YY 0117.3-2024 Pending Industry standards-Medicine

YY 0117.3-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings

YY 0117.3-2024 Implants for surgery—Forgings,castings for bone joint prostheses—Part 3:Cobalt chromium molybdenum alloy castings

Publish Date: 2024-07-08 Implement Date: 2027-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0117.3-2024
Standard Type: Industry standards
Standard Status: Pending
is_force_gb: no
CCS Name: Orthopaedic surgery, orthopaedic instruments
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2024-07-08
Implement Date: 2027-07-20
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: 12 pages

Scope

本文件规定了外科植入物用钴铬钼合金材料制造外科植入物骨关节假体铸件的要求、试验方法、 检验规则、质量证明、标记、包装、运输和贮存。
本文件适用于骨关节假体钴铬钼金铸件的生产和验收。

Development Information

Drafting Units:

北京优材京航生物科技有限公司、天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、国家药品监督管理局医疗器械技术审评检查大湾区分中心、大博医疗科技股份有限公司、北京昌航精铸技术有限公司

Drafting Persons:

熊震国、覃格姬、李庆春、李沅、张娜、张家振、孙嘉怿、李铮、卢敏琪、李妮娅、曾达、梁雄伟、谢永志、钟林招

Word Count: 19 Thousand words Pages: 12 pages

Same series standard

Replace the following standards

Referenced Standards

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