Medical Electronics

The proliferation of wireless communication devices and medical devices utilizing microprocessors is bringing about increased concern about patient safety when electromagnetic interference occurs. Depending on the type of medical device and desired market, regulatory agencies have adopted EMC standards that are changing the design and marketability of these products.

Facilities

CKC Laboratories is one of the best equipped EMC test labs in the United States for EMC testing all types of medical electronics to applicable EMC test standards. For example, we have flush- mounted tables at our Open Area Test Sites (OATS) to accommodate large equipment. This includes a 40 ft. diameter table in Mariposa, CA capable of testing a 30 + ton EUT.   We also operate ambient-free 5 meter full scan height chambers for emissions testing.  These sites are convenient, accurate and completely acceptable for testing electro-medical devices to CISPR 11.  In addition, we have five fully-anechoic chambers located on the West Coast capable of providing European and FDA (per IEC) EMI immunity tests.  See our Laboratory Capabilities  page for the specifications  of each CKC test site.

Medical Device Directive: CE Mark

CKC Laboratories, Inc. provides a wide array of EMC testing, design consultation, and agency submittal services that will help electro-medical device companies gain access to European markets. To apply the CE mark, these products need to comply with the Medical Directive (MDD). The MDD calls for EMC testing in accordance with the latest version of EN 60601-1-2. In many cases, CKC works closely with a MD Directive Notified Body to write a device-specific test plan.  Once the device is tested by CKC, the MD Directive Notified Body prepares a Technical Construction File (TCF). The TCF consists of measurement data, detailed photographs and documentation of the product. 

FDA 510 (k) EMC Requirements

In the United States, EMC test requirements for electro-medical devices are managed by the FDA’s Center for Devices and Radiological Health (CDRH). The FDA's EMC requirements are part of the 510(k) "Substantial Equivalence" process.  Depending on the device type, the FDA requirements typically call for EMC testing and evaluation per IEC 60601-1-2 (2001 with A1:2004).

Per the FDA Website, The Center for Devices and Radiological Health (CDRH) has regulatory authority over a multitude of electro-medical devices.  The CDRH part of FDA has led the way with investigation and examination of medical device EMI (electromagnetic interference).  Laboratory testing by CDRH, and others, has revealed that many devices could be susceptible to problems caused by Electromagnetic Interference (EMI). Indeed, CDRH has been investigating incidents of device EMI and working on solutions (e.g. the 1979 draft EMC test standard for medical devices), since the late 1960s, when there was concern for EMI with cardiac pacemakers.

Powered Wheelchairs and Motorized Scooters

CKC Laboratories has many years of EMC test experience with powered wheelchairs and motorized scooters.  In the 1990’s CKC performed many tests to the early FDA 510(k) EMC requirements.  Today, we continue to test wheelchairs and scooters to the newer ANSI / RESNA WC/Vol. 2-1998 and EN12184 standards.  Our equipment and engineers are well-suited to perform the wheelchair/scooter specific requirements such as charged-frame ESD and expanded power and frequency range for radiated immunity.

Medical Telemetry Devices

Wireless medical telemetry is generally used to monitor patient physiological parameters (e.g., cardiac signals) over a distance via radio-frequency (RF) communications between a transmitter worn by the patient and a central monitoring station.  In addition to the regulatory requirements of the FDA (when marketed in the USA), such devices must meet the regulatory compliance requirements for transmitters of the destination region or countries.  CKC can provide both testing and in-house agency certification for FCC (USA), IC (Canada) and CE mark (Europe).  Please see our Wireless Device Testing and Approvals page for more information.