I.S. 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 PROCEDURE
Hardcopy , PDF
English
01-01-2004
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
Applies 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).
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| SN EN 14136 : 2004 | Identical |
| DIN EN 14136:2004-08 | Identical |
| UNI EN 14136 : 2004 | Identical |
| EN 14136:2004 | Identical |
| UNE-EN 14136:2004 | Identical |
| BS EN 14136:2004 | Identical |
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