HRN EN ISO 10993-18:2008
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials (ISO 10993-18:2005; EN ISO 10993-18:2005)
| Oznaka: | HRN EN ISO 10993-18:2008 |
| Naslov (EN): | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials (ISO 10993-18:2005; EN ISO 10993-18:2005) |
| Područje primjene (EN): | This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment. |
| Izdanje: | 1 |
| ICS: | 11.100 Laboratorijska medicina |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 5/2008 () |
| Glasilo (objava): | HZN Glasilo 6/2008 () |
| Glasilo (povlačenje): | HZN Glasilo 2/2010 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 35,00 € | Jezik: en | Cjenovni razred: F | Broj stranica: 21 |
| Izvornik: | EN ISO 10993-18:2005 |
| Zamjenjena s: | HRN EN ISO 10993-18:2010 |
Obrazac za naručivanje normativnih dokumenata i/ili publikacija (obrazac ob.025-2):