UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Webinars & White Papers

ISO - 15223-2

Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation

active, Most Current
Organization: ISO
Publication Date: 15 January 2010
Status: active
Page Count: 24
ICS Code (Graphical symbols for use on specific equipment): 01.080.20
ICS Code (Medical equipment in general): 11.040.01
scope:

This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of this part of ISO 15223 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in this part of ISO 15223 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.

This part of ISO 15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

Document History

15223-2
January 15, 2010
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
This part of ISO 15223 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 is to ensure that symbols included in...

References

Advertisement