GB14923-2022
Laboratory animal—Genetic quality control
实验动物 遗传质量控制
GB 14923-2022 is a current mandatory Chinese national standard for Laboratory animal—Genetic quality control. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jul 1, 2023.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard applies to the genetic quality control of laboratory animals, specifically covering the genetic classification, nomenclature, and breeding methods for inbred strains, outbred stocks, and hybrids. It is mandatory for all institutions breeding and supplying laboratory animals in China. The standard also includes specific nomenclature guidelines for genetically modified animals created using technologies like CRISPR/Cas9.
Technical requirements
The standard establishes the genetic classification and nomenclature rules for various laboratory animal categories. It details the naming conventions for inbred strains, substrains, recombinant inbred strains, and congenic strains, ensuring standardized identification across breeding facilities. Proper nomenclature is critical for traceability and scientific reproducibility. It specifies the breeding methods required to maintain the genetic integrity of different animal groups. For inbred strains, the standard outlines the structure and mating protocols for foundation stocks, pedigree expansion stocks, and production stocks. For outbred stocks and closed colonies, it emphasizes maintaining genetic heterogeneity and polymorphism while preventing a rapid increase in the inbreeding coefficient. The standard introduces specific requirements for genetically modified animals, including transgenic and targeted mutation animals. It defines the nomenclature principles and quality control procedures to verify the stable inheritance and expression of the modified genes across generations.
Testing methods
The standard outlines several genetic monitoring methods to ensure compliance. Key testing procedures include biochemical marker testing to detect genetic variations, immunological marker testing (such as skin grafting and microcytotoxicity assays), and DNA polymorphism testing utilizing microsatellite and SNP markers. Annual genetic quality testing is required for production colonies. Additional methods like coat color gene testing and mandible measurement are also referenced.
FAQs
What products are regulated under GB 14923-2022?
GB 14923-2022 regulates the genetic quality of laboratory animals, including inbred strains, outbred stocks, hybrids, and genetically modified animals used in research and testing.
Are there any updates from the previous version of GB 14923?
Yes, compared to GB 14923-2010, this version updates the definitions of outbred and closed colonies, adds nomenclature for genetically modified animals using CRISPR/Cas9, and introduces microsatellite and SNP detection methods.
How often should genetic quality testing be conducted?
Genetic quality testing for both inbred and outbred production colonies must be conducted at least once a year.
The summary above provides a high-level overview of GB 14923-2022. To ensure complete compliance for your laboratory animals entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 14923-2022 today to access all detailed parameters, nomenclature rules, and testing procedures.
Applicability hints
- Type
- Foundational
- CCS
- B44
- ICS
- 65.020.30
- Competent department
- Ministry of Science and Technology
- Technical committee
- National Technical Committee on Laboratory Animals of Standardization Administration of China
Relationships
Replaces:GB 14923-2010