GB 9706.8-1995
Replaced
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
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
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
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced