BS EN ISO 10993-2-2006 Biological evaluation of medical devices - Animal welfare requirements《医疗器械的生物评定 动物保护要求》.pdf

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1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58The European Standard EN ISO 10993-2:2006 has the status of a British StandardICS 11.100.20Biologic

2、al evaluation of medical devices Part 2: Animal welfare requirementsBRITISH STANDARDBS EN ISO 10993-2:2006BS EN ISO 10993-2:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006 BSI 2006ISBN 0 580 49160 9Amendments issued sinc

3、e publicationAmd. No. Date CommentsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard was pu

4、blished by BSI. It is the UK implementation of EN ISO 10993-2:2006. It supersedes BS EN ISO 10993-2:1998 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.A list of organizations represented on CH/194 can

5、 be obtained on request to its secretary.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-2 July 2006 ICS 11.100.20 Supersedes EN ISO 10993-2:1998 English Version Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) valuation biologique des

6、dispositifs mdicaux - Partie 2: Exigences relatives la protection des animaux (ISO 10993-2:2006) Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2006) This European Standard was approved by CEN on 14 July 2006. CEN members are bound to comply with the CEN/C

7、ENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to an

8、y CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. C

9、EN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swi

10、tzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref.

11、No. EN ISO 10993-2:2006: EForeword This document (EN ISO 10993-2:2006) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat o

12、f which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2007, and conflicting national standards shall be withdrawn at the latest by January 2007. This document supersedes

13、EN ISO 10993-2:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irela

14、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10993-2:2006 has been approved by CEN as EN ISO 10993-2:2006 without any modifications. EN ISO 10993-

15、2:2006Reference numberISO 10993-2:2006(E)INTERNATIONAL STANDARD ISO10993-2Second edition2006-07-15Biological evaluation of medical devices Part 2: Animal welfare requirements valuation biologique des dispositifs mdicaux Partie 2: Exigences relatives la protection des animaux EN ISO 10993-2:2006ii ii

16、iContents Page Foreword iv Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 3 4.1 General. 3 4.2 Justification for animal tests . 4 4.3 Competence of personnel 4 4.4 Planning and performance of animal tests 4 4.5 Test strategy Sequence of in vitro an

17、d in vivo tests 5 4.6 Animal care and accommodation . 5 4.7 Humane endpoints 6 4.8 Study documentation . 7 4.9 Validity of test results and mutual acceptance of data. 7 Annex A (informative) Rationale for the development of this part of ISO 10993. 8 Annex B (informative) Further suggestions for repl

18、acing, reducing and refining animal tests 12 Bibliography . 13 EN ISO 10993-2:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out thr

19、ough ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collabo

20、rates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Stand

21、ards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of

22、this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-2 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This second edition cancels and replaces the first edition (ISO 10

23、993-2:1992), which has been technically revised. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and testing Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity P

24、art 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for

25、 irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products

26、from ceramics Part 15: Identification and quantification of degradation products from metals and alloys EN ISO 10993-2:2006v Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterizat

27、ion of materials Part 19: Physico-chemical, mechanical and morphological characterization Part 20: Principles and methods for immunotoxicology testing of medical devices EN ISO 10993-2:2006vi Introduction The goal of the ISO 10993 series of International Standards is the protection of humans in the

28、context of the use of medical devices. This part of ISO 10993 supports the goal of the ISO 10993 series by promoting good science through paying proper regard to maximizing the use of scientifically sound non-animal tests and by ensuring that those animal tests performed to evaluate the biological p

29、roperties of materials used in medical devices are conducted humanely according to recognized ethical and scientific principles. The application of such humane experimental techniques, including high standards of animal care and accommodation, both help to ensure the scientific validity of safety te

30、sting and enhance the welfare of the animals used. EN ISO 10993-2:20061Biological evaluation of medical devices Part 2: Animal welfare requirements 1 Scope This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the bi

31、ocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibili

32、ty of materials used in medical devices. It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by oth

33、er scientifically valid means not requiring animal tests. It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than

34、 with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized. 2 Normative references The following referenced documents are indispensable f

35、or 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. ISO 10993-1:2003, Biological evaluation of medical devices Part 1: Evaluation and testing 3 Terms and d

36、efinitions For the purposes of this document, the definitions given in ISO 10993-1 and the following apply. 3.1 alternative method any test method that replaces an animal test, reduces the numbers of animals used, or refines the procedures applied 3.2 animal any live non-human vertebrate, excluding

37、immature forms during the first half of gestation of incubation EN ISO 10993-2:20062 3.3 animal test any use of an animal for scientific purposes NOTE 1 The definition of an animal test excludes acts of recognized veterinary practice applied for the benefit of an animal or the group of animals of wh

38、ich it is part; recognized husbandry practices to manage or conserve the animal or the group of which it is part; marking by methods which cause no more than momentary pain or distress; and euthanasia. NOTE 2 The prevention of pain, suffering, distress or lasting harm by the effective use of anaesth

39、esia or analgesia or other methods of rendering the animal insentient to pain (e.g. decerebration) does not place animal tests outside the scope of this definition. The administration of anaesthetics, analgesics or other methods of rendering the animal insentient to pain are considered to constitute

40、 an integral part of the animal test. 3.4 competent authority body designated or recognized by a national government to take responsibility for overseeing, supervising or regulating animal tests, or the breeding and supply of purpose-bred animals for use on such tests, within the scope of this part

41、of ISO 10993 3.5 euthanasia humane killing of an animal by a method causing a minimum of physical and mental suffering 3.6 humane endpoints pre-determined, specific criteria and measures to be implemented to minimize or terminate pain, suffering or distress caused by animal tests as soon as the scie

42、ntific objectives have been met, or when it is realized they cannot be met, or when the animal welfare problems being encountered are greater than can be justified by the importance, potential benefits, objectives and nature of the study 3.7 procedural training prior training and acclimatizing of an

43、imals to the interventions to be performed during an animal test, with a view to minimizing stress to the animal when animal tests are conducted 3.8 protocol documentation prepared in advance of animal tests being undertaken setting out the justification, rationale and test method (including scienti

44、fic and humane endpoints) for the animal tests 3.9 purpose-bred animal any animal bred with the intention that it be used in animal tests or for other experimental or scientific purposes 3.10 reduction reducing to the essential minimum the number of animals used in an animal test to meet a defined s

45、cientific objective 3.11 refinement sum total of measures taken to safeguard the welfare of the test animals by minimizing any resulting pain, suffering, distress or lasting harm to the animals that are used 3.12 replacement any scientifically valid and reasonably and practically available test meth

46、od that either completely or partially replaces the use of living vertebrate animals with test methods that have not the potential to cause pain or distress to animals EN ISO 10993-2:200633.13 test animal any animal used in in vivo animal tests, or used to provide tissue for ex vivo or in vitro test

47、s 3.14 validation formal process by which the reliability and relevance of a test method is established for a particular purpose 4 Requirements 4.1 General This part of ISO 10993 sets forth essential requirements when animal tests are being considered, planned or performed for the biological evaluat

48、ion of materials used in medical devices. It has been developed to protect the welfare of animals used in the biological evaluation of materials used in medical devices without compromising, indeed to help to ensure, the scientific validity of the test results and the risk assessments that shall sub

49、sequently be performed. This part of ISO 10993 focuses on the need to demonstrate that animal welfare is properly considered when expert judgement has to be exercised in relation to the biological evaluation of medical device materials, and that the principles of humane experimental technique are demonstrably applied to the design and conduct of animal tests. This part of ISO 10993 requires that the need to perform animal tests is justified, and any pain, suffering, distress or lasting harm