DZ/T 0101.12-1994
Active
YY/T 1816-2022
Active
Industry standards-Medicine
YY/T 1816-2022 Implants for surgery—Synthestic non-absorbable patch—Dura patch
YY/T 1816-2022 Implants for surgery—Synthestic non-absorbable patch—Dura patch
Basic Information
Standard Code:
YY/T 1816-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
-
Publish Date:
2022-05-18
Implement Date:
2023-06-01
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(SAC/TC 110)
Pages:
16 pages
Scope
本文件规定了硬脑(脊)膜补片的术语和定义、技术要求、试验方法、标志、包装、贮存和运输的要求。
本文件适用于聚偏二氟乙烯、聚四氟乙烯或膨体聚四氟乙烯材料等人工合成不可吸收材料加工的硬脑(脊)膜补片。
Development Information
Drafting Units:
中国食品药品检定研究院
Drafting Persons:
王健、刘丽、冯晓明、史啟、王春仁
Referenced Standards
GB/T 528-2009 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
YY/T 0500-2021 Cardiovascular implants and extracorporeal systems—vascular prostheses—tubular vascular grafts and vascular patches
中华人民共和国药典(2020年版)
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
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