X-Ray Films - CE-Mark and Related Standards Requirements

I

ISO MAN

#1
Dear All,
I am working in CE-Mark process for x-ray film. I have the following questions:
- Does it have any harmonized r international standards
- Does it covered by the bio-compatibility standard, i.e. do I need to test it.

Thanks
 
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G

Gert Sorensen

#4
The only EU-directive relating to X-ray films that I can find is the MDD 93/42/EEC.

III. CLASSIFICATION 1. Non-invasive devices

4.4. Rule 16
Non-active devices specifically intended for recording of X-ray diagnostic images are in Class IIa.


I would say that if it comes into contact with the body, then yes, you need to test it for biocompatibility. :bigwave:
 
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