標準解讀
《GB/Z 44363-2024 致熱性 醫(yī)療器械熱原試驗的原理和方法》這一標準文件，專注于規(guī)定醫(yī)療器械在使用過程中可能產生的致熱性物質檢測的理論基礎與實踐操作流程。該標準旨在確保醫(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)熱反應的雜質，常見如細菌內毒素）導致患者發(fā)熱或其他不良反應。
標準主要內容概覽：
-
范圍：明確了本標準適用于各類醫(yī)療器械中熱原檢測的應用，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。
-
術語和定義：詳細解釋了“熱原”、“內毒素”、“終點濁度法”等相關專業(yè)術語，為后續(xù)內容的理解奠定基礎。
-
原理：闡述了熱原試驗的基本科學依據，通常涉及利用鱟試劑（一種對細菌內毒素高度敏感的生物試劑）反應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體系統，進而引發(fā)發(fā)熱反應的生理機制。
-
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雜樣品，可能涉及樣品預處理步驟，然后采用動物實驗或其他生物測定方法進一步確認。
-
樣品準備與處理：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。
-
質量控制：強調了實驗過程中應實施的質量控制措施，包括陽性對照、陰性對照的設置，以及實驗室環(huán)境和操作人員的要求，以保證測試結果的準確性和可重復性。
-
結果判定與報告：制定了熱原檢測結果的評判標準，指導如何根據實驗數據判斷醫(yī)療器械是否符合安全使用要求，并規(guī)定了報告應包含的信息內容和格式。
-
附錄：可能包含具體的實驗操作流程圖、參考文獻、鱟試劑的校準方法等補充信息，以增強標準的實用性和可操作性。
實施意義：
該標準通過規(guī)范醫(yī)療器械熱原檢測的方法與程序，為制造商、檢測機構及監(jiān)管單位提供了統一的技術準則，有助于提升醫(yī)療器械的安全水平，保護公眾健康，減少因醫(yī)療器械使用引起的熱原反應風險。
如需獲取更多詳盡信息，請直接參考下方經官方授權發(fā)布的權威標準文檔。
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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準化指導性技術文件
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
國家標準化管理委員會
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
細菌內毒素
······················································································
3
5.3
除內毒素以外的微生物成分
·····································································
3
5.4
促炎細胞因子
····················································································
4
5.5
化學物質和其他致熱原
··········································································
4
5.6
發(fā)熱反應的原理
·················································································
4
6
致熱性評估
···························································································
5
6.1
概述
······························································································
5
6.2
細菌內毒素試驗（BET）
·······································································
5
6.2.1概述
·························································································
5
6.2.2鱟試劑反應的原理
···········································································
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
·············································································
6
6.4
基于人體細胞的熱原試驗（HCPT）
····························································
7
6.4.1概述
·························································································
7
6.4.2HCPT的原理
···············································································
7
6.4.3人類細胞的選擇
·············································································
7
6.4.4細胞因子標志物的選擇
······································································
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確認研究
····················································································
9
7
結論
··································································································
9
參考文獻
································································································
10
Ⅱ
GB/Z44363—2024/ISO/TR21582:2021
前言
本文件按照GB/T1.1—2020《標準化工作導則第1部分：標準化文件的結構和起草規(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的技術報告調整為我國的指導性技術文件。
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容可能涉及專利。本文件的發(fā)布機構不承擔識別專利的責任。
本文件由國家藥品監(jiān)督管理局提出。
本文件由全國醫(yī)療器械生物學評價標準化技術委員會（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、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）中推薦的毒理學研究和其他研究為指導。
材料介導的致熱性表現為一種全身反應，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行總體描述。
熱原反應是指化學物質或其他物質引發(fā)的不良反應，如微生物成分引起的發(fā)熱反應。熱原反應試驗
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、腦脊液（CSF）和與人體相互作用的產品的安
全性。
目前，家兔體內致熱性試驗和體外細菌內毒素試驗已作為評價醫(yī)療器械及其材料致熱性的公認方
法。國際上對已經建立的試驗方法包含試驗樣品的制備方式已經達成共識，并且在相關的指南和藥典均
有體現。
近來，一種使用人免疫細胞進行的體外熱原試驗，即基于人體細胞的熱原試驗（HCPT），已經被
開發(fā)出來并應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胞，目前正在考慮將其
應用于醫(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術語和定義
下列術語和定義適用于本文件。
ISO和IEC維護的用于標準化的術語數據庫，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，不論單獨使用或組合使用的儀
器、設備、
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