GB/T 42062-2022
ActiveMedical devices—Application of risk management to medical devices
医疗器械 风险管理对医疗器械的应用
Application Summary AI generated
This standard specifies the process for identifying hazards, estimating and evaluating risks, controlling risks, and monitoring the effectiveness of that control throughout the lifecycle of a medical device. It is applied by manufacturers during design, production, and post-market surveillance to ensure patient and user safety, and is also used by regulatory bodies and testing laboratories for conformity assessment and certification of medical devices.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.