:1988EN 60068-2-64:1994IEC6.6-6-2 2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-/83/ECFIPS PUB 199EN 62127-1:2007 IEC 62127-1:2007所有当前修订版可在购买时间包含在购买本文件中。

BS EN 45502-1:2015 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard.The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance.This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES.Cross References:EN 60068-2-14:2009IEC 60068-2-14:2009EN 60068-2-27:2009IEC 60068-2-27:2008EN 60068-2-47:2005IEC 60068-2-47:2005EN 60068-2-64:2008IEC 60068-2-64:2008EN 60601-1:2006IEC 60601-1:2005EN 60601-1:2006/A1:2013IEC 60601-1:2005/A1:2012EN 62304:2006IEC 62304:2006EN 62366:2008IEC 62366:2007EN ISO 10993-1:2009ISO 10993-1:2003EN ISO 11607-1:2006ISO 11607-1:2006EN ISO 14155:2011-10ISO 14155:2011EN ISO 14971:2012ISO 14971:2007ISO 8601:2004EN 50061:1988EN 60068-2-64:1994IEC 60068-2-64:1993ISO 7000EN ISO 10993-9:2009ISO 10993-9:2009EN ISO 11135-1ISO 11135-1EN ISO 11137-1ISO 11137-1EN ISO 11137-2ISO 11137-2EN ISO 13485ISO 13485ISO/TR 14283:2004EN ISO 14937ISO 14937EN ISO 15223-1:2012ISO 15223-1:2012EN ISO 17665-1ISO 17665-1ISO/TS 10974AAMI TIR42:201090/385/EEC96/29/EU1999/519/EC2001/83/ECFIPS PUB 199EN 62127-1:2007IEC 62127-1:2007All current amendments available at time of purchase are included with the purchase of this document.