EN 1658:1996
(Main)Requirements for marking of in vitro diagnostic instruments
Requirements for marking of in vitro diagnostic instruments
This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1 : 1993. An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.
Anforderungen an die Kennzeichnung von In-vitro-Diagnostika-Geräten
Diese Norm legt Anforderungen an die Kennzeichnung von In-vitro-Diagnostika- Geräten fest. Bei Anwendung auf elektrische Laborgeräte gelten die Anforderungen zusätzlich zu den in den Abschnitten 5.1 bis 5.3 von EN 61 010-1:1993 festgelegten Anforderungen. Leicht verständliche und einheitliche Kennzeichnung ist wichtig für die sichere und richtige Handhabung von In-vitro-Diagnostika-Geräten.
Exigences de marquage des instruments de diagnostic in vitro
Cette norme définit des exigences relatives au marquage des instruments de diagnostic in vitro. En liaison avec l'équipement électrique utilisé en laboratoire, les exigences sont complémentaires à celles spécifiées dans les articles 5.1 à 5.3 de l'EN 61 010-1:1993. Un marquage uniforme facilement compréhensible des instruments de diagnostic in vitro est important pour leur utilisation correcte et sûre.
Zahteve za označevanje diagnostičnih instrumentov in vitro
General Information
- Status
- Withdrawn
- Publication Date
- 10-Dec-1996
- Withdrawal Date
- 13-May-2004
- 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
- 14-May-2004
- Completion Date
- 14-May-2004
Relations
- Referred By
EN 13532:2002 - General requirements for in vitro diagnostic medical devices for self-testing - Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 1658:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Requirements for marking of in vitro diagnostic instruments". This standard covers: This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1 : 1993. An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.
This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1 : 1993. An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.
EN 1658:1996 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 1658:1996 has the following relationships with other standards: It is inter standard links to EN 13532:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1658:1996 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1658:1996 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anforderungen an die Kennzeichnung von In-vitro-Diagnostika-GerätenExigences de marquage des instruments de diagnostic in vitroRequirements for marking of in vitro diagnostic instrume
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