ATTENTION: European Compliance Standards for Medical Equipment have been updated. The requirements for electromagnetic compatibility and product safety are identified below. They include five new product EMC requirements, as well as changes to the old requirements. Fifty specific product standards now exist. D.L.S. offers a single location for all CE certification requirements. D.L.S will walk you through the declaration process.

BE AWARE: CE Marking for most electrical and electronic medical equipment involves three main aspects per MDD 93/42/EEC:

1. Electromagnetic Compatibility--Immunity EN60601-1-2
Products must continue to operate while being acted upon by unwanted electromagnetic energy, generated in various modes. The number of specific tests in this area has nearly doubled from the earlier first edition. Tests now include Electrostatic Discharge, Radiated Electric Fields, Electrical Fast Transients, Lightning Surge, Conducted Immunity, Magnetic Field Immunity, and Voltage Interruption.

2. Electromagnetic Compatibility--Emissions EN60601-1-2
Products must not emit electromagnetic energy from cables, enclosures, apertures, displays, windows, vents or peripherals higher than the Class A/B emission limits. Testing parameters require measurements for emissions from 150 kHz to 1 GHz, plus Harmonic & Flicker has been added.

3. Medical Device Directive Safety Standard EN60601-1
Unlike the Low-Voltage Directive, the MDD does not allow for CE Marking based solely on a manufacturer's self-declaration. Some level of Notified Body involvement is required. A Notified Body will need to review your quality system for certification. Once the certificate is in place, D.L.S. can assist you with whatever EMC/safety testing and consulting services are necessary to enable your product to meet the MDD requirements.

TAKE ACTION: Speed counts when taking your products to market. D.L.S. is one of the few testing and certification organizations that can perform all the necessary tests required for the CE Mark, as well as offer design assistance, troubleshooting, and problem solving from a certified NARTE engineering staff. Prompt efficient service from the D.L.S. experienced testing and compliance team allows a rapid and seamless transition to the marketplace with your compliant product in just a few days.

REST ASSURED: CE Marking is required for the European Market. Newer, more stringent requirements make your compliance partner choice more important than ever. Meeting these requirements will ensure compliance with laws that mandate the CE Mark for Europe, and combined with D.L.S. test reports, complete your Conformity Assessment process. With D.L.S., experience, speed, and technology are all on your side. Hundreds of companies have utilized D.L.S. for their CE Mark requirements. Don't delay, call D.L.S., the CE Mark Specialist, today at 847-537-6400.