Biomedical Engineering Reference
In-Depth Information
So once again refer to the regulatory bodies for advice. They are controlled documents so
they need a version number, etc.
11.7.2 Declaration (or Certificate) of Cleaning and Sterilization
Devices that are supplied nonsterile and which are intended for sterilization on site will need
a document declaring that they have passed a cleaning and sterilization trial. Again, this is a
controlled document.
11.8 Translation
It is inherent, in most English speaking countries, that the thought of producing a document in
anything else but English is downright silly. Surely everyone reads English as standard. No!
There is a big wide world out there, and we are not allowed to use that as an argument. There
is a regulatory need for you to translate documents into the native language of the country in
which you sell. So if you intend to sell into Latin America, Spanish is obvious. If you intend
to go further south into South America, Portuguese comes into play. If you intend to sell into
the EC then, well, pick a language!
Whatever the language you pick you must have a translation procedure in place, and stick to
it.
Figure 11.19
illustrates a typical translation procedure.
Commission translation house
Receive translation with
certificate of accuracy
Documents
in order
Documents
in order
Send to native speaking practitioner
for confirmation
Production
File appropriately
Figure 11.19
A typical translation procedure.
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