ONORM EN ISO 17511 : 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
01-11-2021
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Metrological traceability chain and calibration hierarchy
4.1 Principles
4.2 Structure and nomenclature
4.3 Considerations in establishing metrological
traceability
4.4 Functions of reference materials
5 Calibration transfer protocols
5.1 Availability and structure
5.2 Cases with primary reference measurement procedure and
primary calibrator(s) giving metrological traceability to
SI
5.3 Cases with international conventional reference
measurement procedure (which is not primary) and
international conventional calibrator(s) without
metrological traceability to SI
5.4 Cases with international conventional reference
measurement procedure (which is not primary) but no
international conventional calibrator and without
metrological traceability to SI
5.5 Cases with international conventional calibrator
(which is not primary) but no international
conventional reference measurement procedure and
without metrological traceability to SI
5.6 Cases with manufacturer's selected measurement
procedure but neither international conventional
reference measurement procedure nor international
conventional calibrator and without metrological
traceability to SI
5.7 Trueness control materials
6 Expression of uncertainty of measurement
7 Validation of metrologically traceable calibration
8 Information on metrological traceability to be given
in the instructions for use of an in vitro diagnostic
medical device
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements
or other provisions of EU Directives
Bibliography
Describes how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement.
DocumentType |
Standard
|
PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
Status |
Withdrawn
|
SupersededBy |
Standards | Relationship |
BS EN ISO 17511:2003 | Identical |
NBN EN ISO 17511 : 2003 | Identical |
I.S. EN ISO 17511:2003 | Identical |
NF EN ISO 17511 : 2004 | Identical |
DIN EN ISO 17511:2003-11 | Identical |
SN EN ISO 17511 : 2003 | Identical |
NEN EN ISO 17511 : 2003 | Identical |
NS EN ISO 17511 : 1ED 2003 | Identical |
UNI EN ISO 17511 : 2004 | Identical |
UNE-EN ISO 17511:2004 | Identical |
ISO 17511:2003 | Identical |
EN ISO 17511:2003 | Identical |
ONORM EN 15842 : 2010 | FOODSTUFFS - DETECTION OF FOOD ALLERGENS - GENERAL CONSIDERATIONS AND VALIDATION OF METHODS |
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