ISO 15223-2:2010
ISO 15223-2:2010-Medical devices-Symbols to be used with medical device labels, labelling, and information to be supplied
Standard´s number: | ISO 15223-2:2010 |
Pages: | 16 |
Edition: | 1 |
Released: | 2010 |
ISO 15223-2:2010
ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.