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- ISO_14971 abstract "ISO 14971 is an ISO standard for the application of risk management to medical devices. The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971 was published by ISO TC 210 to provide expert guidance on the application of this standard.This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality management system standards such as ISO 13485. Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and management, and also specifies a procedure for review and monitoring during production and post-production.In 2012, a European harmonized version of this standard was adopted by CEN as EN ISO 14971:2012. This version is harmonized with respect to the three European Directives associated with medical devices Medical Devices Directive 93/42/EEC, In-vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC through the three 'Zed' Annexes (ZA, ZB & ZC). This was done to address the presumed compliance with the 3 Directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard.Template:Fact?EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 remains the standard recommended for medical device risk management purposes.".
- ISO_14971 wikiPageExternalLink CatalogueDetailPage.CatalogueDetail?CSNUMBER=36786&ICS1=11&ICS2=40&ICS3=1.
- ISO_14971 wikiPageExternalLink iso_technical_committee.htm?commid=54892.
- ISO_14971 wikiPageID "24479606".
- ISO_14971 wikiPageLength "4017".
- ISO_14971 wikiPageOutDegree "17".
- ISO_14971 wikiPageRevisionID "699989882".
- ISO_14971 wikiPageWikiLink Category:Medical_technology.
- ISO_14971 wikiPageWikiLink Category:Regulation_of_medical_devices.
- ISO_14971 wikiPageWikiLink Clinical_engineering.
- ISO_14971 wikiPageWikiLink European_Committee_for_Standardization.
- ISO_14971 wikiPageWikiLink Health_technology.
- ISO_14971 wikiPageWikiLink IEC_Guide_51.
- ISO_14971 wikiPageWikiLink IEC_Guide_63.
- ISO_14971 wikiPageWikiLink ISO_13485.
- ISO_14971 wikiPageWikiLink ISO_690.
- ISO_14971 wikiPageWikiLink International_Organization_for_Standardization.
- ISO_14971 wikiPageWikiLink List_of_International_Organization_for_Standardization_standards.
- ISO_14971 wikiPageWikiLink Medical_Devices_Directive.
- ISO_14971 wikiPageWikiLink Medical_device.
- ISO_14971 wikiPageWikiLink System_suitability_test.
- ISO_14971 wikiPageWikiLinkText "ISO 14971".
- ISO_14971 wikiPageWikiLinkText "Medical Device Risk Management - ISO 14971".
- ISO_14971 wikiPageUsesTemplate Template:Fact%3F.
- ISO_14971 wikiPageUsesTemplate Template:ISO_standards.
- ISO_14971 wikiPageUsesTemplate Template:Reflist.
- ISO_14971 subject Category:Medical_technology.
- ISO_14971 subject Category:Regulation_of_medical_devices.
- ISO_14971 hypernym ISO.
- ISO_14971 type Organisation.
- ISO_14971 comment "ISO 14971 is an ISO standard for the application of risk management to medical devices. The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The latest significant revision was published in 2007 with a minor update published in 2009.".
- ISO_14971 label "ISO 14971".
- ISO_14971 sameAs Q1459101.
- ISO_14971 sameAs ISO_14971.
- ISO_14971 sameAs ISO_14971.
- ISO_14971 sameAs ISO_14971.
- ISO_14971 sameAs m.080n0ry.
- ISO_14971 sameAs Q1459101.
- ISO_14971 sameAs ISO_14971.
- ISO_14971 wasDerivedFrom ISO_14971?oldid=699989882.
- ISO_14971 isPrimaryTopicOf ISO_14971.