prEN ISO 15193

SLOVENSKI STANDARD
01-marec-2024
Diagnostični medicinski pripomočki in vitro - Zahteve za predstavitev referenčnih
merilnih postopkov (ISO/DIS 15193:2023)
In vitro diagnostic medical devices - Requirements for reference measurement
procedures (ISO/DIS 15193:2023)
In‑vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO/DIS 15193:2023)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des
échantillons d'origine biologique - Exigences relatives au contenu et à la présentation
des procédures de mesure de référence (ISO/DIS 15193:2023)
Ta slovenski standard je istoveten z: prEN ISO 15193
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-12-26 2024-03-19
In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:

In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for a reference measurement procedure .10
4.1 General . 10
4.2 Elements of a reference measurement procedure . 10
4.3 Warning and safety precautions . 11
4.4 Introduction . 11
4.5 Scope . .12
4.6 Terms, definitions, symbols, and abbreviated terms .12
4.6.1 Concepts .12
4.6.2 Nomenclature . 12
4.6.3 Trivial names .12
4.7 Measurement principle and measurement method .12
4.8 Reagents and materials .13
4.8.1 General .13
4.8.2 Descriptive items .13
4.8.3 Influence quantities . 14
4.8.4 Expression of concentration . 14
4.8.5 Expression of dilution . 14
4.8.6 Reference to patented items . 15
4.9 Apparatus and equipment .15
4.9.1 Description .15
4.9.2 Auxiliary equipment .15
4.10 Consumables . . . 15
4.11 Sampling and sample .15
4.11.1 General .15
4.11.2 Samples .15
4.12 Preparation of measuring system and analytical portion . 16
4.12.1 General . 16
4.12.2 Preparation of apparatus . 16
4.12.3 Calibration . . . 16
4.12.4 Types of analytical sample . 16
4.12.5 Design of analytical series . 17
4.12.6 Analytical portion . 17
4.12.7 Analytical solution . 17
4.13 Operation of measuring system . 17
4.13.1 Sequence of measurement steps . 17
4.13.2 Blank . 17
4.13.3 Validation of measurement conditions . 17
4.14 Data processing. 18
4.14.1 Calculation of measurement results . 18
4.14.2 Conversion equations . 18
4.15 Validation . 18
4.15.1 Concepts, values, and their use . . 18
4.15.2 Analytical calibration function . 19
4.15.3 Analytical measurement function . 19
4.15.4 Analytical sensitivity . 19
4.15.5 Analytical influence quantities . 19
4.15.6 Blank measurement . 19
4.15.7 Recovery studies . 19
iii
ISO/DIS 15193:2023(E)
4.15.8 Measurement trueness .20
4.15.9 Measurement precision .20
4.15.10 Repeatability standard deviation, s . 20
r
4.15.11 Intermediate precision standard deviation . 20
4.15.12 Reproducibility standard deviation, s . 20
R
4.15.13 Limit of detection . 20
4.15.14 Measuremen
...