IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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	DIN EN 12287:1999-08

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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DIN EN ISO 15194:2009-10

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