YY/T 1813-2022: Methods for operational reliability information collection and evaluation of medical electrical equipment

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Scope

This Document specifies the methods for collecting operational reliability information and
assessing the operational reliability of medical electrical equipment and medical electrical
systems (hereinafter referred to as ME equipment and ME systems) within the period of use
specified by the manufacturer.
This Document is applicable to the collection of operational reliability information and
assessment of operational reliability assessment of ME equipment and ME systems.

Basic Data

Standard ID	YY/T 1813-2022 (YY/T1813-2022)
Description (Translated English)	Methods for operational reliability information collection and evaluation of medical electrical equipment
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	21,230
Issuing agency(ies)	State Drug Administration