SIST EN 980:2000

Graphical symbols for use in the labelling of medical devices

This European Standard specifies graphical symbols for use in the information supplied by the manufacturer with medical devices.  Note: This standard does not specify the circumstances under which particular symbols are used. Guidance on this is given in prEN 1041.

Graphische Symbole zur Kennzeichnung von Medizinprodukten

Diese europäische Norm legt die graphischen Symbole fest, die von den Herstellern für Informationen zu Medizinprodukten, wie sie in den EG-Richtlinien über Medizinprodukte, aktive implantierbare Medizinprodukte und In-vitro-Diagnostika (in Vorbereitung) definiert sind, verwendet werden sollten.

Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux

La présente norme européenne spécifie les symboles graphiques destinés a etre inclus dans les informations fournies par le fabricant avec les dispositifs médicaux, tels que définis dans les Directives de la CEE relatives aux dispositifs médicaux, aux dispositifs médicaux implantables actifs et aux dispositifs médicaux de diagnostic in vitro (en cours d'élaboration).

Grafični simboli za označevanje medicinskih pripomočkov

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 31-Aug-2003
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Sep-2003
• Due Date: 01-Sep-2003
• Completion Date: 01-Sep-2003
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: EN 980:1996 - Graphical symbols for use in the labelling of medical devices

Relations

• Amended By: SIST EN 980:2000/A2:2002 - Graphical symbols for use in the labelling of medical devices
• Effective Date: 22-Dec-2008
• Amended By: SIST EN 980:2000/A1:2000 - Graphical symbols for use in the labelling of medical devices
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN 980:2003 - Graphical symbols for use in the labelling of medical devices
• Effective Date: 01-Sep-2003

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 980:2000
01-januar-2000
*UDILþQLVLPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
Graphical symbols for use in the labelling of medical devices
Graphische Symbole zur Kennzeichnung von Medizinprodukten
Symboles graphiques utilisés pour l'étiquetage des dispositifs médicaux
Ta slovenski standard je istoveten z: EN 980:1996
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.120.01 Farmacija na splošno Pharmaceutics in general
SIST EN 980:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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