EN ISO 15193:2009
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 (ISO 15193:2009)
01-05-2009
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
ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.ISO 15193:2009 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.
| Committee |
CEN/TC 140
|
| DevelopmentNote |
Supersedes EN 12286. (09/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| SS-EN ISO 15193 : 2009 | Identical |
| SN EN ISO 15193:2009 | Identical |
| I.S. EN ISO 15193:2009 | Identical |
| NF EN ISO 15193 : 2009 | Identical |
| UNI EN ISO 15193 : 2009 | Identical |
| NEN EN ISO 15193 : 2009 | Identical |
| BS EN ISO 15193:2009 | Identical |
| DIN EN ISO 15193:2009-10 | Identical |
| UNE-EN ISO 15193:2009 | Identical |
| NBN EN ISO 15193 : 2009 | Identical |
| ISO 15193:2009 | Identical |
| NS EN ISO 15193 : 2009 | Identical |
| PN EN 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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.