[PSES] SV: [PSES] 21 CFR § 1040.10 - Laser products.

2020-05-19 Thread Amund Westin
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

[PSES] integrated or non-user serviceable Li-ion batteries

2020-05-19 Thread Chester Summers
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

Re: [PSES] 21 CFR § 1040.10 - Laser products.

2020-05-19 Thread David Nyffenegger
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

Re: [PSES] 21 CFR § 1040.10 - Laser products.

2020-05-19 Thread lauren . crane
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

[PSES] 21 CFR § 1040.10 - Laser products.

2020-05-19 Thread Amund Westin
Anyone who have been through the process for complying to 21 CFR § 1040.10? Time consuming process? BR Amund - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the