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Implant for surgery—Test method for determining the self-tapping performance of metallic bone screws
Standard in brief
Scope of Application:
本标准用于测量具有自攻性能的金属接骨螺钉(以下简称“螺钉”)旋入标准材料时所需的轴向压力。使用本标准试验方法所得结果与螺钉在旋入人骨时所需的轴向压力并没有直接联系。本标准仅用于确认被测产品的一致性,或用于比较尺寸相近的不同产品的相关性能。
本标准不适用于在攻入时与人骨自动挤压形成配合螺纹,无需预制导向孔的“自钻”或“自钻/自攻”形式的金属接骨螺钉。
Basic information
Standard No:YY/T 1505-2016
Standard Name:外科植入物 金属接骨螺钉自攻性能试验方法
English Name:Implant for surgery—Test method for determining the self-tapping performance of metallic bone screws
Standard Status:现行
Release Date:2016-07-29
Effective Date:2017-06-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.40
CCS Number:C35
Publication Information
Number of pages:12
Number of words:12 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-04-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1505
Drafter:高进涛、李楠、段青娇
Drafting Organization:天津市医疗器械质量监督检验中心
Management Organization:全国外科植入物和矫形器械标准化技术委员会骨科植入物分技术委员会(SAC/TC 110/SC 1)
Proposing Department:国家食品药品监督管理总局