GB/T 35823-2018 in English

General Requirements for Laboratory Animals - GB/T 35823—2018 Standard In-depth Interpretation

1. Background and Significance of Standard Formulation

GB/T 35823—2018 standard is formulated based on the rapid development of laboratory animal science and the needs of technological evolution, combined with practical experience at home and abroad. Its core is to standardize the management process, technical operation and quality assurance of various animal experiments to ensure the reliability of experimental results.

2. Comparative analysis of standard frameworks

3. Interpretation of the core content of the standard

3.1 Responsibilities of the Laboratory Animal Care and Use Committee (IACUC)

Principles of legality, necessity, scientificity, and ethical review: IACUC is responsible for annual reviews of the use of experimental animals to ensure that all experimental projects comply with legal and ethical requirements. If an approved project needs to be modified, it must be resubmitted for review.

3.2 Experimental conditions and facilities

• Environmental facilities: Comply with the requirements of GB14925 and GB50447, including the site selection, building layout and regional division of animal laboratories.
• Safety protection: Equip with personal protective equipment, establish occupational health guidelines and risk prevention plans.
• Instruments and equipment: Equip with animal-specific equipment such as anesthesia, ECG monitoring, and weighing to meet the experimental purpose and animal welfare needs.

3.3 Laboratory animal quality control

The microorganisms, parasites and genetic background of the experimental animals must comply with the requirements of GB14922.1, GB14922.2 and GB14923. All animals must exclude pathogens that are harmful to humans, and ensure that their appearance, behavior and physiological indicators are normal.

3.4 Basic Technical Operation Specifications

• Animal Acquisition: Purchase or receive animals legally, and obtain relevant certification materials to ensure that the source and genetic background are clear.
• Animal Transportation: Comply with GB14925 and the Guiding Opinions on the Kind Treatment of Laboratory Animals.
• Isolation and Quarantine: Formulate standard operating procedures, strict disinfection and safety protection measures.
• Animal Restraint and Anesthesia: Scientific and reasonable methods, minimize the restraint time and provide postoperative care.

3.5 Experimental Records and File Management

Experimental records must be accurate, complete, clear, and properly preserved. Computer-generated data should be backed up to ensure long-term traceability.