This standard specifies methods for evaluating the presence or absence of media effects in the field of in vitro diagnostic testing. This standard specifies methods for evaluating media effects for reference materials, calibrators, control agents, and external quality control evaluation materials. .This standard can be used by diagnostic product manufacturers, external quality control test providers, and licensing agencies.
KS P 1800-2013 history
2019KS P 1800-2019 Protocol for evaluation of matrix effects in in-vitro diagnostic test
2013KS P 1800-2013 Protocol for evaluation of matrix effects in in-vitro diagnostic test