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GB/T 27416-2014: Laboratory animal institutions -- General requirements for quality and competence
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Laboratory animal institutions -- General requirements for quality and competence
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GB/T 27416-2014
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Basic data | Standard ID | GB/T 27416-2014 (GB/T27416-2014) | | Description (Translated English) | Laboratory animal institutions -- General requirements for quality and competence | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | B44 | | Classification of International Standard | 65.020.30 | | Word Count Estimation | 41,448 | | Date of Issue | 9/3/2014 | | Date of Implementation | 10/1/2014 | | Quoted Standard | GB 14925-2010; GB 19489-2008; GB/T 24001; GB/T 27025; GB/T 28001; GB/T 28002; GB 50436-2011; GB 50447-2008 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Standard specifies the experimental animal facility organization, management and operation of the quality, safety, animal welfare, occupational health, and should meet the basic requirements. Including the various sources of laboratory animals and ex | GB/T 27416-2014: Laboratory animal institutions -- General requirements for quality and competence
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Laboratory animal institutions. General requirements for quality and competence
ICS 65.020.30
B44
National Standards of People's Republic of China
General requirements for animal agencies for quality and competence
Issued on. 2014-09-03
2014-10-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Management System 2
4.1 Organization and Management 2
Personnel requirements 4 4.2
4.3 file management system 4
4.4 Management Manual 4
5 4.5 program files
4.6 Description and procedures 5
4.7 Safety Manual 5
4.8 Record 5
4.9 Identification System 6
File Control 6 4.10
4.11 Work Plan 6
Check 7 4.12
4.13 does not meet the terms of the identification and control 7
4.14 Corrective Action 8
4.15 Precautions 8
Continuous improvement 8 4.16
4.17 Internal Audit 8
4.18 Management Review 8
4.19 emergency management and incident reporting 9
10 5 Laboratory Animal Facility
5.1 Planning and Design 10
5.2 requires the construction of 12
17 6 Animal Feeding
6.1 General 17
6.2 Environmental Control and Monitoring 18
6.3 Animal Behavior Management 18
6.4 Animal identification 18
6.5 Monitoring animal genetic characteristics and genetic manipulation 19
6.6 Animal Nutrition and Health 19
Environmental Health 20 6.7 Feeding
6.8 Waste Management 20
6.9 Management of animals during the holiday 21
Animal care 7 21
21 7.1 Purchasing Animals
7.2 Packaging and transport of animals 21
7.3 animal disease prevention and control 21
7.4 animal disease treatment and care 23
8 Occupational Health and Safety 27
8.1 General 27
8.2 Risk Assessment 28
8.3 Hazard Management and Control 28
8.4 Code of Conduct 29
8.5 staff competency requirements and training 29
8.6 facility design and operation management to ensure 29
8.7 Equipment Inspection and performance guarantee 29
8.8 Personal Protective Equipment 30
8.9 Occupational health care 30
8.10 occupational health and safety information communication 31
8.11 occupational health and safety performance monitoring 31
Responsibility and Management Appendix A (Normative Appendix) IACUC requirements 32
Annex B (informative) reduce animal use, optimization and substitution principle 35
Foreword
The standard configuration according to GB/T 1.1-2009 "Standardization Guide Part 1. Standard structure and write rules" establishment.
This standard certification and accreditation by the National Standardization Technical Committee (SAC/TC261) and focal points.
This standard drafting units. China National Accreditation Center, Beijing Laboratory Animal Management Office of Military
Experimental Animal Center of Medical Sciences, Institute of Medical Laboratory Animal Chinese Academy of Medical Sciences, Shanghai Experimental Animal Research Center, Beijing laboratory animals
Material research center, Chinese Academy of Food and Drug test, Kunming Institute of Zoology, Chinese Academy of Sciences, Guangdong Provincial monitoring of laboratory animals, and out of Guangdong
Habitat Inspection and Quarantine Bureau, Peking University Experimental Animal Center.
The main drafters of this standard. Lu Jing, Zeng Lin, The history of our, LIU Yun-bo, Crosby, yellow tough, Lusheng Ming, Zhu Desheng, He contention, Li Genping, Cheng Shujun,
Fan Wei, Zhao-increasing, Long Bao Lu, Li Minghua, Liu Zhonghua, white.
Introduction
Experimental animals is an important object of scientific research and experimental animals using a mechanism related industries to ensure quality laboratory animals and animal experiments
Quality carrier, to regulate their personnel, facilities, environmental, management and operational procedures is a good way to ensure the quality of animals and animal quality.
With the change of social development and human consciousness, focus on animal welfare is an inevitable trend. Animal welfare and animal quality are inextricably linked,
For animal life, its advantages and disadvantages benefits will have a direct impact on the growth and quality of life.
We should realize that what is animal welfare itself really needed is difficult to have a unified answer, by its social, economic and cultural development
Exhibition of. Since entering civilized society, people and animals by humanity itself understanding of the relationship between man and animals, the formation of many common
Knowledge, but this knowledge is constantly growing and changing. Therefore, the use of this standard should pay attention to track the latest developments in the field. At least, real
Mortem animal bodies can be done according to the requirements of relevant authorities, in accordance with the concept of the system of work of the staff and the management
Animal growth and living environment control, treatment and use of laboratory animals, according to the current acceptable social norms.
The purpose of this standard is to learn by internationally recognized management tools and science achievement, guide agencies through animal experiments involving animals
Production and use of the whole breeding cycle management, achieve scientific and humane treatment of animals and to reduce or avoid the use of animals, while Paul
Quality Certificate experimental animals and animal experiments to ensure that employee occupational health, safety and environment-friendly, and to promote the development of science and industry.
General requirements for animal agencies for quality and competence
1 Scope
This standard specifies the laboratory animal facility organization, management and operation of quality, safety, animal welfare, occupational health and other aspects to be met
basic requirements. Including a variety of sources for animal experiments and experimental animals mentioned in this standard.
This standard applies to all persons engaged in animal breeding and production organizations engaged in animal experiments.
2 Normative references
The following documents for the application of this standard is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 14925-2010 Laboratory Animal Facilities and Environment
GB 19489-2008 General requirements for laboratory biosafety
GB/T 24001 Environmental management systems - Requirements with guidance for use
GB/T 27025 testing and calibration laboratories General requirements
GB/T 28001 Occupational Health and Safety Management System Requirements
GB/T 28002 Occupational Health and Safety Management System Implementation Guide
GB 50346-2011 biological safety laboratory construction technical specifications
GB 50447-2008 Laboratory Animal Facility Construction Specification
3 Terms and definitions
3.1
Animal experiments animalexperiment
For the purpose of any acceptable use of experimental animals, a process that may cause animals pain, suffering, anguish, persistent loss
Injury, pregnancy and maternity.
Note 1. The experimental procedure including the former experiment and after the experiment. Before the experiment process means an animal preparation, including animal tag; a prepared experiment
The animals were used until no longer required for further experiments animals were observed so far; refers to the process of the experiment does not need to be used for animal experiments of the
Configuration process.
Note 2. Does not include practicing veterinarians in clinical behavior.
Note 3. The purpose of animal experiments should be consistent with the principles of national laws and regulations and international practice.
3.2
Experimental animals laboratoryanimals
Accordance with relevant standards specially bred and reared intended for experiments or for other scientific purposes animals.
Note 1. nurture and rearing animals may need to allow the competent authorities.
Note 2. The animals need genetic backgrounds are definite or whose sources are clear, and the exercise of control over their carrying microbes, parasites, and health status.
Note 3. In view of our language habits, when no special distinction, generalized experimental animals with experiments on animals (see 3.5 of this standard).
3.3
Environmental enrichment environmentalenrichment
To the experimental animals as much as possible to meet its environmental and nature items.
NOTE. Environmental enrichment is also known as environmental richness.
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