NF EN ISO 15195 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES
19-03-2019
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences relatives au système de management
4.1 Organisation et management
4.2 Système de management de la qualité
4.3 Personnel
4.4 Documentation et enregistrements relatifs aux mesures
4.5 Contractualisation
5 Exigences techniques
5.1 Locaux et conditions environnementales
5.2 Traitement des échantillons
5.3 Équipement
5.4 Matériaux de référence
5.5 Modes opératoires de mesure de référence
5.6 Traçabilité métrologique - Incertitude de mesure
5.7 Assurance qualité
5.8 Compte rendu des résultats
5.8.1 Exigences minimales requises pour le compte rendu
5.8.2 Éléments facultatifs
Annexe A (informative) Références croisées avec l'ISO/CEI
17025:1999
Bibliographie
Specifies the requirements for reference measurement laboratories in laboratory medicine.
| DevelopmentNote |
Indice de classement: S92-062. Supersedes NFS 92 062. (09/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NS EN ISO 15195 : 1ED 2003 | Identical |
| ISO 15195:2003 | Identical |
| BS EN ISO 15195:2003 | Identical |
| EN ISO 15195:2003 | Identical |
| NEN EN ISO 15195 : 2003 | Identical |
| I.S. EN ISO 15195:2003 | Identical |
| SN EN ISO 15195 : 2003 | Identical |
| UNI EN ISO 15195 : 2004 | Identical |
| ONORM EN ISO 15195 : 2004 | Identical |
| UNE-EN ISO 15195:2004 | Identical |
| DIN EN ISO 15195:2004-01 | Identical |
| 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 15193:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures |
| NF EN ISO 17511 : 2004 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS |
| NF EN ISO 18153 : 2004 | 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 |
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