BS EN 14136:2004 - Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

BS EN 14136:2004

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

Status : Confirmed, Current   Published : May 2004

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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.




Standard NumberBS EN 14136:2004
TitleUse of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
StatusConfirmed, Current
Publication Date26 May 2004
Confirm Date20 February 2020
Normative References(Required to achieve compliance to this standard)EN 45003:1995, EN ISO 15195, ISO 17511:2003, ISO/FDIS 15195:2003, EN ISO 18153, EN ISO 17511, ISO 18153:2003, ISO 3534-1:1993, EN 12286:1998, EN 375:2001
Informative References(Provided for Information)98/79/EC, ISO/IEC Guide 43-1:1997, WHO/DIL/LAB/99.2., ISO/DIS 15189.2:2003, ISO/Remco N 263:1992, ISO/DIS 13528, EN ISO 15189, EN ISO/IEC 17025, ISO/Remco N 231:1991, ISO/IEC Guide 43-2, ISO 1000, ISO/IEC 17025:1999
International RelationshipsEN 14136:2004
Draft Superseded By01/561148 DC
DescriptorsDiagnostic programs, Assessed quality, Diagnosis (medical)
ICS11.100.10
Title in FrenchUtilisation des programmes d'evaluation externe de la qualite dans l'evaluation de la performance des procedures de diagnostic in vitro
Title in GermanVerwendung externer Qualitaetssicherungsprogramme bei der Bewertung der Durchfuehrung von Untersuchungsverfahren in der In-vitro-Diagnostik
CommitteeCH/212
ISBN0 580 43819 8
PublisherBSI
FormatA4
DeliveryYes
Pages14
File Size291 KB
Price£112.00


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