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BS EN ISO 15193:2009

Current
Current

The latest, up-to-date edition.

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Presentation of a reference measurement procedure
  4.1 Elements of a reference measurement
       procedure
  4.2 Warning and safety precautions
  4.3 Introduction
  4.4 Scope
  4.5 Terms, definitions, symbols and abbreviated
       terms
  4.6 Measurement principle and measurement
       method
  4.7 Check list
  4.8 Reagents and materials
  4.9 Apparatus
  4.10 Sampling and sample
  4.11 Preparation of measuring system and
       analytical portion
  4.12 Operation of measuring system
  4.13 Data processing
  4.14 Analytical reliability
  4.15 Special cases
  4.16 Validation of a reference measurement
       procedure
  4.17 Reporting
  4.18 Quality assurance
  4.19 Bibliography
  4.20 Dates of authorization and revision
Annex A (informative) - Reference procedures for
        properties other than differential and rational
        quantities
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 98/79

Describes requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval.

This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure.

NOTE 2 In this International Standard, “international measurement standard” designates a material standard. The term “international standard” is used by WHO for reference materials.

Committee
CH/212
DevelopmentNote
Supersedes BS EN 12286 & 06/30154803 DC. (05/2009)
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 15193:2009 Identical
ISO 15193:2009 Identical

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
ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
ISO 4791-1:1985 Laboratory apparatus — Vocabulary relating to apparatus made essentially from glass, porcelain or vitreous silica — Part 1: Names for items of apparatus
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
ISO Guide 33:2015 Reference materials Good practice in using reference materials
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
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
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO 6353-3:1987 Reagents for chemical analysis — Part 3: Specifications — Second series
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO Guide 34:2009 General requirements for the competence of reference material producers
ISO 78-2:1999 Chemistry Layouts for standards Part 2: Methods of chemical analysis
ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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