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Project

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023

Abstract

This document specifies requirements for the content and format of a reference measurement procedure. This document applies to reference measurement procedures providing values of differential or rational quantities. This document is valid for any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

Begin

2021-03-29

WI

00140149

Planned document number

DIN EN ISO 15193

Project number

06302083

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140/WG 3 - Quality management in the medical laboratory  

Responsible international committee

ISO/TC 212/WG 2 - Reference systems  

draft standard

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023
2024-02
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previous edition(s)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009
2009-10

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Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

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