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EN 12287 : 1999

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date

01-05-2009

Published date

23-06-1999

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and naming of reference materials
5 Description of a reference material
6 Label
7 Certificate
8 Package insert
Annex A (informative) Materials with properties other than
         quantities
Annex B (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU directives

Defines requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This standard also provides instruction on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate.

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Withdrawn

Standards Relationship
DIN EN 12287:1999-08 Identical
BS EN 12287:1999 Identical
UNE-EN 12287:2000 Identical
NS EN 12287 : 1999 Identical
SN EN 12287 : 1999 Identical
NBN EN 12287 : 1999 Identical
PN EN 12287 : 2006 Identical
I.S. EN 12287:1999 Identical
NF EN 12287 : 1999 Identical
UNI EN 12287 : 2001 Identical
NEN EN 12287 : 1999 Identical

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 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
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

EN 12286:1998/A1:2000 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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 Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
CLSI NRSCL13 A : 1ED 2000 THE REFERENCE SYSTEM FOR THE CLINICAL LABORATORY: CRITERIA FOR DEVELOPMENT AND CREDENTIALING OF METHODS AND MATERIALS FOR HARMONIZATION OF RESULTS

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