GB/T 35823-2018 English PDF (GB/T35823-2018)

GB/T 35823-2018: Laboratory animals - General requirements for animal experiment
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GB/T 35823-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S 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.
GB/T 35823-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S 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.