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UNI EN ISO 15194 : 2009

Current
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
Published date

09-03-2009

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 FORMATO SISTEMATICO DELLE PROPRIETA NELLA
  DOCUMENTAZIONE DI SUPPORTO DI UN MATERIALE
  DI RIFERIMENTO CERTIFICATO
5 PROPRIETA, PRODUZIONE E CARATTERIZZAZIONE DI
  UN MATERIALE DI RIFERIMENTO CERTIFICATO
6 CONTENUTO DELLA DOCUMENTAZIONE DI SUPPORTO
APPENDICE A (informativa) - MATERIALI DI RIFERIMENTO
  CERTIFICATI CON PROPRIETA NOMINALI O GRANDEZZE
  ORDINALI
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
  NORMA EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
  UE 98/79
BIBLIOGRAFIA

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
CT 44
DevelopmentNote
Supersedes UNI EN 12287. (10/2009)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

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 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 14971:2007 Medical devices Application of risk management to medical devices
ECA 4-14 : 2003 THE SELECTION AND USE OF REFERENCE MATERIALS
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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