EN ISO 14971:2000/AC:2002

Medical devices - Application of risk management to medical devices (ISO 14971:2000)

CLC - Implementation of CENELEC/BT Resolution (D102/154) => New DOW + dual logo title pages

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2000)

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2000)

Medicinski pripomočki - Uporaba obvladovanja tveganja pri medicinskih pripomočkih (ISO 14971:2000)

General Information

• Status: Withdrawn
• Publication Date: 26-Feb-2002
• Withdrawal Date: 14-Mar-2007
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Mar-2007
• Completion Date: 15-Mar-2007
• 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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14971:2001/AC:2003 - Medical devices - Application of risk management to medical devices (ISO 14971:2000)

Relations

• Corrects: EN ISO 14971:2000 - Medical devices - Application of risk management to medical devices (ISO 14971:2000)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 14971:2007 - Medical devices - Application of risk management to medical devices (ISO 14971:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical devices - Application of risk management to medical devices (ISO 14971:2000)VNLKDispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2000)Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2000)Ta slovenski standard je istoveten z:EN ISO 14971:2000/AC:2002SIST EN ISO 14971:2001/AC:2003en11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:SLOVENSKI
STANDARDSIST EN ISO 14971:2001/AC:200301-september-2003







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14971December 2000ICS 11.040.01Supersedes EN 1441:1997English versionMedical devices - Application of risk management to medicaldevices (ISO 14971:2000)Dispositifs médicaux - Application de la gestion des risquesaux dispositifs médicaux (ISO 14971:2000)Medizinprodukte - Anwendung des Risikomanagementsauf Medizinprodukte (ISO 14971:2000)This European Standard was approved by CEN on 3 December 2000, and by CENELEC on 2 May 2001.CEN/CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thisEuropean Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning suchnational standards may be obtained on application to the Management Centre or to any CEN/CENELEC member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN/CENELEC member into its own language and notified to the Management Centre has the same status asthe official versions.CEN/CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgiu
...