Slide background




EN ISO 17511:2021

ID 13867 | | Visite: 722 | News NormazionePermalink: https://www.certifico.com/id/13867

EN ISO 17511 2021

EN ISO 17511:2021 | In vitro diagnostic medical devices

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

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.

NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.

This document is applicable to:

a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD). This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components; d) properties reported as nominal scales and ordinal scales, where no magnitude is involved. NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.

Preview Attached

...

Fonte: ISO

Collegati

Descrizione Livello Dimensione Downloads
Allegato riservato Preview EN ISO 17511 2021.pdf
 
457 kB 1

Tags: Normazione Abbonati Normazione

Articoli correlati
Articoli correlati

Ultimi archiviati Normazione

CEI 82 25 2022
Set 24, 2022 91

CEI 82-25:2022

CEI 82-25:2022 / Guida alla progettazione, realizzazione e gestione di sistemi di generazione fotovoltaica Parte 1: Generalità - Acronimi, Definizioni e Principali Leggi, Deliberazioni e Norme Classificazione CEI: 82-25Data pubblicazione: 08.2022 Questo documento costituisce la Parte 1 della Guida… Leggi tutto
Set 19, 2022 49

UNI ISO 37301:2021

UNI ISO 37301:2021 / Sistemi di gestione per la compliance organizzazione ID 17641 | 19.09.2022 / Preview in allegato Sistemi di gestione per la compliance - Requisiti con guida per l'utilizzo La norma specifica i requisiti e fornisce linee guida per istituire, sviluppare, attuare, valutare,… Leggi tutto
Set 18, 2022 79

CEI EN IEC 62135-2:2022

CEI EN IEC 62135-2:2022 / Preview in allegato Classificazione CEI: 26-32Apparecchiatura per la saldatura a resistenzaParte 2: Prescrizioni per la compatibilità elettromagnetica (EMC) Questa Norma si applica alle apparecchiature per la saldatura a resistenza e i processi affini collegate a reti di… Leggi tutto
Set 05, 2022 140

UNI EN ISO 20346:2022

UNI EN ISO 20346:2022 Dispositivi di protezione individuale - Calzature di protezione La norma specifica i requisiti di base e supplementari (facoltativi) per le calzature di protezione per usi generali. Essa include, per esempio, rischi meccanici, resistenza allo scivolamento, rischi termici e… Leggi tutto
Set 05, 2022 129

UNI EN ISO 20345:2022

UNI EN ISO 20345:2022 Dispositivi di protezione individuale - Calzature di sicurezza La norma specifica i requisiti di base e supplementari (facoltativi) per le calzature di sicurezza per usi generali. Essa include, per esempio, rischi meccanici, resistenza allo scivolamento, rischi termici e… Leggi tutto
Set 05, 2022 122

UNI ISO/TR 23476:2022

UNI ISO/TR 23476:2022 Ergonomia - Applicazione della ISO 11226, della serie ISO 11228 e della ISO/TR 12295 nel settore agricolo Il rapporto tecnico è destinato a essere utilizzato insieme alle norme ISO/TR 12295, ISO 11226 e alla serie ISO 11228 nel settore agricolo. Il documento fornisce… Leggi tutto
UNI EN 81 70 2022
Set 05, 2022 149

UNI EN 81-70:2022

UNI EN 81-70:2022 / Accessibilità agli ascensori delle persone, comprese le persone con disabilità ID 17513 | 05.09.2022 / Preview in allegato UNI EN 81-70:2022 (EN 81-70 + A1:2021)Regole di sicurezza per la costruzione e l'installazione degli ascensori - Applicazioni particolari per ascensori per… Leggi tutto

Più letti Normazione