敷料類產(chǎn)品在進(jìn)行生物相容性評(píng)價(jià)時(shí)
敷料類產(chǎn)品在臨床使用過程中經(jīng)常需要更換,并且產(chǎn)
品本身具有一定的液體吸收性。因此在生物相容性評(píng)價(jià)中需關(guān)注以下問題:
1)關(guān)于浸提液制備
,其浸提時(shí)間應(yīng)考慮產(chǎn)品的臨床累積使用時(shí)間,其浸提介質(zhì)的體積除考慮浸提比例外,還應(yīng)考慮產(chǎn)品對(duì)所用浸提介質(zhì)的吸收量。
2)關(guān)于評(píng)價(jià)項(xiàng)目
,應(yīng)考慮產(chǎn)品與人體的累積接觸時(shí)間,而不是單次接觸時(shí)間。
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廣東藥監(jiān)局發(fā)布10項(xiàng)要點(diǎn),落實(shí)醫(yī)療器械【委托生產(chǎn)】主體責(zé)任! ?警惕,這是假的?
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FDA會(huì)給醫(yī)療器械企業(yè)發(fā)注冊(cè)證書?警惕,這是假的! !" linktype="text" imgurl="" imgdata="null" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1" style="margin: 0px; padding: 0px; outline: 0px; text-decoration-line: none; -webkit-tap-highlight-color: rgba(0, 0, 0, 0); -webkit-user-drag: none; cursor: pointer; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;">