GB/T 16886.6-2022 Active National standards

GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 2022-04-15 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.6-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2022-04-15

Implement Date: 2023-05-01

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: 28 pages

Scope

本文件规定了用于评估医疗器械所用生物材料植入后局部反应的试验方法。本文件适用于下列材料：--固形和非固形材料，如多孔材料、液体、胶状、膏状和颗粒材料，--非吸收性材料，和--可降解和/或可吸收性固形或非固形材料。本文件也适用于评价临床上预期用于局部损伤表面或损伤内表面的医疗器械产生的局部组织反应。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、山东大学

Drafting Persons:

刘佳、孙立魁、刘尚明、朱福余、刘兆华、于洋

Word Count: 56 Thousand words Pages: 28 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 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 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 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Referenced Standards

ISO 10993-1 ISO 10993-2 ISO 10993-4 ISO 10993-12 ISO 10993-16

Adopt standards

ISO 10993-6:2016

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