YY/T 0127.4-2023 Active Industry standards-Medicine

YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry—Part 4:Bone implant test

Publish Date: 2023-11-22 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: YY/T 0127.4-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental materials

Publish Date: 2023-11-22

Implement Date: 2024-12-01

Publisher: 国家药品监督管理局

Technical Committee: 全国口腔材料和器械设备标准化技术委员会(SAC/TC 99)

Pages: 16 pages

Scope

本文件描述了口腔医疗器械的骨植入试验方法。本文件适用于评价组织对拟长期或持久与口腔骨组织接触的口腔医疗器械的生物学反应。

Development Information

Drafting Units:

北京大学口腔医学院口腔医疗器械检验中心、四川大学(四川医疗器械生物材料和制品检验中心)、上海交通大学医学院附属第九人民医院

Drafting Persons:

韩建民、袁暾、刘昕、吴洋、林红、戴政宁、贾莉芳、梁洁、孙皎、任欣欣、柴媛、隋佰延

Word Count: 23 Thousand words Pages: 16 pages

Same series standard

YY/T 0127.19-2023 Biological evaluation of medical devices used in dentistry—Part 19:Subacute and subchronic systemic toxicity test:implant route

Replace the following standards

YY/T 0127.4-2009 Oral medical device biocontamination evaluation. The second unit: test methods, Bone implant test

Referenced Standards

Related Standards

GB/T 6387-1986 Replaced

GB/T 6387-1986 Vocabulary of dental materials

Publish Date: 1986-05-14

YY 0270-2003 Replaced

YY 0270-2003 Dentistry—Denture base polymers

Publish Date: 2003-06-20

YY 0462-2003 Replaced

YY 0462-2003 Dental gypsum products

Publish Date: 2003-06-20

YY 0463-2003 Replaced

YY 0463-2003 Dental phosphate-bonded casting investments

Publish Date: 2003-06-20

YY 1042-2003 Replaced

YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials

Publish Date: 2003-06-20

YY 0493-2004 Replaced

YY 0493-2004 Dentistry—Elastomeric impression materials

Publish Date: 2004-11-08