BS EN ISO 17511:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
07-06-2021
English
19-08-2003
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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.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NS EN ISO 17511 : 1ED 2003 | Identical |
| UNI EN ISO 17511 : 2004 | Identical |
| I.S. EN ISO 17511:2003 | Identical |
| UNE-EN ISO 17511:2004 | Identical |
| ISO 17511:2003 | Identical |
| EN ISO 17511:2003 | Identical |
| NBN 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 |
| ONORM EN ISO 17511 : 2003 | Identical |
| ENV 1614 : 1995 | HEALTHCARE INFORMATICS - STRUCTURE FOR NOMENCLATURE, CLASSIFICATION AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCE |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO Guide 32:1997 | Calibration in analytical chemistry and use of certified reference materials |
| EN 12286:1998/A1:2000 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES |
| EN 12287 : 1999 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS |
| 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 |
| EN 375 : 2001 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 181:1981 | Plastics — Determination of flammability characteristics of rigid plastics in the form of small specimens in contact with an incandescent rod |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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