Abstract: Objective According to the setting mode of performance specifications determined by the Milan Conference in Italy, the performance specifications are derived based on the biological variation ( BV) and current technological level mode to recommend the allowable total error ( TEa)，allowable imprecision ( CV) and allowable bias ( Bias) of 18 tumor marker tests in China. Methods The extemal quality assessment ( EQA) and internal quality control ( IQC) data of laboratories participating in the EQA activity of tumor markers implemented by the National Center for Clinical Laboratories during 2019 and 2021 were collected using the clinet-EQA software. For the tests with BV data, the percentage difference [ ( measurement result - target value )/ target valueX 100% ] of EQA data and the in-control coefficient of variation ( CV) of the current month of IQC data for each test were compared with the evaluation criteria of three levels derived based on BV. Then, the passing rates of the percentage difference and CV of all batches in each year were calculated. When the passing rate reached 80%, the performance specifications of this level met the requirements of the recommended per- formance specifications of the test. For the tests without BV data or tests whose performance specifications at three levels derived based on BV could not be used as recommended criteria, the recommended performance specifications were derived based on the current technological level. The TEa。，em [ 1/2x(P∞-P1)], P80 of in-control CV of the current month and| Bias |(≤TEa-zxCV) could be used as the allowable TE, CV and bias, respectively. Results The recommended TEa/CV of 18 tests were as follows: AFP (21%/7%),CEA (20.5%/6.8%)， HCG ( 23.4%/7. 8%)，β-HCG ( 20. 4%/6.8%)，T-PSA and F-PSA ( 24. 4%/7.5%)，CA125 ( 20.9%/6.5%)，CA15-3 (20. 8%/ 7%)，CA19-9 ( 25%/7.8%)，CA50 and CA242 ( 24%/8%)，CA72-4 ( 22. 8%/7.6%)，HE4 and CYFRA21-1 (21 .9%/7.3%)，NSE ( 20.9%/8.2%), SCCA ( 22.9%/7.7%), FEeritin (25%/ 7.1%), and β2-MG (21.3%/7.1%).Conclusion The allowable total error, imprecision and bias of 18 tumor marker tests that meet the current detection level of Chinese laboratories are recommended.