DZ/T 0101.12-1994
Active
GB/T 16886.10-2024
Active
National standards
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
Basic Information
Standard Code:
GB/T 16886.10-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2024-08-23
Implement Date:
2025-09-01
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:
48 pages
Scope
本文件规定了医疗器械及其组成材料诱导潜在皮肤致敏反应的评估步骤。
本文件适用于：
——详细的体内皮肤致敏试验步骤；
——结果解释的关键因素。
注： 与上述试验有关的特定材料制备说明见附录A。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、四川大学、江苏省医疗器械检验所
Drafting Persons:
侯丽、孙令骁、梁洁、严小莉、贾莉芳、孙晓霞、高静贤
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
ISO 10993-12
ISO 10993-18
Adopt standards
ISO 10993-10:2021
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DZ 4-1981
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SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
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