This document specifies the general requirements and basic methods for carrying out reliability work during the life cycle of medical electrical equipment (hereinafter referred to as ME equipment) and medical electrical systems (hereinafter referred to as ME system). This document is applicable to the reliability work of various types of ME equipment or ME system. This document does not contain relevant requirements and methods specific to software reliability. NOTE. All chapters and clauses in the main text of this document have corresponding relevant principle explanations in Annex A.
Basic Data
Standard ID
YY/T 1837-2022 (YY/T1837-2022)
Description (Translated English)
Medical electrical equipment - General requirements for reliability
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
