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EN ISO 17511:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
Superseded date

12-06-2021

Published date

15-08-2003

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Metrological traceability chain and calibration hierarchy
   4.1 Principles
   4.2 Structure and nomenclature
   4.3 Considerations in establishing metrological
       traceability
   4.4 Functions of reference materials
5 Calibration transfer protocols
   5.1 Availability and structure
   5.2 Cases with primary reference measurement procedure and
       primary calibrator(s) giving metrological traceability to
       SI
   5.3 Cases with international conventional reference
       measurement procedure (which is not primary) and
       international conventional calibrator(s) without
       metrological traceability to SI
   5.4 Cases with international conventional reference
       measurement procedure (which is not primary) but no
       international conventional calibrator and without
       metrological traceability to SI
   5.5 Cases with international conventional calibrator
       (which is not primary) but no international
       conventional reference measurement procedure and
       without metrological traceability to SI
   5.6 Cases with manufacturer's selected measurement
       procedure but neither international conventional
       reference measurement procedure nor international
       conventional calibrator and without metrological
       traceability to SI
   5.7 Trueness control materials
6 Expression of uncertainty of measurement
7 Validation of metrologically traceable calibration
8 Information on metrological traceability to be given
   in the instructions for use of an in vitro diagnostic
   medical device
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

ISO 17511:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of ISO 17511:2003.ISO 17511:2003 is not applicable to control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such "horizontal" correlation does not provide metrological traceability; calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; and properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

I.S. EN ISO 15195:2003 LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES
08/30182372 DC : DRAFT JULY 2008 BS EN 15842 - FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
UNI EN 15842 : 2010 FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
DIN EN 15842:2010-06 FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
NF EN 15842 : 2010 FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
DIN EN 15842 E : 2010 FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
BS EN 15842:2010 Foodstuffs. Detection of food allergens. General considerations and validation of methods
BS EN ISO 15195:2003 Laboratory medicine. Requirements for reference measurement laboratories
ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
I.S. EN 15842:2010 FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
EN 15842:2010 Foodstuffs - Detection of food allergens - General considerations and validation of methods
EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DIN EN ISO 15195:2004-01 LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES

ENV 1614 : 1995 HEALTHCARE INFORMATICS - STRUCTURE FOR NOMENCLATURE, CLASSIFICATION AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCE
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
EN 12286:1998/A1:2000 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
EN 12287 : 1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS
ISO Guide 33:2015 Reference materials Good practice in using reference materials
ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO 18153:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO Guide 30:2015 Reference materials Selected terms and definitions
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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