التفاصيل البيبلوغرافية
| العنوان: |
Tissue Culture Agar Overlay Test. Een in vitro cytotoxiciteitstest ter bepaling van biocompatibiliteit van medische hulpmiddelen ; [Validation of The Tissue Culture Agar Overlay Test. An in vitro cytotoxicity test to assess 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, biocomptabiliteit, bioveiligheid, materiaaltesten, toxiciteitstesten, validatie, normen, medical devices, biosafety, materials testing, toxicity testing, validation, standards, tissue culture agar overlay test, tcao-test |
| الوقت: |
01 |
| الوصف: |
niet beschikbaar ; The Tissue Culture Agar Overlay Test (TCAO-test), an indirect contact in vitro cytotoxicity assay, has been validated and made available for practical applications concerning medical device safety testing. This assay fits in the test matrix as presented by the International Organisation for Standardisation (ISO) and will be adopted in the European Biocompatibility testing scheme of CEN (Comite Europeen de Normalisation). Forthcoming Notified Bodies may apply this TCAO-test complying with the essential requirements of the Active Implantable Medical Device Directive. The detailed testprotocol is described and testresults are presented. ; DGVGZ/GMV |
| نوع الوثيقة: |
report |
| وصف الملف: |
30 p |
| اللغة: |
Dutch; Flemish |
| العلاقة: |
RIVM Rapport 319011005; http://www.rivm.nl/bibliotheek/rapporten/319011005.htmlTest; 319011005; http://hdl.handle.net/10029/262309Test |
| الإتاحة: |
http://hdl.handle.net/10029/262309Test |
| رقم الانضمام: |
edsbas.AAE7CDAC |
| قاعدة البيانات: |
BASE |
