EN 1441:1997

Medical devices - Risk analysis

This standard specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used.  This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard.  This standard is not intended to give detailed guidance on management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications  and contra-indications for the use of a particular device.

Medizinprodukte - Risikoanalyse

Diese Norm legt für den Hersteller ein Verfahren fest, mit dem unter Verwendung der verfügbaren Informationen die Sicherheit eines Medizinprodukts, einschließlich der von Produkten zur In-Vitro-Diagnostik oder Zubehör, untersucht wird, indem die mit dem Produkt verbundenen Gefährdungen festgestellt und deren Risiken eingeschätzt werden. Dies ist besonders hilfreich in Bereichen, in denen relevante harmonisierte Normen nicht verfügbar sind oder nicht angewendet werden.

Dispositifs médicaux - Analyse des risques

La présente norme spécifie une procédure qui permet au fabricant d'examiner, en utilisant des informations disponibles, la sécurité d'un dispositif médical, y compris les dispositifs ou accessoires de diagnostic in vitro, en identifiant les dangers et en estimant les risques qui sont associés au dispositif. Elle constitue une aide particulièrement intéressante, notamment dans les domaines où des normes correspondantes sont indisponibles ou inutilisées.

Medical devices - Risk analysis

General Information

• Status: Withdrawn
• Publication Date: 21-Oct-1997
• Withdrawal Date: 26-Feb-2002
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/SS S99 - Health, environment and medical equipment - Undetermined
• Drafting Committee: CEN/SS S99 - Health, environment and medical equipment - Undetermined
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 27-Feb-2002
• Completion Date: 27-Feb-2002
• 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 1441:2000 - Medical devices - Risk analysis

Relations

• Replaced By: EN ISO 14971:2000 - Medical devices - Application of risk management to medical devices (ISO 14971:2000)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical devices - Risk analysisMedizinprodukte - RisikoanalyseDispositifs médicaux - Analyse des risquesMedical devices - Risk analysis11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN 1441:1997SIST EN 1441:2000en01-april-2000SIST EN 1441:2000SLOVENSKI
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