GB/T 27416-2014Laboratory animal institutions - General requirements for quality and competence (English PDF)

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.

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

China's national standard setting the general requirements for the quality and competence of laboratory animal institutions. It specifies the requirements for the management, the personnel, the facilities, the environment, the animal care and the operating procedures of the organisations that breed, supply and use laboratory animals, and it is the technical basis on which such institutions are accredited. The standard rests on a proposition that is stated plainly in its introduction: the quality of the animal and the quality of the experiment cannot be separated. A laboratory animal is a biological reagent whose genetic background, microbiological status, nutrition, environment and handling all affect the result obtained from it, and an experiment carried out on an animal of unknown or variable status produces data of unknown value. Everything the standard requires follows from that - the control of the genetic and microbiological status, the environment and its monitoring, the feed and water, the caging and the husbandry, the records, and the competence and training of the people who do the work. The second proposition, given equal weight, is animal welfare. The introduction is candid that what an animal actually needs is not a settled question and that the answer moves with social, economic and cultural development, but it treats welfare and quality as inseparable in practice: the conditions in which an animal lives affect its growth, its physiology and therefore the data it produces, so welfare is not a constraint imposed on good science from outside but a component of it. The standard therefore covers the ethical review, the housing and enrichment, the humane endpoints and the handling procedures alongside the technical requirements. Issued on 3 September 2014 and in force since 1 October 2014.

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.