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FDA指南:有源医疗器械电磁兼容(EMC)信息

阅读: 2017年12月28日

本指南文件于2016年7月11日发布

本指南文件的草案于2015年11月2日发布


FDA指南:有源医疗器械电磁兼容(EMC)信息


1
概况和范围


美国食品药品监督管理局 (FDA) 发布此指南文件,旨在描述市场准入申请(上市前许可(PMA)申请、人道主义器械豁免(HDE)申请、上市前通告[510(k)]、试验用器械豁免(IDE)申请和de novo认证申请)时应提供的相关信息,为有源医疗器械的电磁兼容(EMC)符合性提供支撑。有源器械包括AC(电源)供电的器械、电池供电的器械、以及有源植入性器械。在本指南文件中,EMC是指器械在其预期的电磁环境中安全有效运行的能力,包括器械的电磁抗扰性以及器械本身不排放过量的可能干扰其它设备的电磁干扰(辐射)。


通常情况下,器械市场准入申请中的EMC信息的评审是基于与在审器械的EMC故障或退化相关的风险、以及适当的FDA认可标准或适当的共识标准的使用。


有源医疗器械的制造商在器械市场准入申请中通常会参考与EMC相关的FDA认可的共识的国家或国际标准。对于医用电气设备或医用电气系统(IEC 60601-1《医用电气设备 - 第1部分:基本安全和基本性能通用要求》中的定义),制造商主要参考IEC 60601-1-2标准或等同的美国版本。此外,在IEC 60601-1系列标准之下,还有一些器械专用的共识标准(“专用标准”)(如:在IEC 60601-2-X中,X代表一种器械专用的标准)。这些专用标准可增强或取代IEC 60601-1-2标准中的规定。有源植入性医疗器械也有包含EMC信息的共识标准。比如:ISO 14708《外科植入物 - 有源植入性医疗器械 - 第3部分:植入式神经刺激器》和ISO 14117《有源植入性医疗器械 - 电磁兼容性 - 植入式心脏起博器、植入式心律转复除颤器和心脏再同步治疗设备的电磁兼容性(EMC)试验协议》。


以下所列的条目旨在帮助确保器械市场准入申请中提供的有关医疗器械电磁兼容(EMC)的信息是清晰一致的,且符合适当标准中的相关规定。本指南文件中参考的FDA认可标准的现行版本,可查阅FDA数据库(认可的共识标准)。该指南文件中的信息预期与其它FDA指南文件结合使用,包括一些器械专用指南(如:《输液泵产品全生命周期》), 以及一些交叉指南(如:《家用医疗器械设计要素》)。


FDA的指南文件,包括本指南,并不具备法规强制性。指南仅是用于表述FDA目前对某个问题的看法,应该当作一种推荐来采纳,除非在其中引用了特定的法规要求。FDA指南文件中用到的单词“should(应、应当、应该)”表示建议或推荐,而不是要求。


2
EMC信息


为便于器械上市准入申请和评审,器械EMC符合性说明应提供以下所列信息:

 A.由制造商定义的医疗器械预期使用的环境;

 B.为支撑EMC而进行的测试的概述;

 C.器械所满足的标准的相关规定(包括抗扰度测试级别);

 D.所使用的器械特定的合格/不合格准则的综述,包括合格/不合格准则如何得来。每个医疗器械应当有基于器械功能、适应症、预期用途和基本性能的特定的合格/不合格准则。器械专用标准(如:IEC 60601-2-X、ISO 14708-3)可能包含同样可以参考的器械特定的检测方法和合格/不合格准则;

 E.被测的器械特定功能(比如:就IEC 60601 -1 -2 而言,器械的特定功能应包括由制造商确定为基本性能的性能)以及在检测过程中如何监控这些功能。例如,用定量测度方法和目测法来监控医疗器械的特定功能。监控系统不应对测试造成干扰;

 F.在每次测试过程中有关器械性能的特有信息,证明器械满足电磁辐射和电磁抗扰的合格/不合格准则。包括在测试过程中发现的任何器械不利影响、毁坏或退化的概述以及这些不利影响、毁坏或退化如何缓解(见下面的第J点);

 G.所用到的标准中的任何允差的判定及其理由(如适用);

 H.与参考标准中的规定的任何偏差的描述及其理由。理由应说明偏差为何不会对器械的安全性和有效性(性能)造成影响;

 I.符合参考标准中标识(识别、标记和文件)规定的器械标识和证据;

 J.为通过EMC测试对器械的测试版本所做的所有更改或整改的详细描述。若进行了整改,应在器械市场准入申请时提供一份声明,明确表示在器械上市前会将所做的更改或整改应用到合法上市的器械版本中,并依照设计控制将其记录在设计历史文件中。此外,应评估这些整改是否会影响器械的其他性能(如:生物相容性),并在申请文件中的器械描述部分提供相关信息来证明这些整改不会对器械的其他性能造成影响或整改过的器械已经进行了其他方面的性能测试。


对于某些特定的有源医疗器械(如:有源植入性器械),FDA可能会根据其预期用途和预期使用环境要求制造商提供以上所列条目之外的其他信息,来证明其电磁兼容(EMC)的符合性。

英语原文

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices


Guidance for Industry and

Food and Drug Administration Staff


Document issued on July 11, 2016.

The draft of this document was issued on November 2, 2015.


1
Introduction and Scope


The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be provided in a premarket submission, (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification [510(k)] submissions, investigational device exemption (IDE) applications and de novo requests), to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. Electrically-powered devices include those that are AC (mains) powered devices, battery powered devices, and active implantable devices. For the purpose of this document, EMC is defined as the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference1), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.


Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.


Manufacturers of electrically-powered medical devices often reference FDA-recognized consensus national or international standards for EMC in pre-market submissions. For medical electrical equipment or medical electrical systems (as defined in the International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety and Essential Performance), manufacturers primarily reference the IEC 60601-1-2 standard or the equivalent United States (US) version. In addition, there are device-specific consensus standards, or “particular” standards, under the IEC 60601-1 family (e.g., IEC 60601-2-X, where X denotes a particular device standard). These particular standards may augment or supersede the specifications in the IEC 60601-1-2 standard. There are also consensus standards for active implantable medical devices that include information on EMC. Some examples include International Organization for Standardization (ISO) 14708 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators for Implantable neurostimulators and ISO 14117 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.


The items listed below are intended to help ensure that clear and consistent information are provided in premarket submissions regarding medical device EMC, and are consistent with the specifications included in the appropriate standards. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. The information in this guidance is intended to be used in conjunction with other FDA guidance documents, including device-specific guidances such as Infusion Pumps Total Product Life Cycle, and cross-cutting guidances such as Design Considerations for Devices Intended for Home Use.


FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.


2
EMC Information


To facilitate premarket submissions and reviews, a claim of EMC for a device should be accompanied by the information listed below:


 A.The environments defined by the manufacturer for which the medical device is intended to be used;

 B.a summary of the testing that was performed to support EMC;

 C.the specifications of the standard that were met (including immunity test levels);

 D.a summary of the device-specific pass/fail criteria used, including how the pass/fail criteria were derived. Each medical device should have specific criteria based on the device functions, indications, intended use, and essential performance. Particular device standards (e.g., IEC 60601-2-X, ISO 14708-3) may contain device-specific test methods and pass/fail criteria that can also be referenced;

 E.the specific functions of the device that were tested (e.g., for IEC 60601-1-2, this should include performance that was determined by the manufacturer to be essential performance) and how these functions were monitored during testing. For example, use quantitative measurements and visual observation to monitor the specific functions of the medical devices. The monitoring system should not perturb the test;

 F.specific information about the performance of the device during each test, demonstrating that the device met the emissions and immunity pass/fail criteria. This includes a summary of any device effects, disruptions, or degradations observed during testing and how these were mitigated (see point J below);

 G.an identification of and a justification for any of the standard’s allowances that were used, if applicable;

 H.a description of and justification for any deviations from the specifications of the referenced standard. The justification should explain how the deviations would not compromise the safety and effectiveness (performance) of the device;

 I.the device labeling and evidence of compliance with the reference standard’s labeling (identification, marking and documents) specifications; and

 J.a detailed description of all changes or modifications that were made to the tested version of the device in order to pass any of the EMC tests. If modifications were made, a statement should be included in the premarket submission indicating that the changes or modifications will be incorporated into the legally marketed version of the device prior to marketing and documented in the design history file in accordance with design controls. In addition, you should assess whether these modifications might impact other aspects of the device performance (e.g., biocompatibility) and provide information in the device description section of the submission to demonstrate that the modifications would have no impact on the other aspects or that the modified device was used for the other performance tests.


Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g., implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).


来自:FDA

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