BS EN ISO 14971:2009

BS EN ISO 14971:2009 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 BS EN ISO 14971:2009 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.

The requirements of this standard are applicable to all stages of the life-cycle of a medical device. The standard provides manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. BS EN ISO 14971:2009 deals with the processes for managing risks to the patient, the operator and other people, to other equipment and to the environment.

BS EN ISO 14971:2009 was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this standard could be used as informative guidance in developing and maintaining a risk management system and process.

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. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity.

The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.

All stakeholders need to understand that the use of a medical device entails some degree of risk. The acceptability of a risk to a stakeholder is influenced by the components listed above and by the stakeholder's perception of the risk. Each stakeholder's perception of the risk can vary greatly depending upon their cultural background, the socio-economic and educational background of the society concerned, the actual and perceived state of health of the patient, and many other factors. The way a risk is perceived also takes into account, for example, whether exposure to the hazard seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society. The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure. Such judgments should take into account the intended use, performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure or the circumstances of use. Some of these judgments can be made only by a qualified medical practitioner with knowledge of the state of health of an individual patient or the patient's own opinion.

As one of the stakeholders, the manufacturer makes judgments relating to safety of a medical device, including the acceptability of risks, taking into account the generally accepted state of the art, in order to determine the suitability of a medical device to be placed on the market for its intended use.

For any particular medical device, other International Standards could require the application of specific methods for managing risk. The standard does not apply to clinical decision making, nor does it specify acceptable risk levels.