HRN EN ISO 10993-3:2015
Biološka procjena medicinskih proizvoda -- 3. dio: Ispitivanja za genotoksičnost, karcinogenetiku i reproduktivnu toksičnost (ISO 10993-3:2014; EN ISO 10993-3:2014)
| Oznaka: | HRN EN ISO 10993-3:2015 |
| Naslov (HR): | Biološka procjena medicinskih proizvoda -- 3. dio: Ispitivanja za genotoksičnost, karcinogenetiku i reproduktivnu toksičnost (ISO 10993-3:2014; EN ISO 10993-3:2014) |
| Naslov (EN): | Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014; EN ISO 10993-3:2014) |
| Područje primjene (EN): | ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. |
| Izdanje: | 3 |
| ICS: | 11.100.20 Biološko vrednovanje medicinskih proizvoda |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN Glasilo 6/2011 () |
| Glasilo (objava): | HZN e-Glasilo 2/2015 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 48,00 € | Jezik: en | Cjenovni razred: I | Broj stranica: 41 |
| Izvornik: | EN ISO 10993-3:2014 |
| Zamjenjuje: | HRN EN ISO 10993-3:2010 |
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