EN 591:1994
(Main)In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use
This standard specifies user manuals for in-vitro diagnostic instruments for professional use. User manuals are essential to enable the safe and proper operation of instruments. This standard is not applicable to field repair instructions.
In-vitro Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-Diagnostika-Geräte zum Gebrauch durch Fachpersonal
Diese Norm legt den Inhalt von Benutzerhandbüchern für In-vitro-Diagnostica- Geräte zum Gebrauch durch Fachpersonal fest. Benutzerhandbücher sind erforderlich, um den sicheren und fachgerechten Betrieb von Geräten zu ermöglichen. Diese Norm ist nicht anwendbar auf Anweisungen für die Durchführung von Reparaturen.
Systèmes d'analyses médicales in vitro - Règles pour les manuels d'utilisation d'instruments pour le diagnostic in vitro pour usage professionnel
Cette norme spécifie le contenu des manuels d'utilisation pour les instruments de diagnostic in vitro pour usage professionnel. Les manuels d'utilisation sont essentiels pour permettre un usage correct et sans danger des instruments. Cette norme ne s'applique pas aux instructions de réparation.
Diagnostični sistemi in vitro - Zahteve za priročnike za uporabnike diagnostičnih instrumentov in vitro za profesionalno uporabo
General Information
- Status
- Withdrawn
- Publication Date
- 08-Sep-1994
- Withdrawal Date
- 20-Mar-2001
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140/WG 1 - Labelling and performance evaluation
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 21-Mar-2001
- Completion Date
- 21-Mar-2001
Relations
- Replaced By
EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use - Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Referred By
EN ISO 2495:2000 - Iron blue pigments - Specifications and methods of test (ISO 2495:1995) - Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 591:1994 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use". This standard covers: This standard specifies user manuals for in-vitro diagnostic instruments for professional use. User manuals are essential to enable the safe and proper operation of instruments. This standard is not applicable to field repair instructions.
This standard specifies user manuals for in-vitro diagnostic instruments for professional use. User manuals are essential to enable the safe and proper operation of instruments. This standard is not applicable to field repair instructions.
EN 591:1994 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 591:1994 has the following relationships with other standards: It is inter standard links to EN 591:2001, EN ISO 788:2022, EN ISO 1248:2008, EN ISO 2495:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 591:1994 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
'LDJQRVWLþQLVLVWHPLLQYLWUR=DKWHYH]DSULURþQLNH]DXSRUDEQLNHGLDJQRVWLþQLK
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In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic
instruments for professional use
In-vitro Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-
Diagnostika-Geräte zum Gebrauch durch Fachpersonal
Systemes d'analyses médicales in vitro - Regles pour les manuels d'utilisation
d'instruments pour le diagnostic in vitro pour usage professionnel
Ta slovenski standard je istoveten z: EN 591:1994
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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