RE: Initial Laser Reports submitions to the CDRH-FDA?

Hello Jorge, If I remember correctly you need to check 21 CFR 1040. Best regards, Dave Osborn Philips Medical Systems Cardiac and Monitoring Systems Secretary, ISO TC 121/SC3 d.g.osb...@ieee.org + 1 978 659 3178 fax +1 978 685 5624 -Original Message- From: jsarell...@tuvam.com

RE: EU Packaging Query

Hello Bobbie, We have experienced this problem as well with all of the EEA. This is a protection of the natural environment issue v/v insects in the wood that became effect last summer. I don't have ready access to standard/regulation that required this, but others on this list will. Best

Directives and standards applicable to a passive speaker

Hello all, I have a new (for me, at least) question. I have a team looking at providing a passive external speaker option to one of our ITE systems. Are there any specific directives or standards that one needs to consider in Europe v/v CE-marking? For instance, does a passive speaker fall