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無源醫(yī)療器械的生物學(xué)ISO10993測試當(dāng)中，包含共17條測試標(biāo)準(zhǔn)

生物相容性分類分別為

細(xì)胞毒性，刺激及

皮膚致敏，材料介入導(dǎo)致熱源，急性全身毒性，亞急性毒性，

亞慢性毒性，慢性毒性，植入效果，血液相容性，基因毒性，致癌性，生殖與發(fā)育毒性等......

我們應(yīng)先判定器械的種類，接觸部位，接觸時(shí)間，判定如何選擇測試標(biāo)準(zhǔn)

測試標(biāo)準(zhǔn)如下：

ISO 10993-2:2006, Biological evaluation of medical devices — Part 2: Animal welfare requirements

ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials

ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

判定方式如下：

根據(jù)ISO 10993-1:2018(E)當(dāng)中的Figure 1 — Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process

根據(jù)器械特點(diǎn)，判定流程走向

再結(jié)合Table A.1 — Endpoints to be addressed in a biological risk assessment

生物學(xué)進(jìn)行綜合評估，需要結(jié)合制造風(fēng)險(xiǎn)（ISO14971:2019）判定生產(chǎn)工藝流程，是否引入新的生物風(fēng)險(xiǎn)源

總結(jié)

生物學(xué)報(bào)告需要總結(jié)出兩項(xiàng)內(nèi)容

1，設(shè)備做的生物學(xué)檢測，是否滿足需求

2，制造風(fēng)險(xiǎn)是否有新的生物風(fēng)險(xiǎn)，并且得到控

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