内容提示: Reference numberISO 10993-5:2009(E)© ISO 2009 INTERNATIONAL STANDARD ISO10993-5Third edition2009-06-01Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity Évaluation biologique des dispositifs médicaux — Partie 5: Essais concernant la cytotoxicité in...
细胞毒性测试的可比性值得怀疑。只有 58% 的聚乙烯和聚氯乙烯实验室确认了预期结果。ISO 10993-5 标准允许很大的自由度,这可能会导致结果大相径庭。 研究表明,除了提取条件有很大影响外,血清浓度或细胞培养时间等变化也会对结果产生重大影响。例如,培养时间超过 70 小时的实验室能可靠地检测出聚氯乙烯的细胞毒性潜能,...
ISO 10993-5:1999 standard of cytotoxicity evaluation of biomaterials according to RGR.Xiaohua ShiShaoliang WangYiming ZhangYicheng WangZhi YangXin ZhouZeyuan LeiDongli Fan
Reference number ISO 10993-5:2009(E) © ISO 2009INTERNATIONAL STANDARD ISO 10993-5 Third edition 2009-06-01 Biological uation of medical devices — Part 5: Tests for in vitro cytotoxicity Évaluation biologique des dispositifs médicaux — Partie 5: Essais concernant la cytotoxicité in vitro...
REFERENCENUMBERISO1099352009EISO2009INTERNATIONALSTANDARDISO109935THIRDEDITION20090601BIOLOGICALEVALUATIONOFMEDICALDEVICESPART5TESTSFORINVITROCYTOTOXICITYVALUATIONBIOLOGIQUEDESDISPOSITIFSMDICAUXPARTIE5ESSAISCONCERNANTLACYTOTOXICITINVITROCOPYRIGHTINTERNATIONALORGANIZATIONFORSTANDARDIZATIONPROVIDEDBYIHSUNDERLICENSEWITHISOLICENSEEISTANBUL...
内容提示: AReference numberISO 10993-5:1999(E)INTERNATIONALSTANDARDISO10993-5Second edition1999-05-15Biological evaluation of medical devices —Part 5:Tests for in vitro cytotoxicityÉvaluation biologique des dispositifs médicaux —Partie 5: Essais concernant la cytotoxicité in vitroCopyright ...
The culture medium was evaluated according to the standard "Biological evaluation of medical devices, Part 5: Test for cytotoxicity: in vitro methods" (ISO 10993-5: 1992). The test was performed on cells 3T3 A31, which is a cell... GORROCHATEGUI BARRUETA ALBERTO,SIMON ELIZUNDIA JOSU - ...
In the paper the cytotoxicity testing procedures according to the ISO 10993 standard are reviewed and the benefits of performing these procedures to ensure the biocompatibility of a medical device are discussed. It is concluded that a negative result of the test indicates that a material is free ...
ISO 10993-1-2018中文+英文,医疗器械的生物评价.第1部分.pdf,ISO 10993-1:2018(E) 中英文版 INTERNATIONAL Fifth edition 第5版 STANDARD 2018-08 国际标准 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process 医
STANDARD2014-10-01国际标准Biologicalevaluationofmedicaldevices—Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity医疗器械生物学评价第3部分:遗传毒性、致癌性和生殖毒性试验(中英文版)2024年03月翻译ReferencenumberISO10993-3:2014(E)PAGE:1©ISO2014–Allrightsreserved...