EN ISO 15195:2019

Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE       Requirements for medical laboratories are specified in ISO 15189[1].

Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit Referenzmessverfahren (ISO 15195:2018)

Dieses Dokument legt, unter Verwendung der Anforderungen von ISO/IEC 17025:2017 als normative Verweisung, die Anforderungen an die Kompetenz zur Durchführung von Referenzmessverfahren in der Laboratoriumsmedizin fest und listet weitere Anforderungen an Kalibrierlaboratorien auf, damit diese ihre Aufgaben adäquat ausführen.
Der Zusammenhang zwischen Abschnitten dieses Dokument und ISO/IEC 17025:2017 ist in Anhang A erläutert.
Die Untersuchung von Eigenschaften, deren Ergebnisse auf Nominal  oder Ordinalskalen dargestellt werden, gehört nicht zum Anwendungsbereich dieser Norm.
Dieses Dokument ist nicht auf medizinische Laboratorien anwendbar.
ANMERKUNG   Die Anforderungen an medizinische Laboratorien sind in ISO 15189 [1] festgelegt.

Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence (ISO 15195:2018)

Le présent document spécifie les exigences relatives à la compétence des laboratoires d'étalonnages utilisant des procédures de mesure de référence dans le domaine de la biologie médicale, en appliquant les exigences de l'ISO/IEC 17025:2017 comme référence normative et en répertoriant les exigences supplémentaires applicables pour que les laboratoires d'étalonnages puissent s'acquitter de leur tâche de manière appropriée.
La relation entre les articles et paragraphes du présent document et ceux de l'ISO/IEC 17025:2017 est résumée dans l'Annexe A.
Les examens dont les propriétés conduisent à des résultats exprimés selon une échelle nominale ou ordinale ne sont pas concernés.
Le présent document n'est pas applicable aux laboratoires de biologie médicale.
NOTE       Les exigences applicables aux laboratoires de biologie médicale sont spécifiées dans l'ISO 15189[1].

Laboratorijska medicina - Zahteve za usposobljenost kalibracijskih laboratorijev z uporabo referenčnih merilnih postopkov (ISO 15195:2018)

Ta dokument določa zahteve za usposobljenost za izvajanje referenčnih merilnih postopkov v laboratorijski medicini na podlagi zahtev standarda ISO/IEC 17025:2017 kot normativne reference, navaja pa tudi dodatne zahteve, ki jih morajo upoštevati kalibracijski laboratoriji za ustrezno izvajanje opravil.
Razmerje med točkami tega dokumenta in standardom ISO/IEC 17025:2017 so povzeti v dodatku A.
Preskusi lastnosti z rezultati, o katerih se poroča po nominalni ali razvrstitveni lestvici, niso zajeti.
Ta dokument se ne uporablja za medicinske laboratorije.
OPOMBA: Zahteve za naprave za medicinske laboratorije so določene v standardu ISO 15189[1].

General Information

• Status: Published
• Publication Date: 05-Feb-2019
• Withdrawal Date: 27-Feb-2022
• ICS: 03.120.20 - Product and company certification. Conformity assessment
• ICS: 11.100 - Laboratory medicine
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 06-Feb-2019
• Completion Date: 06-Feb-2019
• Directive: 765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• Mandate: M/417 - Standardisation mandate addessed to CEN, CENELEC, and ETSI for the use of Harmonised Standards in support of the new legal framework and sectoral certification schemes
• Ref Project: SIST EN ISO 15195:2019 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)

Relations

• Replaces: EN ISO 15195:2003 - Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
• Effective Date: 30-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15195:2019
01-april-2019
1DGRPHãþD
SIST EN ISO 15195:2003
/DERUDWRULMVNDPHGLFLQD=DKWHYH]DXVSRVREOMHQRVWNDOLEUDFLMVNLKODERUDWRULMHY]
XSRUDERUHIHUHQþQLKPHULOQLKSRVWRSNRY,62
Laboratory medicine - Requirements for the competence of calibration laboratories using
reference measurement procedures (ISO 15195:2018)
Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit
Referenzmessverfahren (ISO 15195:2018)
Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage
utilisant des procédures de mesure de référence (ISO 15195:2018)
Ta slovenski standard je istoveten z: EN ISO 15195:2019
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15195:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15195:2019

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SIST EN ISO 15195:2019


EN ISO 15195
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2019
EUROPÄISCHE NORM
ICS 11.100.99 Supersedes EN ISO 15195:2003
English Version

Laboratory medicine - Requirements for the competence
of calibration laboratories using reference measurement
procedures (ISO 15195:2018)
Biologie médicale - Exigences relatives à la compétence Laboratoriumsmedizin - Anforderungen an die
des laboratoires d'étalonnage utilisant des procédures Kompetenz von Kalibrierlaboratorien mit
de mesure de référence (ISO 15195:2018) Referenzmessverfahren (ISO 15195:2018)
This European Standard was approved by CEN on 7 December 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15195:2019 E
worldwide for CEN national Members.

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SIST EN ISO 15195:2019
EN ISO 15195:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 15195:2019
EN ISO 15195:2019 (E)
European foreword
This document (EN ISO 15195:2019) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2019, and conflicting national standards shall
be withdrawn at the latest by February 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15195:2003.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the U
...