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BS EN ISO 17511:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
Available format(s)

Hardcopy , PDF

Superseded date

07-06-2021

Language(s)

English

Published date

19-08-2003

Publisher

British Standards Institution

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

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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Hardcopy - English
PDF - English
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