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IEC Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits for example, interoperability , defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security the key properties.
IEC does not specify acceptable risk levels. IEC applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices.
IEC applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization.
It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person. Check out our FAQs. Buy this standard. CHF Buy. Life cycle A standard is reviewed every 5 years 00 Preliminary. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting.
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What Does IEC 80001-1 Mean to You?
As with any standard, much is lost to the reader of the final document who was not involved in the development process. Although the standard itself is one of the shorter consensus standards at only 42 pages, we can still only discuss highlights in a magazine article. As such, this article will discuss the major points in , their importance to the reader, and, as much as practical, explain some of the intent behind them. To all of us, will mean some amount of confusion; about the best way to implement it, learning how to achieve goals with your co-workers that may appear at first glance to be both counterintuitive and counterproductive, and all those other things you expect from a new initiative. Since confusion typically decreases efficiency, it is reasonable to expect that institutions that embrace the risk management process will see the benefits of implementation far faster than those institutions that struggle with the new process.
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