Biomedical Engineering Reference
In-Depth Information
Do not forget, the translation house has become a critical supplier. Hence they must have
followed the approved supplier procedure described previously. You cannot pick any old
translator. Note: if this is a translation for the Japanese market you must use a Japanese
translation house…you cannot use one based in your own country.
Please take extra special care with your labels: these will need translating too. But the text on
labels can lead to weird translations. So make sure your professional end-user looks at these
as well. The last thing you want is a “nova” issue. 2
11.9 Summary
In this chapter we looked at the essential documents you need to produce. We looked at
labeling, packaging, and additional documents. We saw the importance of the IFU and its
sister document the surgical technique. To finish we recognized that translation is an important
activity that needs to be conducted with a recognized translation house and the help of your
end-users.
References
ISO (2007). ISO 15223-1 Medical devices - Symbols to be used with medical devices, labeling and information
required - General requirements.
ISO (2009). ISO 17665-2 Sterilization of healthcare products—Moist heat—Guidance on the application of ISO
17665-1.
ISO (2010). ISO 15223-2 Medical devices - Symbols to be used with medical devices, labeling and information to
be supplied - Symbol development, selection and validation.
2 In the UK the Vauxhall motor company produced a new car they called the Nova, which was intended for sale
across the EC. They forget to check its translation and hence missed the point that in Spanish it means “doesn't
go!” The same problem applied to the Toyota MR2 but with more embarrassing issues for French-speaking
peoples.
 
Search WWH ::




Custom Search