活性可植入医疗装置.制造商提供的安全,标记和信息的一般要求

BS EN 45502-1-1998

活性可植入医疗装置.制造商提供的安全,标记和信息的一般要求

Aktive implantierbare medizinische Geraete. Allgemeine Festlegungen fuer die Sicherheit,Aufschriften und vom Hersteller zur Verfuegung zu stellende Informationen Active Implantable Medical Devices Part 1:General Requirements for Safety,Marking and Information to be Provided by the Manufacturer Dispositifs medicaux implantables actifs. Regles generales de securite,marquage et informations fournies par le fabricant

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适用范围：This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential 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 a 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 devices (see note 1). NOTE 1. The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. 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.

实施日期： 1998-02-15

中标分类号： C35 - 医药、卫生、劳动保护 - 矫形外科、骨科器械

ICS分类号： 11.040.40 - 医药卫生技术 - 外科植入物、假体和矫形

标准组织： BS - 英国标准学会标准

全文来源： WF

中文关键词：包装性能试验设备无线电波危害电气试验静电学可混用性电磁兼容性修复装置电压生物分析和试验无菌设备介电强度试验外科植入物超声检验去纤颤器脉冲电压试验防护电气设备电气安全试验条件电驱动装置修复术超声危害医用电气设备耐久性泄漏电流温度交付危害热试验设计电荷包装件机械试验可靠度事故预防耐久试验环境试验寿命作标记安全措施医疗设备使用说明

语种：汉语

页数： 32

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活性可植入医疗装置.制造商提供的安全,标记和信息的一般要求

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