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Gap Analysis between the second and third editions of IEC 60601-1

Gap Analysis between the second and third editions of IEC 60601-1

The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees. International standard IEC 60601-1 has been prepared by subcommittee 62A, common aspects of electrical equipment used in medical practice. The third edition of the standard was published in 2005, and this cancels and replaces the second edition published in 1988.

This standard IEC 60601-1, 3rd edition, applies to the basic safety and essential performance of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. Few new clauses have been introduced, and amendments have been made to some of the existing clauses. For instance, under Clause 9, subclause 9.2.2.4 dealing with GUARDS and protective measures has been newly introduced in the third edition. At the same time, subclause 9.4.2.2 in the third edition “Instability excluding transport” has been amended by modifying subclauses 24.1, 24.3 c), 24.3, 24.3 Indent 1 and 24.3 Indent 2 from the second edition of IEC 60601-1.

This Whitepaper focuses on the gaps between the two editions of IEC 60601-1, viz., 2nd and 3rd editions which affect the Mechanical, Electrical and Electromechanical standards of any medical devices. This paper provides an approach to close the gaps which exist between the above said editions of IEC 60601-1.

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