YY 0341.1-2020 Active Industry standards-Medicine

YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants

Publish Date: 2020-09-27 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0341.1-2020

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: 2020-09-27

Implement Date: 2022-06-01

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骨科植入物分技术委员会(SAC/TC 110/SC 1)

Pages: 16 pages

Scope

YY 0341的本部分规定了骨接合用无源外科植入物（以下简称“骨接合植入物”)的特殊要求，包括骨接合植入物的术语和定义、要求、试验方法、制造、灭菌、包装和制造商提供的信息等。
YY 0341的本部分适用于骨接合植入物，不适用于带有表面涂层的骨接合植入物的涂层部分。

Development Information

Drafting Units:

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、北京纳通科技集团有限公司

Drafting Persons:

姜熙、张路、付瑞芝、宋铎、刘斌、刘英慧、李仁耀、赵文文

Word Count: 26 Thousand words Pages: 16 pages

Same series standard

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants

Replace the following standards

YY 0341-2009

Referenced Standards

YY/T 0640-2016 Non-active surgical implants—General requirements GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 1074-2002 Implants for surgery—Measuring method for pitting corrosion potential on stainless products YY/T 1615-2018 Surgical implants—Anodizing oxide layers on titanium and titanium alloys—General requirements GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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