YY 0450.1-2020 Active Industry standards-Medicine

YY 0450.1-2020 Accessory devices for sterile single-use intravascular catheters—Part 1:Introducers

YY 0450.1-2020 Accessory devices for sterile single-use intravascular catheters—Part 1:Introducers

Publish Date: 2020-02-25 Implement Date: 2021-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0450.1-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Medical equipment
Publish Date: 2020-02-25
Implement Date: 2021-08-01
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
Pages: 29 pages

Scope

YY 0450的本部分规定了与符合YY 0285标准要求的血管内导管一起使用、以无菌状态供应的一次性使用穿刺针、导引套管、导管鞘、导丝和扩张器的要求。
本部分适用于与符合YY 0285标准要求的血管内导管一起使用、以无菌状态供应的一次性使用穿刺针、导引套管、导管鞘、导丝和扩张器。
注: 附录A给出了这些辅助器械的材料和设计指南。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、乐普(北京)医疗器械股份有限公司、美敦力(上海)管理有限公司、上海微创医疗器械(集团)有限公司、山东威高集团医用高分子制品股份有限公司

Drafting Persons:

万敏、许佳佳、朱磊、余克龙、宋修山

Word Count: 56 Thousand words Pages: 29 pages

Replace the following standards

Referenced Standards

YY/T 0586-2016 Medical polymer products-Test methods of radiopacity GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB/T 7408-1994 Data elements and interchange formats—Information interchange—Representation of dates and times GB/T 7408-2005 Data elements and interchange formats—Information interchange—Representation of dates and times GB/T 7408.1-2023 Date and time—Representations for information interchange—Part 1:Basic rules GB 15810-2001 Sterile hypodermic syringes for single use GB 15810-2019 Sterile syringes for single use 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 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements GB/T 7408.2-2025 Date and time—Representation for information interchange—Part 2:Extensions

Adopt standards

ISO 11070:2014

Related Standards

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