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
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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
Pages: 29 pages

Scope

This part of YY 0450 specifies the requirements for disposable use puncture needles, guide sheaths, catheter sheaths, guide wires, and dilators supplied in a sterile state for use with intravascular catheters that comply with the requirements of the YY 0285 standard.
This part applies to disposable use puncture needles, guide sheaths, catheter sheaths, guide wires, and dilators supplied in a sterile state for use with intravascular catheters that comply with the requirements of the YY 0285 standard.
Note: Appendix A provides guidelines for the materials and design of these auxiliary devices.

Development Information

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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