EN ISO 14971-2012 pdf download.Medical devices – Application of risk management to medical devices (ISO 1497 1:2007, Corrected version 2007-10-01).
EN ISO 14971 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.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
2.1 accompanying document
document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety
NOTE Adapted from IEC 60601-1:2005, definition 3.4.
2.2 harm physical injury or damage to the health of people, or damage to property or the environment
[ISO/IEC Guide 51:1999, definition 3.3]
3 General requirements for risk management
3.1 Risk management process
The manufacturer shall establish, document and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls. This process shall include the following elements:
risk analysis;
— risk evaluation; risk control;
production and post-production information.
Where a documented product realization process exists, such as that described in Clause 7 of ISO 1 3485:2003[8J, it shall incorporate the appropriate parts of the risk management process.
NOTE I A documented quality management system process can be used to deal with safety in a systematic manner, in particular to enable the early identification of hazards and hazardous situations in complex medical devices and systems.EN ISO 14971 pdf free download.
Tags: Medical devices
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