GB/T 46302-2025 Pending National standards

GB/T 46302-2025 Automatic sample processing system for medical use

Publish Date: 2025-10-05 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: GB/T 46302-2025

Standard Type: National standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2025-10-05

Implement Date: 2026-11-01

Pages: 24 pages

Scope

This document specifies the requirements, markings, labels, and user manuals for fully automatic medical sample processing systems, as well as their packaging, storage, and transportation, and describes the corresponding testing methods.
This document applies to clinical sample processing systems that connect medical detection modules based on automated track and information network technologies before and after detection.
This document does not apply to equipment used for precise reagent and sample injection functions prior to analysis by clinical testing instruments.

Development Information

Word Count: 33 Thousand words Pages: 24 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use GB/T 42125.1-2024 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 1:General requirements GB/T 42125.5-2024 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 5:Particular requirements for laboratory centrifuges GB/T 42125.14-2023 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 14:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes YY/T 0086-2020 Medical refrigerator YY/T 0657-2017 Medical centrifuge

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