EN 12287 : 1999
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
01-05-2009
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Withdrawn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) |
| 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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