DIN EN ISO 15194:2009-10
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
01-01-2009
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Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Systematisches Format der Eigenschaften in
der Begleitdokumentation eines
zertifizierten Referenzmaterials
5 Eigenschaften, Herstellung und Charakterisierung
eines zertifizierten Referenzmaterials
6 Inhalt der Begleitdokumentation
Anhang A (informativ) Zertifizierte Referenzmaterialien
mit Nominaleigenschaften oder Ordinalgrössen
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den grundlegenden
Anforderungen der EG-Richtlinie 98/79/EG
This standard is included in DIN Handbook 378.
| DevelopmentNote |
Supersedes DIN EN 12287. (10/2009)
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 15194:2009 | Identical |
| ISO 15194:2009 | Identical |
| DIN HDBK 378 : 3ED 2014 | |
| DIN EN ISO 15189:2014-11 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| DIN EN ISO 15193:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| DIN EN ISO 15197:2015-12 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
| 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 |
| DIN EN ISO 15193:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| DIN ISO 5725-2:2002-12 | 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 5725-2:1994 including Technical Corrigendum 1:2002) |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| DIN EN ISO 17511:2003-11 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| 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 |
| DIN EN ISO 18113-2:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| ISO Guide 33:2015 | Reference materials — Good practice in using reference materials |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| 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 |
| DIN 820-120:2012-09 | STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999) |
| 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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