FDA, ASCA, EU Medical Device Testing
Compatible Electronics evaluates and tests medical electrical devices to the standards 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, IEC60601-2-4, EN 60601-2-12 and other medical device standards to include IEC 61010-2-101. To help the customer streamline FDA submissions, we are FDA ASCA certified Laboratory. Our staff have years of experience in testing medical device applications and often improve testing quality by ensuring all the most current protocols are utilized, which can result in efficient testing delivery.
Why Partner With Compatible Electronics?
By utilizing Compatible Electronics NVLAP accredited testing (Lab Codes: 200063-0, 200527-0, and 200528-0), FDA ASCA certification, and ILAC certification for your EMI/EMC compliance for medical devices, you 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: Our EMC/EMI diagnostic services allow our 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.
Our Medical Device Testing Expertise
Compatible Electronics is a leading medical testing service provider and has tested thousands of products. Many of our engineers have years of testing experience, making them a reliable resource for all your testing needs. Due to our wealth of experience, our team is a go-to resource for information about medical devices, device mechanics, and regulatory requirements. Most importantly, our team can apply risk analysis to your product to deliver quick and cost-effective validation and verification of your device.
Medical Device EMC Testing
All medical devices adhere to EMC testing standards to ensure the products operate properly and interact correctly with other medical and non-medical devices. Our 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
Form a Partnership With Compatible Electronics Today
Compatible Electronics is one of California’s most extensive testing and consulting companies, making us an excellent choice for your EMC/EMI testing needs. Throughout our years in business, our staff has gained a wealth of experience, making us keenly aware of your needs in medical device testing. We have seven semi-anechoic facilities to accommodate your testing needs on short notice. In addition, we welcome customers to witness our testing process in person at one of our many locations across Southern California.
To learn more about becoming a Compatible Electronics Partner, we encourage you to complete our online contact form or call our team at our Brea office at 714-579-0500, our Newbury Park office 805-480-4044, or our Lake Forest office at 949-587-0400.