ISO 14971
 |
This article needs additional citations for verification. (April 2010) |
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.
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,[5] In-vitro Diagnostic Medical Device Directive 98/79/EC,[6] and Active Implantable Medical Device Directive 90/385/EEC [7] 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.
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.
See also[edit]
- List of ISO standards
- ISO 13485
- Medical technology
- Medical device
- Medical Devices Directive
- Clinical Engineering
- System suitability test
- ISO 690
References[edit]
- ^ ISO Catalogue: Medical devices -- Application of risk management to medical devices
- ^ http://www.iso.org/iso/catalogue_detail.htm?csnumber=53940
- ^ http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=50729
- ^ http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59587
- ^ http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm
- ^ http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=en
- ^ http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/implantable-medical-devices/
External links[edit]
- ISO 13485—Medical devices—Quality management systems—Requirements for regulatory purposes
- ISO TC 210—Quality management and corresponding general aspects for medical devices
Categories
