• Iso 14971

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.This International Standard does not apply to clinical decision making.This International Standard does not specify acceptable risk levels.

ISO 14971 is an standard for the application of risk management to. 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,. 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. 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 as EN ISO.

This version is harmonized with respect to the three European Directives associated with medical devices Active Implantable Medical Device Directive 90/385/EEC, 93/42/EEC, and In-vitro Diagnostic Medical Device Directive 98/79/EC, 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 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO remains the standard recommended for medical device risk management purposes. Retrieved 13 September 2015. Manookian, Brian. Cummings Manookian. Retrieved 13 September 2015.

^ (PDF). Department of Health and Human Services Food and Drug Administration. February 3, 2016. This article incorporates text from this source, which is in the.

Iso 14971

One or more of the preceding sentences incorporates text from a work now in the: Applying Human Factors and Usability Engineering to Medical Devices, U.S. Department of Health and Human Services Food and Drug AdministrationExternal links. —Medical devices—Quality management systems—Requirements for regulatory purposes. —Quality management and corresponding general aspects for medical devices.