The ISO series of standards addresses symbols that can be used to convey information that is essential for the safe and proper use of medical devices. As such, in most regulatory domains the symbols are required to be presented with the device. The information can be required to be presented on the device itself, as part of the label or provided with the device. This standard is in two parts , under the general title Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied If the symbol validation process detailed in BS ISO has been complied with, then the residual risks associated with the usability of a medical device symbol are presumed to be acceptable unless there is objective evidence to the contrary.
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BS ISO 15223-2:2010
ISO specifies a process for developing, selecting and validating symbols for inclusion in ISO The purpose of ISO is to ensure that symbols included in ISO are readily understood by the target group. If the symbol validation process detailed in ISO has been complied with, then the residual risks, as defined in ISO and IEC , associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. ISO is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. Check out our FAQs. Buy this standard.
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