Standard No.:	YY 0341.1-2020
English Name:	Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants
Chinese Name:	无源外科植入物 骨接合与脊柱植入物 第1部分：骨接合植入物特殊要求
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2020-09-27
Implemented on:	2022-6-1
Status:	valid
Superseding:	YY 0341-2009 General technological requirements for non-active metallic surgical implants for osteosynthesis
Target Language:	English
File Format:	PDF
Word Count:	8000 words
Translation Price(USD):	240.0
Delivery:	via email in 1~3 business day

本标准规定了无源外科脊柱植入物的特殊要求，除YY/T 0640规定的要求外，还规定了脊柱植入物的定义、要求、试验方法、制造、灭菌、包装和制造商提供的信息等。
本标准适用于除人工椎间盘植入物以外的无源外科脊柱植入物。