Over deze norm
|Commissie||Medische hulpmiddelen - horizontale onderwerpen|
Identifies symbols and their meanings which may be used to convey information essential to the user and others for safe and effective use of medical devices. It is primarily intended to be used by the following: - manufacturers of medical devices who market their products in a number of countries having different language requirements for medical device labelling; - users of medical devices who draw their supplies from a number of sources and may have varied language capabilities; - those responsible for postmarket surveillance; - health care regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and having responsibility for post market surveillance. This report may also be of assistance to: - manufacturers having to cope with space limitations on small labels; - distributors of medical devices or other representatives of manufacturers; - health care authorities responsible for training as well as those being trained.
|Engelse titel||Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied|