The Infona portal uses cookies, i.e. strings of text saved by a browser on the user's device. The portal can access those files and use them to remember the user's data, such as their chosen settings (screen view, interface language, etc.), or their login data. By using the Infona portal the user accepts automatic saving and using this information for portal operation purposes. More information on the subject can be found in the Privacy Policy and Terms of Service. By closing this window the user confirms that they have read the information on cookie usage, and they accept the privacy policy and the way cookies are used by the portal. You can change the cookie settings in your browser.
Medical device manufacturers are responsible for ensuring that their medical products are safe. However, safe does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefit expected an d the alternatives available. Medical device manufacturers, the Food and Drug Administration (FDA) and medical device users have an important role to play in maintaining...
Often misunderstood, risk categories are briefly discussed, and the significance of risk categories 3 and 4 is discussed with the objective of clarifying their application.
In the paper a vibration meter estimating the hand-arm exposure of worker using percussion machines is proposed. The device is able to check the safety requirements and the health risk during the machine use. A recurrent exposure to high vibration levels may be cause of pathologies affecting vascular and neurological systems. With the passing of time syndromes to hand-arm bones and muscles may occur...
Ten years have passed since the functional safety standard was issued, and it has extended to a lot of fields including the safety system of the plant. Recently, operation based on a quantitative risk analysis has been required as part of the safety lifecycle also in the field of maintenance and the preventive maintenance. In this paper, it meets the functional safety technology of IEC 61508, and...
This paper describes the certification of the ASCET code generator to a safety standard, the IEC 61508. A certificate confirms the compliance of a product, a process, or a service to set of requirements by an independent authority. For this paper, the requirements are taken from the IEC 61508. First, the underlying idea of the standard is explained. The motivation for a certification is highlighted...
Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.