Press Release

Press Release: March 26, 2017...11:21am Mega Electronics, Inc. New Brunswick, NJ

FDA extends EMC standard transition date to December 2018

FDA recently announced an extension to the transition date for the Medical EMC standard ANSI/AAMI/IEC 60601-1-2 to December 2018. Although the transition date is now set for 2018, UL Medical EMC experts advise that FDA’s publication “Design Considerations for Devices Intended for Home Use –Guidance for Industry and Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now to cover test levels which may not be appropriately addressed in the 3rd edition.

Key Changes
Following are some of the key changes in the 4th edition.
Use environments are split into three areas:
• Professional Healthcare Facility Environment
• Home Healthcare Environment
• Special Environment (test levels specified in Annex E)

Small clinic, and Home use equipment need CISPR 11 Class B emission, IEC 61000-3-2 Class A harmonic distortion, and IEC 61000-3-3 voltage fluctuation and flicker. The home use equipment needs 10 V/m, 80 MHz to 1 GHz immunity.

For equipment that is installed in an aircraft or an ambulance, additional testing per ISO 7137 and CISPR 25 applies.

For an EUT with auto ranging power supply, most tests are required to be performed at one nominal voltage only. Only voltage interruptions need to be performed at maximum and minimum voltage if the rated voltage range is >25% of lowest rated input voltage.

Immunity test levels increase:
• The range of testing for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in the 3rd edition)
• Magnetic immunity at 30A/m
• Conducted immunity at 6V in ISM bands
• ESD at 8kV contact and 15kV air (up from 6kV and 8kV in the 3rd edition)
• Voltage dips and interruptions at additional phase angles

In addition to these Immunity changes:
• Immunity levels (Table 9) are harmonized with IEC 60601-1-11
• Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards
• Immunity to proximity fields from RF wireless communications equipment is now included, and is based on a minimum separation distance of 30cm
• There is a procedure for continuing to test a product that is damaged by an immunity test signal

And Risk Management is expanded:
• Manufacturers will be required to submit a test plan and the risk analysis document before testing
• Operating modes are based on risk analysis
• Reasonably foreseeable electromagnetic disturbances (Annex F) shall be taken into account in the risk management process
• The risk management process is used to determine whether subsystem testing is allowed
• The minimum separation distance are considered in the risk management process
• Reduced test levels (e.g. based on the intended use of the product) must be justified in the risk management file

MEGA Electronics Is updating our entire line of medical power supplies to met the new 4th edition requirements. We will be pleased to provide you with a quotation for power supplies that meet the new 4th edition.

Reach us at , telephone 732-249-2656 or
February 9, 2017:

Card edge power connectors for faster appliance connections

Looking to the growing use of electronic boards in modern appliances and considering the increasing interest for card edge connections not only for signal but also for power I am pleased to inform you that MEGA Electronics Inc has developed a new range of card edge power connectors.

This new product is defined as PC440 connector and is shown here below:
These connectors over mold a 4 space receptacle with 5mm pitch distance between the spaces and using fork type for PCB Edge mating terminals, in conformity to Molex 94529 or Mikroplax WB5004H.
The plastic material of the receptacle is Nylon 66 UL94V2.
If requested the PC440 family also provide the possibility to have a ground wire that comes out from the body of the connector (pls see the red circle in the below picture), that could be customized in length and termination.
The PC440 family accept Up To 5 conductors cable, 4 conductors in the edge connector and 1 as external ground. The terminals accept conductors size between mm 0,5 to 1,00 or AWG 18-20. PC 440 is molded with PVC as per standard plugs and can be fitted on cables of Maximum OD of 8mmsq. either in PVC or Rubber. This product is also available in a LSZH (low smoke zero halogen) version for Environmental friendly applications.

The PC440 connector is available in combination with a range of international plugs to create a variety of international extension cords, or could be supplied with a cable that can be finished based on customer preference as in a usual power cord.

This solution provides to the customer a strong and reliable electrical connection of the cable to the electronic board, with very fast connection time, and consequent reduction of the labor cost for the product assembly.

The over molding provides protection to dust and water and robustness on the crimping and contact insertion.
In the attached drawing you can see the dimension of the PC440 and the receptacle.

For any further information you may need you can feel free to get in touch with me.
Thanks in advance for your kind attention
February 10, 2017:

Japan CTI requirements and Proof of Tracking

The Comparative Tracking Index or CTI is used to measure the electrical breakdown (tracking) properties of an insulating material. To measure the tracking, 50 drops of 0.1% ammonium chloride solution are dropped on the material, and the voltage measured for a 3 mm thickness is considered representative of the material performance. Also, the term PTI (Proof Tracking Index) is used: it means voltage at which during testing on five samples the samples pass the test with no failures.

Tracking is an electrical breakdown on the surface of an insulating material. A large voltage difference gradually creates a conductive leakage path across the surface of the material by forming a carbonized track that could ultimately cause risk of fire.

PTI requirement on plugs surface has been introduced by Japan as a mandatory requirement approximately one year ago, you can see in attachment the PSE requirement.

All Japan plugs supplied by MEGA Electronics Inc are in conformity with the PTI requirement as they have been made with certain plastic materials and design specifications to assure that this test is passed.