Hi,
Could some one help on rationale about the number of samples required for EO residual testing. I have checked standards (ISO 10993-7, 11135) and not found any requirements about how many samples you need to select for EO residual testing. So, does that mean I can test two samples or one sample would be enough. Our lab mentioned that as a minimum, two replicates for each product from each aeration time are recommended.
Also, we have mixed products, so can I put one sample from each product i.e. in one chamber I can put 2 different products (similar packaging but different product configurations) and take one sample from each product.
Thanks
Could some one help on rationale about the number of samples required for EO residual testing. I have checked standards (ISO 10993-7, 11135) and not found any requirements about how many samples you need to select for EO residual testing. So, does that mean I can test two samples or one sample would be enough. Our lab mentioned that as a minimum, two replicates for each product from each aeration time are recommended.
Also, we have mixed products, so can I put one sample from each product i.e. in one chamber I can put 2 different products (similar packaging but different product configurations) and take one sample from each product.
Thanks