GB/T 42062-2022: Medical devices - Application of risk management to medical devices

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Scope

This document specifies terminology, principles and a process for risk management of medical
devices, including software as a medical device and in vitro diagnostic medical devices. The
process described in this document intends to assist manufacturers of medical devices to
identify the hazards associated with the medical device, to estimate and evaluate the associated
risks, to control these risks, and to monitor the effectiveness of the controls.

Basic Data

Standard ID	GB/T 42062-2022 (GB/T42062-2022)
Description (Translated English)	Medical devices - Application of risk management to medical devices
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	38,372
Date of Issue	2022-10-12
Date of Implementation	2023-11-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration