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I.S. 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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Superseded date

29-06-2021

Superseded by

I.S. EN ISO 17511:2021

Language(s)

English

Published date

01-01-2003

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

€64.00
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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

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

DocumentType
Standard
Pages
64
PublisherName
National Standards Authority of Ireland
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
CLSI NRSCL8 A : 1998 TERMINOLOGY AND DEFINITIONS FOR USE IN NCCLS DOCUMENTS
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
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
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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