GB/Z 44363-2024
ActivePyrogenicity—Principles and methods for pyrogen testing of medical devices
致热性 医疗器械热原试验的原理和方法
Application Summary AI generated
This standard specifies the principles and methods for testing the pyrogenicity of medical devices, focusing on detecting fever-causing contaminants. It is applied in the quality control and safety evaluation of medical devices, particularly those that come into direct or indirect contact with the human body, such as surgical instruments, implants, and infusion sets. The standard guides manufacturers and testing laboratories in China to ensure compliance with regulatory requirements for biological safety.
Related Standards
GB/T 19634-2005
In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 47486-2026
General technical requirements for vasculature-on-a-chip
GB/Z 30154-2013
Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
GB/Z 16886.22-2022
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/Z 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 136-2026
Medical laboratories—Reagents for staining biological specimen—Guidance for users
GB/Z 157-2026
In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.