SANS 10386-2008 The care and use of animals for scientific purposes《用于科研目的的动物护理及使用》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22296-3 SANS 10386:2008Edition 1SOUTH AFRICAN NATIONAL STANDARD The care and use of animals for scientific purposes Published by SABS Stan

4、dards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 10386:2008 Edition 1 Table of changes Change No. Date Scope Acknowledgement This South African standard is based on the Australian Standard of Practice for the

5、 care and use of animals for scientific purposes, September 1997, drawn up by the National Health and Medical Research Council of Australia (copyright Commonwealth of Australia, reproduced by permission), and on the European Convention for the protection of vertebrate animals used for scientific stu

6、dy and for other scientific purposes. Foreword This South African standard was approved by National Committee SABS SC 1040D, Steering committee for nature conservation The care and use of animals for scientific purposes, in accordance with procedures of the SABS Standards Division, in compliance wit

7、h annex 3 of the WTO/TBT agreement. This document was published in December 2008. Annexes A to P are for information only. Introduction The purpose of this standard is to ensure the ethical and humane care of animals used for scientific purposes, as well as for teaching activities. Its aims are to:

8、a) emphasise the responsibilities of researchers, teachers and institutions using animals; b) ensure that the welfare of animals is always considered; c) ensure that the use of animals is justified by the establishment of Animal Ethics Committees (AECs) so as to ensure adherence to the principles of

9、 Replacement, Reduction and Refinement (the 3 Rs); d) prevent or minimize pain or distress, where possible, for each animal used in scientific studies and teaching activities; e) ensure minimum uniform national standards regarding animal care and use; f) minimize the number of animals used in scient

10、ific studies and teaching activities in such a way that this does not jeopardise the validity of the studies or activities; and g) promote the development and use of techniques which adhere to the principles of Replace, Reduce and Refine animal use in scientific studies and teaching activities (see

11、(c). SANS 10386:2008 Edition 1 1 Contents Page Acknowledgement Foreword Introduction 1 Scope . 5 2 Normative references 5 3 Definitions . 6 4 General principles for the care and use of animals for scientific studies and teaching activities 9 4.1 Purpose. 9 4.2 Justification and responsibilities 9 4.

12、3 Replacement . 10 4.4 Reduction 10 4.5 Refinement 10 5 Responsibilities of institutions and their AECs 11 5.1 Responsibilities of institutions. 11 5.2 Responsibilities and operation of AECs 13 5.2.1 Compliance with this standard . 13 5.2.2 Terms of reference. 13 5.2.3 Membership . 14 5.2.4 Written

13、proposals . 16 5.2.5 Operating procedures 18 5.2.6 Assessing proposals 195.2.7 Monitoring. 19 5.2.8 Annual review. 19 5.2.9 Reporting to institutions 20 5.2.10 Categorizing proposals 21 5.2.11 Scientific studies and teaching activities at more than one institution . 21 5.2.12 Non-institutional appli

14、cants and the responsibility of the AEC. 21 6 Responsibilities of researchers and teachers . 21 6.1 General 21 6.2 Planning studies 23 6.3 Conduct of scientific studies and teaching activities. 23 6.3.1 General considerations 23 6.3.2 Additional considerations . 27 7 Acquisition and care of animals

15、in breeding and holding areas 32 7.1 General . 32 7.2 Animals obtained from facilities within the Republic of South Africa (RSA) . 33 7.3 Animals obtained from other countries . 34 7.4 Admission of new animals into holding facilities . 34 SANS 10386:2008 Edition 1 2 Contents (continued) Page 7.5 Car

16、e of animals in holding and production facilities 34 7.5.1 General 34 7.5.2 Outdoor holding facilities 35 7.5.3 Indoor housing 35 7.5.4 Environmental factors 36 7.5.5 Food and water 37 7.5.6 Pens, cages, containers and the immediate environment of the animals . 38 7.5.7 Environmental enrichment . 39

17、 7.6 Species-specific minimum housing requirements. 39 7.7 Management and staff 51 7.7.1 Person-in-charge of breeding and holding facilities. 51 7.7.2 Staff . 53 7.7.3 Routine husbandry procedures 53 7.7.4 Identification of animals 54 7.7.5 Disposal of animal carcasses and waste. 54 8 Wildlife studi

18、es 54 8.1 General 54 8.2 Wildlife captured from natural habitats 54 8.3 Capturing of wildlife. 55 8.3.1 General 55 8.3.2 Use of traps 55 8.3.3 Non-trap capture 56 8.3.4 Handling and restraint of wildlife 56 8.3.5 Holding and release . 57 8.3.6 Transport 57 8.3.7 Identification . 58 8.3.8 Field techn

19、iques. 58 8.3.9 Voucher specimens 58 8.3.10 Wildlife interaction studies 58 8.3.11 Feral animal studies. 59 9 Care and use of farm animals for scientific studies and teaching activities 59 9.1 General . 59 9.2 General requirements . 59 9.3 AEC applications. 60 9.4 Teaching and demonstration requirem

20、ents for all farm animals. 60 10 The use of animals to demonstrate knowledge or techniques in scientific disciplines in schools and tertiary institutions 61 10.1 General . 61 10.2 General principles . 61 10.3 Responsibilities of lecturers and teachers . 61 10.4 Animals used in primary and secondary

21、schools 62 SANS 10386:2008 Edition 1 3 Contents (concluded) Page Annex A (informative) Genetic and microbiological status of laboratory animals 63 Annex B (informative) Care and management of laboratory animals Amphibians (Frogs (Xenopus laevis) 67 Annex C (informative) Care and management of labora

22、tory animals Birds . 81 Annex D (informative) Care and management of laboratory animals Cattle 104 Annex E (informative) Care and management of laboratory animals Cephalopods 111 Annex F (informative) Care and management of laboratory animals Dogs and cats 120 Annex G (informative) Care and manageme

23、nt of laboratory animals Fish. 137 Annex H (informative) Care and management of laboratory animals Horses 151 Annex I (informative) Care and management of laboratory animals Non-human primates (baboons and vervet monkeys). 157 Annex J (informative) Care and management of laboratory animals Pigs. 165

24、 Annex K (informative) Care and management of laboratory animals Rabbits and guinea pigs 172 Annex L (informative) Care and management of laboratory animals Rodents (mice, rats and hamsters) . 180 Annex M (informative) Care and management of laboratory animals Sheep and goats 188 Annex N (informativ

25、e) Care and management of laboratory animals Terrestrial reptiles. 195 Annex O (informative) Pain management and humane endpoints 205 Annex P (informative) Animal welfare incident report forms 222 Bibliography. 225 SANS 10386:2008 Edition 1 4 This page is intentionally left blank SANS 10386:2008 Edi

26、tion 1 5 The care and use of animals for scientific purposes 1 Scope This standard encompasses all aspects of the care and use of, or interaction with, animals for scientific purposes in medicine, biology, agriculture, veterinary and other animal sciences, as well as industry and teaching studies in

27、 South Africa. It includes animal use in research, teaching, field trials, product testing, diagnosis, the production of biological substances and environmental studies. It provides general principles for the care and use of animals, specifies the responsibilities of researchers and institutions, an

28、d details the terms of reference, membership and operation of institutional Animal Ethics Committees (AECs). It also provides guidelines for the humane conduct of scientific studies and teaching activities, and for the acquisition of animals and their care, including their environmental needs. Where

29、 applicable, this standard is intended to be used as a supporting document to be read in conjunction with the Animals Protection Act, 1962 (Act No. 71 of 1962), the Animal Diseases Act, 1984 (Act No. 35 of 1984), the Veterinary and Paraveterinary Professions Act, 1982 (Act No. 19 of 1982) and the su

30、bsequent Notice 1445 of 1997, published in the Government Gazette 18313 of 3 October 1997: Rules relating to the practising of the Paraveterinary professions of Laboratory Animal Technologists, the Animal Health Act, 2002 (Act No. 7 of 2002), the Medicines and Related Substances Control Act, 1965 (A

31、ct No. 101 of 1965) and the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947) and any other relevant provincial and national legislation. This standard covers all live non-human vertebrates and higher invertebrates such as the advanced members from the

32、Cephalopoda and Decapoda. It also covers eggs, foetuses and embryos and their treatment in a humane manner where development of an integrated nervous system is evident. NOTE Researchers should forward proposals to use lower order invertebrates to AECs. 2 Normative references The following referenced

33、 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. Information on currently valid national and international standards can b

34、e obtained from the SABS Standards Division. 2.1 Standards SANS 10331 (SABS 0331), Translocation of certain species of wild herbivore. 2.2 Other publications Canadian Council on Animal Care (CCAC). 1993. Guide Volume 1, 2ndEdition. Available at: http:/www.ccac.ca/en/CCAC_Programs/Guidelines_Policies

35、/guides/english/v1_93/chap/chiii.htm. International Air Transport Association (IATA). 2008/2009. Live Animal Regulations (LAR), English manual. SANS 10386:2008 Edition 1 6 Working Party EU Commission Directive. 1997. Recommendations for Euthanasia of Study Animals. Working Party Report, EU Commissio

36、n Directive 86/609/EEC of 24 November 1986. Livestock Welfare Co-ordinating Committee (LWCC), University of Pretoria Faculty of Veterinary Science Onderstepoort. 2003. Optimising animal welfare when carrying out standard farm procedures and operations on livestock Available at: http:/www.samic.co.za

37、/SAMIC/LWCC.htm. Wildlife Decision Support Services. The Capture and Care Manual, 1983. Edited by McKenzie, A. The Wildlife Decision Support Services and South African Veterinary Foundation, Pretoria. 3 Definitions 3.1 animal live, sentient non-human vertebrate, including eggs, foetuses and embryos,

38、 that is; fish, amphibians, reptiles, birds and mammals, and encompassing domestic animals, purpose-bred animals, farm animals, wildlife (see 3.28) and higher invertebrates such as the advanced members from the Cephalopoda and Decapoda 3.2 Animal Ethics Committee AEC committee constituted in accorda

39、nce with the terms of reference and membership laid down in this standard 3.3 animal studies procedure that uses animals for one or more of the following reasons: a) for the advancement of knowledge; b) to test a hypothesis; c) to supply a product other than cosmetic products; d) to produce a biolog

40、ical substance; e) to provide tissues, organs or serum; f) to act as a host; g) to impart or demonstrate existing knowledge; h) to teach or learn surgical techniques; and i) to fulfil statutory requirements for the testing or collecting of data on a substance or product. 3.4 approved study study whi

41、ch has been formally approved by a properly constituted AEC on the basis of a written proposal SANS 10386:2008 Edition 1 7 3.5 distress acute or chronic response of an animal caused by stimuli that produce biological stress which manifests as observable, abnormal physiological or behavioural respons

42、es 3.6 environmental enrichment measures taken to enable species-specific behaviour, to alleviate boredom and to eliminate abnormal or harmful behaviour 3.7 euthanasia act or practice of ending the life of an animal as painlessly and humanely as possible 3.8 farm animals animals which are used in co

43、mmercial agriculture, including cattle, sheep, pigs, poultry, goats, horses, fish and wildlife that is intensively farmed 3.9 feral existing in a wild state, after having been domesticated 3.10 humane endpoint deliberate measure of using the death of an animal(s) for evaluating biological or chemica

44、l processes, responses or effects, or based on humane reasons to alleviate pain, suffering and distress 3.11 institution entity that uses animals for scientific purposes and teaching studies 3.12 Institutional Biological Safety Committee IBSC committee charged with reviewing proposed use of biohazar

45、dous agents, human material, and recombinant deoxyribonucleic acid (DNA) molecules to assess compliance with applicable regulatory guidelines 3.13 laboratory animals animals or a group of animals with a known genetic or microbiological composition (or both) (see annex A) 3.14 laboratory animal scien

46、ce multi-disciplinary branch of science that contributes to the humane use of animals in biomedical research and the collection of informative, unbiased and reproducible data NOTE Laboratory animal science encompasses the study of the biology of laboratory animals, their husbandry and environmental

47、requirements, genetic and microbiological standardization procedures, prevention and treatment of diseases, optimisation of study techniques and improvement of anaesthesia, analgesia and euthanasia. SANS 10386:2008 Edition 1 8 3.15 modifying animal behaviour procedures used to alter an animals behav

48、iour or to induce it to perform specific tasks 3.16 pain awareness of acute or chronic discomfort that occurs in varying degrees of severity as a result of study procedures, injury, disease or confinement 3.17 person-in-charge person who, by appointment or delegation, is in charge of an animal facil

49、ity and has total control and responsibility for the care and wellbeing of animals in the facility 3.18 proposal written outline of a scientific study or teaching activity submitted to an AEC for consideration 3.19 rehabilitation preparation of an animal for release into its natural environment 3.20 researcher person recognized by an AEC as competent to conduct an approved scientific study that involves animals 3.21 scientific study study or a series of related studies that form a discrete piece of work, performed to acquire and develop knowledge or t