GB 14922-2022Laboratory animal - Microbiological and parasitological standards and monitoring (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part

1.Structure and Drafting Rules for Standardization Documents" drafting. This document replaces GB 14922.1-2001 "Parasitology Grades and Monitoring of Laboratory Animals" and GB 14922.2-2011 "Laboratory Animals Microbiological Grades and Monitoring", compared with GB 14922.1-2001 and GB 14922.2-2011, except for structural adjustments and editorial changes In addition, the main technical changes are as follows:

a) The concept of animals of each class has been changed (see Chapter 3, Chapter 3 of GB 14922.1-2001, Chapter 3 of GB 14922.2-2011 Chapter 3);

b) Delete the terms and definitions of clean animals (see

3.2 of GB 14922.1-2001,

3.2 of GB 14922.2-2011);

c) Delete the classification of clean animals (see Chapter 4 of GB 14922.1-2001, Chapter 4 of GB 14922.2-2011); Table 1 of GB 14922.2-2011); Test items when necessary (see Table 1 and Table 2, Table 1 and Table 2 of GB 14922.2-2011); Table 4); Table 4 of GB 14922.2-2011);

i) Rat Coronavirus (RCV)/Sialo- Table 1 and Table 2 of GB 14922.1-2001);

k) Pneumocystiscarinii changed to Pneumocystis carinii in the mouse, rat, guinea pig, gopher and rabbit parasites project Pneumocystisspp. Included in the pathogen detection items (see Table 1, Table 2, Table 1, Table 2 of GB 14922.1-2001); virus) (see Table 1, Table 4); Table 2 of GB 14922.2-2011);

n) The English name of Monkeypox Virus was changed from SimianPoxVirus (SPV) to MonkeypoxVirus (MPV), and changed to Mandatory Test items when necessary (see Table 6, Table 6 of GB 14922.2-2011);

o) Added selection of sentinel animals as testing animals (see 8.3.1);

p) The items that must be tested have been changed (see 8.4.1,

8.4.1 of GB 14922.2-2011);

q) Changed the detection items when necessary (see 8.4.2,

1 Scope

GB 14922 defines the microbiological and parasitological grades of laboratory animals in China - conventional, clean, specific pathogen free and germ free - by listing, for each species and each grade, the organisms that must be absent. It then sets the monitoring: which animals to sample, how often, by what method, and how to judge the result. It is the standard that decides whether a facility may call its colony SPF, and therefore whether experiments done in it are accepted. It merges and replaces GB 14922.1-2001 on parasitology and GB 14922.2-2011 on microbiology. Issued on 29 December 2022, in force since 1 July 2023. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the edition it replaces are taken from there. The clause text, the tables and the numeric limits are not reproduced on this page - they are in the document itself, which is delivered in full in English translation.

This document stipulates the grade classification of experimental animal microbiology and parasitology, monitoring indicators and items, rules, result judgment and reporting, etc. Requirements describe the monitoring methods and procedures. This document is applicable to the quality monitoring of experimental animals such as mice, rats, guinea pigs, hamsters, rabbits, dogs and monkeys.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 14926 (all parts) Laboratory animals (microbiological testing methods)

GB/T 18448 (all parts) Laboratory animals (parasite detection methods)

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 common animal Do not carry the specified pathogens of zoonotic diseases and pathogens of severe animal infectious diseases that cause serious harm to animal and (or) human health experimental animals.

3.2 Specific Pathogen Free Animals SPF animals In addition to the pathogens that should be excluded from ordinary animals, those that do not carry pathogens that are harmful to animal health and/or interfere with scientific research experimental animals.

3.3 Germfree(GF)animal Germ-free animals Experimental animals in which no living organisms can be detected in the animal body.

4 Experimental animal microbiology and parasitology level

Experimental animals are classified according to the level of microorganisms and parasites, including ordinary animals, specific pathogen-free animals, and sterile animals.