YY/T 1651.1-2019 Active Industry standards-Medicine

YY/T 1651.1-2019 Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assay

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1651.1-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2019-05-31

Implement Date: 2020-06-01

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: 10 pages

Scope

YY/T 1651的本部分规定了吸光度测定溶血法和血红蛋白浓度测定溶血法。
本部分适用于医疗器械/材料介导的溶血作用的评价。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、深圳市医疗器械检测中心、中国医学科学院输血研究所、上海松力生物技术有限公司

Drafting Persons:

赵增琳、侯丽、曹苹、钟锐、李芳娜

Word Count: 16 Thousand words Pages: 10 pages

Referenced Standards

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

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

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

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

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24