We have one issue where the resin that was supplied by a supplier had some color variation. Since there was no limit samples for the resin, the lot was released by QC. After molding, we saw that the color of the molded samples was way off the "finished product samples".
The customer is requesting us to test the molded samples as per ISO 10993 - 5 for the cytotoxicity testing. I am trying to put up the justification that testing per ISO 10993 - 5 is not required as there is no change in the raw material per se and the chemical properties of the resin are unaffected. We have also written to the supplier and a detailed investigation is underway.
How would you handle this situation ? Is testing per ISO 10993 - 5 required ?
The customer is requesting us to test the molded samples as per ISO 10993 - 5 for the cytotoxicity testing. I am trying to put up the justification that testing per ISO 10993 - 5 is not required as there is no change in the raw material per se and the chemical properties of the resin are unaffected. We have also written to the supplier and a detailed investigation is underway.
How would you handle this situation ? Is testing per ISO 10993 - 5 required ?