GB 12264-1990
Replaced
YY/T 0489-2023
Active
Industry standards-Medicine
YY/T 0489-2023 Sterile drainage catheters and accessory devices for single use
YY/T 0489-2023 Sterile drainage catheters and accessory devices for single use
Basic Information
Standard Code:
YY/T 0489-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2023-11-22
Implement Date:
2024-12-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
36 pages
Scope
本文件规定了一次性使用无菌的引流导管、伤口和积液引流系统、手术引流导管和有关组件的要求，其中导管以手术或经皮方式放置于体腔或伤口中，用于将液体或空气引流到体外。引流导管留作自然引流或连接至吸引源（以加快组织肉芽形成）。本文件不适用于：--抽吸导管；--气管导管；--导尿管；注
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、江苏扬子江医疗科技股份有限公司、北京天地和协科技有限公司、山东百多安医疗器械股份有限公司、巴德医疗科技(上海)有限公司
Drafting Persons:
万敏、李元彧、徐浩宇、王万明、张海军、石凯、刘爱娟、栾园园、朱艺馨
Replace the following standards
Referenced Standards
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
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
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
YY/T 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
Adopt standards
ISO 20697:2018
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced