BS EN ISO 15194:2009
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
Hardcopy , PDF
English
31-01-2016
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Systematic format of properties in the supporting
documentation of a certified reference material
4.1 Format of properties
4.2 Construction of systematic designations
4.3 Trivial names
5 Properties, production, and characterization of a
certified reference material
5.1 Hierarchical position
5.2 Properties
5.3 Production and characterization
6 Content of supporting documentation
6.1 Supporting documentation
6.2 Label
6.3 Certificate
6.4 Certification report
Annex A (informative) - Certified reference materials
with nominal properties or ordinal quantities
Bibliography
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directive 98/79
Describes requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes BS EN 12287 & 07/30157023 DC. (05/2009)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
| Standards | Relationship |
| EN ISO 15194:2009 | Identical |
| ISO 15194:2009 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO Guide 32:1997 | Calibration in analytical chemistry and use of certified reference materials |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| ISO 15193:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| 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/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in 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 Guide 30:2015 | Reference materials — Selected terms and definitions |
| 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 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO Guide 31:2015 | Reference materials — Contents of certificates, labels and accompanying documentation |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| 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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