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Subject:International warnings and cautions From:"Martha Silverspring" <msilverspring -at- sent -dot- com> To:techwr-l -at- lists -dot- techwr-l -dot- com Date:Wed, 27 Sep 2006 10:37:27 -0700
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.
Thanks.
Martha
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