ISO 14971

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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.

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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