Celgroeiremmingstest voor bepaling van de biocompatibiliteit van medische hulpmiddelen ; [Cell growth inhibition test, Validation in the determination of the biocompatibility of Medical Devices.]

التفاصيل البيبلوغرافية
العنوان: Celgroeiremmingstest voor bepaling van de biocompatibiliteit van medische hulpmiddelen ; [Cell growth inhibition test, Validation in the determination of the biocompatibility of Medical Devices.]
المؤلفون: Orzechowski TJH, Machielsen JCA, Geffen MF van
سنة النشر: 2012
المجموعة: National Inst. for Public Health and the Environment, Netherlands (RIVM): Webbased Archive of RIVM Publications (WARP)
مصطلحات موضوعية: medische hulpmiddelen, biocompatibiliteit, bioveiligheid, materiaaltesten, toxiciteitstesten, validatie, normen, medical devices, biosafety, materials testing, toxicity testing, validation, standards, cell growth inhibition test
الوقت: 01
الوصف: niet beschikbaar ; In order to assess the biocompatibility of medical devices a set of test norms has been developed by the ISO (International Organisation for Standardisation) and the CEN/CENELEC (Comite Europeen de Normalisation, Comite Europeen de Normalisation Electrotechnique). Cytotoxicity tests play an important role in the testmatrix of biocompatibility testing. The agar overlay test is an internationally accepted standard test for determination of the cytotoxicity of biomaterials. Because of the disadvantages mentioned in the introduction a fast, reproducible and quantitative cytotoxicity test has been developed. Extracts of medical devices are tested for their effect on celgrowth. A detailed testprotocol and the validation results of this celgrowth inhibition test are described. In addition some applications are presented. From the results we conclude that the celgrowth inhibition test is sensitive and reproducible. Also induced cytotoxic effects of extracts (sheep collagen, non-wovens) and desinfectantia/sterilants (EtO) can be detected. ; DGVGZ/GMV
نوع الوثيقة: report
وصف الملف: 38 p
اللغة: Dutch; Flemish
العلاقة: RIVM Rapport 319011003; http://www.rivm.nl/bibliotheek/rapporten/319011003.htmlTest; 319011003; http://hdl.handle.net/10029/261176Test
الإتاحة: http://hdl.handle.net/10029/261176Test
رقم الانضمام: edsbas.64283D7A
قاعدة البيانات: BASE