STN EN ISO 15194
| Name: | STN EN ISO 15194 |
| Validity: | Valid |
| Number of pages: | 36 |
| Language: |
EN
|
| Paper: | 17,20€ |
| Electronic version |
a) Only read (without ability to print and copy)
15,48€ b) Without ability to print, with ability to copy (printscreen) 17,20€ c) With ability to print and copy (printscreen) 22,36€ |
| Slovak title | Diagnostické zdravotnícke pomôcky in vitro. Požiadavky na certifikované referenčné materiály a obsah sprievodnej dokumentácie (ISO 15194: 2026) |
| English title | In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2026) |
| Release Date: | 01. 10. 2026 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1011 |
| Level of incorporation: | idt EN ISO 15194:2026, idt ISO 15194:2026 |
| Official Journal | 09/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 15194:2009-10 (85 1011) |
| Note in Official Journal: | |
| Subject of the standard: | 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 ... |
| Preview: | Náhľad normy (PDF) |