YY/T 0841-2023: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

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Scope

This document specifies testing of medical electrical equipment and medical electrical
system (hereafter referred to as ME equipment and ME systems) or parts of such
equipment or systems, which comply with GB 9706.1, before putting into service,
during maintenance, during inspection, after repair and in other services, or on occasion
of recurrent tests.

Basic Data

Standard ID	YY/T 0841-2023 (YY/T0841-2023)
Description (Translated English)	Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040
Word Count Estimation	49,484
Date of Issue	2023-09-05
Date of Implementation	2025-09-15
Older Standard (superseded by this standard)	YY/T 0841-2011
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the testing, or cycles, of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) that comply with GB 9706.1 and their components before delivery, during maintenance, inspection, after repair and other services. Sex testing requirements. This document does not specify requirements for repairs, parts exchanges and changes to ME EQUIPMENT or ME SYSTEMS. This standard applies to ME equipment and ME systems conforming to GB 9706.1 and their components. This document does not apply to the assessment of whether the design of ME EQUIPMENT, ME SYSTEM or some other equipment complies with their relevant standards. This document does not apply to the assembly of ME systems. Regarding the assembly of ME systems, see Chapter 16 of GB 9706.1-2020.