| rdfs:comment
| - Risk levels are based on risk-based management techniques (e.g. device safety, device risks, and device reliability) and can therefore be considered the identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or equipment mishaps. Note: "/" means "or"
* a) the probability of occurrence of harm;
* b) the consequences of that harm, that is, how severe it might be.
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| abstract
| - Risk levels are based on risk-based management techniques (e.g. device safety, device risks, and device reliability) and can therefore be considered the identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or equipment mishaps. Note: "/" means "or" It is this author's recommendation that no significant risk items still be accountable items for inventory purpose and dollar value accountability but assign a "zero" or "no" scheduled maintenance cycle inspection as part of the risk-based management initiative. These devices would only serve for for unscheduled maintenance work order accountability and hazard device alert tracking. Disclaimer: First always consult OEM recommendations. BiomedGuy 23:05, November 21, 2010 (UTC) In 2007, the latest revision ISO 14971 standard was published that represents the requirements for a risk management system for 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. Today, It is accepted that the concept of risk has two components:
* a) the probability of occurrence of harm;
* b) the consequences of that harm, that is, how severe it might be. 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.
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