Uni Cei En Iso 14971 Medical Devices

 
Uni Cei En Iso 14971 Medical DevicesUni Cei En Iso 14971 Medical Devices

ISO 14971: Medical devices - Application of risk management to medical devices. BS EN 12442-1 November 15, 2000. Buy UNI CEI EN ISO Medical Devices - Application Of Risk Management To Medical Devices from SAI Global. Find the most up-to-date version of CEI UNI EN ISO 14971 at Engineering360.

2nd Edition Introduction Reasoning Meaning more. 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.

Gimp Install Separate Windows Excel. However, risk management can be an integral part of a quality management system.

Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process Medical laboratories - Requirements for quality and competence Directive 98/79/Ec Of The European Parliament And Of The Council Of 27 October 1998 On In Vitro Diagnostic Medical Devices Council Directive 93/42/Eec Of 14 June 1993 Concerning Medical Devices Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software.