| 词条 | ISO 14971 |
| 释义 |
ISO 14971 is an ISO standard for the application of risk management to medical devices.[1] 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,[2] and ISO/IEC Guide 63.[3] The latest significant revision was published in 2007 with a minor update published in 2009. In 2013, a technical report ISO/TR 24971[4] 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.[5][6] 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 Active Implantable Medical Device Directive 90/385/EEC[7], Medical Devices Directive 93/42/EEC,[8] and In-vitro Diagnostic Medical Device Directive 98/79/EC,[9] 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.{{fact?|date=September 2015}} 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 risk management optionsInherent safety by designFor example:
Protective measures in the medical device itself or in the manufacturing processFor example:
Information for safetyFor example:
See also
References1. ^ISO Catalogue: Medical devices -- Application of risk management to medical devices 2. ^{{cite web|url=http://www.iso.org/iso/catalogue_detail.htm?csnumber=53940|title=ISO/IEC Guide 51:2014 - Safety aspects -- Guidelines for their inclusion in standards|author=|date=|website=www.iso.org}} 3. ^{{cite web|url=http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50729|title=ISO/IEC Guide 63:2012 - Guide to the development and inclusion of safety aspects in International Standards for medical devices|author=|date=|website=www.iso.org}} 4. ^{{cite web|url=http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59587|title=ISO/TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971|author=|date=|website=www.iso.org}} 5. ^{{cite web|title=Medical devices -- Application of risk management to medical devices|url=http://www.iso.org/iso/catalogue_detail?csnumber=38193|publisher=ISO|accessdate=13 September 2015}} 6. ^{{cite web|last1=Manookian|first1=Brian|title=Technical Information About ISO 14971|url=https://www.cmtriallawyers.com/blog/2015/02/11/technical-information-about-iso-14971/|publisher=Cummings Manookian|accessdate=13 September 2015}} 7. ^[https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31990L0385 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] 8. ^[https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31993L0042 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices] 9. ^Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 10. ^1 2 {{Cite web|url=https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf|title=Applying Human Factors and Usability Engineering to Medical Devices|last=|first=|date=February 3, 2016|publisher=U.S. Department of Health and Human Services Food and Drug Administration}} {{PD-notice}} 11. ^{{Citation-attribution|Applying Human Factors and Usability Engineering to Medical Devices, U.S. Department of Health and Human Services Food and Drug Administration}} External links
3 : ISO standards|Regulation of medical devices|Medical technology |
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