Name: UNI EN ISO 15193 : 2009
Brand: UNI

IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES

Published date

09-03-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 PRESENTAZIONE DI UNA PROCEDURA DI MISURA DI RIFERIMENTO
APPENDICE A (informativa) - PROCEDURE DI RIFERIMENTO PER LE
  PROPRIETA DIVERSE DALLE GRANDEZZE DIFFERENZIALI E
  RAZIONALI
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE NORMA
  EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA UE 98/79
BIBLIOGRAFIA

Describes requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

Committee	CT 44
DevelopmentNote	Supersedes UNI EN 12286. (10/2009)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN 12286 : 2000

Standards	Relationship
EN ISO 15193:2009	Identical
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
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
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)