HRN EN ISO 10993-13:2011
Biološka procjena medicinskih proizvoda -- 13. dio: Identifikacija i količinsko određivanje istrošenosti proizvoda od polimerskih medicinskih proizvoda (ISO 10993-13:2010; EN ISO 10993-13:2010)
| Oznaka: | HRN EN ISO 10993-13:2011 |
| Naslov (HR): | Biološka procjena medicinskih proizvoda -- 13. dio: Identifikacija i količinsko određivanje istrošenosti proizvoda od polimerskih medicinskih proizvoda (ISO 10993-13:2010; EN ISO 10993-13:2010) |
| Naslov (EN): | Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010; EN ISO 10993-13:2010) |
| Područje primjene (EN): | ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. |
| 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 2/2010 () |
| Glasilo (objava): | HZN Glasilo 1/2011 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 32,00 € | Jezik: en | Cjenovni razred: E | Broj stranica: 20 |
| Izvornik: | EN ISO 10993-13:2010 |
| Zamjenjuje: | HRN EN ISO 10993-13:2010 |
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