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View Full Version : X-Ray Films - CE-Mark and Related Standards Requirements ISO MAN 8th August 2007, 10:17 AM 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 Ajit Basrur 10th August 2007, 12:34 AM any takers for this question ? gprasadhc 10th August 2007, 01:49 AM Dear . Some links with reference to ISO on X ray films ISO 9236-1: 2004 ISO 4090:2001 ISO 5799 :1991 --------------- GURUPRASAD Gert Sorensen 14th August 2007, 03:41 AM 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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