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- Q1459101 subject Q8647021.
- Q1459101 subject Q9999445.
- Q1459101 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.".
- Q1459101 wikiPageExternalLink CatalogueDetailPage.CatalogueDetail?CSNUMBER=36786&ICS1=11&ICS2=40&ICS3=1.
- Q1459101 wikiPageExternalLink iso_technical_committee.htm?commid=54892.
- Q1459101 wikiPageWikiLink Q1421629.
- Q1459101 wikiPageWikiLink Q15028.
- Q1459101 wikiPageWikiLink Q1519843.
- Q1459101 wikiPageWikiLink Q1654689.
- Q1459101 wikiPageWikiLink Q3275615.
- Q1459101 wikiPageWikiLink Q385738.
- Q1459101 wikiPageWikiLink Q648403.
- Q1459101 wikiPageWikiLink Q6554101.
- Q1459101 wikiPageWikiLink Q749445.
- Q1459101 wikiPageWikiLink Q8647021.
- Q1459101 wikiPageWikiLink Q9999445.
- Q1459101 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.".
- Q1459101 label "ISO 14971".