I.S. EN ISO 17511:2021
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Hardcopy , PDF
English
21-06-2021
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviated terms
4 General requirements to be fulfilled by a manufacturer for establishing, validating
and documenting metrological traceability of human sample values determined
with a specified IVD MD
5 Model calibration hierarchies for metrological traceability
6 Labelling information to be provided to end-users by the manufacturer
Bibliography
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs.
| Committee |
TC 212
|
| DocumentType |
Standard
|
| Pages |
76
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 17511:2021 | Identical |
| ISO 17511:2020 | Identical |
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