YY 0285.3-2017 English PDF

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YY 0285.3-2017: [Including 2019XG1] Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
YY 0285.3-2017
Intravascular catheters-Sterile and single-use catheters-Part 3. Central venous catheters
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0285.3-1999
Intravascular catheter disposable sterile catheter
Part 3. Central venous catheter
Part 3. Centralvenouscatheters
(ISO 10555-3.2013, Intravascularcatheters-Sterileandsingle-usecatheters-
Part 3. Centralvenouscatheters, MOD)
2017-07-17 released.2019-01-01 implementation
State Food and Drug Administration issued
Foreword
YY 0285 "Intravascular catheter disposable sterile catheter" consists of four parts.
--- Part 1. General requirements;
--- Part 3. Central venous catheter;
--- Part 4. Balloon dilatation catheter;
--- Part 5. trocar peripheral catheter.
This part is the third part of YY 0285.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0285.3-1999 "Single use sterile intravascular catheters Part 3. Central venous catheters", and
Compared with YY 0285.3-1999, the main technical changes are as follows.
--- Updated normative references;
--- Removed Appendix A.
This section uses the redrafting method to modify the use of ISO 10555-3.2013 "Intravascular catheter disposable sterile catheter Part 3
Minute. Central Venous Catheter.
The technical differences between this part and ISO 10555-3.2013 and their reasons are as follows.
---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Replaced ISO 10555-1.2013 with YY 0285.1-2017 modified to international standards.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Cook (China) Medical Trade Co., Ltd., Shandong Xinhuaan
Medical Products Co., Ltd.
The main drafters of this section. Wang Changbin, Yu Xiaohui, Liu Xin, Tian Xiaolei.
The previous versions released in this section are as follows.
---YY 0285.3-1999.
Intravascular catheter disposable sterile catheter
Part 3. Central venous catheter
1 Scope
This section of YY 0285 specifies the requirements for a sterile supply and single-use central venous catheter.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY 0285.1-2017 single-use sterile catheters - Part 1 . General requirements (ISO 10555-1.2013,
MOD)
3 Terms and definitions
The following terms and definitions defined in YY 0285.1-2017 apply to this document.
3.1
Central venous catheter centralvenouscatheter
Insert into the central venous system for the input of fluids or blood samples and/or intravascular catheters for pressure or other measurements, divided into single lumens
Or multiple chambers.
Note. The catheter can have a fixation system that is part of the instrument.
4 requirements
4.1 General
The conduit shall comply with the requirements of YY 0285.1-2017, except for the peak tensile force (see 4.6 in YY 0285.1-2017), the peak tensile force shall be
Meet the requirements of 4.4.
4.2 Distance identification
If there is a distance indicator on the catheter, the marking should be indicated from the top of the end. Starting from the first marker, the distance between the markers
The distance should not be greater than 5cm.
It is recommended that the marking interval of the catheter marking portion be 1 cm, which may have a user's determination of the position of the catheter and monitoring the movement of the catheter.
Significance.
4.3 lumen identification
For multi-lumen catheters, each chamber should have an identification that is easily identifiable by the user.
4.4 Peak tension
For ducts with a softer head end or a head end configuration that differs from the body structure and that has a soft end length of no more than 20 mm, when pressed
When the method given in Appendix B of YY 0285.1-2017 is tested, the minimum peak tensile force at the head end shall comply with the requirements of Table 1.
The minimum peak tensile force of other parts of the catheter shall comply with the requirements of 4.6 of YY 0285.1-2017.
Table 1 Minimum peak tension of the soft end of the length not more than 20mm
Minimum outer diameter of the catheter body
Mm
Minimum peak pull
≥0.550 and < 0.75 3
≥0.75 and < 1.85 4
≥1.85 5
4.5 Information provided by the manufacturer
The information provided by the manufacturer shall comply with the requirements of YY 0285.1-2017 and shall include the following information.
a) a description of the marking method if there is a distance marking on the catheter;
b) the flow rate of each cavity;
c) the maximum diameter of the guide wire to be applied;
d) warnings of withdrawal of the catheter through the puncture needle, if applicable;
e) At least one recommended cleaner.
Units of measurement other than those specified in this section may be additionally used.