UNI EN ISO 15194 : 2009
Current
The latest, up-to-date edition.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
03-09-2009
PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 FORMATO SISTEMATICO DELLE PROPRIETA NELLA
DOCUMENTAZIONE DI SUPPORTO DI UN MATERIALE
DI RIFERIMENTO CERTIFICATO
5 PROPRIETA, PRODUZIONE E CARATTERIZZAZIONE DI
UN MATERIALE DI RIFERIMENTO CERTIFICATO
6 CONTENUTO DELLA DOCUMENTAZIONE DI SUPPORTO
APPENDICE A (informativa) - MATERIALI DI RIFERIMENTO
CERTIFICATI CON PROPRIETA NOMINALI O GRANDEZZE
ORDINALI
APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
NORMA EUROPEA E I REQUISITI ESSENZIALI DELLA DIRETTIVA
UE 98/79
BIBLIOGRAFIA
Describes requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511.
| Committee |
CT 44
|
| DevelopmentNote |
Supersedes UNI EN 12287. (10/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 15194:2009 | Identical |
| ISO 15194:2009 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO Guide 32:1997 | Calibration in analytical chemistry and use of certified reference materials |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| 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 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO Guide 33:2015 | Reference materials — Good practice in using reference materials |
| ISO Guide 35:2017 | Reference materials — Guidance for characterization and assessment of homogeneity and stability |
| 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/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| ISO/IEC Guide 15:1977 | ISO/IEC code of principles on "reference to standards" |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| 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 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 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ECA 4-14 : 2003 | THE SELECTION AND USE OF REFERENCE MATERIALS |
| ISO Guide 31:2015 | Reference materials — Contents of certificates, labels and accompanying documentation |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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