Medical Device Link.

Originally Published MEM Fall 2002

From the Editor

Sherrie Conroy

In 2001, a new standard expanded the EMC requirements for medical devices. Now, IEC 60601-1-2 has taken on even more significance because the Food and Drug Administration has recently begun accepting test results to the international standard as a means of demonstrating compliance with EMC engineering criteria in the United States. In his article that starts on page 82, Dan Hoolihan, former vice president of TÜV America, reviews the new standard with an eye toward clarifying some of the highlights of the standard.

He notes that one of the key new elements of the standard is the pass-fail determination in the immunity tests. The new requirements state that a device should "maintain its essential performance and remain safe" under the applied immunity tests. The first edition allowed a product to fail, under an applied electromagnetic disturbance, as long as it failed safely, Hoolihan says.

This standard could affect many devices already on the market. "While both FDA and the European Union will not expect instantaneous upgrading of devices to the new standard, the extent of the impact to products (including accompanying documents and labeling) suggests that manufacturers of affected devices should begin the process of identifying the changes necessary to bring those devices currently in production into compliance," says Mike Schmidt, secretary of IEC subcommittee 62D.

Schmidt cautions that the new document can be very confusing, so manufacturers need to be doubly aware when testing to provide adequate documentation in advance to ensure that safety failures are correctly identified.

The new standard has much more information, including a greater focus on safety-related failures during immunity testing, says Schmidt, who is cochair of the AAMI Electrical Safety Committee and senior standards associate for Ethicon Endo-Surgery (New Brunswick, NJ).

To ensure efficient testing and safety of the equipment, he stresses the importance of manufacturers understanding the electromagnetic environment in which the equipment or system will be used.

The European Union will effectively allow use of the old standard until November 2004, but manufacturers need to evaluate whether products currently in the development phase of the product life cycle should be designed to the new standard. Now is the time to define a strategy for implementing changes.

Sherrie Conroy, Editor

Copyright © 2002 Medical Electronics Manufacturing