EN 14136:2004
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
19-05-2004
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
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.NOTEExternal 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 |
CEN/TC 140
|
DevelopmentNote |
Supersedes PREN 14136 (10/2005)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Current
|
Standards | Relationship |
NS EN 14136 : 1ED 2004 | Identical |
BS EN 14136:2004 | 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 |
PN EN 14136 : 2007 | Identical |
NBN EN 14136 : 2004 | Identical |
DIN EN 14136:2004-08 | Identical |
15/30327269 DC : 0 | BS EN ISO 17034 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
UNE-EN ISO/IEC 17043:2010 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
UNI CEI EN ISO/IEC 17043 : 2010 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
CLSI MM14 A : 1ED 2005 | PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS |
BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
I.S. EN ISO/IEC 17043:2010 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
DIN EN ISO/IEC 17043:2010-05 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
EN ISO/IEC 17043:2010 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
BS EN ISO/IEC 17043:2010 | Conformity assessment. General requirements for proficiency testing |
CEI UNI EN ISO/IEC 17043 : 2011 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
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) |
ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
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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