FDA CDRH standards recognition IEC 601-1-4

FDA CDRH Office of Device Evaluation standards recognition statement for ” IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements For safety; 4. Collateral Standard: Programmable electrical medical systems”. FDA did not choose to recognize this standard for software submissions or even outright for risk management. They did issue a recognition statement explaining their position and conditions under which this standard might be used. An excerpt of their comments are “Portions of this standard related to risk estimation do not appropriately address failures of a systematic nature (hardware design failures and all software failures). The risk associated with a random failure is assessed by considering both the severity of the hazard caused by the failure and the rate of its occurrence. Unlike for random failure, however, the probability or likelihood of systematic failure is impossible to predict. Consequently, hazards associated with risk-related functions subject to systematic failure should be managed based on the severity of the hazard resulting from failure and the assumption that the failure will occur. Hazard management should focus on the mitigation or elimination of hazards that adversely affect patient safety. Hazard analysis should begin with the identification of system requirements and continue throughout the product life cycle. Where applicable, design features should be incorporated that prevent single component failures from adversely affecting patient safety. When reviewing programmable electrical medical systems, reviewers may request documentation from the risk management file described in IEC 60601-1-4, for example, system requirement specifications, hazard analysis, hazard mitigation features, and validation reports. In addition, because conformity to the IEC 60601-1-4 standard may not be sufficient for purposes of demonstrating safety for regulatory submissions, manufacturers should be encouraged to contact the appropriate ODE reviewing group to determine the applicability of this standard for a specific medical device. “

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