-
- Available Formats
- Options
- Availability
- Priced From ( in USD )
-
-
Secure PDF
Secure PDF Files
Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.
-
What you can do with a Secure PDF:
- Print
- Search
- Highlight
- Bookmark
- Immediate download
- $378.46
- Add to Cart
-
Secure PDF
-
- Printed Edition
- Ships in 1-2 business days
- $378.46
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- $510.54
- Add to Cart
Customers Who Bought This Also Bought
-
ISO/IEC Guide 51:2014
Priced From $116.00 -
ISO 13485:2016
Priced From $185.00 -
ISO 9000:2015
Priced From $237.00 -
BS PD IEC/TR 60878:2022
Priced From $68.58
About This Item
Full Description
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.
Document History
-
BS EN ISO 14971:2019+A11:2021
Medical devices. Application of risk management to medical devices- Most Recent
-
BS EN ISO 14971:2019
Medical devices. Application of risk management to medical devices- Historical Version
-
BS EN ISO 14971:2012
Medical devices. Application of risk management to medical devices- Historical Version
-
BS EN ISO 14971:2009
currently
viewing
Medical devices. Application of risk management to medical devices- Historical Version
-
BS EN ISO 14971:2007
Medical devices. Application of risk management to medical devices- Historical Version
-
BS 05/30140005 DC
BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices- Historical Version
-
BS EN ISO 14971:2001
Medical devices. Application of risk management to medical devices- Historical Version
-
BS EN 1441:1998
Medical devices. Risk analysis- Historical Version