RE: International warnings and cautions

["Andrew Warren" <awarren -at- synaptics -dot- com>]

Martha Silverspring wrote:

> Does anyone know what the ISO, ANSI, etc. international requirements
> are for the content of warnings and cautions? If you can cite your
> sources, that would be helpful. I write about an eletrical medical
> device and accompanying software, and am trying to be *ruthlessly*
> compliant with FDA and international requirements. But the FDA QSR
> about labeling is somewhat vague.

Martha:

ISO 3864 and ANSI Z535.4 describe the various symbols and the formats
for safety signs and labels.  In your industry, the specific wording of
the text in those safety labels should probably be determined by your
company's lawyer, who'll presumably be familiar with US law (21 CFR 801,
16 CFR 1500, etc.) as well as the relevant international laws.

-Andrew

=== Andrew Warren  - awarren -at- synaptics -dot- com
=== Synaptics, Inc - Santa Clara, CA
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