GB/T 16886.11-1997
Replaced
YY/T 1899-2023
Active
Industry standards-Medicine
YY/T 1899-2023 Method of tissue histological sample preparation and evaluation for absorbable medical devices after implantation
YY/T 1899-2023 Method of tissue histological sample preparation and evaluation for absorbable medical devices after implantation
Basic Information
Standard Code:
YY/T 1899-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2023-06-20
Implement Date:
2024-07-01
Publisher:
国家药品监督管理局
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:
12 pages
Scope
本文件描述了可吸收医疗器械植入后局部组织病理学样本的制备、组织反应及降解情况的评价方法。
本文件适用于可吸收医疗器械。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、北京大学口腔医院、上海交通大学医学院附属第九人民医院、天津市医疗器械质量监督检验中心
Drafting Persons:
刘佳、孙立魁、韩建民、隋佰延、袁博、任欣欣、孙皎、车国喜、孙晓霞
Referenced Standards
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced