共找到 150 條與 可瀝濾物 相關(guān)的標(biāo)準(zhǔn)，共 10 頁
La presente norma è la versione ufficiale in lingua italiana della norma europea EN ISO 10993-17 (edizione dicembre 2002) e tiene conto delle
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
GB/T 16886的本部分規(guī)定了醫(yī)療器械可瀝濾物允許限量的確定方法，其目的是獲得標(biāo)準(zhǔn)的運(yùn)用及未建立標(biāo)準(zhǔn)的限量的適當(dāng)評(píng)估。本部分描述了一個(gè)系統(tǒng)過程，通過該過程，醫(yī)療器械中毒害物質(zhì)產(chǎn)生的確定風(fēng)險(xiǎn)（risks）被量化。 本部分不適用不與病人接觸的器械（如體外診斷器械
Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
Biological evaluation of medical devices.Part 17: Establishment of allowable limits for teachable substances
La presente norma è la versione ufficiale in lingua inglese della norma europea EN ISO 10993-17 (edizione aprile 2009). La norma specifica un
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
本文件規(guī)定了與醫(yī)療器械相關(guān)的設(shè)計(jì)和實(shí)施毒代動(dòng)力學(xué)研究的原則。 附錄A描述了醫(yī)療器械生物學(xué)評(píng)價(jià)中毒代動(dòng)力學(xué)研究中考慮的問題。 本文件適用于醫(yī)療器械降解產(chǎn)物與可瀝濾物的毒代動(dòng)力學(xué)研究
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
GB/T16886 的本部分給出了設(shè)計(jì)和實(shí)施醫(yī)療器械毒代動(dòng)力學(xué)研究的原則。 附錄A描述了醫(yī)療器械生物學(xué)評(píng)價(jià)中毒代動(dòng)力學(xué)研究應(yīng)考慮的問題
Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes
Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
本文件描述了在模擬臨床輸液條件下或臨床輸液條件下，一次性使用輸液器具與藥物接觸過程中可瀝濾物中未知物的研究方法。本文件適用于需要開展未知可瀝濾物研究的特定輸液器具，需要時(shí)，與經(jīng)論證的藥物替代溶劑或擬輸液的藥物，開展未知可瀝濾物研究。其他輸注器具如需評(píng)價(jià)時(shí)，參考使用
Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 3:Leachable study—Unknown substance
Guidelines for Compatibility Study of Disposable Infusion Sets and Drugs Part 2: Known Substances for Leachables Study
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables.
Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables ISO 10993-16: 1997
本文件規(guī)定了醫(yī)療器械成分的定性和定量(如必要)框架,通過漸進(jìn)式的化學(xué)表征進(jìn)行材料成分的生物學(xué)危險(xiǎn)(源)識(shí)別以及其生物學(xué)風(fēng)險(xiǎn)評(píng)估和控制。 本文件適用于以下一項(xiàng)或多項(xiàng): ———其制造材料的定性(醫(yī)療器械構(gòu)造); ———通過材料化學(xué)成分的定性和定量進(jìn)行的制造材料的表征(材料組成); ———針對醫(yī)療器械在
Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
本文件規(guī)定了通過醫(yī)療器械體外降解研究的設(shè)計(jì)和實(shí)施,對其潛在的和已觀察到的降解進(jìn)行系統(tǒng)評(píng)價(jià)的基本原則。這些研究所獲得的信息能用于GB/T(Z)16886 系列標(biāo)準(zhǔn)所述的生物學(xué)評(píng)價(jià)。 本文件適用于預(yù)期在體內(nèi)降解的材料以及非預(yù)期降解的材料。 本文件不適用于: a)純機(jī)械過程產(chǎn)生的降解的評(píng)價(jià);產(chǎn)生這類降解
Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products
