Standard Number: YY/T 0606.14-2014(YY/T0606.14-2014)
Chinese:组织工程医疗产品 第14部分：评价基质及支架免疫反应的试验方法：ELISA法
English:Tissue engineered medical products -Part 14:Standard practice for evaluation of immune responses of substrate and scaffolds products: ELISA tests
Effective Date:2015-07-01
ICS:11.040.40
Standard Applicability:This part of YY/T 0606 specifies the test method for evaluating the mammalian humoral immune response due to matrix or scaffold of tissue-engineered medical products: ELISA. This part is applicable to the biological evaluation of matrix or scaffold of tissue-engineered medical products. NOTE: The tests described in this standard are not diagnostic tests for human conditions, although they may also be used for the detection of human specimens or for research purposes and may provide data for clinical follow-up. In addition to the methods selected in this section, other equivalent methods may be adopted. Not all materials and applications require testing in accordance with this part, so careful consideration should be given to the applicability of the methods in this part. The information suggested by the results of the tests recommended in GB/T 16886.1 or the regulatory part should be considered before performing the tests recommended in this part.
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