YY/T 1535-2017 in English

This standard outlines the procedures for evaluating the biological safety of medical devices used in human in vitro assisted reproductive technology. It specifically focuses on the assessment of sperm viability as a key parameter. The methodology described provides a standardized approach to testing, ensuring consistency and reliability in the results. The guidelines cover the preparation of test samples, the conditions under which the tests are conducted, and the criteria for interpreting the outcomes. This standard is intended to support the development and validation of medical devices that interact with human sperm cells. It also includes requirements for documentation and reporting of test results. The standard ensures that the evaluation process is thorough and scientifically valid.