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BS EN 14136:2004

BS EN 14136:2004

Current

Current

The latest, up-to-date edition.

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-26-2004

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design requirements for EQAS
5 Requirements for organisations conducting EQAS
6 Assessment of analytical examination procedures
7 Using results to identify possible deficiencies
8 Archiving documents
9 Confidentiality
Annex ZA (informative) Clauses of this European Standard
                       addressing essential requirements
                       or other provisions of EU Directives
Bibliography

Applicable to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs).

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organisation; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

Committee
CH/212
DevelopmentNote
Supersedes 01/561148 DC. (06/2004)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
NS EN 14136 : 1ED 2004 Identical
SN EN 14136 : 2004 Identical
UNE-EN 14136:2004 Identical
I.S. EN 14136:2004 Identical
UNI EN 14136 : 2004 Identical
NEN EN 14136 : 2004 Identical
NF EN 14136 : 2004 Identical
EN 14136:2004 Identical
NBN EN 14136 : 2004 Identical
DIN EN 14136:2004-08 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
EN 12286:1998/A1:2000 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
EN 45003 : 1995 CALIBRATION AND TESTING LABORATORY ACCREDITATION SYSTEM - GENERAL REQUIREMENTS FOR OPERATION AND RECOGNITION
EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
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
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
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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