YY/T 1670.1-2019 Active Industry standards-Medicine

YY/T 1670.1-2019 Evaluation of neurotoxicity of medical devices—Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1670.1-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2019-07-24

Implement Date: 2020-08-01

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: 7 pages

Scope

YY/T 1670的本部分规定了评价潜在神经毒性的试验选择指南。本部分适用于结合医疗器械的用途评估医疗器械的潜在神经毒性。

Development Information

Drafting Units:

中国食品药品检定研究院、南通大学、中国人民解放军总医院、山东省医疗器械产品质量检验中心

Drafting Persons:

韩倩倩、唐佩福、顾晓松、薛城斌、王春仁、孙立魁、王迎、刘佳

Word Count: 10 Thousand words Pages: 7 pages

Referenced Standards

中华人民共和国药典(2015年版) GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity

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