STN EN ISO 17511
| Name: | STN EN ISO 17511 |
| Validity: | Valid |
| Number of pages: | 72 |
| Language: |
EN
|
| Paper: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Diagnostické zdravotnícke pomôcky in vitro. Požiadavky na zavedenie metrologickej nadväznosti hodnôt priradených kalibračným, skutočným kontrolným materiálom a ľudským vzorkám (ISO 17511: 2020) |
| English title | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020) |
| Release Date: | 01. 09. 2021 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1017 |
| Level of incorporation: | idt EN ISO 17511:2021, idt ISO 17511:2020 |
| Official Journal | 08/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 17511:2004-05 (85 1017) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs). All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs. |
| Preview: | Náhľad normy (PDF) |