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ISO10993.1-2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process[S]. 5. GB/T16886.12-2017 ;SuhVhuirf[ċN ,{12R7hT6RYNSgqPge[S]. 6. GB/T16886.18-2011;SuhVhuirf[ċN ,{18RPgeSf[h_[S]. 7. GB/T16886.17-2005;SuhVhuirf[ċN ,{17RSlnirAQPϑv^z[S]. 8. USP-35<1226>Verification of compendial methods. 9.fT Ğ[e hgRNI{. RgelnxQ[N~[J]. oirRgBg_.2015,351 :183-189. 10.fT Ğ[e hgRNI{. Rgel0lyTnxi_㉐g[J]. oirRgBg_. 2015,3501 :169-175. 11.ISO/IEC 17025-2017 General requirements for the competence of testing and calibration laboratories[S]. 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