R
Hi everyone,
I have a question regarding the biocomp Evaluation of a medical device.
What we usually do is evaluating the device according to ISO 10993 (cytotox, sensitization, Irritation...).
We are also stating that our Primary packaging materials (eye drops) are free of phtalates and BPA in this context.
Here we are further referring to a document that states numerous "Free of..." parts. We are also adressing SVHC, GMO, BSE/TSE, Heavy Metals and a lot more.
I was wondering of what would be really mandatory and what not since the ISO 10993 never requested one of those Topics (to my knowledge) explicitly. So how can you show safety without exaggerating everything.
Is it even possible to leave out some of the components that are not in contact with either the product or the Patient.
Thank you and Kind regards,
Phil
I have a question regarding the biocomp Evaluation of a medical device.
What we usually do is evaluating the device according to ISO 10993 (cytotox, sensitization, Irritation...).
We are also stating that our Primary packaging materials (eye drops) are free of phtalates and BPA in this context.
Here we are further referring to a document that states numerous "Free of..." parts. We are also adressing SVHC, GMO, BSE/TSE, Heavy Metals and a lot more.
I was wondering of what would be really mandatory and what not since the ISO 10993 never requested one of those Topics (to my knowledge) explicitly. So how can you show safety without exaggerating everything.
Is it even possible to leave out some of the components that are not in contact with either the product or the Patient.
Thank you and Kind regards,
Phil