GB/T 16886.9-2022 Active National standards

GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Publish Date: 2022-12-30 Implement Date: 2024-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.9-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2022-12-30

Implement Date: 2024-01-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)

Pages: 13 pages

Scope

本文件规定了通过医疗器械体外降解研究的设计和实施，对其潜在的和已观察到的降解进行系统评价的基本原则。这些研究所获得的信息能用于GB/T（Z） 16886系列标准所述的生物学评价。本文件适用于预期在体内降解的材料以及非预期降解的材料。本文件不适用于：a）纯机械过程产生的降解的评价；产生这类降解产物的方法学见具体产品标准（若有）；

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、山东非金属材料研究所

Drafting Persons:

郭利娟、杜福映、李颖、吴长岩、刘霞、彭健

Word Count: 28 Thousand words Pages: 13 pages

Same series standard

GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Replace the following standards

GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Referenced Standards

ISO 10993-1 ISO 10993-2 ISO 10993-13 ISO 10993-14 ISO 10993-15

Adopt standards

ISO 10993-9:2019

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