GB/T 27401-2026Criterion on the quality control of laboratories - Veterinary testing (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. This document supersedes GB/T 27401-2008 "Laboratory Quality Control Standards for Animal Quarantine" and is consistent with GB/T 27401-2008. Compared to previous versions, aside from structural adjustments and editorial changes, the main technical changes are as follows:

a) The terminology and definitions have been changed (see Chapter 3, Chapter 3 of the.2008 edition);

b) Added "General Requirements" (see Chapter 4);

c) The wording of the "Epidemic Reporting" element has been changed; the content is included in the "Confidentiality" section of this document (see 4.2.4,

6.8 of the.2008 version);

d) The name and some content of the "Organization" element have been changed (see Chapter 5,

4.1 of the.2008 edition);

e) The "Personnel" element has been revised, clarifying the requirements for personnel competency, selection, training, supervision, authorization, and competency monitoring. See section 6.2, section

5.2 of the.2008 edition;

f) The content of the "Facility and Environmental Conditions" and "Laboratory Reagents and Waste Management" elements has been revised, and the management of facility and environmental conditions has been refined. Requirements (see 6.3,

5.3 of the.2008 edition);

g) The content of the "Equipment" element has been changed (see 6.4,

5.4 in the.2008 version);

1 Scope

GB/T 27401-2026 is the Chinese national standard covering quality control in a veterinary diagnostic laboratory - the facilities and biosafety containment, the equipment and reagents, the competence of the analysts, the method validation and the quality control alongside routine testing. It replaces GB/T 27401-2008, completing the set of five GB/T 2740x laboratory standards revised together. It was issued on 28 January 2026 and has been in force since 1 March 2026, replacing GB/T 27401-2008. The document is under the responsibility of the Standardization Administration of China. This page is published from the official record of the 2026 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

This document specifies the general requirements, structural requirements, resource requirements, process requirements, and management requirements for quality control in veterinary testing laboratories. This document applies to quality control and competency assessment of veterinary testing laboratories.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB/T 18894-2016 Standard for Electronic Document Archiving and Electronic Records Management

GB 19489-2008 General Requirements for Laboratory Biosafety

GB/T 27000 Conformity Assessment Vocabulary and General Principles

GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories

GB/T 39759 Terminology for Laboratory Animals

GB/T 43051-2023 General Requirements for Biosafety in Laboratory Animals

GB 50346-2011 Technical Specification for Biosafety Laboratory Construction

WS589-2018 Biosafety Labels for Pathogenic Microorganism Laboratories

3 Terms and Definitions

The terms and definitions defined in GB/T 27000, GB/T 27025-2019, and GB/T 39759, as well as the following terms and definitions, apply to this document.

3.1 Veterinary laboratory Conducting research on animal pathogenic microorganisms and parasites, engaging in the development and clinical evaluation of veterinary biological products, veterinary pathology testing, and veterinary clinical practice. A laboratory for bed testing, diagnosis, detection and monitoring of animal diseases, as well as testing of laboratory animal quality and facility environment. [Source: NY/T 2961-2016, 3.1, with modifications]

3.2 sample Materials or materials derived from animals, animal products, or the environment that are intended to reflect the condition of individual animals, groups, products, or the environment through testing or experimentation. thing. [Source: SN/T 2028-2015, 6.11]

3.3 Laboratory biosafety The laboratory's biosafety conditions and status are not lower than permissible levels, preventing harm to laboratory personnel, visitors, the community, and the environment. The damage is acceptable and complies with the relevant regulations and standards regarding laboratory biosafety responsibilities. [Source: GB 19489-2008, 2.13]