GBZ44363-2024 English PDF

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GBZ44363-2024: Pyrogenicity - Principles and methods for pyrogen testing of medical devices
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Similar standards

GB/T 42061   GB/T 16886.9   GB/T 42062   GB/T 44353.2   GB/T 44353.1   

Basic data

Standard ID: GB/Z 44363-2024 (GB/Z44363-2024)
Description (Translated English): Pyrogenicity - Principles and methods for pyrogen testing of medical devices
Sector / Industry: National Standard
Classification of Chinese Standard: C30
Word Count Estimation: 24,283
Date of Issue: 2024-08-23
Date of Implementation: 2024-08-23
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GBZ44363-2024: Pyrogenicity - Principles and methods for pyrogen testing of medical devices

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB /Z 44363-2024 Pyrogenicity - Principles and methods for pyrogen testing of medical devices Pyrogen testing of pyrogenic medical devices Principles and methods (ISO /TR 21582.2021, IDT) ICS 11.100.20 CCS C 30 Guiding technical documents of the People's Republic of China on national standardization Released on 2024-08-23 2025-09-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface ... Ⅲ Introduction ... Ⅳ 1 Scope ... 1 2 Normative references ... 1 3 Terms and Definitions ... 1 4 Abbreviations ... 2 5 Characteristics of pyrogens ... 3 5.1 Overview ... 3 5.2 Bacterial endotoxins 3 5.3 Microbial components other than endotoxins 3 5.4 Proinflammatory cytokines 4 5.5 Chemical substances and other pyrogens 4 5.6 Principle of exothermic reaction ... 4 6 Pyrogenicity Assessment ... 5 6.1 Overview ... 5 6.2 Bacterial endotoxin test (BET) 5 6.2.1 Overview ... 5 6.2.2 Principle of horseshoe crab reagent reaction ... 5 6.2.3 General steps of BET ... 5 6.2.4 Characteristics of BET 6 6.3 Rabbit pyrogen test 6 6.3.1 Overview 6 6.3.2 Principles of rabbit experiment 6 6.3.3 Steps of the rabbit experiment 6 6.3.4 Characteristics of rabbit experiments 6 6.4 Human Cell-Based Pyrogen Test (HCPT) 7 6.4.1 Overview 7 6.4.2 Principle of HCPT 7 6.4.3 Selection of human cells 7 6.4.4 Selection of cytokine markers 7 6.4.5 Steps of HCPT 8 6.4.6 Characteristics of HCPT 9 6.4.7 Confirmation studies 9 7 Conclusion ... 9 References ... 10

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting is required. This document is equivalent to ISO /TR 21582.2021 "Principles and methods of pyrogen testing for pyrogenic medical devices". ISO 's technical reports are adjusted to become my country's guiding technical documents. The following minimal editorial changes were made to this document. Added Note 2 to 3.1.- Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Biological Evaluation of Medical Devices (SAC/TC 248). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Tianjin Medical Device Quality Supervision and Inspection Center, Baxter Medical Supplies Co., Ltd. The main drafters of this document are. Liu Jia, Yuan Bo, Xu Haiyan, Xu Jing, Li Zhenqiang, Li Lingmei, Tian Shuo, and Yang Jing.

Introduction

Currently, the safety assessment of medical devices is guided by toxicology studies and other studies recommended in ISO 10993 (all parts). Material-mediated pyrogenicity manifests as a systemic reaction. Although it is covered in Appendix G of GB/T 16886.11-2021, this article This document is intended to provide a general description of pyrogen testing. Pyrogenic reaction refers to adverse reactions caused by chemicals or other substances, such as fever caused by microbial components. It has been required to evaluate the safety of products that come into direct or indirect contact with the circulating blood and lymphatic system, cerebrospinal fluid (CSF) and interact with the human body. All nature. At present, the rabbit in vivo pyrogenicity test and in vitro bacterial endotoxin test have been recognized as the methods for evaluating the pyrogenicity of medical devices and their materials. International consensus has been reached on the established test methods, including the preparation of test samples, and these methods are clearly stated in relevant guidelines and pharmacopoeias. There is manifestation. Recently, an in vitro pyrogen test using human immune cells, the human cell-based pyrogen test (HCPT), has been Developed and applied to the pyrogen test of parenteral drugs. Because this method directly or indirectly contacts human blood cells, it is currently being considered for Applied to pyrogen detection of medical devices. Pyrogen testing of pyrogenic medical devices Principles and methods

1 Scope

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

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document. ISO and IEC maintain terminology databases for standardization at the following addresses. 3.1 Medical Devices The manufacturer intends that the device, whether used alone or in combination, be used for human beings for one or more of the following specific medical purposes. apparatus, device, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related thing These purposes are to. The diagnosis, prevention, monitoring, treatment or alleviation of disease;- diagnosis, monitoring, treatment, relief or compensation for injury;- The study, replacement, regulation or support of anatomical or physiological processes;- Support or sustain life;- Pregnancy control;- Sterilization of medical devices;- Providing medical information through in vitro examination of samples taken from the human body. - Its primary designed effect on the human body surface or body is not achieved by pharmacological, immunological or metabolic means, but these can be The means participate and play a certain auxiliary role. Note 1.Products that are considered medical devices by some regulatory agencies but not by others are. Disinfecting substances;- Assistive devices for disabled persons;- Devices containing animal and/or human tissue;- Devices for in vitro fertilization or assisted reproductive technology. - Note 2.The definition of medical devices in the Regulations on Supervision and Administration of Medical Devices is as follows. Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or Related articles, including computer software if required; their effects are primarily achieved through physical means, rather than pharmacological, immunological or metabolic or, although these methods are involved, they only play a supporting role; their purpose is to. (1) diagnosis, prevention, monitoring, treatment or alleviation of diseases; ......

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