ISO-7405-1997.pdf
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1、INTERNATIONAL IS0 STANDARD 7405 First edition 1997008- 15 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials Art dentaire - cvalua tion pr a=400net; p=iso; o=isocs; s=central Printed in Switzerland ii Copyright Internationa
2、l Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- 0 IS0 IS0 7405:1997(E) Introduction This International Standard conce
3、rns the preclinical testing of dental materials in medical devices used in dentistry. It has been developed from and supersedes ISORR 74051984, Biological evaluation of dental materials, and its supplements, and should be read in conjunction with the IS0 10993, Biological evaluation of medical devic
4、es, series of standards. This International Standard differs from ISO/TR 7405 in several important ways. Firstly, it contains details of test methods applicable only to dental materials. Many test methods previously included in ISO/TR 7405 are now included in the IS0 10993 series of standards and de
5、tails of them have therefore been excluded from this standard. Secondly, only test methods for which the members of the committee considered there was sufficient published data have been included. Thirdly, in recommending test methods, the need to minimize the use of animals was given a high priorit
6、y. The annexes are informative, to encourage the development of in vitro and in vivo test methods which will further reduce the use of animals in the preclinical evaluation of the biocompatibility of medical devices used in dentistry. Copyright International Organization for Standardization Provided
7、 by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- This page intentionally left blank Copyright International Organization for Standardization Provided by IHS unde
8、r license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD o IS0 IS0 7405:1997(E) Dentistry - Preclinical evaluation of biocompatibility of medical devices used
9、 in dentistry - Test methods for dental materials 1 Scope This International Standard specifies methods for the evaluation of biological effects of dental materials. It includes testing of pharmacological agents that are an integral part of the device under test. 2 Normative references The following
10、 standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encourag
11、ed to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 1942-2:1989, Dental vocabulary - Part 2: Dental materials IS0 10993-l: - A), Biological evaluation of med
12、ical devices - Part I: Evaluation and testing IS0 10993-2: 1992, Biological evaluation of medical devices - Part 2: Animal welfare requirements IS0 10993-3: 1992, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity IS0 10993-5: 1992, B
13、iological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods IS0 10993-6: 1994, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation ISOTTR 10993-9:1994, Biological evaluation of medical devices - Part 9: Degradation of materials
14、 related to biological testing IS0 10993-l 0:1995, Biological evaluation of medical devices - Pan 10: Tests for irritation and sensitization IS0 10993-l 1 :1993, Bio/ogica/ evaluation of medical devices - Part 11: Tests for systemic toxicity IS0 10993-l 2: -2), Biological evaluation of medical devic
15、es - Part 12: Sample preparation and reference materials IS0 10993-l 3:-2), Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymers IS0 10993-l 4:- 2), Biological evaluation of medical devices - Part 14: Identification and quantific
16、ation of degradation products from ceramics IS0 10993-l 5:- 2), Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from coated and uncoated metals and alloys IS0 10993-l 6:- 21, Biological evaluation of medical devices - Part 16: Toxicokinet
17、ic study design for degradation products and leachables. 1) To be published. (Revision of IS0 109931:1992) 2) To be published Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:5
18、1:18 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 7405: 1997(E) 0 IS0 3 Definitions For the purposes of this International Standard, the definitions given in IS0 10993-1, IS0 1942-2 and the following definitions apply. 3.1 medical device: Any instrument, apparatus, a
19、ppliance, material or other article, including software, whether used alone or in combination, intended by the manufacturer to be used for human beings solely or principally for the purpose of - diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap; - investigati
20、on, replacement or modification of the anatomy or of a physiological process; - control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means, NOTE
21、1 Devices are different from drugs, and their biological evaluation requires a different approach. NOTE 2 In this International Standard, the term “medical device” is understood to include dental devices and dental materials. 3.2 dental material: Substance or combination of substances specially prep
22、ared and/or presented for the use of authorized persons in the practice of dentistry and/or its associated procedures. 3.3 final product: Medical device in its “as-used” state. NOTE - Many dental materials are used in a freshly mixed state, and evaluation of the materials in both freshly mixed and s
23、et conditions should be considered. 3.4 positive-control material: Material or substance which, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible, appropriate positive or reactive response in the test system. 3.5 negative-control material;
24、reference material: Material or substance which, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible, appropriate negative, nonreactive or background response in the test system. 4 Categorization of medical devices used in dentistry 4.1 Categ
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