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GB/T 35823-2018 English PDF (GBT35823-2018)

GB/T 35823-2018 English PDF (GBT35823-2018)

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GB/T 35823-2018: Laboratory animals -- General requirements for animal experiment

This Standard specifies animal experiment review, laboratory management, experimental conditions, quality of laboratory animals, basic technical operations, experimental records and archiving requirements in various animal experiments. This Standard is applicable to various institutions engaged in animal experiment.
GB/T 35823-2018
GB
NATIONAL STANDARD OF THE
PEOPLE REPUBLIC OF CHINA
ICS 65.020.30
B 44
Laboratory animals -
General requirements for animal experiment
ISSUED ON. FEBRUARY 06, 2018
IMPLEMENTED ON. SEPTEMBER 01, 2018
Issued by. General Administration of Quality Supervision, Inspection and Quarantine;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Animal experiment review ... 6
5 Animal laboratory management ... 6
6 Experimental conditions ... 7
7 Laboratory animal quality ... 9
8 Basic technical operation specification ... 9
9 Experimental record and file management ... 11
Laboratory animals -
General requirements for animal experiment
1 Scope
This Standard specifies animal experiment review, laboratory management, experimental conditions, quality of laboratory animals, basic technical operations, experimental records and archiving requirements in various animal experiments.
This Standard is applicable to various institutions engaged in animal experiment. 2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749, Standards for drinking water quality
GB 14922.1, Laboratory animal - Standards and monitoring for parasitology GB 14922.2, Laboratory animal - Microbiological standards and monitoring GB 14923, Laboratory animal - Genetic quality control of mammalian
laboratory animals
GB/T 14924.1, Laboratory animals - General quality STANDARD for formula feeds
GB 14924.3, Laboratory animals - Nutrients for formula feeds
GB 14925, Laboratory animal - Requirements of environment and housing
facilities
GB 18871, Basic Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources
GB 19489, Laboratories - General Requirements for Biosafety
GB/T 29510, General requirements for the distribution of personal protection organization to review and regulate the use of laboratory animals and welfare ethics
3.9 humane endpoint
during the animal experiment, when the experimental results are known, the early stage of selecting the animal to express pain and pain is the end point of the experiment
3.10 euthanasia
a method of humane termination of animal life that minimizes or eliminates animal panic and pain, allowing animals to die quietly and quickly
4 Animal experiment review
4.1 Responsibilities of Institutional Animal Care and Use Committee
The legal entity engaged in animal experiment work shall establish an
experimental animal management committee, formulate the charter, review procedures, supervision system, regular meeting system, reporting system, work discipline, professional training plan, etc. of the experimental animal management committee.
4.2 Review principle
The review shall adhere to and abide by the principles of legitimacy, necessity, science, animal welfare, ethics, impartiality, balance of interests, etc. 4.3 Review procedure
4.3.1 The person in charge of various animal experiment projects shall submit an application for review to the experimental animal management committee, and the experimental animal management committee shall make an
examination opinion.
4.3.2 The Institutional Animal Care and Use Committee shall implement an annual review of approved projects. Project leader submits project
implementation. Modifications related to animal operations are subject to review by the Institutional Animal Care and Use Committee.
5 Animal laboratory management
5.1 Management agency
The animal experiment institution shall set up an animal experiment
8.4.2 Fixation devices shall be matched to the size of the animal, easy to operate, and can best meet animal welfare requirements. Before using fixation device, the adaptability training shall be performed for the animal.
8.4.3 Under the premise of meeting the experimental requirements, the fixation time shall be shortened as much as possible. When an animal has an abnormal condition during fixation, it shall be released from the fixation device as soon as possible.
8.5 Animal anesthesia and analgesia
8.5.1 Establish scientific and rational anesthesia and analgesia methods and related plans.
8.5.2 Personnel performing anesthesia shall undergo appropriate professional training and have the corresponding ability.
8.6 Postoperative care
Establish reasonable postoperative care, observation and related plans based on animal and surgical characteristics.
8.7 Humane endpoint
Develop and implement the humane endpoint table based on animal breeds
and research purposes.
8.8 Euthanasia
8.8.1 Institutions conducting animal experiments shall comply with relevant regulations or guidelines. According to animal species, age, research purposes, safety and other factors, develop standard operating procedures for the implementation and evaluation of euthanasia.
8.8.2 The person responsible for implementing the euthanasia must undergo special training.
8.8.3 It is not advisable to have other animals present in the operation area where the euthanasia is implemented. The information of each animal must be confirmed before euthanasia. After the death is confirmed, it shall be treated harmlessly.
8.8.4 Non-human primates are not allowed to be executed in principle.
8.9 Waste treatment
Sewage, waste, animal carcasses, etc. produced by animal experiments shall be conducted in accordance with the requirements of GB 14925.

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