GB14922-2022

Laboratory animal—Microbiological and parasitical standards and monitoring

实验动物微生物、寄生虫学等级及监测

GB 14922-2022 é uma norma nacional chinesa obrigatória vigente: Laboratory animal—Microbiological and parasitical standards and monitoring. Setor: Alimentos. Foco: Segurança de produtos. Entrada em vigor: 1 de jul. de 2023.

A aplicabilidade depende do escopo do produto, da via de certificação, dos avisos da autoridade competente e das regras de transição. Solicite uma tradução ou verifique a fonte antes de usar este registro em uma decisão de conformidade.

Visão geral de conformidade

Esta visão geral está disponível por enquanto apenas em inglês.

Escopo e aplicabilidade

This standard applies to the microbiological and parasitological quality monitoring of laboratory animals, specifically covering mice, rats, guinea pigs, hamsters, rabbits, dogs, and monkeys. It is mandatory for all facilities breeding or utilizing these laboratory animals for research and testing within China. It does not apply to agricultural or companion animals outside the laboratory animal scope.

Requisitos técnicos

The standard classifies laboratory animals into three microbiological and parasitological grades: Conventional (CV) animals, Specific Pathogen Free (SPF) animals, and Germ Free (GF) animals. It mandates that all animals must appear healthy and show no clinical abnormalities. For each grade and species, the standard specifies detailed requirements for pathogenic bacteria, viruses, and parasites. Animals must test negative for all mandatory pathogens specified for their respective grade. Additionally, it defines necessary testing items which are required during disease outbreaks, import/export, or when specific experimental requirements demand it. The standard also introduces targeted requirements for immunodeficient mice, requiring them to be free of specific agents like Corynebacterium bovis and Norovirus.

Métodos de ensaio

Monitoring procedures involve a combination of clinical observation, skin sampling, fur collection for fungal and ectoparasite detection, and blood collection for serological antibody testing. Post-mortem examinations include the isolation of bacteria from tracheal secretions, intestinal contents, and organs. The standard references GB/T 14926 and GB/T 18448 for the specific methodologies used in microbiological and parasitical testing. Testing frequencies and sample sizes are strictly defined based on the animal grade and the size of the breeding colony.

Perguntas frequentes

What products and facilities are regulated under GB 14922-2022?

It applies to the quality monitoring of laboratory animals, specifically mice, rats, guinea pigs, hamsters, rabbits, dogs, and monkeys. It is mandatory for facilities breeding or utilizing these specific animals for research in China.

Are there any significant updates from the previous versions of this standard?

This version merges the previous parasitological and microbiological standards. It removes the clean grade (CV) animal category, updates pathogen names (e.g., Monkeypox Virus), and introduces new testing requirements for immunodeficient mice, such as checking for Corynebacterium bovis and Norovirus.

How does GB 14922-2022 differ from international standards like ISO?

While the core principles align with international laboratory animal guidelines, GB 14922-2022 establishes the specific legal framework and mandatory pathogen lists required for compliance in China. Overseas facilities must adhere strictly to these local parameters when supplying to the Chinese market.

The summary above provides a high-level overview of GB 14922-2022. To ensure complete compliance for your laboratory animals entering or being utilized in the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 14922-2022 today to access all detailed pathogen parameters, monitoring tables, and testing procedures.

Indicações de aplicabilidade

Tipo: Básica
CCS: B44
ICS: 65.020.30
Órgão competente: Ministry of Science and Technology
Comitê técnico: National Technical Committee on Laboratory Animals of Standardization Administration of China

Relações

Substitui:GB 14922.1-2001, GB 14922.2-2011