Device class

Petard d alarme (Fr). A device classed as an artifice de signalisatlon sonore and used on railroads for signalling purposes. It consisted of a waterproof container with a mixt of 2p Sb sulfide and Ip K chlorate, to which was added a small quantity of powdered glass. After inserting a primer, the ensemble was attached to the upper surface of a rail. When the wheel of a locomotive contacted the primer the charge expld, producing a loud report Ref Pepin Lehalleur (1935), 477... 

Special rules 13-18 govern several hazardous characteristics that may be found in certain devices and require a certain level of control and conformity assessment. Rule 13 deals with devices incorporating a medicinal substance whose action is ancillary to that of the device -Class 111, for example, antibiotic bone cements, condoms with spermicides, heparin-coated catheters. 

As may be seen from Table I, the response times in hydrogen exposures of capacitor structures tend to be comparable to those of diode structures however, the capacitor structures can be susceptible to the HID phenomenon (16) especially at elevated temperatures. In general, the presence of water vapor or oxygen reduces the response and recovery times of both device classes. There are differences in gas sensing ability between the two structures. For example,. the Pd/TiOx/Si and Pd/SiOx/Si diodes do not respond to CO in... 

The device class classification under Section 513 of the Act and the appropriate panel (if known) should be submitted. Justification should be provided for devices not classified. 

European Directive 93/42/EEC concerning medical devices — class lib Parts in and V. 

The right side of Fig. 5.63 shows a sample screenshot of a Comos PT flowsheet (class IComosDDocument), which includes a collection (class IComosDCollection) of devices (class IComosDDevice), i.e. a distillation column, two heat exchangers, a vessel, a pump, and a valve. These devices are connected via certain streams, sjmibolized as edges between the devices. Internally, a stream is also represented as an instance of class IComosDDevice. 

A postamendment device is one that was first distributed commercially on or after May 28, 1976. Postamendment devices that the FDA determines are substantially equivalent to preamendment device Class III devices are subject to the same requirements as the preamendment devices. The FDA determines substantial equivalence after reviewing an applicant s premarket notification 510(k). Postamendment devices determined by the FDA to be not substantially equivalent to either pre- or postamendment devices classified into Class I or II are new devices and fall automatically into Class III. Before such devices can be marketed, they must have an approved premarket approval application or be reclassified into Class I or II. 

Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices are replacement heart valves, silicone-filled breast implants, and implanted cerebella stimulators. 

DIPHOTERINE solutions, including practical experience using these decontaminating agents. These products are classified as a medical device (class Ila). They have undergone a variety of toxicity tests. Taken together, the classification, the reported toxicity tests, and case reports show that the products can be considered safe to use. 

The amended UN Regulation No. 46 enables the use of camera monitor systems instead of mirrors for Class I, II, III and IV devices. Class V and VI CMS have already been possible since 2005 (see Sect. 1.7). Their requirements remained unchanged. The required mirrors for Class VII devices (only relevant for category L with body work) will be the only ones which cannot be replaced by CMS. This is partly due to the fact that the scope of ISO 16505 in its initial version from 2015 is limited to devices for vehicle categories M and N, and therefore does not include Class VII devices. 

Table 5 Overview of device classes and their required field of vision, source [32]...

In addition, the total area of all obstmctions within the required field of vision is limited to a maximum of 15 % for devices of Class I and 10 % for all other device classes. It should be noted that these values already existed for mirrors. For Class I devices, they address obstructions due to backlight wipers, heating elements, etc. and for all other classes of devices obstructions due to bodywork, door handles etc. Therefore, not only overlays, but also all the other relevant obstructions fall under those limits. The amount of those other relevant obstructions mainly depends on the vehicle layout and positioning of the devices for indirect vision. Sports cars with wide rear fenders typically come close to the 10 % obstmction of the required field of vision in the outside mirror. In case of camera monitor systems that are supposed to have even shorter camera holders, the obstruction might even increase for bodyworks of the same type. Therefore, further obstructions in the form of reasonable overlays are unlikely to be included for some vehicle types. For the... 

Overlays have to be included when calculating the obstructions within the required field of vision (obstructions are limited to a maximum of 15 % for devices of Class I and to a maximum of 10 % for all other device classes)... 

Human Interface device class data acquisition system... 

Different types of device classes, namely, human interface device (HID) class, test and measurement class (USBTMC), mass storage class (MSC), and USB host capability are available. The designer has to select the appropriate class depending upon his needs. 

In the FDA regulatory classifications there are three classes of medical devices Class I, Class II, and Class III. This classification is based upon classifications for medical devices currently legally marketed in the United States. The FDA determines the device classification by the device s intended use and the risk that it presents to the patient. New medical devices are compared to legally marketed medical devices with the same intended use and technological characteristics to determine the classification. 

Device trade or proprietary name, common or usual name or classification, class of the device (Class I, II, III). 

Health Canada (2009) Classification of medical devices Class I or Class II patient management software. Health Canada notice file number 09-122095-269. http //www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md notice software im avis logicels-eng.php. Accessed 17 September 2009... 

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