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  • BS EN ISO 17511:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-06-2021

    Language(s):  English

    Published date:  19-08-2003

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Describes how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement.

    General Product Information - (Show below) - (Hide below)

    Committee CH/212
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    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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