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HCL Technologies

IEC 60601-1-2 Edition 4.0 Gap Analysis

IEC 60601-1-2 Edition 4.0 Gap Analysis

The International Electrotechnical Commission (IEC) is a global organization for standardization. It comprises all national electrotechnical committees. International standard IEC 60601-1-2 is a collateral standard under the general standard IEC 60601-1 which has been prepared by subcommittee 62A on common aspects of electrical equipment used in the medical practice. The Edition 4.0 of IEC 60601-1-2 was published in February 2014, and this cancels and replaces the Edition 3.0 published in 2007.

The standard IEC 60601-1-2, Edition 4.0 applies to the essential performance and basic safety of medical electrical equipment and medical electrical systems in the presence of electromagnetic disturbances and to the electromagnetic disturbances emitted.

This whitepaper focuses on the gaps between Edition 3.0 and Edition 4.0 of IEC 60601-1-2. What are the new recommendations and what are its effect on the EMC Compliance for medical electrical systems? How will IEC 60601-1-2, Edition 4.0 affect the business?