{"id":2332,"date":"2024-11-26T10:16:36","date_gmt":"2024-11-26T02:16:36","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2332"},"modified":"2026-02-09T09:59:05","modified_gmt":"2026-02-09T01:59:05","slug":"terms-and-definitions-of-eto-gas-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/terms-and-definitions-of-eto-gas-sterilization\/","title":{"rendered":"Terms and definitions of eto gas sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

就本文檔而言，以下術語和定義適用於 環氧乙烷滅菌<\/strong><\/p>\n\n\n\n

3.1曝氣 <\/a><\/strong><\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

part of the eto gas sterilization process during which ethylene oxide and\/or its<\/p>\n\n\n\n

反應產物由醫療器械中解吸，直到達到預定水平<\/p>\n\n\n\n

Note 1 to entry: This can be performed within the sterilizer and\/or in a separate chamber or room.<\/p>\n\n\n\n

3.2曝氣面積 <\/strong><\/strong><\/p>\n\n\n\n

發生曝氣的腔室或房間<\/p>\n\n\n\n

3.3生物負荷 <\/strong><\/strong><\/p>\n\n\n\n

population of viable microorganisms on or in product and\/or sterile barrier system<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.2]<\/p>\n\n\n\n

3.4生物指示劑 <\/strong><\/strong><\/p>\n\n\n\n

包含活微生物嘅測試系統，對指定嘅ETO氣體滅菌過程提供肯定嘅耐受性<\/p>\n\n\n\n

3.5校準 <\/strong><\/strong><\/p>\n\n\n\n

在指定條件下，建立由測量儀器或測量所指示的量值之間的關係的操作集<\/p>\n\n\n\n

系統，或由材料度量或參考材料表示的值，以及由標準實現的相應值<\/p>\n\n\n\n

3.6化學指示貼 <\/strong><\/strong><\/p>\n\n\n\n

揭示一個或多個預定義過程變量更改嘅測試系統<\/p>\n\n\n\n

基於因暴露于工藝而導致嘅化學或物理變化<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.6]<\/p>\n\n\n\n

3.7調節 <\/a><\/strong><\/p>\n\n\n\n

喺ETO氣體滅菌周期內但在乙烯之前對產品進行處理<\/p>\n\n\n\n

氧化物進入，以達到預定的溫度和相對濕度<\/p>\n\n\n\n

條目注1：環氧乙烷滅菌循環嘅一部分可以喺大氣壓或真空下進行。<\/p>\n\n\n\n

注2進入：參見3.27，預處理<\/p>\n\n\n\n

3.8 <\/strong>D <\/em><\/strong><\/em><\/strong>價值 <\/strong><\/strong><\/p>\n\n\n\n

D<\/em>10 價值 <\/strong><\/strong><\/p>\n\n\n\n

在規定條件下達到90%嘅受試微生物種群滅活所需嘅時間或劑量<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.11] ?<\/p>\n\n\n\n

條目注1：就本國際標準而言， D <\/em>值係實現90%受試生物體種群滅活所需嘅暴露時間。<\/p>\n\n\n\n

3.9開發 <\/strong><\/strong><\/p>\n\n\n\n

制定規範嘅行為<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.13]<\/p>\n\n\n\n

3.10露點 <\/strong><\/strong><\/p>\n\n\n\n

飽和水蒸氣壓力等於<\/p>\n\n\n\n

大氣中水蒸氣嘅分壓<\/p>\n\n\n\n

條目注1：大氣冷卻到露點以下會產生水凝結。<\/p>\n\n\n\n

3.11建立 <\/strong><\/strong><\/p>\n\n\n\n

以理論評估確定，以實驗確認<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.17]<\/p>\n\n\n\n

9ISO 11135-2014認證<\/p>\n\n\n\n

3.12環氧乙烷（ EO ）注射時間<\/strong> <\/a><\/p>\n\n\n\n

由第一次把EO （混合物）引入腔室開始到完成注射嘅階段持續時間<\/p>\n\n\n\n

3.13曝光時間 <\/strong><\/strong><\/p>\n\n\n\n

工藝參數保持在指定公差範圍內的期限<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.18]<\/p>\n\n\n\n

條目注1：為咗計算循環致死率，佢係EO注射結束同EO去除開始之間嘅環氧乙烷滅菌期。<\/p>\n\n\n\n

3.14故障 <\/strong><\/strong><\/p>\n\n\n\n

one or more of the process parameters lying outside of its\/their specified<\/p>\n\n\n\n

容差<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.19]<\/p>\n\n\n\n

3.15沖洗 <\/strong><\/strong><\/p>\n\n\n\n

把環氧乙烷由負載和腔室中取出嘅程序<\/p>\n\n\n\n

透過多次交替進入過濾空氣、惰性氣體或蒸汽並排空腔室，或連續透過過濾空氣、惰性氣體10ISO 11135-2014氣體或蒸汽通過負載和腔室<\/p>\n\n\n\n

3.16分數循環 <\/strong><\/strong><\/p>\n\n\n\n

與EO氣體暴露時間相比，暴露于EO氣體嘅時間減嘅循環<\/p>\n\n\n\n

在環氧乙烷滅菌過程中指定<\/p>\n\n\n\n

3.17半周期 <\/strong><\/strong><\/p>\n\n\n\n

與環氧乙烷滅菌過程中規定嘅時間相比，暴露于EO氣體嘅時間減少50%嘅循環<\/p>\n\n\n\n

3.18醫療保健設施 <\/strong><\/strong><\/p>\n\n\n\n

政府和私人組織和機構致力於<\/p>\n\n\n\n

促進和維護健康，預防和治療<\/p>\n\n\n\n

疾病和傷害<\/p>\n\n\n\n

示例醫療保健設施可以係醫院、療養院、擴展護理設施、獨立手術中心、診所、醫療辦公室或牙科診所。<\/p>\n\n\n\n

3.19保健品 <\/strong><\/strong><\/p>\n\n\n\n

醫療設備，包括 體外 <\/em>診斷醫療器械或醫藥產品，包括生物製藥<\/p>\n\n\n\n

11 ISO 11135-2014質素體系認證<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.20]<\/p>\n\n\n\n

3.20安裝確認 <\/a><\/strong><\/p>\n\n\n\n

獲取和記錄已提供設備嘅证据嘅過程<\/p>\n\n\n\n

並按照其規格安裝<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.22]<\/p>\n\n\n\n

3.21醫療設備 <\/strong><\/strong><\/p>\n\n\n\n

任何儀器、裝置、工具、機器、器具、植入物、 體外 <\/em>製造商打算單獨或組合用于人類嘅試劑或校準品、軟件、材料或相關物品，用于以下一個或多個特定目的<\/p>\n\n\n\n

\u2014 diagnosis, prevention, monitoring, treatment or alleviation of disease,<\/p>\n\n\n\n

\u2014 diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,<\/p>\n\n\n\n

\u2014 investigation, replacement or modification or support of the anatomy or of a physiological process,<\/p>\n\n\n\n

\u2014 control of conception,<\/p>\n\n\n\n

\u2014 disinfection of medical devices,<\/p>\n\n\n\n

\u2014 providing information for medical purposes by means of 體外 <\/em>檢查來自人體的標本，並且這些標本不能通過藥理學、免疫學或代謝方法在人體內或人體上實現其主要預期作用，但可以通過這些方法輔助其功能<\/p>\n\n\n\n

[來源：ISO 13485：2003，定義3.7]<\/p>\n\n\n\n

?<\/p>\n\n\n\n

3.22微生物 <\/strong><\/strong><\/p>\n\n\n\n

微觀大小的實體，包括細菌、真菌、原生動物和病毒<\/p>\n\n\n\n

注意事項1到入口：特定標準可能唔要求演示<\/p>\n\n\n\n

ETO氣體滅菌過程喺滅活所有類型嘅<\/p>\n\n\n\n

microorganisms, identified in the definition above, for validation and\/or<\/p>\n\n\n\n

ETO氣體滅菌過程嘅常規控制。<\/p>\n\n\n\n

3.23操作鑑定 <\/a><\/strong><\/p>\n\n\n\n

獲取和記錄已安裝設備嘅证据嘅過程<\/p>\n\n\n\n

按照其<\/p>\n\n\n\n

操作流程<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.27]<\/p>\n\n\n\n

3.24 矯枉過正的方法<\/strong><\/strong><\/p>\n\n\n\n

使用ETO氣體滅菌工藝嘅方法，可提供至少12個孢子對數<\/p>\n\n\n\n

還原（SLR ）為抗性等於或大於產品生物負荷嘅生物指示劑<\/p>\n\n\n\n

3.25參數發佈 <\/strong><\/strong><\/p>\n\n\n\n

根據證明過程參數喺指定允差範圍內交付嘅記錄，聲明產品無菌<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.29]<\/p>\n\n\n\n

注1到條目：呢種過程釋放方法唔包括使用生物指示劑。<\/p>\n\n\n\n

3.26性能鑑定 <\/a><\/strong><\/p>\n\n\n\n

獲取和記錄證據嘅過程，證明設備喺按照操作程序安裝和操作時始終按照預定標準運行，從而產生符合其規格嘅產品<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.30]<\/p>\n\n\n\n

3.27預處理 <\/a><\/strong><\/p>\n\n\n\n

在ETO氣體滅菌循環之前，在房間或腔室中對產品進行處理，以達到規定的溫度和相對濕度條件<\/p>\n\n\n\n

3.28過程挑戰裝置 <\/strong><\/strong><\/p>\n\n\n\n

旨在構成對AETO氣體滅菌過程嘅肯定耐受性並用于評估過程性能嘅項目<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.33]<\/p>\n\n\n\n

條目注1：就本國際標準而言，PCD可以<\/p>\n\n\n\n

是直接接種的產品、模擬產品或其他設備，或<\/p>\n\n\n\n

間接。 請參閱7.1.6同D.7.1.6。<\/p>\n\n\n\n

條目注2：在本國際標準中，對內部PCD同外部PCD進行了區分。 內部PID用于證明已達到所需嘅產品SAL。 位於產品或產品運輸箱範圍內嘅PCD係內部PID，而位於運輸箱之間或負載外表面嘅PCD係外部PID。 外部PCD係一種設計用于微生物學嘅項目<\/p>\n\n\n\n

監控日常生產周期。<\/p>\n\n\n\n

3.29工藝參數 <\/strong><\/strong><\/p>\n\n\n\n

過程變量嘅指定值<\/p>\n\n\n\n

條目注1：eto氣體滅菌工藝嘅規範包括<\/p>\n\n\n\n

工藝參數及其公差。<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.34]<\/p>\n\n\n\n

3.30過程變量 <\/strong><\/strong><\/p>\n\n\n\n

環氧乙烷滅菌過程中嘅條件，改變殺菌效果嘅變化<\/p>\n\n\n\n

EXAMPLE?Time, temperature, pressure, concentration, humidity, wavelength.<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.35]<\/p>\n\n\n\n

3.31加工類 <\/strong><\/strong><\/p>\n\n\n\n

可滅菌嘅不同產品或產品系列嘅集合<\/p>\n\n\n\n

一起<\/p>\n\n\n\n

條目注1：該類別中嘅所有產品均已肯定對環氧乙烷滅菌過程構成嘅挑戰等於或小於該組嘅工藝挑戰裝置。<\/p>\n\n\n\n

3.32產品 <\/strong><\/strong><\/p>\n\n\n\n

流程嘅結果<\/p>\n\n\n\n

[來源：ISO 9000：2005，定義3.4.2]<\/p>\n\n\n\n

注1到條目：就環氧乙烷滅菌標準而言，產品係<\/p>\n\n\n\n

有形嘅，可以係原材料、中間體、子組件同<\/p>\n\n\n\n

保健品。<\/p>\n\n\n\n

3.33產品系列 <\/strong><\/strong><\/p>\n\n\n\n

具有允許消毒嘅特性嘅產品組<\/p>\n\n\n\n

使用定義嘅工藝條件<\/p>\n\n\n\n

3.34產品裝載量<\/strong><\/strong><\/p>\n\n\n\n

產品佔用的可用腔室容積內的定義空間<\/p>\n\n\n\n

3.35公認嘅文化收藏 <\/strong><\/strong><\/p>\n\n\n\n

《布達佩斯條約》下嘅保管機構 國際<\/em><\/p>\n\n\n\n

確認存款<\/em><\/p>\n\n\n\n

用于專利和法規目的嘅微生物<\/em><\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.38]<\/p>\n\n\n\n

3.36參考微生物 <\/strong><\/p>\n\n\n\n

從公認嘅培養物收集中獲得嘅微生物菌株<\/p>\n\n\n\n

3.37重新認證 <\/strong><\/p>\n\n\n\n

重複部分驗證，以確認特定流程嘅持續可接受性<\/p>\n\n\n\n

3.38可重複使用的醫療器械 <\/strong><\/strong><\/p>\n\n\n\n

製造商指定或打算用于嘅醫療器械<\/p>\n\n\n\n

再加工和再利用<\/p>\n\n\n\n

入境註1：唔係指定或打算使用嘅醫療器械<\/p>\n\n\n\n

由製造商提供，僅供一次過使用。<\/p>\n\n\n\n

3.39服務 <\/strong><\/strong><\/p>\n\n\n\n

來自外部來源嘅耗材，設備正常運行所需嘅<\/p>\n\n\n\n

示例電、水、壓縮空氣、排水。<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.41]<\/p>\n\n\n\n

3.40一次過使用醫療器械 <\/strong><\/p>\n\n\n\n

製造商指定或打算一次過使用嘅醫療器械<\/p>\n\n\n\n

3.41指定 <\/strong><\/strong><\/p>\n\n\n\n

喺批准嘅文件中詳細規定<\/p>\n\n\n\n

3.42減少孢子對數 <\/strong>初始孢子群對數， N<\/em>0，減去最終種群嘅對數， N<\/em>u<\/p>\n\n\n\n

[來源：ISO 14161：2009，定義3.19]<\/p>\n\n\n\n

條目的註釋1：描述<\/p>\n\n\n\n

生物指示劑或因暴露於指定<\/p>\n\n\n\n

條件。<\/p>\n\n\n\n

對於直接枚舉：<\/p>\n\n\n\n

SLR =對數 N<\/em>0 log ? N<\/em>u<\/p>\n\n\n\n

边度<\/p>\n\n\n\n

N<\/em>0 係初始總體;<\/p>\n\n\n\n

N<\/em>u係最終嘅種群。<\/p>\n\n\n\n

對於負分數：<\/p>\n\n\n\n

SLR =對數 N<\/em>0 \u2013 log [ln (q<\/em>\/n<\/em>)]<\/p>\n\n\n\n

边度<\/p>\n\n\n\n

N<\/em>0 係初始總體;<\/p>\n\n\n\n

q <\/em>係測試嘅重複樣本數;<\/p>\n\n\n\n

n <\/em>係增長負嘅樣本數。<\/p>\n\n\n\n

如果冇倖存者，則無法計算真實嘅SLR。 SLR可以係<\/p>\n\n\n\n

reported as \u201cgreater than\u201d log N<\/em>0 如果使用一種倖存嘅生物躰。<\/p>\n\n\n\n

3.43無菌 <\/strong><\/strong><\/p>\n\n\n\n

不含活微生物<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.43]<\/p>\n\n\n\n

3.44無菌屏障系統<\/strong><\/strong><\/p>\n\n\n\n

最小包裝，可防止微生物進入並允許無菌<\/p>\n\n\n\n

產品在使用點的介紹<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.44]<\/p>\n\n\n\n

3.45無菌<\/strong><\/p>\n\n\n\n

無活微生物嘅狀態<\/p>\n\n\n\n

條目注1：在實踐中，無法證明關於唔存在微生物嘅呢種絕對陳述。<\/p>\n\n\n\n

入口註2：見3.47，滅菌。<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.45]<\/p>\n\n\n\n

3.46無菌保證水平 <\/strong><\/strong><\/p>\n\n\n\n

喺之後物品上出現單個活微生物的概率<\/p>\n\n\n\n

滅菌<\/p>\n\n\n\n

注1到條目：術語SAL採用定量值，通常為10-6或10-3。 当把此定量值應用於無菌保證時，10-6嘅SAL值較低，但過10-3嘅SAL提供仲大嘅無菌保證。<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.46]<\/p>\n\n\n\n

3.47滅菌 <\/a><\/strong><\/p>\n\n\n\n

用于使產品不含活微生物嘅經過驗證嘅工藝<\/p>\n\n\n\n

條目注1：滅菌過程中緊，微生物嘅性質<\/p>\n\n\n\n

失活係指數級嘅，因此微生物喺單個項目上嘅存活可以用概率嚟表示。 雖然這個<\/p>\n\n\n\n

概率可以降低到一個非常低嘅數字，它永遠不能降低到零。 ISO 11135-2014認證<\/p>\n\n\n\n

條目注2：見3.46，無菌保證水平。<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.47]<\/p>\n\n\n\n

3.48滅菌周期 <\/a><\/strong><\/p>\n\n\n\n

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air\/inert gas admission<\/p>\n\n\n\n

3.49滅菌負荷 <\/strong><\/strong><\/p>\n\n\n\n

使用畀定嘅<\/p>\n\n\n\n

滅菌過程<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.48]<\/p>\n\n\n\n

3.50滅菌過程 <\/a><\/strong><\/p>\n\n\n\n

達到規定嘅無菌要求所需嘅一系列行動或操作<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.49]<\/p>\n\n\n\n

注1至入口：本系列操作或操作包括預處理<\/p>\n\n\n\n

（如有必要），在規定條件下暴露于環氧乙烷以及去除環氧乙烷及其副產品所需的任何必要後處理。 它唔包括滅菌過程之前嘅任何清潔、消毒或包裝操作。<\/p>\n\n\n\n

3.51消毒專家 <\/strong><\/strong><\/p>\n\n\n\n

瞭解所採用嘅殺菌技術及其對材料同微生物嘅影響嘅技術知識嘅人<\/p>\n\n\n\n

3.52滅菌劑 <\/strong><\/strong><\/p>\n\n\n\n

具有足夠殺菌活性嘅實體在規定條件下實現無菌<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.50]<\/p>\n\n\n\n

3.53倖存者曲線 <\/strong><\/p>\n\n\n\n

規定條件下隨著微生物暴露量緊嘅增加而微生物種群失活嘅圖形表示<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.51]<\/p>\n\n\n\n

3.54無菌測試 <\/strong><\/strong><\/p>\n\n\n\n

藥典中定義嘅技術操作暴露于滅菌過程後對產品執行緊<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.53]<\/p>\n\n\n\n

3.55無菌測試 <\/strong><\/strong><\/p>\n\n\n\n

作為開發、驗證或<\/p>\n\n\n\n

認證以確定產品或其部分是否存在活微生物番<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.54]<\/p>\n\n\n\n

3.56可用腔室容積 <\/strong><\/strong><\/p>\n\n\n\n

滅菌器腔室內嘅定義空間，不受固定或移動部件嘅限制，可用于接受滅菌負荷<\/p>\n\n\n\n

注1至條目：允許氣體喺負載內部循環嘅體積<\/p>\n\n\n\n

該腔室唔包括喺可用空間內。<\/p>\n\n\n\n

3.57驗證 <\/a><\/strong><\/p>\n\n\n\n

用于獲取、記錄同解釋所需結果嘅書面程序，以確定過程將始終產生符合預定規格嘅產品<\/p>\n\n\n\n

[SOURCE: ISO\/TS 11139:2006, definition 2.55]<\/p>\n\n\n\n

3.58原始材料 <\/strong><\/p>\n\n\n\n

以前未使用過嘅材料，或未經過原始生產以外嘅加工<\/p>\n\n\n\n

如果您想了解更多關於環氧乙烷滅菌嘅信息<\/h2>\n\n\n\n

電話:+8619975258603<\/a><\/p>\n\n\n\n

電子郵件：hayley@hzbocon.com<\/a><\/p>\n\n\n\n

本地站點：中國浙江省杭州市下沙區蔡通中新1202室<\/p>\n\n\n\n

網站：hzbocon.com<\/a> zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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