标准解读
《GB/Z 44363-2024 致热性 医疗器械热原试验的原理和方法》这一标准文件，专注于规定医疗器械在使用过程中可能产生的致热性物质检测的理论基础与实践操作流程。该标准旨在确保医疗器械的安全性，防止因其携带的热原（即能引起人体发热反应的杂质，常见如细菌内毒素）导致患者发热或其他不良反应。
标准主要内容概览：
-
范围：明确了本标准适用于各类医疗器械中热原检测的应用，包括但不限于输液器具、植入材料等，但不涵盖对药品热原的测试。
-
术语和定义：详细解释了“热原”、“内毒素”、“终点浊度法”等相关专业术语，为后续内容的理解奠定基础。
-
原理：阐述了热原试验的基本科学依据，通常涉及利用鲎试剂（一种对细菌内毒素高度敏感的生物试剂）反应来定性或定量测定样品中的热原含量。原理部分还可能介绍热原如何激活血液中的补体系统，进而引发发热反应的生理机制。
-
试验方法：
- 直接检测法：直接测量医疗器械提取液与鲎试剂反应的浊度变化，以判断热原的存在及其大致浓度。
- 间接检测法：适用于不便直接测试的复杂样品，可能涉及样品预处理步骤，然后采用动物实验或其他生物测定方法进一步确认。
-
样品准备与处理：具体说明了从医疗器械中提取检测样本的详细步骤，包括清洗、消毒、提取液体等，确保提取过程不会引入新的污染。
-
质量控制：强调了实验过程中应实施的质量控制措施，包括阳性对照、阴性对照的设置，以及实验室环境和操作人员的要求，以保证测试结果的准确性和可重复性。
-
结果判定与报告：制定了热原检测结果的评判标准，指导如何根据实验数据判断医疗器械是否符合安全使用要求，并规定了报告应包含的信息内容和格式。
-
附录：可能包含具体的实验操作流程图、参考文献、鲎试剂的校准方法等补充信息，以增强标准的实用性和可操作性。
实施意义：
该标准通过规范医疗器械热原检测的方法与程序，为制造商、检测机构及监管单位提供了统一的技术准则，有助于提升医疗器械的安全水平，保护公众健康，减少因医疗器械使用引起的热原反应风险。
如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。
....
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- 2024-08-23 颁布
- 2025-09-01 实施
文档简介
ICS
11.100.20
CCS
C30
中华人民共和国国家标准化指导性技术文件
GB/Z44363—2024/ISO/TR21582:2021
致热性医疗器械热原试验的
原理和方法
Pyrogenicity—Principlesandmethodsforpyrogentestingofmedicaldevices
（ISO/TR21582:2021，IDT）
2024-08-23发布2025-09-01实施
国家市场监督管理总局发布
国家标准化管理委员会
GB/Z44363—2024/ISO/TR21582:2021
目次
前言
·····································································································
Ⅲ
引言
·····································································································
Ⅳ
1
范围
··································································································
1
2
规范性引用文件
······················································································
1
3
术语和定义
···························································································
1
4
缩略语
································································································
2
5
热原的特性
···························································································
3
5.1
概述
······························································································
3
5.2
细菌内毒素
······················································································
3
5.3
除内毒素以外的微生物成分
·····································································
3
5.4
促炎细胞因子
····················································································
4
5.5
化学物质和其他致热原
··········································································
4
5.6
发热反应的原理
·················································································
4
6
致热性评估
···························································································
5
6.1
概述
······························································································
5
6.2
细菌内毒素试验（BET）
·······································································
5
6.2.1概述
·························································································
5
6.2.2鲎试剂反应的原理
···········································································
5
6.2.3BET的一般步骤
············································································
5
6.2.4BET的特性
·················································································
6
6.3
家兔热原试验
····················································································
6
6.3.1概述
·························································································
6
6.3.2家兔试验的原理
·············································································
6
6.3.3家兔试验的步骤
·············································································
6
6.3.4家兔试验的特点
·············································································
6
6.4
基于人体细胞的热原试验（HCPT）
····························································
7
6.4.1概述
·························································································
7
6.4.2HCPT的原理
···············································································
7
6.4.3人类细胞的选择
·············································································
7
6.4.4细胞因子标志物的选择
······································································
7
6.4.5HCPT的步骤
···············································································
8
6.4.6HCPT的特性
···············································································
9
Ⅰ
GB/Z44363—2024/ISO/TR21582:2021
6.4.7确认研究
····················································································
9
7
结论
··································································································
9
参考文献
································································································
10
Ⅱ
GB/Z44363—2024/ISO/TR21582:2021
前言
本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规
定起草。
本文件等同采用ISO/TR21582：2021《致热性医疗器械热原试验的原理和方法》，文件类型由
ISO的技术报告调整为我国的指导性技术文件。
本文件做了下列最小限度的编辑性改动：
—3.1中增加了注2。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。
本文件由国家药品监督管理局提出。
本文件由全国医疗器械生物学评价标准化技术委员会（SAC/TC248）归口。
本文件起草单位：山东省医疗器械和药品包装检验研究院、天津市医疗器械质量监督检验中心、苏
州百特医疗用品有限公司。
本文件主要起草人：刘佳、袁博、徐海燕、许晶、李振强、李凌梅、田硕、杨婧。
Ⅲ
GB/Z44363—2024/ISO/TR21582:2021
引言
目前，医疗器械的安全评估以ISO10993（所有部分）中推荐的毒理学研究和其他研究为指导。
材料介导的致热性表现为一种全身反应，虽然在GB/T16886.11—2021附录G中有涉及，但本文
件致力于对热原试验进行总体描述。
热原反应是指化学物质或其他物质引发的不良反应，如微生物成分引起的发热反应。热原反应试验
已被要求用于评价直接或间接接触循环血液和淋巴系统、脑脊液（CSF）和与人体相互作用的产品的安
全性。
目前，家兔体内致热性试验和体外细菌内毒素试验已作为评价医疗器械及其材料致热性的公认方
法。国际上对已经建立的试验方法包含试验样品的制备方式已经达成共识，并且在相关的指南和药典均
有体现。
近来，一种使用人免疫细胞进行的体外热原试验，即基于人体细胞的热原试验（HCPT），已经被
开发出来并应用于胃肠外药物的热原试验。由于该方法直接或间接接触人体血细胞，目前正在考虑将其
应用于医疗器械热原检测。
Ⅳ
GB/Z44363—2024/ISO/TR21582:2021
致热性医疗器械热原试验的
原理和方法
1范围
本文件规定了医疗器械及其材料的热原试验的原理和方法。
本文件适用于医疗器械及其材料的热原试验。
2规范性引用文件
本文件没有规范性引用文件。
3术语和定义
下列术语和定义适用于本文件。
ISO和IEC维护的用于标准化的术语数据库，地址如下：
—IEC电子百科：/；
—ISO在线浏览平台：/obp。
3.1
医疗器械medicaldevice
制造商的预期用途是为下列一个或多个特定医疗目的用于人类的，不论单独使用或组合使用的仪
器、设备、
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