GB/T 16886.13-2001 in English

SUPERSEDED

Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Issued on:2001-09-24
Implemented on:2002-02-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	GB/T 16886.13-2001
Document status:	SUPERSEDED
Superseded by:	GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices
Superseded on:	2018-07-01
Title in English:	Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Title in Chinese:	医疗器械生物学评价第13部分：聚合物医疗器械的降解产物的定性与定量
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2001-09-24
Implemented on:	2002-02-01
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	polymeric medical devices scopethis part degradation products finished polymeric medical devices soluble degradation products medical devices
Related Topics:	Qualitative biology product Polymer Characterization Degradation products Biomedical polymer degradation Polymer Characterization Terahertz and Biomedicine Medical Device Biology Medical Device Biology Degradation products Microbiological Testing of Medical Devices Chemical Evaluation of Medical Devices What are the first class medical devices? polymer product polymer production Biological Evaluation of Medical Devices Biological Evaluation of Medical Devices product standard partial product National Medical Devices Medical Device Evaluation Quantitative product Leachable Medical Devices Degradation Methods for Medical Devices Degradation Methods for Medical Devices biological standard Quantitative and qualitative Medical Device Evaluation Medical Devices for Animals microbiology and medical Quantitative and qualitative Biomaterial Medical Devices Class II medical device products medical equipment Microbiological Requirements for Medical Devices Medical Device Country Frontiers in Biomedical Engineering Medical Bioanalyzer Cutting-edge technologies and products of medical devices GB/T 16886.13 GB/T 16886.13-2001 GB/T 16886.13-2017 Medical Devices and Biomaterials The role of polymers Medical device product effectiveness Qualitative and quantitative detection methods for polymer degradation products Medical device microbial testing Anti-static at the production site of active medical devices Qualitative and quantitative methods for polymer degradation products Quality assessment of medical device plastic parts Moisturizing test of medical device products Disk method for contacting microorganisms on the surface of medical devices Class I medical device production quality biomedical materials Medical device leachable standards Class II medical device selection Decomposition product evaluation Quantitative and qualitative

《GB/T 16886.13-2001医疗器械生物学评价第13部分:聚合物医疗器械的降解产物的定性与定量》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/T 16886的本部分为准备用于临床的成品聚合物医疗器械的降解产物的定性与定量试验设计提供了指南。GB/T 16886的本部分描述了两种生成降解产物的试验方法，一是作为筛选方法的加速降解试验，另一是实际时间降解试验。对在使用时方进行聚合的材料，试验时使用固化的聚合物。试验所得数据用于聚合物的生物学评价。GB/T 16886的本部分只涉及成品聚合物器械因化学变化所产生的降解产物，不涉及由机械应力，摩擦或电磁辐射所引起的聚合物器械的降解。GB/T 16886的本部分未涉及碎片和可溶降解产物的生物活性，对此建议按照GB/T 16886.1和ISO 10993-17中的原理进行评价。由于医疗器械所用聚合物材料的范围很广，因此没有规定或指定专项分析技术。GB/T 16886的本部分不对降解产物的可接受水平规定具体要求。

Scope

This part of GB/T 16886 provides guidance on the design of qualitative and quantitative tests for degradation products of finished polymeric medical devices intended for clinical use. This part of GB/T 16886 describes two test methods for the formation of degradation products, one is the accelerated degradation test as a screening method, and the other is the actual time degradation test. For materials that polymerize upon use, the cured polymer is used in the test. The data obtained from the experiment were used for the biological evaluation of the polymer. This part of GB/T 16886 only deals with the degradation products of finished polymer devices due to chemical changes, and does not involve the degradation of polymer devices caused by mechanical stress, friction or electromagnetic radiation. This part of GB/T16886 does not involve the biological activity of fragments and soluble degradation products, and it is recommended to evaluate it according to the principles in GB/T16886.1 and ISO10993-17. Due to the wide range of polymeric materials used in medical devices, no specific analytical technique is specified or specified. This part of GB/T 16886 does not specify specific requirements for acceptable levels of degradation products.

More samples: GB 18306-2015 YD/T 3934-2021 QC/T 942-2021

Sample only — not a preview of GB/T 16886.13-2001

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