Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

Available format(s)

Hardcopy , PDF

Language(s)

English, German

Published date

01-08-2004

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DocumentType	Standard
Pages	12
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NS EN 14136 : 1ED 2004	Identical
BS EN 14136:2004	Identical
SN EN 14136 : 2004	Identical
UNE-EN 14136:2004	Identical
I.S. EN 14136:2004	Identical
UNI EN 14136 : 2004	Identical
NEN EN 14136 : 2004	Identical
NF EN 14136 : 2004	Identical
EN 14136:2004	Identical
NBN EN 14136 : 2004	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 15195:2003	Laboratory medicine Requirements for reference measurement laboratories
EN 12286:1998/A1:2000	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
EN 45003 : 1995	CALIBRATION AND TESTING LABORATORY ACCREDITATION SYSTEM - GENERAL REQUIREMENTS FOR OPERATION AND RECOGNITION
EN ISO 18153:2003	In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
ISO 15189:2012	Medical laboratories — Requirements for quality and competence
EN ISO 15195:2003	Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
ISO/IEC Guide 43-1:1997	Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
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 17511:2003	In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
EN 375 : 2001	INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO/IEC Guide 43-2:1997	Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
EN 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 17511:2003)
ISO 3534-1:2006	Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability