GB/T 16886.19-2022 Active National standards

GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

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 16886.19-2022

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

本文件规定了能够用于识别与评价最终医疗器械材料的物理特性，如物理化学、形态学和表面特性（PMT）的各种参数和试验方法。这种评估仅限于与生物学评价和医疗器械的预期用途（临床应用和使用时间）相关的性能，即使这类性能与临床有效性重合。本文件适用于最终医疗器械材料。本文件不适用于对降解产物的定性或定量测定，也不适用于对降解材料的理化性能进行评价，其相关内容见ISO 109939、ISO 1099313、ISO 1099314、ISO 1099315，材料化学表征见ISO 1099318。GB/T（Z） 16886（所有部分）不适用于与人体无直接或间接接触的医疗器械和材料。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、山东大学

Drafting Persons:

万敏、卢文博、吕宇鹏、王常斌、刘冰

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 16886.15-2022 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/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials

Replace the following standards

GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials

Referenced Standards

ISO 10993-1 ISO 10993-18

Adopt standards

ISO/TS 10993-19:2020

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