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YY 0450.1-2020

Chinese Standard: 'YY 0450.1-2020'
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YY 0450.1-2020English579 Add to Cart Days<=5 Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers Valid YY 0450.1-2020
YY 0450.1-2020Chinese25 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY0450.1-2020 (YY0450.1-2020)
Description (Translated English) Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.25
Word Count Estimation 29,223
Date of Issue 2020-02-25
Date of Implementation 2021-08-01
Older Standard (superseded by this standard) YY 0450.1-2003
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Lepu (Beijing) Medical Devices Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Shanghai MicroPort Medical Devices (Group) Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Medical Infusion Apparatus
Regulation (derived from) Announcement No. 18 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY 0450.1-2020
Accessory devices for sterile single-use intravascular catheters--Part 1. Introducers
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replace YY 0450.1-2003
Disposable sterile intravascular catheter accessories
Part 1. Guiding instruments
Part 1. Introducers
(ISO 11070..2014, Sterilesingle-useintravascularintroducers,
Published on February 25, 2020
2021-08-01 implementation
Issued by the State Drug Administration
Contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 5
4.1 Sterilization 5
4.2 Biocompatibility 5
4.3 Surface 5
4.4 Corrosion resistance 5
4.5 Ray detectability 5
4.6 Information provided by the manufacturer 5
5 Additional requirements for puncture needles 5
5.1 General 5
5.2 Specification Mark 6
5.3 Needle tip 6
5.4 Block 6
5.4.1 Conical joint 6
5.4.2 Connection strength between needle tube and needle base 6
5.5 Information provided by the manufacturer 6
6 Additional requirements for guide bushing 6
6.1 General 6
6.2 Headend 6
6.3 Peak tension 6
6.4 Block 6
6.5 Specification mark 7
6.6 Information provided by the manufacturer 7
7 Additional requirements for catheter sheaths 7
7.1 General 7
7.2 Specification Mark 7
7.3 No leakage of catheter sheath 7
7.4 No leakage of hemostatic valve 8
7.5 seat 8
7.6 Peak tension 8
7.7 Information provided by the manufacturer 8
8 Additional requirements for guide wires 8
8.1 General 8
8.2 Specification Mark 8
8.3 Safety wire 8
8.4 Rupture test 8
8.5 Bending test 8
8.6 Peak tension of guide wire 8
8.7 Information provided by the manufacturer 9
9 Additional requirements for expanders 9
9.1 General 9
9.2 Specification Mark 9
9.3 Block 9
9.3.1 General 9
9.3.2 Conical joints 9
9.3.3 Connection strength of the base and the dilator 9
9.4 Information provided by the manufacturer 9
10 Additional requirements for complete sets containing devices specified in this part 9
11 Connection strength test of the needle tube and needle seat of the puncture needle 10
Appendix A (Informative Appendix) Materials and Design 11
Appendix B (Normative Appendix) Corrosion Resistance Test Method 12
Appendix C (Normative Appendix) Method for Determining Peak Tension of Guide Cannula, Catheter Sheath and Dilator
Appendix D (Normative Appendix) Test Method for Liquid Leakage under Catheter Sheath 15
Appendix E (Normative Appendix) Test Method for Liquid Leakage of Catheter Hemostasis Valve 17
Appendix F (Normative Appendix) Guidewire rupture test method 18
Appendix G (Normative Appendix) Test Method for Resistance to Bending Failure of Guide Wires 20
Appendix H (Normative) Method for determining the peak tension of the guide wire 22
Appendix I (Normative) Determination of the strength of the needle hub and needle tube connection 24
References 25
Figure 1 Example of guide cannula and puncture needle 3
Figure 2 Example of catheter sheath and dilator 3
Figure 3 Example of guide wire 4
Figure 4 Example of puncture needle tip and guide cannula tip 7
Figure D.1 Catheter sheath liquid leakage test device 16
Figure F.1 Guide wire rupture test device 19
Figure G.1 Guide wire bending performance test device 21
Figure H.1 Example of wedge-shaped opening fixture 23
Table 1 Identification of nominal size of puncture needle and guide cannula 6
Table 2 Peak tensile force of the test section of the guide sleeve, catheter sheath and dilator
Table 3 Peak tension of guide wire 9
Table 4 Dimensions to be given for the complete set 10
Table C.1 Example of 20mm/(min · mm) strain rate condition 13
Foreword
Part 6.2 of this section is recommended, and the rest is mandatory.
YY 0450 "Single-use sterile intravascular catheter accessories" consists of the following parts.
--- Part 1. Guiding instruments;
--- Part 2. Peripheral catheter tube plug of trocar;
--- Part 3. Balloon inflation device for balloon dilatation catheter.
This part is part 1 of YY 0450.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0450.1-2003 "Disposable sterile intravascular catheter accessories Part 1. Guiding instruments".
Compared with YY 0450.1-2003, the main technical changes except for editorial changes are as follows.
--- Revised some requirements and test methods of guide wire (see Chapter 8, see Chapter 8 of the.2003 edition);
--- Revised the requirements for size marking (see 5.2, 6.5, 7.2, 8.2 and 9.2, see the 5.2, 6.5, 7.2, 8.2 and 9.2 of the.2003 edition);
--- Added Appendix I needle seat and needle joint strength measurement method (see Appendix I);
This part uses the redrafting method to modify and adopt ISO 11070..2014 "Disposable sterile intravascular catheter guiding instruments".
Compared with ISO 11070..2014, there are structural differences between this part and these differences and the reasons are as follows.
--- Added Chapter 11 "Test of the connection strength of the needle tube and the needle seat of the puncture needle", so that the chapter quotes Appendix I; at the same time amended 5.4.2,
Make this article refer to Chapter 11. In order to comply with the requirements of GB/T 1.1 for the order of volume appendix in this part, it is in accordance with ISO 11070..2014
No technical differences.
There are technical differences between this part and ISO 11070..2014. These differences and reasons are as follows.
--- With regard to normative quotation documents, this part has been adjusted with technical differences to adapt to China's technical conditions
The situation is reflected in Chapter 2 "Regulatory Reference Documents", with specific adjustments as follows.
● Replaced ISO 594-1 with GB/T 1962.1 equivalent to international standards;
● Replaced ISO 594-2 with GB/T 1962.2 equivalent to international standards;
● Replace ISO 8601 with GB/T 7408 equivalent to international standards;
● Replaced ISO 7886-1 with GB 15810 equivalent to the international standard;
● Replaced 10993-1 with GB/T 16886.1 equivalent to international standards;
● Replaced ISO 15223-1 with YY/T 0466.1 equivalent to international standards;
● Replaced ASTMF640-12 and DIN13273-7 with YY/T 0586-2016.
--- Regarding footnotes, this section has made adjustments with technical differences, the specific adjustments are as follows.
Modified footnote 1) and footnote 2) to adapt to international and current technical conditions in China.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Apparatus.
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Lepu (Beijing) Medical Devices Co., Ltd., Medtronic
(Shanghai) Management Co., Ltd., Shanghai MicroPort Medical Devices (Group) Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd.
the company.
The main drafters of this section. Wan Min, Xu Jiajia, Zhu Lei, Yu Kelong, Song Xiushan.
The previous versions of the standard replaced by this part are as follows.
--- YY 0450.1-2003.
Disposable sterile intravascular catheter accessories
Part 1. Guiding instruments
1 Scope
This part of YY 0450 stipulates the use of an intravascular catheter that meets the requirements of YY 0285 standard and is supplied aseptically.
Requirements for secondary use of puncture needles, guide cannulas, catheter sheaths, guide wires and dilators.
This part is suitable for single-use wear that is used together with the intravascular catheter that meets the requirements of the YY 0285 standard and is supplied in a sterile state.
Needle, guide cannula, catheter sheath, guide wire and dilator.
Note. Appendix A gives the materials and design guidelines for these auxiliary devices.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 1962.11) 6% (Luer) conical joints for syringes, needles and other medical devices Part 1. General requirements
(GB/T 1962.1-2015, ISO 594-1. 1986, IDT)
GB/T 1962.22) 6% (Luer) conical connectors for syringes, injection needles and other medical devices. Part 2. Locking connectors
(GB/T 1962.2-2001, ISO 594-2..1998, IDT)
GB/T 7408 data element and exchange format information exchange date and time representation (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB 15810 disposable sterile syringes (GB 15810-2001, ISO 7886-1..1993, IDT)
GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information of medical devices Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1..2012, IDT)
YY/T 0586-2016 Medical polymer products X-ray opacity test method
3 Terms and definitions
The following terms and definitions apply to this document.
Note. Figure 1, Figure 2, Figure 3 and Figure 4 give a legend for the instruments described in this section, and gives examples of terms.
3.1
(Guide wire) winding wire (ofaguidewire)
Spiral wound wire.
1) If ISO 80369-7 is converted into Chinese standards, it will replace GB/T 1962.1 and GB/T 1962.2.
2) If ISO 803690-7 is converted into Chinese standards, it will replace GB/T 1962.1 and GB/T 1962.2.
3.2
Core wire (ofaguidewire)
It is used to make the guide wire reach a certain rigidity.
Related standard:   YY/T 0450.3-2016  YY 0167-2020
Related PDF sample:   YY/T 0328-2015  YY 0285.5-2018
   
 
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