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This document was written to augment ISO 10993-18:2020. Specifically, this document addresses and provides best practice recommendations for:
— Uncertainty in Leachables and Extractables Measurements;
— Derivation, Calculation and Application of the Analytical Evaluation Threshold (AET);
— Best Practices for Leachables and Extractables Identification;
— Best Practices for Leachables and Extractables Quantification;
— Requirements for Instrumentation and Human Resources.
Reģistrācijas numurs (WIID)
90037
Darbības sfēra
This document was written to augment ISO 10993-18:2020. Specifically, this document addresses and provides best practice recommendations for:
— Uncertainty in Leachables and Extractables Measurements;
— Derivation, Calculation and Application of the Analytical Evaluation Threshold (AET);
— Best Practices for Leachables and Extractables Identification;
— Best Practices for Leachables and Extractables Quantification;
— Requirements for Instrumentation and Human Resources.
