EN 1041:1998

Information supplied by the manufacturer with medical devices

This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.

Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts

Diese Norm legt Informationen fest, die ein Hersteller nach der einschlägigen Anforderungen der EU-Richtlinien für verschiedene Kategorien von Medizinprodukten bereitstellen muß. Die Sprache, in der solche Informationen zu geben sind, wird nicht festgelegt. Es ist beabsichtigt, daß sie die besonderen Anforderungen der EG-Richtlinien über Medizinprodukte dadurch ergänzt, daß sie angibt, wie gewisse Anforderungen erfüllt werden können.

Informations fournies par le fabricant avec les dispositifs médicaux

La présente norme spécifie les informations qui doivent être fournies par le fabricant pour les différentes catégories de dispositifs médicaux, conformément aux Directives de l'UE pertinentes. Elle ne spécifie pas la langue dans laquelle ces informations doivent être rédigées. Elle est destinée à compléter les exigences particulières des Directive de l'UE relatives aux dispositifs médicaux en spécifiant les moyens qui permettent de satisfaire à certaines exigences.

Informacije, ki jih proizvajalec priloži medicinskim pripomočkom

General Information

• Status: Withdrawn
• Publication Date: 17-Feb-1998
• Withdrawal Date: 05-Aug-2008
• ICS: 01.110 - Technical product documentation
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/TC 257/WG 2 - Information provided with medical devices by the manufacturer
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-Aug-2008
• Completion Date: 06-Aug-2008
• 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
• 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: SIST EN 1041:2000 - Information supplied by the manufacturer with medical devices

Relations

• Replaced By: EN 1041:2008 - Information supplied by the manufacturer of medical devices
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Bereitstellung von Informationen durch den Hersteller eines MedizinproduktsInformations fournies par le fabricant avec les dispositifs médicauxInformation supplied by the manufacturer with medical devices11.040.01Medicinska oprema na splošnoMedical equipment in general01.110L]GHONHTechnical product documentationICS:Ta slovenski standard je istoveten z:EN 1041:1998SIST EN 1041:2000en01-januar-2000SIST EN 1041:2000SLOVENSKI
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