YY/T 0648-2025 Pending Industry standards-Medicine

YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment

Publish Date: 2025-09-15 Implement Date: 2026-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 0648-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2025-09-15

Implement Date: 2026-11-01

Pages: 20 pages

Scope

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.

Development Information

Word Count: 25 Thousand words Pages: 20 pages

Replace the following standards

YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment

Referenced Standards

ISO 306 ISO 361 ISO 3746 ISO 7000 ISO 9614-1 ISO/IEC Guide 51 IEC 60027(所有部分) IEC 60065 IEC 60068-2-14 IEC 60068-2-75 IEC 60073 IEC 60227(所有部分) IEC 60245(所有部分) IEC 60309(所有部分) IEC 60320(所有部分) IEC 60332-1-2 IEC 60332-2-2 IEC 60335-2-89 IEC 60364-4-44 IEC 60417 IEC 60529 IEC 60664-3 IEC 60695-11-10 IEC 60799 IEC 60825-1 IEC 60947-2 IEC 60947-3 IEC 61180 IEC 61672-1 IEC 61672-2 IEC 62262 IEC 62471 IEC TR 62471-2 IEC 62598 IEC Guide 104 EN 378-2 GB/T 29791.5-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 5:In vitro diagnostic instruments for selftesting GB/T 42062-2022 Medical devices—Application of risk management to medical devices GB/T 42125.1-2024 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 1:General requirements