EN ISO 14971:2000/AC:2002
(Corrigendum)Medical devices - Application of risk management to medical devices (ISO 14971:2000)
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- Withdrawn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
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Mar-2007
- Completion Date
- 15-Mar-2007
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN ISO 14971:2000/AC:2002 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Medical devices - Application of risk management to medical devices (ISO 14971:2000)". This standard covers: CLC - Implementation of CENELEC/BT Resolution (D102/154) => New DOW + dual logo title pages
CLC - Implementation of CENELEC/BT Resolution (D102/154) => New DOW + dual logo title pages
EN ISO 14971:2000/AC:2002 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14971:2000/AC:2002 has the following relationships with other standards: It is inter standard links to EN ISO 14971:2007, EN ISO 14971:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14971:2000/AC:2002 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/295. 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 ISO 14971:2000/AC:2002 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.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
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