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EN 12286:1998/A1:2000

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
Withdrawn date

11-24-2000

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Presentation of a reference measurement procedures
Annex A (informative) Reference procedures for
        properties other than quantities
Annex B (informative) Bibliography

Defines requirements for the drafting of a reference measurement procedure. Applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

Committee
TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

BS 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 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
EN 12287 : 1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS
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)
I.S. 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
DIN EN ISO 18153:2003-11 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 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
BS EN 12287:1999 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
01/561148 DC : DRAFT MAR 2001 BS EN 14136 - USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC PROCEDURES
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)
BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
BS 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
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)
EN 13612:2002/AC:2002 PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
00/565675 DC : DRAFT DEC 2000 BS EN ISO 17511 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

ISO 6353-3:1987 Reagents for chemical analysis — Part 3: Specifications — Second series
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

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