Medical Equipment Certification Standards

A white paper from Planar Systems, Inc., discusses in detail important new developments in electronic medical equipment certification, and its implications for manufacturers and medical customers alike. We excerpt part of the paper here, to whet your appetite — the entire document can be read at www.rsleads.com/205df-336

Increased concern for patient well-being is resulting in more technical certification standards for electronic medical systems than ever before. Agencies such as the U.S. Food & Drug Administration (FDA) and European Union Medical Device Directive (MDD) have enacted stricter regulations to govern product attributes from the electrical to the ergonomic and beyond.

Driving these tougher standards are advances in the technology itself…Then there’s the issue of electromagnetic immunity…defined by the FDA as “the ability of an electrical or electronic product to operate as intended without performance degradation in the presence of an electromagnetic disturbance.” In Europe, the greatly increasing amount of electromagnetic activity in medical equipment has led to issuing a strict new standard — IEC 60601-1-2, 2nd Edition — that dramatically increases the level of protection in medical facilities. The standard requires manufacturers to perform extensive analysis to assure that equipment or systems have adequate immunity to electromagnetic disturbances.

Planar's 17.4-inch flat-panel display is certified for safe use within close proximity to patients (UL-2601)

In most cases, electromagnetic interference is a minor concern, but EMI can have tragic consequences, too…And as part of the growing move to harmonize more standards worldwide, a new U.S. safety standard for medical equipment, UL 2601-1, will become effective January 1, 2003. It is based on Europe’s IEC 60601-1 and presents manufacturers with a more complex set of requirements in the areas of product design and documentation.

…just as certification has become tougher for medical equipment manufacturers, so have penalties for non-compliance…Any discussion of standards becomes more complex when considering the various regional and regulatory entities that can impact the certification process. But fundamentally, there are six areas of concern common to all of the standards, regardless of their regional origin or enforcing authority:

• Leakage current through ground, the enclosure, and to the patient
• Dielectric withstand (resistance to insulation breakdown)
• Voltages present and accessible by the user or patient
• Current consumption, and power consumption and dissipation
• Liquid ingress (during spillage events and cleaning)
• Electromagnetic interference (EMI), to and from other equipment in the patient vicinity

These are not arbitrary measures. Rather, they present a framework that shows concern for patient and caregiver safety. In turn, these areas are the subjects of a growing list of nomenclated standards.