HRN EN ISO 10993-10:2011
Biološka procjena medicinskih proizvoda -- 10. dio: Ispitivanja za iritaciju i osjetljivost kože (ISO 10993-10:2010; EN ISO 10993-10:2010)
| Oznaka: | HRN EN ISO 10993-10:2011 |
| Naslov (HR): | Biološka procjena medicinskih proizvoda -- 10. dio: Ispitivanja za iritaciju i osjetljivost kože (ISO 10993-10:2010; EN ISO 10993-10:2010) |
| Naslov (EN): | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010; EN ISO 10993-10:2010) |
| Područje primjene (EN): | ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin. |
| Izdanje: | 3 |
| ICS: | 11.100.20 Biološko vrednovanje medicinskih proizvoda |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 2/2010 () |
| Glasilo (objava): | HZN Glasilo 1/2011 () |
| Glasilo (povlačenje): | 6/2013 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 60,00 € | Jezik: en | Cjenovni razred: M | Broj stranica: 73 |
| Izvornik: | EN ISO 10993-10:2010 |
| Zamjenjuje: | HRN EN ISO 10993-10:2010 |
| Zamjenjena s: | HRN EN ISO 10993-10:2013 |
| Direktiva/Uredba: | kandidat |
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