DZ/T 0101.12-1994
Active
YY/T 0325-2022
Active
Industry standards-Medicine
YY/T 0325-2022 Sterile urethral catheter for single use
YY/T 0325-2022 Sterile urethral catheter for single use
Basic Information
Standard Code:
YY/T 0325-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
-
Publish Date:
2022-08-17
Implement Date:
2023-09-01
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导尿管的要求和试验方法。
本文件适用于一次性使用无菌有球囊和无球囊导尿管。
本文件不适用于YY 0489中包含的引流管，如输尿管导管、肾造口导管和耻骨上导管。本文件也不适用于输尿管支架。
注：YY/T 0872 规定了输尿管支架试验方法。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、广州维力医疗器械股份有限公司、广东百合医疗科技股份有限公司、贝朗医疗(上海)国际贸易有限公司、杭州妥爱沐医疗器械有限公司、康维德(中国)医疗用品有限公司、江苏苏云医疗器材有限公司
Drafting Persons:
张丽梅、余克龙、刘晶、胡巧玲、潘木球、王常斌、王妞、李聪、孟凯、伍梅花
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 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
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
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
Adopt standards
ISO 20696:2018
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DZ 4-1981
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SC 72-1982
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