EN ISO 15195:2003

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.
ISO 15195:2003 is not applicable to routine medical laboratories.
The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".
ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

Laboratoriumsmedizin - Anforderungen an Referenzmesslaboratorien (ISO 15195:2003)

Médecine de laboratoires - Exigences pour les laboratoires réalisant des mesurages de référence (ISO 15195:2003)

L'ISO 15195:2003 décrit les exigences spécifiques requises à l'égard des laboratoires qui effectuent des mesures de référence dans le domaine de la biologie médicale. Les examens des propriétés conduisant à des résultats exprimés selon une échelle nominale ou ordinale ne sont pas concernés.
L'ISO 15195:2003 n'est pas applicable aux laboratoires de biologie médicale effectuant des analyses en routine.
Il relève de la responsabilité du laboratoire de satisfaire aux exigences réglementaires en vigueur en matière d'hygiène et de sécurité.
Les exigences générales relatives à la compétence des laboratoires d'étalonnage sont fixées dans l'ISO/CEI 17025 qui se rapporte aux laboratoires d'étalonnages et d'essais. L'ISO 15195:2003 concerne les aspects spécifiques relatifs aux laboratoires d'étalonnage dans le domaine de la biologie médicale où ces «laboratoires d'étalonnage» sont généralement appelés «laboratoires réalisant des mesures de référence».
L'ISO 15195:2003 peut constituer une base pour l'accréditation d'un laboratoire réalisant des mesures de référence et demandant une reconnaissance officielle pour la mise en oeuvre d'un mode opératoire de mesure de référence. En général, les laboratoires réalisant des mesures de référence sont accrédités par les instituts nationaux de métrologie ou par des organismes nationaux d'accréditation.

Laboratorijska medicina – Zahteve za referenčne merilne laboratorije (ISO 15195:2003)

General Information

• Status: Withdrawn
• Publication Date: 30-Sep-2003
• Withdrawal Date: 05-Feb-2019
• ICS: 03.120.20 - Product and company certification. Conformity assessment
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 4 - Reference systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• 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 15195:2003 - Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)

Relations

• Replaced By: EN ISO 15195:2019 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
• Effective Date: 30-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15195:2003
01-december-2003
/DERUDWRULMVNDPHGLFLQD±=DKWHYH]DUHIHUHQþQHPHULOQHODERUDWRULMH,62

Laboratory medicine - Requirements for reference measurement laboratories (ISO
15195:2003)
Laboratoriumsmedizin - Anforderungen an Referenzmesslaboratorien (ISO 15195:2003)
Médecine de laboratoires - Exigences pour les laboratoires réalisant des mesurages de
référence (ISO 15195:2003)
Ta slovenski standard je istoveten z: EN ISO 15195:2003
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15195:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15195:2003

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SIST EN ISO 15195:2003
EUROPEAN STANDARD
EN ISO 15195
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2003
ICS 11.100
English version
Laboratory medicine - Requirements for reference measurement
laboratories (ISO 15195:2003)
Médecine de laboratoires - Exigences pour les laboratoires Laboratoriumsmedizin - Anforderungen an
réalisant des mesurages de référence (ISO 15195:2003) Referenzmesslaboratorien (ISO 15195:2003)
This European Standard was approved by CEN on 24 July 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15195:2003 E
worldwide for CEN national Members.

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SIST EN ISO 15195:2003
EN ISO 15195:2003 (E)
Foreword
This document (EN ISO 15195:2003) 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 April 2004, and conflicting national
standards shall be withdrawn at the latest by April 2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 15195:2003 has been approved by CEN as EN ISO 15195:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2

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SIST EN ISO 15195:2003
EN ISO 15195:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 17511 2003 In vitro diagnostic medical devices - EN ISO 17511 2003
Measurement of quantities in biological
samples - Metrological traceability of
values assigned to calibrators and
control materials
ISO 18153 2003 In vitro diagnostic medical devices - EN ISO 18153 2003
Measurement of quantities in biological
samples - Metrological tr
...