IEC 80002 PDF

IEC TR Edition INTERNATIONAL. STANDARD. Medical device software –. Part 3: Process reference model of medical device software. IEC/TR Edition TECHNICAL. REPORT. Medical device software –. Part 1: Guidance on the application of ISO to medical device. I want to know if IEC can be used for risk management our software or it is for medical products with software (not stand alone).

Author: Shakakora Kagalkis
Country: Bhutan
Language: English (Spanish)
Genre: Life
Published (Last): 27 May 2017
Pages: 419
PDF File Size: 3.92 Mb
ePub File Size: 13.91 Mb
ISBN: 122-4-88534-774-8
Downloads: 12404
Price: Free* [*Free Regsitration Required]
Uploader: Magar

Click to learn more. These categories are specific to software, arising from the difficulty of correctly specifying and implementing a complex system and the difficulty of completely verifying a complex system.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Your basket is empty.

We use cookies to make our website easier to use and to better understand your needs. A sequences of events representing unforeseen software responses to inputs errors in specification of the software B sequences of events arising from iex coding errors in implementation of the software.

IEC/TR and ISO Medical Devices Software Package

Software sequences of events which contribute to hazardous situations may fall into two categories: Life durabilityHazards, Electrical equipment, Computer technology, Equipment safety, Life cycle, Quality assurance systems, Software engineering techniques, Safety measures, Maintenance, Risk assessment, Medical equipment, Electrical medical equipment, Design, Quality management, Computer software.

  KOYA HIJIRI PDF

Areas already covered by existing or planned standards, e. This package can be to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device.

Application 8002 risk management to medical devices BS EN You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.

Software should always be considered in a system perspective and software risk management cannot be performed in isolation from the system. If the document is revised or amended, you will be notified by email.

Subscription pricing is determined by: Guidance on the application of ISO to medical device software Jec It includes ISO Your Alert Profile lists the documents that will be monitored. Even though ISO and this technical report focus on medical devices, this technical report could also be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device.

Much of the task of software risk management consists of identifying those sequences of events that can lead to a hazardous situation and identifying points in the sequences of events at which the sequence can be interrupted, preventing harm or reducing its probability.

Learn more about the cookies we use and how to change your settings. Standards Subsctiption may be the perfect solution. The following clauses contain additional details regarding the specifics of software and idc guidance for understanding ISO You may experience issues viewing this site in Idc Explorer 9, 10 or Software sequences of events which contribute to hazardous situations may fall into two categories:.

  DUMITRU STANILOAIE DOGMATICA PDF

Find Similar Items This product falls into the following categories. Risk management is always a challenge and becomes even more challenging when software is involved.

Search all products by. Risks arising from software anomalies need most often to be evaluated on the severity of the harm alone. Proceed to Checkout Continue Shopping.

As the voice of the U. It is important to understand that software is not itself a hazard, but software may contribute to hazardous situations.

PD IEC/TR 80002-1:2009

Please first log in with a verified email before subscribing to alerts. Please first verify your email before subscribing to alerts. You may find similar items within these categories ice selecting from the choices below:.

The faster, easier way to work with standards. Please download Chrome or Firefox or view our browser tips.