GB/T 16886.20-2015 in English

VALID

Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices

Issued on:2015-12-10
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	GB/T 16886.20-2015
Document status:	VALID
Title in English:	Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
Title in Chinese:	医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原则和方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2015-12-10
Implemented on:	2017-01-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	medical devices scopethis part medical devices immunotoxicology testing immunotoxicology relevant devices
Related Topics:	toxicology biology medical molecular biology immune system. immune system immune system immune evaluation immune evaluation Medical Device Testing Laboratory Medical Device Aging Test Principles of Medical Devices Medical Device Biology Medical Device Biology Microbiological Testing of Medical Devices third party medical Chemical Evaluation of Medical Devices Medical Device Aging Test Toxicology+ Biological Evaluation Toxicology Toxicity of Medical Devices Biological Evaluation Program medical supplies test What are the first class medical devices? Biological Evaluation of Medical Devices Biological Evaluation of Medical Devices Collagen Medical Grade therapeutic medicine Toxicology test medical experiment method Medical Device Evaluation immune organ Toxicology test medical immunization self-immune Degradation Methods for Medical Devices medical immunization Degradation Methods for Medical Devices Accelerated testing of medical devices biological standard Immunity immunosuppression test Medical Device Evaluation molecular biology medicine principles and methods Medical Test Reagents Principles of Medical Devices Verification methods for medical device products Medical Device Disposal Methods Medical Immunology Validation methods for medical devices Medical Devices for Animals medical toxicity Test Principle or Methodology Active medical device aging test Methodological principles Medical device test method validation medical equipment Medical Device Toxicology Product verification methods for medical devices Microbiological Requirements for Medical Devices hapten biomedical medicine medical test method GB/T 16886.20 GB/T 16886.20-2015 Medical Devices and Biomaterials Biological Evaluation of Medical Devices Part 10: Systemic Toxicity Test NF1 immunotherapy GB/T 16886.20-2015 Medical device microbial testing Medical device methodology validation Methods to depyrogenate medical devices Medical device depyrogenation methods Medical device methodology verification related What are the immune scoring methods? Toxicological evaluation of Class I medical devices Disk method for contacting microorganisms on the surface of medical devices Medical device methodology validation Biochemical testing methods for medical devices Medical Methodology Validation Medical device real-time aging test Class I medical device production quality European medical device voltage test method Medical device chemical performance testing methods Medical device infrared spectrum testing Toxicological evaluation of medical devices Methodology Validation of Medical Devices Medical device aging test industry Class II medical device selection Toxicological evaluation of medical devices Statistical methods for precision medicine Medical device withstand voltage tester measurement method

《GB/T 16886.20-2015医疗器械生物学评价第20部分：医疗器械免疫毒理学试验原则和方法》由TC248（全国医疗器械生物学评价标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB/T16886的本部分给出了医疗器械潜在免疫毒性方面的免疫毒理学综述。本部分还给出了用于检验不同类型医疗器械免疫毒性的方法指南。
本部分是根据过去几十年间由不同免疫毒理学专家组撰写的几种出版物给出的,免疫毒理学作为毒理学范畴内的一个独立分支在发展。
附录 A 中描述了关于免疫毒性的当前认知状态,附录 B给出了迄今为止与医疗器械相关的免疫毒理学临床经验概述。
注:见参考文献[11]。

Scope

This part of GB/T 16886 gives an overview of immunotoxicology on the potential immunotoxicity of medical devices. This section also gives guidance on methods used to test the immunotoxicity of different types of medical devices. This section is based on several publications written over the past few decades by different expert groups in immunotoxicology, which has developed as a separate branch within the field of toxicology. The current state of knowledge regarding immunotoxicity is described in Appendix A, and an overview of clinical experience in immunotoxicology relevant to medical devices to date is given in Appendix B.

More samples: GB 50021-2001(2009) NB/T 47013.2-2015 QC/T 942-2021

Sample only — not a preview of GB/T 16886.20-2015

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