EMC Requirements for 医疗设备

在本文中, 史蒂夫·海斯讨论了在研究电磁干扰对医疗设备的影响时的关键要求. He explains some issues manufacturers should consider for risk assessment, electrical safety, EMC, and radio testing. 他指出，单一标准并不能提供制造商所需的所有信息.

EMC requirements for medical devices - why is it important? 

医疗设备 目前市场上是否有一些监管最严格的产品类型. 这是有充分理由的——任何类型的产品故障都可能产生负面后果, 从病人看不到设备的治疗效果到受伤甚至死亡.

When the medical device is merged with wireless functionality, the regulatory framework becomes even more complex. 我们需要更多地了解法规遵从性，以确保我们的产品安全, 符合目的, and meet all the relevant regulations. 因此， 电磁兼容测试 of medical devices is a critical part of any testing program.

可以理解的是，许多医疗器械制造商专注于其产品的临床方面. 他们并不总是理解它在接近其他电气设备或无线设备的情况下使用的影响. This paper seeks to highlight these issues and provide guidance on what to do.

电磁兼容测试 of non-radio medical devices

In the medical world, 术语“EMC”不足以根据全球各种法规的要求对电磁干扰评估进行分类.

为确保医疗设备提供预期的好处和保护，需要进行EMC测试. This includes assessing the product's basic safety and essential performance. 这些要求可以被视为类似于评估其他工业领域电磁干扰的功能安全.

EM testing is not, ,不能, 定义医疗设备的电磁兼容性要求是EMC测试工程师或社区的唯一责任. 临床评估和风险管理是实现电磁兼容和电磁安全的关键. The actual EM testing is a relatively small part of medical device approval. It considers the environment and EM risk identification, 分析, and controls to mitigate the threats posed by other electrical equipment. 

IEC 60601 1 edition 4

The IEC updated the EMC standard for medical, IEC 60601-1-2 in 2014, and it now stands as the 4th Edition more recently amended by AMD1:2020. 该标准的当前版本和早期版本之间有一个根本的区别. It is now a medical device safety testing standard, whereas before it was a medical device 电磁兼容测试 standard. 

乍一看, the changes may appear minor, 但他们的关注点已经从基于功能的标准转向了基于安全的标准. The IEC has issued a new document, IEC 60601-4-2 to underline the differences. 该文件对该问题以及电磁性能和电磁安全评估之间的区别提供了更清晰的说明.

EMC Risk assessment & 目标7351731 

Risk Management is at the very heart of 电磁兼容测试 of medical devices. 制造商必须根据与他们识别的任何风险相关的标准进行评估. 

美国食品和药物管理局(FDA)要求制造商在暴露于医院使用的已知射频设备时考虑其影响. 目标7351731 specifically addresses the threats from Radio Frequency Identification Readers (RFID) and is recognized by FDA for doing so. 该标准适用于任何可能暴露于RFID的医疗电气产品，并评估特定调制(跨越其工作的几个频带)。.

im体育APP has experience with conventional 电磁兼容测试 并开发了一系列服务，以帮助制造商准备和测试目标7351731标准. 我们可以帮助您进行测试和风险管理，并减轻医疗设备EMC测试的此类风险.

Radio-frequency in medical devices

When a medical electrical product incorporates a wireless function, it increases the regulatory requirements considerably. Besides supplementary EMC assessments, manufacturers need to consider the international transmissions from the product. This is to make sure that the product operates on the correct frequency, and transmits the right power level, and other essential radio characteristics. These aspects are regulated through agencies such as the FCC (US), 产品适用 (Canada), and the 欧洲an Radio Equipment Directive (CE标记).

Radio-frequency wireless technology in medical devices 

Regarding the EMC for a 无线设备, 制造商需要确定(或缺乏)无线连接是否会影响设备的基本性能或基本安全. 很明显, if a 无线设备 cannot communicate, its performance will be affected and its intended functionality is undermined.

Given that more and more products are designed for wireless use, the radio spectrum is becoming very congested. 蓝牙无线网络, 无线个域网, and ANT+ are all technologies that use the 2.4GHz ISM band and must coexist with one another to ensure they work as intended. 智能手机失去Wi-Fi只会带来不便，直到手机被用来加快医疗环境中的重要评估过程. 

依靠Wi-Fi连接到护士站的远程警报，如果用于警告病人的关键迹象或静脉注射药物失败，同样会产生重大影响. 对医疗设备进行适当的无线电干扰和抗扰性测试有助于确保这些关键功能在日益拥挤的空间中继续发挥作用.

“Given that more and more products are designed for wireless use, the radio spectrum is becoming very congested, increasing the probability of interference.”

AAMI TIR69 and AMSI C63.27 

医疗器械进步协会(AAMI)发布了一项名为AAMI TIR69:2017的标准-医疗设备和系统的射频无线共存风险管理. The standard helps guide manufacturers with the assessment of 无线设备s, ensuring that they coexist with other wireless products. 

ANSI C63.27:17 17(美国国家标准评估无线共存)提供了测试方法，并确保无线设备在其预期的电磁环境中与其他无线设备一起工作.

The assessment for coexistence involves the communication of the medical product, 然后引入与基频相近或谐波相关的干扰信号. 这确保了产品的基本性能和沟通得以保持.

How can im体育APP help?

im体育APP has a range of services to help, guide, and test for wireless coexistence and can offer these services in a variety of locations both in the UK and the US. You can count on us for 电磁兼容测试, certification, and global market access for your electronic medical devices.  

有关医疗设备EMC要求的更多信息，或者如果您有任何疑问，请 立即im体育APP.