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упутства за употребу

"a manual usually accompanying a technical device and explaining how to install or operate it"

Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1:

Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging of each unit. If not practicable, the information must be set out in the leaflet supplied with one or more devices.

Instructions for use must be included in the packaging for every device. By way of exception, no such instruction leaflet is needed for devices in Class I or Class IIa if they can be used completely safely without any such instructions.

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