IEC Releases New Edition of Basic Standard for Electromedical Equipment
December 19, 2005
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The International Electrotechnical Commission (IEC) released IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, the latest edition of the basic standard covering electrical equipment used in medicine. The new standard includes a formal risk management system (RMS) that meets
ISO 14971, as required for compliance with
IEC 60601-1.
The standard will give manufacturers an efficient and comprehensive guide and meet regulatory authorities' requirements for thoroughness, testability and safety. For the other requirements not covered in the basic standard, the IEC intends to develop specific product standards.
Another major change concerns requirements for essential performance. Earlier editions of IEC 60601-1 tacitly recognized that a patient is sometimes at risk if a piece of medical electrical equipment fails to perform properly.
According to Charles Sidebottom, director corporate standards for Medtronic Inc. in the USA, the basic standard doesn't have many general "essential performance" requirements because that is largely an issue related to particular equipment. IEC 60601-1 clearly establishes that identifying the essential performance of a particular piece of equipment is the responsibility of the writers of Part 2 standards in the IEC 60601-1 family.
Source: International Electrotechnical Commission (IEC).