STN EN ISO 10993-18
| Označenie: | STN EN ISO 10993-18 |
| Platnosť: | Platná |
| Počet strán: | 85 |
| Jazyk: |
EN
|
| Listinná verzia: | 28,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
25,92€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 28,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 37,44€ |
| Slovenský názov: | Biologické hodnotenie zdravotníckych pomôcok. Časť 18: Chemická charakterizácia materiálov zdravotníckych pomôcok v procese riadenia rizík (ISO 10993-18: 2020) |
| Anglický názov: | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) |
| Dátum vydania: | 01. 09. 2020 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6510 |
| Úroveň zapracovania: | idt EN ISO 10993-18:2020, idt ISO 10993-18:2020 |
| Vestník: | 08/20 |
| Zmeny: | Zmena A1 V 09/23 |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-18:2009-08 (85 6510) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); |
| Náhľad normy: | Náhľad normy (PDF) |