MT 25 - TC 62/SC 62A/MT 25

IEC TR 60878:2022 provides a compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment. The graphical symbols are grouped in sections according to their specific field of application (see Clause 4).
IEC TR 60878:2022 cancels and replaces the third edition published in 2015. This fourth edition constitutes a technical revision.
The main changes compared with IEC TR 60878:2015 are as follows:
• A total of 109 new symbols and safety signs that have been identified since the publication of the third edition have been added. For identification, the number of the new symbol or safety sign is printed in red followed by “New”.
• Of the symbols and safety signs in the third edition, 14 have changes in their title or description. For identification, the number of a modified symbol or safety sign is printed in red followed by “Mod”.
The contents of the corrigendum of February 2023 have been included in this copy.

IEC TR 60878:2015 provides a comprehensive compilation, for easy reference, of graphical symbols (graphics, title, description) and safety signs for medical electrical equipment. The graphical symbols are grouped in sections according to their specific field of application. This third edition cancels and replaces the second edition published in 2003. This third edition constitutes a technical revision.

IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.