This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United …

引入新的通则5.1.13.【热原性（Pyrogenicity）】，以指导企业选择和实施适当的检查方法：细菌内毒素检查（BET）或单核细胞活化试验（MAT）。 新增的通则将涵盖风险评估，以支持使 …

Material-mediated pyrogenicity represents a systemic effect that is included in of ISO 10993-11:2017, Annex G, but efforts have been taken to generally address pyrogenicity testing in this …

Pyrogenicity and endotoxin testing are crucial steps that can make all the difference in determining whether your product is approved to go to market or not. As part of our process …

It has been shown that reductions of approximately 80% in the pyrogenicity of E. coli endotoxin in dialyzers have occurred after exposure to ethylene oxide.

This document specifies the principles and methods for pyrogen testing of medical devices and their materials.

When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate? For certain biological products, 21 CFR 610.13(b) requires a rabbit pyrogen test.

The meaning of PYROGENICITY is the quality or state of being pyrogenic; especially : capacity to produce fever.

国家标准计划《致热性 医疗器械热原试验的原理和方法》由SAC/TC248（全国医疗器械生物学评价标准化技术委员会）归口上报及执行，主管部门为国家药品监督管理局。 拟实施日期：发 …

2023年1月1日 · Pyrogenicity presents a challenge to clinicians, medical device manufacturers, and regulators. A pyrogen is, by definition, a substance that produces a rise in temperature in …