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First thank you for reading this!
First some back ground;
Disposable single use
All PVC but with blank ink printing
Limited Contact Mucosal memebrane per 10993
I am looking into testing for heavy metal as it came up with PMDA on a previous device but the question was never answered to my full satisfaction. I have found EN71 which refers to Heavy Metals in toys and USP661 which talks about it as it realtes to containers for food and cosmetics. I cannot find anywhere that specifically covers medical devices. Is it just assumed that the ISO 10993 Cyto, Irritation and Maximization will detect it? Does anyone have any info to steer me in the right direction as far as a standard or requirements on this? I want to include it in a DID I am doing currently.
Thanks
First some back ground;
Disposable single use
All PVC but with blank ink printing
Limited Contact Mucosal memebrane per 10993
I am looking into testing for heavy metal as it came up with PMDA on a previous device but the question was never answered to my full satisfaction. I have found EN71 which refers to Heavy Metals in toys and USP661 which talks about it as it realtes to containers for food and cosmetics. I cannot find anywhere that specifically covers medical devices. Is it just assumed that the ISO 10993 Cyto, Irritation and Maximization will detect it? Does anyone have any info to steer me in the right direction as far as a standard or requirements on this? I want to include it in a DID I am doing currently.
Thanks