Thanks Lauren
The final product is a kind of industrial measurement device and it contains a
laser device which is bought from an external manufacturer.
Right now, I do not have any information about the laser device, but I wonder
if this paragraph might be applicable:
§ 1040.10 Laser pr
Greetings, listmates-
What safety standards should I consider when designing an integrated/built-in,
or otherwise non-user serviceable Li-ion battery in a portable outdoor product?
For a product typically covered by IEC 61010-1 is there a supplementary
standard worth considering for the built-i
Hi Amund,
Yes, and it depends on the power of the laser and the complexity of the
product. The requirements are more stringent for higher power lasers. An
initial product report must be submitted to FDA for each laser product and
it can take some time to put that together depending on the comple
Hi Amund,
It's been a key aspect of my work for several years. It can be quite
challenging. Terminology and meaning are a little tricky. The amount of time
consumed sort of depends on whether you are dealing with a product that fits
nicely 'between the lines'.
Regards,
-Lauren
-Origina
Anyone who have been through the process for complying to 21 CFR §
1040.10?
Time consuming process?
BR
Amund
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