BSI Management Systems has reissued its position on the harmonized standard for electromagnetic compatibility testing for medical devices.
EN 60601-1-2:2002, the international standard for EMC testing of medical electrical equipment, is formally recognized as a harmonized standard under the Medical Devices Directive, published in the European Official Journal on Dec.13, 2002. The previous version of this standard will lose its harmonized status, and with it the presumption of conformity with the essential requirements of the MDD, on Nov. 1.
The standard is voluntary, but it reflects the expectations of the technical community in Europe for addressing the relevant essential requirements of the MDD. Manufacturers of active devices are strongly recommended to obtain the new standard and consider it in any design, development and testing program intended to meet the MDD and CE marking requirements.
For existing active devices that already carry the CE Mark, manufacturers are recommended to obtain the new standard and consider whether a gap analysis between testing against the requirements of the previous standard and the new harmonized standard is required, and how it effects the compliance of their active devices. They should also consider updating their risk analysis in technical documentation to demonstrate that they have considered and addressed the affect of the new standard.
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