Din En Iso 14971 Pdf Download
You have to enable javascript in your browser to use an application built with Vaadin. DIN EN ISO 14971 PDF - DINENISOMedical devices - Application of risk management to medical devices (ISO, Corrected version ); German version. You think you are so smart? Then why are you still using search engines to find and download pdf files? You know that you can visit my website and download your pdf file in 2 minutes. It is also available in German (DIN EN ISO ) and Spanish (UNE EN ISO ). From the Foreword International Standard ISO 14971 was prepared by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and Subcommittee IEC/SC 62A, Common aspects of electrical equipment used in medical practice.
En Iso 14971:2012
Most recent DIN EN ISO Medical devices - Application of risk management to medical devices (ISO, Corrected version 2007-10-01); German version EN ISO (Foreign Standard)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. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
An identical version of this document is available outside the United States and Canada as. It is also available in German and Spanish.From the ForewordInternational Standard ISO 14971 was prepared by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and Subcommittee IEC/SC 62A, Common aspects of electrical equipment used in medical practice. Annex H, 'Guidance on risk management for in vitro diagnostic medical devices', was prepared by ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO ) as well as the amendment ISO /Amd.1:2003.For purposes of future IEC maintenance, Subcommittee 62A has decided that the contents of this publication will remain unchanged until the maintenance result date1) indicated on the IEC web site under in the data related to the specific publication. At this date, the publication will be- reconfirmed,- withdrawn,- replaced by a revised edition or- amended.IntroductionThe requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.This International Standard was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this International Standard could be used as informative guidance in developing and maintaining a risk management system and process.This International Standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment.As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards which can cause loss of or damage to something they value.