HRN EN ISO 10993-4:2017
Biološka procjena medicinskih proizvoda -- 4. dio: Odabir ispitivanja za interakciju s krvlju (ISO 10993-4:2017; EN ISO 10993-4:2017)
| Oznaka: | HRN EN ISO 10993-4:2017 |
| Naslov (HR): | Biološka procjena medicinskih proizvoda -- 4. dio: Odabir ispitivanja za interakciju s krvlju (ISO 10993-4:2017; EN ISO 10993-4:2017) |
| Naslov (EN): | Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017; EN ISO 10993-4:2017) |
| Područje primjene (EN): | ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended. |
| 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): | 6/2015 () |
| Glasilo (objava): | 6/2017 () |
| Glasilo (povlačenje): | 1/2018 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 60,00 € | Jezik: en | Cjenovni razred: M | Broj stranica: 77 |
| Izvornik: | EN ISO 10993-4:2017 |
| Zamjenjuje: | HRN EN ISO 10993-4:2010 |
| Zamjenjena s: | HRN EN ISO 10993-4:2018 |
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