YY/T 0648-2025

1.1.1 Equipment Applicable to This Document
The main purpose of this document is to serve as a safety standard for products mentioned in its scope, but it is also applicable to documents developed by technical committees based on the principles stipulated in IEC Guide 104 and ISO/IEC Guide 51 for products similar to those mentioned in this document's scope.
This document specifies general safety requirements for electrical equipment and its accessories intended for the following types of use, regardless of their location.
a) Electrical testing and measurement equipment
This document applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including equipment for self-testing for IVD medical purposes.
In vitro diagnostic medical equipment, whether used alone or in combination, is intended by the manufacturer for in vitro sample examination, including samples from the human body such as blood and tissues, with the sole or primary purpose of providing information on one or more of the following aspects:
● A physiological or pathological state; or
● A congenital abnormality;
● Determining the safety and compatibility of potential recipients;
● Monitoring of treatment measures.
Self-testing in vitro diagnostic medical equipment is intended by the manufacturer for use by non-professionals in a home environment.
Note: If all or a part of the equipment falls within the scope of this document and also within the scope of one or several other GB/T 42125 standards, the other GB/T 42125 standards need to be considered.