By Nick Otto
All device makers manufacturing within the European Economic Area must ensure their products conform to the third edition of the EN 60601 electrical safety standard by December 31, 2017.
Annex ZZ of EN 60601-1 third edition includes some notes for the transition period of compliance that may indicate a compliance date much sooner, according to the updated standard, published in the Official Journal of the European Union.
However, Richard Vincins, vice president of quality assurance consulting at Emergo Group, says companies should still expect the December 2017 (at the latest) cessation deadline to be enforced.
Vincins adds that differences still exist between major versions of the electrical safety standard — International Electrotechnical Commission (IEC), Underwriters Laboratories (UL) and Europe’s EN designation. In other words, manufacturers in compliance with IEC 60601 3rd Edition may still have work to do in order to meet the requirements of EN 60601-1 or UL 60601-1. He also added that device makers should consult with their electrical safety testing laboratories regarding the differences in particular where they plan to sell and distribute their electrical and electronic equipment.
The IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the IEC.
Back in the States
The FDA in May updated its list of recognized standards, restoring recognition to three radiology standards used in premarket reviews of radiology devices. The list is used by device makers that opt to declare conformity with consensus standards to meet certain regulatory requirements for their products.
The standards being restored include:
- IEC 60601-2-33 Edition 3.0 2010-03, Medical electrical equipment — Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis;
- IEC 60601-2-22 Third edition 2007-05 Medical electrical equipment — Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; and
- IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral standard: radiation protection in diagnostic x-ray equipment.
The May 15 Federal Register notice does say that recognition will be restored “with transition period,” but gives no specification to an exact timeline.