EN ISO 19001:2013

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien für biologische Färbungen (ISO 19001:2013)

Diese Internationale Norm legt Anforderungen an die Bereitstellung von Informationen durch den Hersteller von Reagenzien für biologische Färbungen fest. Sie gilt für die Hersteller, Lieferanten und Vertreiber von Farbstoffen, Farbstofflösungen, farbgebenden Reagenzien und anderen für biologische Färbungen verwendeten Reagenzien. Die in dieser Internationalen Norm aufgeführten Anforderungen an die vom Hersteller bereitgestellten Informationen sind Voraussetzung für das Erzielen vergleichbarer und reproduzierbarer Ergebnisse in allen Bereichen biologischer Färbungen.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant avec les réactifs de coloration de diagnostic in vitro utilisés en biologie (ISO 19001:2013)

L'ISO 19001:2013 spécifie des exigences relatives aux informations fournies par le fabricant et applicables aux colorants utilisés en biologie. Elle s'adresse aux fabricants, fournisseurs et distributeurs de teintures, colorants, réactifs chromogènes et autres réactifs de coloration utilisés en histologie et en cytologie, notamment en bactériologie, en hématologie, en histochimie, effectuées en laboratoires médicaux, en bactériologie de routine et de recherche. Les exigences relatives aux informations fournies par le fabricant et spécifiées dans la présente Norme internationale constituent une condition préalable à l'obtention de résultats comparables et reproductibles dans le domaine des colorations biologiques.

Diagnostični preskusni sistemi in vitro - Informacije, ki jih priskrbi proizvajalec diagnostičnih reagentov za barvanje in vitro v biologiji (ISO 19001:2013)

Ta mednarodni standard določa zahteve za informacije, ki jih priskrbi proizvajalec diagnostičnih reagentov, ki se uporabljajo pri barvanju v biologiji. Velja za proizvajalce, dobavitelje in prodajalce barvil, barv, kromogenih in drugih reagentov, ki se uporabljajo za barvanje v histologiji in citologiji, vključno z bakteriologijo, hematologijo, histokemijo, kot se izvaja v medicinskih laboratorijih, tako na področju rutinske kot tudi raziskovalne bakteriologije. Zahteve za informacije, ki jih zagotovi proizvajalec in so navedene v tem mednarodnem standardu, so predpogoj za dosego primerljivih in ponovljivih rezultatov na vseh področjih barvanja v biologiji.

General Information

• Status: Published
• Publication Date: 19-Mar-2013
• Withdrawal Date: 30-Mar-2016
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.100.10 - In vitro diagnostic test systems
• 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: 20-Mar-2013
• Completion Date: 20-Mar-2013
• Ref Project: SIST EN ISO 19001:2013 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

Relations

• Replaces: EN 12376:1999 - In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
• Effective Date: 24-Apr-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 19001:2013
01-junij-2013
1DGRPHãþD
SIST EN 12376:2000
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR,QIRUPDFLMHNLMLKSULVNUELSURL]YDMDOHF
GLDJQRVWLþQLKUHDJHQWRY]DEDUYDQMHLQYLWURYELRORJLML,62
In vitro diagnostic medical devices - Information supplied by the manufacturer with in
vitro diagnostic reagents for staining in biology (ISO 19001:2013)
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-
diagnostischen Reagenzien für biologische Färbungen (ISO 19001:2013)
Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant avec
les réactifs de coloration de diagnostic in vitro utilisés en biologie (ISO 19001:2013)
Ta slovenski standard je istoveten z: EN ISO 19001:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 19001:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19001:2013

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SIST EN ISO 19001:2013


EUROPEAN STANDARD
EN ISO 19001

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2013
ICS 11.100.10; 11.040.55 Supersedes EN 12376:1999
English Version
In vitro diagnostic medical devices - Information supplied by the
manufacturer with in vitro diagnostic reagents for staining in
biology (ISO 19001:2013)
Dispositifs médicaux de diagnostic in vitro - Informations In-vitro-Diagnostika - Bereitstellung von Informationen
fournies par le fabricant avec les réactifs de coloration de durch den Hersteller von in-vitro-diagnostischen
diagnostic in vitro utilisés en biologie (ISO 19001:2013) Reagenzien für biologische Färbungen (ISO 19001:2013)
This European Standard was approved by CEN on 14 March 2013.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19001:2013: E
worldwide for CEN national Members.

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SIST EN ISO 19001:2013
EN ISO 19001:2013 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 19001:2013
EN ISO 19001:2013 (E)
Foreword
This document (EN ISO 19001:2013) 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 September 2013, and conflicting national standards shall be
withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12376:1999.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turke
...