Thanks Martin, Notice 42 makes it clear. I can only think the guy I talked
to at CDRH either didn't know about it or he is interpreting it to only
include the examples noted in the notice (CD players, etc. where the laser
is totally buried in the product). My application is similar to yours wher
The following requirements are for those products that must be C-tick marked
* Your Australian representative must apply for approval to use the
C-tick marking
* Anyone may apply the marking once approval is granted
* Depending on the method of identification of the manufacture
Safety related instructions for the user should be in the vernacular under
73/23/EEC.
There is more latitude on language for safety-related instructions for an
'installer'. However if installer's instructions have life-threatening
consequences you reduce legal exposure by using a widely-understo
Our company makes open frame linear and switch-mode component power
supplies in the range of 5-500W. Applications include industrial, and
medical equipment.
The sales distributor we use in Australia has contacted us asking for
EMC documentation to support C-Tick marking of our products, as
requ
Paul,
This is not from the EMC or LVD , but you mentioned 1010-1 which includes
laboratory equipment, so for the medical directives, including the one for
in vitro diagnostic medical devices, it is very clearly specified.
For the MDD, See article 4, paragraph 4
Member States may require the in
All
I contacted the CDRH in Feb 2000 on this very issue of incorporated
certified Class I lasers into a product. After much passing up the
management chain until I found some one who could answer the question ,
I got the following reply. As it comes form the chief of the Electronics
Products Branc
6 matches
Mail list logo
