《BS-EN-ISO-10993-2-1998.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-10993-2-1998.pdf（16页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 10993-2:1998 Biological evaluation of medical devices Part 2: Animal welfare requirements The European Standard EN ISO 10993-2:1998 has the status of a British Standard ICS 11.040.01; 11.060.01; 11.100; 11.120.01 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55
2、:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-2:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1998 BSI 04-1999 ISBN 0 580 296
3、61 X National foreword This British Standard is the English language version of EN ISO 10993-2:1998. It is identical with ISO 10993-2:1992. The UK participation in its preparation was entrusted to Technical Committee CH/26, Biological testing of medical and dental materials and devices, which has th
4、e responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the
5、UK. A list of organizations represented on this committee can be obtained on request to its secretary. For in vivo tests, attention is drawn to the provisions of the Animals (Scientific Procedures) Act 1986, which regulates the use of animals for experimental and other scientific purposes in the UK.
6、 The Act requires that: Studies be justified and subjected by the Home Office to a cost benefit analysis. Animals are only used when it would not be feasible to use alternative methods, and when the standards of care and accommodation equal or surpass the minimum set out in Codes of Practice issued
7、under the Act. Protocols of minimum severity are used. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which i
8、mplement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not p
9、urport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside fron
10、t cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 4 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments
11、 issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-2:1998 BSI 04-1999i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 10993-21 Licensed Copy: sh
12、effieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-2 February 1998 ICS 11.020 Desc
13、riptors: See ISO document English version Biological evaluation of medical devices Part 2: Animal welfare requirements (ISO 10993-2:1992) Evaluation biologique des dispositifs mdicaux Partie 2: Exigences concernant la protection des animaux (ISO 10993-2:1992) Biologische Beurteilung von Medizinprodu
14、kten Teil 2: Tierschutzbestimmungen (ISO 10993-2:1992) This European Standard was approved by CEN on 1 January 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without an
15、y alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by
16、 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. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ire
17、land, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation
18、 in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-2:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-2:1998 BSI 04-1999 2 Foreword The text of the International Standard from
19、Technical Committee ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization (ISO) has been taken over as a European Standard by Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices”, the secretariat of which
20、is held by NNI. ISO 10993 consists of the following parts, under the general title “Biological evaluation of medical devices”: Part 1: Guidance on selection of tests; Part 2: Animal welfare requirements; Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity; Part 4: Selection of
21、tests for interactions with blood; Part 5: Tests for cytotoxicity: in vitro methods; Part 6: Tests for local effects after implantation; Part 7: Ethylene oxide sterilization residuals; Part 9: Degradation of materials related to biological testing; Part 10: Tests for irritation and sensitization; Pa
22、rt 11: Tests for systemic toxicity; Part 12: Sample preparation and reference materials; Part 13: Identification and quantification of degradation products from polymers; Part 14: Identification and quantification of degradation products from ceramics; Part 15: Identification and quantification of d
23、egradation products from coated and uncoated metals and alloys; Part 16: Toxicokinetic study design for degradation products and leachables; Part 17: Glutaraldehyde and formaldehyde residues in industrially sterilized medical devices. Future parts will deal with other relevant aspects of biological
24、testing. Annex A of this part of ISO 10993 is for information only. 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 August 1998, and conflicting national standards shall be withdrawn at the latest
25、 by August 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherl
26、ands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10993-2:1992 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (norma
27、tive). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-2:1998 ii BSI 04-1999 Contents Page Forewordiii Introduction1 1Sco
28、pe 1 2Normative reference1 3Definitions1 4Requirements2 5Recommendations3 Annex A (informative) Bibliography4 Annex ZA (normative) Normative references to international publications with their relevant European publications 4 Descriptors: Medical equipment, surgical equipment, surgical implants, den
29、tal equipment, tests, biological tests, laboratory animals. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-2:1998 BSI 04-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of nat
30、ional standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through 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. Interna
31、tional organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical commi
32、ttees 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. International Standard ISO 10993-2 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. ISO 1099
33、3 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Guidance on selection of tests; Part 2: Animal welfare requirements; Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity; Part 4: Selection of tests for interactions wit
34、h blood; Part 5: Tests for cytotoxicity: in vitro methods; Part 6: Tests for local effects after implantation; Part 7: Ethylene oxide sterilization residuals; Part 8: Clinical investigation; Part 9: Degradation of materials related to biological testing; Part 10: Tests for irritation and sensitizati
35、on; Part 11: Tests for systemic toxicity; Part 12: Sample preparation and reference materials. Future parts will deal with other relevant aspects of biological testing. Annex A of this part of ISO 10993 is for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:0
36、0 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-2:1998 BSI 04-19991 Introduction The protection of humans is the primary goal of the ISO 10993 series of standards. A second equally imp
37、ortant goal is to ensure animal welfare and to minimize the number and exposure of the laboratory animals. This part of ISO 10993 was developed to ensure the welfare of animals used in biological evaluation testing. Therefore, minimum requirements for the care and use of animals are stated. A list o
38、f international documents concerning the care and handling of animals in biomedical research is given in Annex A for information. 1 Scope This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended a) to establish guidel
39、ines which allow the scientist to respect life in general; b) to reduce the number of animal experiments and the number of animals used in experiments, among other ways by optimization of those performed; c) to minimize suffering and maintain the quality of life of the animals used in the experiment
40、s. This part of ISO 10993 applies to the experimentation performed on vertebrates. It does not apply to experimentation performed on less differentiated animals; nor does it apply to that part of the experimental work performed on isolated tissues and organs. This part of ISO 10993 also makes recomm
41、endations concerned with the aim of reducing the number of animals used for biocompatibility testing and when possible abolishing animal experiments in this area. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this par
42、t of ISO 10993. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of
43、IEC and ISO maintain registers of currently valid International Standards. ISO 10993-1:1992, Biological evaluation of medical devices Part 1: Guidance on selection of tests. 3 Definitions For the purposes of this part of ISO 10993, the definitions given in ISO 10993-1 and the following definitions a
44、pply. 3.1 animal any live non-human vertebrate, excluding foetal or embryonic forms, unless otherwise qualified 3.2 experimental animal animal used or to be used in experiments 3.3 bred animal animal specially bred for use in experiments in facilities accredited by, or registered with, the competent
45、 authority 3.4 animal experiment any use of an animal for scientific purposes which may cause it pain, anxiety, suffering, distress or lasting harm, excluding the least painful methods accepted in modern veterinary or laboratory practice (i.e. “humane” methods) of killing or marking an animal an exp
46、eriment starts when an animal is first prepared for use and ends when no further observations are to be made for that experiment NOTE 1The prevention, elimination and minimization of pain, suffering, distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does not
47、 place the use of an animal outside the scope of this definition. 3.5 competent authority that authority designated by each state as being responsible for supervising the experiments within the scope of this part of ISO 10993 3.6 properly anaesthezized deprived of sensation by methods of anaesthesia
48、 (whether local or general) as effective as those used in good veterinary practice 3.7 humane method of killing killing of an animal with a minimum of physical and mental suffering NOTE 2Appropriate means will vary according to the animal species. 3.8 unnecessary repetition duplication of the same e
49、xperiment without scientific need Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:02 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-2:1998 2 BSI 04-1999 NOTE 3If experimental results are properly confirmed, further repetitions are considered unnecessary. This statement does not apply to the necessary controls within an experiment. 4 Requirements NOTE 4See Annex A for bibliographical references. 4.1 Sequence of in vitro and in vivo tests Animal experiments shall not be perf