GB/T 16886.23-2023 Active National standards

GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation

Publish Date: 2023-11-27 Implement Date: 2024-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.23-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2023-11-27

Implement Date: 2024-12-01

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: 68 pages

Scope

本文件规定了医疗器械及其组成材料潜在刺激的评估步骤，包括以下内容：--刺激试验前的考虑，包括皮肤接触方面的计算机模拟试验和体外方法；--详细的体外和体内刺激试验步骤；--结果解释的关键因素。本文件适用于根据ISO 109931和ISO 109932对医疗器械、材料或其浸提液的潜在刺激性进行预测和分类。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、中国食品药品检定研究院、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)

Drafting Persons:

范春光、王国伟、陈亮、王蕊、陈丽媛、贺学英、刘香东

Word Count: 120 Thousand words Pages: 68 pages

Same series standard

GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Referenced Standards

GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process ISO 10993-1 ISO 10993-2 ISO 10993-9 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-18 ISO 14155 OECD 404 OECD 439