EN 45502第1部分规定了通常适用于活动可植入医疗器械的要求。 注1对于特定类型的活动可植入医疗器械，这些一般要求由构成本欧洲标准附加部分的特定标准的要求进行补充或修改。 EN 45502中规定的试验是型式试验，并且要对活性可植入医疗装置的样品进行试验以证明符合性。 EN 45502的第1部分不仅适用于电力供电的活动可植入医疗器械，还适用于由其他能源（例如通过气体压力或弹簧）供电的那些。 EN 45502的第1部分也适用于有源可植入医疗器械的一些非植入部件和附件。 注2:本欧洲标准中使用的术语旨在符合90/385/EEC指令的术语。 注3在本欧洲标准中，按照第3条的规定使用小写字母打印的术语。如果在另一个术语中将定义的术语用作限定词，则不会以小写字母打印，除非也定义了合格的概念

This Part 1 of EN 45502 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 1 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 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.