STN EN ISO 15194
| Označenie: | STN EN ISO 15194 |
| Platnosť: | Platná |
| Počet strán: | 36 |
| Jazyk: |
EN
|
| Listinná verzia: | 17,20€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
15,48€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 17,20€ c) S možnosťou tlače, prenosu textu a obrázkov: 22,36€ |
| Slovenský názov: | Diagnostické zdravotnícke pomôcky in vitro. Požiadavky na certifikované referenčné materiály a obsah sprievodnej dokumentácie (ISO 15194: 2026) |
| Anglický názov: | In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2026) |
| Dátum vydania: | 01. 10. 2026 |
| Dátum zrušenia: | |
| ICS: | 11.100.10 |
| Triediaci znak: | 85 1011 |
| Úroveň zapracovania: | idt EN ISO 15194:2026, idt ISO 15194:2026 |
| Vestník: | 09/26 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 15194:2009-10 (85 1011) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty. This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1. When a CRM includes multiple measurands, this document is applied ... |
| Náhľad normy: | Náhľad normy (PDF) |