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Compatible Electronics specializes in evaluating and testing medical electrical devices to meet industry standards such as AAMI 60601-1:2012, IEC/EN 60601-1, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-2 Ed. 4.1, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-1-8, IEC/EN 60601-1-11:2015, IEC 60601-2-2, IEC 60601-2-4, EN 60601-2-12, and other relevant medical device standards, including IEC 61010-2-101. The company's expertise extends to FDA ASCA certification, offering streamlined support for customer FDA submissions. With a team of experienced professionals, Compatible Electronics ensures the utilization of the latest protocols to improve testing quality and deliver efficient testing services for medical device applications.

Why Partner With Compatible Electronics?

By utilizing Compatible Electronics' NVLAP, FDA ASCA certification, and ILAC certification for EMI/EMC compliance in medical devices, customers can expect the following:

• Efficient overall process delivery and reporting
• Availability of Lab scheduling access to meet your testing needs and deadlines.
• The most current regulations needed
• Technical design consulting for device development
• Rapid project commencement
• Competitive quotations

Importance of EMC/EMI Testing for Medical Devices

In a world full of technology-driven products, it is vital that Electromagnetic compatibility (EMC) and electromagnetic interference (EMI) design and testing ensure medical devices do not cause interference in their use to cause abnormal clinical data to be used. Conducted or radiated emissions are more problematic than in the past, so testing to the appropriate requirements, like CISPR 11/EN 55011, is essential. Conducting EMI/EMC testing helps gauge if a medical device can function without causing interference and can operate as intended in its electromagnetic environment without experiencing an adverse reaction.

Compatible Electronics provides a world-class EMI/EMC test lab for medical electrical devices and offers a wide array of EMI/EMC and Safety testing and certifications for all device components. Some of the testing services we offer include:

• EMC pre-compliance scans: EMC/EMI diagnostic services allows the team to identify problem frequencies and their locations in a repeatable procedure.
• Radiated emissions: Compatible Electronics can measure the power of unintentional and intentional emissions and identify whether these emissions comply with specific limits.
• Radiated immunity testing: Compatible Electronics can provide many levels of testing for standards like IEC 61000-4-3, and IEC 60601-1-2 Table 9 RF proximity fields.
• Electrostatic discharge (ESD): ESD testing stimulates electrostatic impacts a device may encounter during operation and can determine if a device complies with IEC 61000-4-2 standards.

Medical Device Testing Expertise

Compatible Electronics is a renowned medical testing service provider that has successfully tested thousands of products. The company boasts a team of highly experienced engineers, making them a trusted and reliable resource for comprehensive testing requirements. With their extensive expertise, Compatible Electronics serves as a go-to source for valuable insights on medical devices, device mechanics, and regulatory compliance. Leveraging their wealth of experience, the team excels in applying risk analysis methodologies to swiftly and cost-effectively validate and verify medical devices, ensuring optimum quality and compliance.

Medical Device EMC Testing

The company’s medical device EMC certification services include the following:

• Power frequency magnetic fields – IEC 61000-4-8
• Harmonics and flicker IEC 61000-3-3, 3-2
• Surge – IEC 61000-4-5
• Electrical fast transient – IEC 61000-4-4
• Conducted immunity/emissions – EN 55011/CISPR 11
• Radiated immunity/emissions
• Electrostatic discharge – IEC 61000-4-2

Click here to learn more about Compatible Electronics.