YY/T 1707-2020 Active Industry standards-Medicine

YY/T 1707-2020 Implants for surgery—Differential scanning calorimetry of poly ether ether ketone (PEEK)polymers and compounds for use in implantable medical devices

Publish Date: 2020-02-21 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1707-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-02-21

Implement Date: 2021-01-01

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 8 pages

Scope

本标准规定了使用差示扫描量热法(DSC)对制造植入医疗器械用聚醚醚酮(PEEK)聚合物及其复合物进行热分析的方法。
本标准适用于制造植入医疗器械用PEEK及其复合物玻璃化转变温度(Tg)、熔融温度(Tm)和冷却结晶温度(Tc)等转变温度的测定。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、赢创特种化学(上海)有限公司、国家药品监督管理局医疗器械技术审评中心、美敦力(上海)管理有限公司、北京市富乐科技开发有限公司

Drafting Persons:

景明、马春宝、张红、甄珍、张译丹、耿芳、尹安远、白云生、徐秉智

Word Count: 14 Thousand words Pages: 8 pages

Referenced Standards

GB/T 19466.1-2004 Plastics—Differential scanning calorimetry(DSC)—Part 1:General principles GB/T 19466.2-2004 Plastics—Differential scanning calorimetry(DSC)—Part 2:Determination of glass transition temperature GB/T 19466.3-2004 Plastics—Differential scanning calorimetry(DSC)—Part 3:Determination of temperature and enthalpy of melting and crystallization GB/T 19466.1-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 1:General principles GB/T 19466.2-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 2:Determination of glass transition temperature and step height GB/T 19466.3-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 3:Determination of temperature and enthalpy of melting and crystallization

Adopt standards

ISO 15309:2013

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