T/ZMDS 20006-2022 Risk management evaluation for medical electrical equipment applicable to the GB 9706 series standard

Scope

Scope: This document provides a unified method for evaluating and documenting the compliance of medical electrical equipment with the provisions related to risk management in the GB 9706 series of standards. This document is applicable to medical device inspection agencies and manufacturers in assessing the basic safety and basic performance of medical electrical equipment and medical electrical systems during risk management evaluations. Main technical content: GB 9706.1-2020, the third edition of the general standard, is the foundation of this series of standards. It covers the safety and basic performance of medical electrical equipment and is the first national standard for medical electrical equipment safety to introduce risk management principles based on GB/T 42062. This operational document is formulated for the introduction of risk management into the GB 9706 series of standards. This standard specifies the activities or evidence required for each clause in the risk management standard of GB/T 42062. It explains how to evaluate the risk-hazard identified in the GB 9706 series and the risk-hazard not identified in the GB 9706 series. This standard provides a template for the inspection report form (TRF) of the GB 9706 series of standards and a template for the risk management results form provided by manufacturers to demonstrate compliance. At the same time, it provides recommendations on the focus of applying risk management guidelines and related provisions of the risk management standard. This document is modified based on IECEE OD 2044 Edition 2.4 "Evaluation of Risk Management in Medical Electrical Equipment according to the IEC 60601-1 & ISO/IEC 80601-1 Series of Standards".

Development Information

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