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Normas DIN – AENOR
DIN EN ISO 10993-3:2011-08

DIN EN ISO 10993-3:2011-08

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011); German version prEN ISO 10993-3:2011 / Note: Date of issue 2011-08-08

Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO/DIS 10993-3:2011); Version allemande prEN ISO 10993-3:2011 / Attention: Date de parution 2011-08-08

Biologische Beurteilung von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität, Karzinogenität und Reproduktionstoxizität (ISO/DIS 10993-3:2011); Deutsche Fassung prEN ISO 10993-3:2011 / Achtung: Erscheinungsdatum 2011-08-08

Fecha Anulación:
2013-03 /Withdrawn
Equivalencias internacionales:

ISO/DIS 10993-3 (2011-08)

prEN ISO 10993-3 (2011-08)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-3:2013-03

Resumen:
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: - genotoxicity, - carcinogenicity and - reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
Keywords:
Bioassay, Biological, Biological hazards, Biological tests, Carcinogenic materials, Carcinogens, Definitions, Dental equipment, Dental instruments, Dental materials, Evaluations, Fine mechanics, Genes, Genetics, Genotoxicity, Implants (surgical), In vivo, Materials, Medical devices, Medical equipment, Medical sciences, Methods, Preparation, Reproductions, Reproductive system, Sample preparation, Samples, Surgical equipment, Surgical implants, Testing, Toxicity
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