UNI EN 14136 : 2004
Current
The latest, up-to-date edition.
USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC EXAMINATION PROCEDURES
01-10-2004
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design requirements for EQAS
5 Requirements for organisations conducting EQAS
6 Assessment of analytical examination procedures
7 Using results to identify possible deficiencies
8 Archiving documents
9 Confidentiality
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements
or other provisions of EU Directives
Bibliography
Applicable to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs).
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 14136:2004 | Identical |
| I.S. EN 14136:2004 | Identical |
| NS EN 14136 : 1ED 2004 | Identical |
| NBN EN 14136 : 2004 | Identical |
| NF EN 14136 : 2004 | Identical |
| BS EN 14136:2004 | Identical |
| NEN EN 14136 : 2004 | Identical |
| SN EN 14136 : 2004 | Identical |
| EN 14136:2004 | Identical |
| DIN EN 14136:2004-08 | Identical |
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