標(biāo)準(zhǔn)解讀
《GB/Z 44363-2024 致熱性 醫(yī)療器械熱原試驗的原理和方法》這一標(biāo)準(zhǔn)文件，專注于規(guī)定醫(yī)療器械在使用過程中可能產(chǎn)生的致熱性物質(zhì)檢測的理論基礎(chǔ)與實踐操作流程。該標(biāo)準(zhǔn)旨在確保醫(yī)療器械的安全性，防止因其攜帶的熱原（即能引起人體發(fā)熱反應(yīng)的雜質(zhì)，常見如細(xì)菌內(nèi)毒素）導(dǎo)致患者發(fā)熱或其他不良反應(yīng)。
標(biāo)準(zhǔn)主要內(nèi)容概覽：
-
范圍：明確了本標(biāo)準(zhǔn)適用于各類醫(yī)療器械中熱原檢測的應(yīng)用，包括但不限于輸液器具、植入材料等，但不涵蓋對藥品熱原的測試。
-
術(shù)語和定義：詳細(xì)解釋了“熱原”、“內(nèi)毒素”、“終點(diǎn)濁度法”等相關(guān)專業(yè)術(shù)語，為后續(xù)內(nèi)容的理解奠定基礎(chǔ)。
-
原理：闡述了熱原試驗的基本科學(xué)依據(jù)，通常涉及利用鱟試劑（一種對細(xì)菌內(nèi)毒素高度敏感的生物試劑）反應(yīng)來定性或定量測定樣品中的熱原含量。原理部分還可能介紹熱原如何激活血液中的補(bǔ)體系統(tǒng)，進(jìn)而引發(fā)發(fā)熱反應(yīng)的生理機(jī)制。
-
試驗方法：
- 直接檢測法：直接測量醫(yī)療器械提取液與鱟試劑反應(yīng)的濁度變化，以判斷熱原的存在及其大致濃度。
- 間接檢測法：適用于不便直接測試的復(fù)雜樣品，可能涉及樣品預(yù)處理步驟，然后采用動物實驗或其他生物測定方法進(jìn)一步確認(rèn)。
-
樣品準(zhǔn)備與處理：具體說明了從醫(yī)療器械中提取檢測樣本的詳細(xì)步驟，包括清洗、消毒、提取液體等，確保提取過程不會引入新的污染。
-
質(zhì)量控制：強(qiáng)調(diào)了實驗過程中應(yīng)實施的質(zhì)量控制措施，包括陽性對照、陰性對照的設(shè)置，以及實驗室環(huán)境和操作人員的要求，以保證測試結(jié)果的準(zhǔn)確性和可重復(fù)性。
-
結(jié)果判定與報告：制定了熱原檢測結(jié)果的評判標(biāo)準(zhǔn)，指導(dǎo)如何根據(jù)實驗數(shù)據(jù)判斷醫(yī)療器械是否符合安全使用要求，并規(guī)定了報告應(yīng)包含的信息內(nèi)容和格式。
-
附錄：可能包含具體的實驗操作流程圖、參考文獻(xiàn)、鱟試劑的校準(zhǔn)方法等補(bǔ)充信息，以增強(qiáng)標(biāo)準(zhǔn)的實用性和可操作性。
實施意義：
該標(biāo)準(zhǔn)通過規(guī)范醫(yī)療器械熱原檢測的方法與程序，為制造商、檢測機(jī)構(gòu)及監(jiān)管單位提供了統(tǒng)一的技術(shù)準(zhǔn)則，有助于提升醫(yī)療器械的安全水平，保護(hù)公眾健康，減少因醫(yī)療器械使用引起的熱原反應(yīng)風(fēng)險。
如需獲取更多詳盡信息，請直接參考下方經(jīng)官方授權(quán)發(fā)布的權(quán)威標(biāo)準(zhǔn)文檔。
....
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- 即將實施
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- 2024-08-23 頒布
- 2025-09-01 實施
文檔簡介
ICS
11.100.20
CCS
C30
中華人民共和國國家標(biāo)準(zhǔn)化指導(dǎo)性技術(shù)文件
GB/Z44363—2024/ISO/TR21582:2021
致熱性醫(yī)療器械熱原試驗的
原理和方法
Pyrogenicity—Principlesandmethodsforpyrogentestingofmedicaldevices
（ISO/TR21582:2021，IDT）
2024-08-23發(fā)布2025-09-01實施
國家市場監(jiān)督管理總局發(fā)布
國家標(biāo)準(zhǔn)化管理委員會
GB/Z44363—2024/ISO/TR21582:2021
目次
前言
·····································································································
Ⅲ
引言
·····································································································
Ⅳ
1
范圍
··································································································
1
2
規(guī)范性引用文件
······················································································
1
3
術(shù)語和定義
···························································································
1
4
縮略語
································································································
2
5
熱原的特性
···························································································
3
5.1
概述
······························································································
3
5.2
細(xì)菌內(nèi)毒素
······················································································
3
5.3
除內(nèi)毒素以外的微生物成分
·····································································
3
5.4
促炎細(xì)胞因子
····················································································
4
5.5
化學(xué)物質(zhì)和其他致熱原
··········································································
4
5.6
發(fā)熱反應(yīng)的原理
·················································································
4
6
致熱性評估
···························································································
5
6.1
概述
······························································································
5
6.2
細(xì)菌內(nèi)毒素試驗（BET）
·······································································
5
6.2.1概述
·························································································
5
6.2.2鱟試劑反應(yīng)的原理
···········································································
5
6.2.3BET的一般步驟
············································································
5
6.2.4BET的特性
·················································································
6
6.3
家兔熱原試驗
····················································································
6
6.3.1概述
·························································································
6
6.3.2家兔試驗的原理
·············································································
6
6.3.3家兔試驗的步驟
·············································································
6
6.3.4家兔試驗的特點(diǎn)
·············································································
6
6.4
基于人體細(xì)胞的熱原試驗（HCPT）
····························································
7
6.4.1概述
·························································································
7
6.4.2HCPT的原理
···············································································
7
6.4.3人類細(xì)胞的選擇
·············································································
7
6.4.4細(xì)胞因子標(biāo)志物的選擇
······································································
7
6.4.5HCPT的步驟
···············································································
8
6.4.6HCPT的特性
···············································································
9
Ⅰ
GB/Z44363—2024/ISO/TR21582:2021
6.4.7確認(rèn)研究
····················································································
9
7
結(jié)論
··································································································
9
參考文獻(xiàn)
································································································
10
Ⅱ
GB/Z44363—2024/ISO/TR21582:2021
前言
本文件按照GB/T1.1—2020《標(biāo)準(zhǔn)化工作導(dǎo)則第1部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)
定起草。
本文件等同采用ISO/TR21582：2021《致熱性醫(yī)療器械熱原試驗的原理和方法》，文件類型由
ISO的技術(shù)報告調(diào)整為我國的指導(dǎo)性技術(shù)文件。
本文件做了下列最小限度的編輯性改動：
—3.1中增加了注2。
請注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識別專利的責(zé)任。
本文件由國家藥品監(jiān)督管理局提出。
本文件由全國醫(yī)療器械生物學(xué)評價標(biāo)準(zhǔn)化技術(shù)委員會（SAC/TC248）歸口。
本文件起草單位：山東省醫(yī)療器械和藥品包裝檢驗研究院、天津市醫(yī)療器械質(zhì)量監(jiān)督檢驗中心、蘇
州百特醫(yī)療用品有限公司。
本文件主要起草人：劉佳、袁博、徐海燕、許晶、李振強(qiáng)、李凌梅、田碩、楊婧。
Ⅲ
GB/Z44363—2024/ISO/TR21582:2021
引言
目前，醫(yī)療器械的安全評估以ISO10993（所有部分）中推薦的毒理學(xué)研究和其他研究為指導(dǎo)。
材料介導(dǎo)的致熱性表現(xiàn)為一種全身反應(yīng)，雖然在GB/T16886.11—2021附錄G中有涉及，但本文
件致力于對熱原試驗進(jìn)行總體描述。
熱原反應(yīng)是指化學(xué)物質(zhì)或其他物質(zhì)引發(fā)的不良反應(yīng)，如微生物成分引起的發(fā)熱反應(yīng)。熱原反應(yīng)試驗
已被要求用于評價直接或間接接觸循環(huán)血液和淋巴系統(tǒng)、腦脊液（CSF）和與人體相互作用的產(chǎn)品的安
全性。
目前，家兔體內(nèi)致熱性試驗和體外細(xì)菌內(nèi)毒素試驗已作為評價醫(yī)療器械及其材料致熱性的公認(rèn)方
法。國際上對已經(jīng)建立的試驗方法包含試驗樣品的制備方式已經(jīng)達(dá)成共識，并且在相關(guān)的指南和藥典均
有體現(xiàn)。
近來，一種使用人免疫細(xì)胞進(jìn)行的體外熱原試驗，即基于人體細(xì)胞的熱原試驗（HCPT），已經(jīng)被
開發(fā)出來并應(yīng)用于胃腸外藥物的熱原試驗。由于該方法直接或間接接觸人體血細(xì)胞，目前正在考慮將其
應(yīng)用于醫(yī)療器械熱原檢測。
Ⅳ
GB/Z44363—2024/ISO/TR21582:2021
致熱性醫(yī)療器械熱原試驗的
原理和方法
1范圍
本文件規(guī)定了醫(yī)療器械及其材料的熱原試驗的原理和方法。
本文件適用于醫(yī)療器械及其材料的熱原試驗。
2規(guī)范性引用文件
本文件沒有規(guī)范性引用文件。
3術(shù)語和定義
下列術(shù)語和定義適用于本文件。
ISO和IEC維護(hù)的用于標(biāo)準(zhǔn)化的術(shù)語數(shù)據(jù)庫，地址如下：
—IEC電子百科：/；
—ISO在線瀏覽平臺：/obp。
3.1
醫(yī)療器械medicaldevice
制造商的預(yù)期用途是為下列一個或多個特定醫(yī)療目的用于人類的，不論單獨(dú)使用或組合使用的儀
器、設(shè)備、
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