ISO 10993 specifies what biological tests are required based on body contact duration.
What about a medical device that has only incidental contact with skin? Must you still follow the medical device categoration for limited (<24 hour) duration?
ISO 10993 specifies what biological tests are required based on body contact duration.
What about a medical device that has only incidental contact with skin? Must you still follow the medical device categoration for limited (<24 hour) duration?
I think it is worth observing that ISO 10993 does not 'require' any testing to be carried out. It does suggest tests for 'consideration' within a structured programme of assessment.
I think it is worth observing that ISO 10993 does not 'require' any testing to be carried out. It does suggest tests for 'consideration' within a structured programme of assessment.
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