HRN EN ISO 10993-6:2008
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation (ISO 10993-6:2007; EN ISO 10993-6:2007)
| Oznaka: | HRN EN ISO 10993-6:2008 |
| Naslov (EN): | Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation (ISO 10993-6:2007; EN ISO 10993-6:2007) |
| Područje primjene (EN): | This part of ISO 10993 specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The test specimen is implanted into a site and tissue appropriate for evaluation of the biological safety of the material. The implant is not intended to be subjected to mechanical or functional loading. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks). |
| Izdanje: | 1 |
| 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 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: 41,00 € | Jezik: en | Cjenovni razred: G | Broj stranica: 25 |
| Izvornik: | EN ISO 10993-6:2007 |
| Zamjenjena s: | HRN EN ISO 10993-6:2010 |
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