GB/T 16886.15-2022 Active National standards

GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys

GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys

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 16886.15-2022

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: 19 pages

Scope

本文件规定了用于对最终金属医疗器械或可供临床使用的相应材料样品的降解产物进行定性与定量试验设计的通用要求。本文件适用于预期和非预期在体内降解的材料以及在体外降解试验中由最终金属器械发生化学变化而产生的降解产物。本文件不适用于评价纯机械过程发生的降解；产生此类降解产物的方法学在具体产品标准（如有）中有所描述。本文件不包括降解产物的生物活性。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、北京大学

Drafting Persons:

刘爱娟、薄晓文、郑玉峰、刘春月、夏丹丹

Word Count: 40 Thousand words Pages: 19 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 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 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 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys

Referenced Standards

ISO 3585 ISO 3696 ISO 8044 ISO 10993-1 ISO 10993-9 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-16

Adopt standards

ISO 10993-15:2019

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