医疗设备EMC要求

In this article, Steve Hayes discusses the key requirements when looking at the impact of electromagnetic interferences on medical devices. 他解释了制造商在进行风险评估时应该考虑的一些问题, 电气安全, EMC, 无线电测试. He shows that a single standard does not provide all the information manufacturers need.

医疗设备的EMC要求-为什么它很重要? 

Medical devices are some of the most heavily regulated product types available on the market today. It is for good reason - any type of product failure can have negative consequences, from patients not seeing the therapeutic benefit of the device to injuries or even deaths.

当医疗设备与无线功能合并时, 监管框架变得更加复杂. We need to know more about regulatory compliance to make sure our products are safe, fit for purpose, 并符合所有相关规定. As a result, 医疗设备的电磁兼容测试 是任何测试程序的关键部分吗.

Understandably, many medical device manufacturers focus on the clinical aspects of their products. They don’t always understand the impact of its use in close proximity to other electrical equipment or wireless devices. 本文试图突出这些问题，并就如何做提供指导.

非无线电医疗设备的电磁兼容测试

在医学界, the term 'EMC' is not sufficient to categorize the assessment of Electromagnetic Disturbances as required by various regulations around the globe.

To ensure that medical devices provide the benefits and protection intended, EMC testing is required. 这包括评估产品的基本安全性和基本性能. The requirements can be considered as being similar to functional safety for the assessment of EM disturbances in other areas of industry.

电磁测试不是, and cannot, be the sole responsibility of the EMC test engineer or community to define the EM requirements for a medical device. Clinical evaluation and risk management are essential to achieving both electromagnetic compatibility and electromagnetic safety. 实际的电磁测试是医疗器械批准中相对较小的一部分. 它考虑了环境和新兴市场风险识别, analysis, 以及控制以减轻其他电气设备带来的威胁. 

IEC 60601 1版4

IEC更新了医疗EMC标准， 2014年IEC 60601-1-2，现在是AMD1:2020最近修订的第4版. There is a fundamental difference between the current and early versions of the standard. 现已成为医疗器械安全检测标准, 而在此之前，它是医疗设备的EMC测试标准. 

At first glance, 这些变化可能看起来很小, but their focus has shifted from a standard based on functionality to one based on safety. IEC发布了一份新文件IEC 60601-4-2来强调这些差异. The document provides greater clarity on the issue and the difference between electromagnetic performance and electromagnetic safety assessments.

EMC风险评估 & AIM 7351731 

风险管理是医疗设备EMC测试的核心. A manufacturer is required to perform an assessment based on the standard related to any risks they identify. 

The Food and Drug Administration (FDA) in the US requires manufacturers to consider the implications when exposed to known RF devices used in hospitals. AIM 7351731专门针对来自 无线射频识别阅读器(RFID) 并且得到了FDA的认可. The standard applies to any medical electrical product that could be exposed to RFID and assesses the specific modulations (across several frequency bands on which they operate).

im体育APP有常规的经验 EMC testing and has developed a range of services to help manufacturers prepare and test against the AIM 7351731 standard. We can help with testing and risk management and mitigate these types of risks for EMC testing of your medical devices.

医疗设备中的射频

当医疗电气产品包含无线功能时, 这大大增加了监管要求. 除了补充EMC评估外, 制造商需要考虑从产品的国际传输. 这是为了确保产品在正确的频率上运行, 并传输正确的功率水平, 以及其他重要的无线电特性. 这些方面都是通过诸如 FCC (US), ISED (加拿大)和欧洲 无线电设备指令 (CE marking).

医疗设备中的射频无线技术 

关于a的EMC wireless device, the manufacturer needs to determine if (or lack of) a wireless link affects the essential performance or basic safety of the device. Clearly, 如果无线设备无法通信, 它的性能将受到影响，其预期功能将被破坏.

鉴于越来越多的产品被设计为无线使用, 无线电频谱正变得非常拥挤. Bluetooth, Wi-Fi, ZigBee和ANT+都是使用2.并且必须彼此共存以确保它们按预期工作. Wi-Fi loss for a smartphone would be a mere inconvenience until the phone is used to speed up an essential evaluation process in a medical setting. 

Remote alarms that rely on a Wi-Fi connection to a nurse station could equally have a major impact if they were being used to alert critical signs of a patient or IV drug failure. Appropriate radio interference and immunity testing of medical devices help to ensure that these critical functions continue to perform in an increasingly crowded space.

“鉴于越来越多的产品被设计为无线使用, 无线电频谱正变得非常拥挤, 增加干扰的可能性.”

AAMI TIR69和AMSI C63.27 

The Association for the Advancement of Medical Instrumentation (AAMI) published a standard called AAMI TIR69:2017 - Risk management of radio-frequency 无线共存 for medical devices and systems. 该标准有助于指导制造商评估无线设备, 确保它们与其他无线产品共存. 

ANSI C63.27:2017 (American National Standard for Evaluation of Wireless Coexistence) provides test methods and ensures that a wireless device works alongside other wireless devices in its intended EM environment.

共存评估涉及到医疗产品的沟通, followed by introducing interfering signals close or harmonically related to the fundamental frequency. This ensures that the essential performance and communication of the product are maintained.

Element如何提供帮助?

im体育APP有一系列的服务来帮助、指导和测试 无线共存 并且可以在英国和美国的不同地点提供这些服务. 您可以信赖我们的EMC测试，认证和 全球市场准入 你的电子医疗设备.  

For more information about EMC requirements for medical devices, or if you have any questions, contact us today.