【正文】 The culture conditions (. media and incubation conditions), selected for use in determination of bioburden cannot be expected to detect all potential microorganisms. In practice, therefore, it is inevitable that bioburden will be underestimated. Nevertheless, a decision on appropriate culture conditions must be made.經(jīng)過挑選的用來確定生物負(fù)載的培養(yǎng)條件（即媒介和孵化條件），不能夠被用來檢測所有的潛在的微生物。C～35℃下3到7天酵母菌和霉菌薩布羅右旋糖瓊脂麥芽浸提瓊脂孟加拉紅瓊脂氯霉素瓊脂 大豆酪蛋白消化瓊脂(胰蛋白胨大豆瓊脂)馬鈴薯葡萄糖瓊脂薩布羅右旋糖肉湯麥芽浸提肉湯大豆酪蛋白消化肉湯(胰蛋白胨大豆肉湯)20℃～25℃下5 到7 天厭氧菌加強(qiáng)梭狀芽胞桿菌瓊脂c斯氏瓊脂c預(yù)先減少的血液瓊脂c難養(yǎng)的厭氧菌瓊脂c WilkensChalgren 瓊脂c羅伯遜肉湯液體硫糖原酸肉湯30 176。d) 部件數(shù)量。4) work surfaces。? modifications to programs are documented。如果這些限度超標(biāo)，應(yīng)采取措施（） Data derived from determination of bioburden obtained over a period of time shall be used to identify trends. Acceptable limits shall be reviewed and revised as necessary.通過前期獲得的生物負(fù)載測定的推斷資料被應(yīng)用于確定趨勢，觀察可接受的界限并進(jìn)行必要的修正。微生物的類型和在產(chǎn)品上的位置b) the physical or chemical nature of the product to be tested。 應(yīng)規(guī)定生物負(fù)載判定(包括適宜的質(zhì)量試驗(yàn))所用的材料制備和滅菌方法。規(guī)定 specify在批準(zhǔn)件范圍內(nèi)詳細(xì)約定的內(nèi)容。注3 糾正()和糾正措施是有區(qū)別的[ISO/TS 11139:2006, 定義 ]培養(yǎng)條件 culture conditions促進(jìn)微生物發(fā)芽、生長和/或繁殖所采用的生長培養(yǎng)基和培養(yǎng)方法的組合。附錄c(資料性附錄)參考文獻(xiàn)…………………………2規(guī)范性引用文件……………………………………3術(shù)語和定義………………………………注1：微生物特性的本質(zhì)和限度以生物負(fù)載的預(yù)期使用目的為基礎(chǔ)。其作用于人體體表或體內(nèi)的主要設(shè)計(jì)作用不是用藥理學(xué)、免疫學(xué)或代謝的手段獲得，但有可能有這些手段參與并起一定輔助作用。 ISO 11737本部分使用的文件和記錄應(yīng)經(jīng)制定人員審核及批準(zhǔn)(see )。否則SIP應(yīng)由產(chǎn)品的多部分組成，隨便地選擇，其制成產(chǎn)品的每種材料適當(dāng)?shù)拇?。群體形態(tài)d) use of selective culturing。評價(jià)于確定結(jié)果的改變的影響b) establishment of the recovery efficiency of the method following the change.建立以下變化方法的回收率NOTE The assessment of the change could indicate that the previous validation and recovery efficiency are still 。? inappropriate test materials (. storage, pipettes, filtration apparatus)。9) storage conditions。If data from bioburden determinations are to be used to establish a sterilization process, the period of time that elapses between the selection of product samples and the determination of bioburden should reflect the time period between pletion of the last manufacturing step and sterilization of product. 樣品份額 (SIP)生物負(fù)載判定宜盡可能使用整個(gè)產(chǎn)品，但這可能做不到，因?yàn)楝F(xiàn)有的實(shí)驗(yàn)室玻璃器皿不可能容納整個(gè)產(chǎn)品。很多方法可以用于醫(yī)療器械上微生物組成的生物負(fù)載的微生物表征。但是，這種方法可以用于生物負(fù)載水平較低的產(chǎn)品。按照標(biāo)準(zhǔn)機(jī)構(gòu)或參考測試的定義，被認(rèn)可的參考方法已經(jīng)經(jīng)過了多個(gè)實(shí)驗(yàn)室的比較。 是判定樹一般用于最初階段生物負(fù)載判定方法選擇。如果是用不合格品，則宜選擇那些已經(jīng)過各個(gè)關(guān)鍵的生產(chǎn)過程階段(包括清洗和包裝過程)的產(chǎn)品。b) the need to increase the sample size and/or frequency。 Normative references參考標(biāo)準(zhǔn)The requirements of documents included as normative references are requirements of this part of ISO 11737 only to the extent that they are cited in a normative part of this part of ISO 11737。適當(dāng)?shù)奈⑸锪信e評估，包括培養(yǎng)條件和微生物計(jì)算技術(shù)。3），消除微生物技術(shù)的能力b) possible type(s) of microorganism and their location(s) on product。 11737的這部分的要求由幾個(gè)獨(dú)立的質(zhì)量管理系統(tǒng)組織承擔(dān)，應(yīng)規(guī)定每部分的職責(zé)和職權(quán)。.NOTE 2 采取預(yù)防措施是為了防止發(fā)生，采取糾正措施 () 是為了防止再發(fā)生。ISO 10012, ISO 13485:2003, 醫(yī)療器械 質(zhì)量管理體系 用于法規(guī)的要求ISO/IEC 17025:2005, 檢測和校準(zhǔn)實(shí)驗(yàn)室資格的一般要求 3術(shù)語和定義 下列術(shù)語和定義適用于本部分。8技術(shù)的使用…………醫(yī)療器械的滅菌 微生物方法 第一部分：產(chǎn)品上微生物總數(shù)的估計(jì)目 次前言…………7技術(shù)選擇……………………………………………凡是注日期的引用文件，其現(xiàn)行版本版適用于本部分，凡是不注日期的引用文件，其最新版本適用于本部分。注 1 一個(gè)潛在不合格可以有若干個(gè)原因。按照ISO 13485 或 ISO/IEC 17025要求將責(zé)任分派給能勝任的人員。1。 回收率的測定以便于推斷糾正因子c) assessment of the adequacy of the enumeration of microorganisms, including culture conditions and microbiological counting techniques。Methods other than those given in this annex may be used, but these alternative methods should be demonstrated as being effective in achieving pliance with the requirements of this part of ISO ，對于其他可供選擇的方法應(yīng)被論證This annex is not intended as a checklist for assessing pliance with the requirements of this part of ISO 11737要求的清單 。? errors of calculation or transcription.If the results are due to an error, the bioburden result that exceeds the specified limit should be verified by the performance of a repeat determination employing samples from the same batch of product. If product supports microbial growth or if the same batch is no longer available, a new batch may be used.If the original result is confirmed as a true finding, at least the following should be considered in the second phase of the investigation:a) the implication of the result in relation to the effectiveness of the sterilization process。I此類樣品的選擇取決于眾多因素，但是先決條件是所選樣品能盡可能地具有生物負(fù)載代表性。 生物負(fù)載的判定方法和微生物表征 生物負(fù)載 選擇適當(dāng)?shù)姆椒ㄈ绻m當(dāng), 分子鍵入的方法, 譬如DNA 程序化, 可以用作補(bǔ)充培養(yǎng)方法。Laboratories are generally encouraged to use methods described in national and International Standards, such as those published by pharmacopoeias, ISO, AOAC, ASTM, etc. Recognised reference methods, as defined in standards or reference tests, have undergone interlaboratory parison. A laboratory using such recognised methods should need only to verify their accuracy and reliability under its unique conditions of use.通常，國家以及國際標(biāo)準(zhǔn)權(quán)威機(jī)構(gòu)，例如藥典，ISO,AOAC,ASTM等，會(huì)鼓勵(lì)實(shí)驗(yàn)室使用其所規(guī)定的的方法。For further guidance on enumeration, see .對于列舉的進(jìn)一步指導(dǎo)， A determination of bioburden can only be an estimate of the bioburden on product. In improving the percentage recovery for a particular technique, the accuracy of the determination of bioburden can be increased. Since there are a variety of techniques that can be used to remove microorganisms, the percentage recovery obtained using a particular technique is a factor in deciding the technique to be used. If the percentage recovery is found to be less than 50 %, improvements to the technique or the use of alternative techniques should be considered. It is noted that there can be certain circumstances where it is not possible to have a recovery above 50 %.對生物負(fù)載的確認(rèn)只能是對產(chǎn)品的生物負(fù)載的一個(gè)估計(jì)值。判定隔離種群可以使用傳統(tǒng)試驗(yàn)，如形態(tài)學(xué)、革蘭和孢子染色反應(yīng)及簡單的生物化學(xué)反應(yīng)（如：過氧化氫酶、氧化酶、吲哚），通常提供一些關(guān)于微生物屬于哪個(gè)科或種的指示。在這種情況下，選用的產(chǎn)品部分應(yīng)盡可能大，通過對所用的產(chǎn)品部分的生物負(fù)載判定應(yīng)能判定出整個(gè)產(chǎn)品的生物負(fù)載。d) microbial characterization of org