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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 — действующий обязательный национальный стандарт Китая: Laboratory animal—Microbiological and parasitical standards and monitoring. Отрасль: Пищевая. Тема: Безопасность продукции. Дата вступления в силу: 1 июл. 2023 г..
Применимость зависит от продукции, схемы сертификации, уведомлений компетентных органов и переходных правил. Закажите перевод или проверьте источник, прежде чем использовать эту запись в решениях по соответствию.
Обзор требований
Этот обзор пока доступен только на английском языке.
Область применения
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.
Технические требования
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.
Методы испытаний
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.
Частые вопросы
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.
Подсказки по применимости
- Тип
- Основополагающий
- CCS
- B44
- ICS
- 65.020.30
- Компетентное ведомство
- Ministry of Science and Technology
- Технический комитет
- National Technical Committee on Laboratory Animals of Standardization Administration of China
Связи
Заменяет:GB 14922.1-2001, GB 14922.2-2011