YY 0285.5-2018 English PDF (YY0285.5-2018)

This part of YY 0285 specifies the requirements for over-needle peripheral catheters for insertion into the peripheral vasculature that are supplied sterile and in single-use.

YY 0285.5-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0285.5-2004
Intravascular catheters - Sterile and single-use
catheters - Part 5. Over-needle peripheral catheters
(ISO 10555-5.2013, MOD)
ISSUED ON. FEBRUARY 24, 2018
IMPLEMENTED ON. MARCH 01, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 7
Appendix A (Normative) Determination of connection strength between needle hub and needle tube ... 10
Appendix B (Informative) Opaque catheter seat color ... 11
Appendix C (Informative) Needle tip geometry ... 12
Appendix D (Normative) Determination of liquid leakage from vent fittings ... 13 References ... 15
Foreword
YY 0285 “Intravascular catheters - Sterile and single-use catheters” is divided into the following parts.
- Part 1. General requirements;
- Part 3. Central venous catheter;
- Part 4. Balloon dilatation catheter;
- Part 5. Over-needle peripheral catheters.
This part is the part 5 of YY 0285.
The following parts have been revoked and are already included in Part 1. - Part 2. Angiographic catheters.
This part was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0285.5-2004 “Intravascular catheters - Sterile and single- use catheters - Part 5. Over-needle peripheral catheters”. As compared with YY 0285.5-2004, the main changes are as follows.
- MODIFY the normative reference documents;
- DELETE Appendix A.
This part uses the redrafting method to modify and use of ISO 10555-5.2013 “Intravascular catheters - Sterile and single-use catheters - Part 5. Over-needle peripheral catheters”.
The technical differences and reasons for this part and ISO 10555-5.2013 are as follows.
- Regarding the normative reference documents, this standard has made
adjustments with technical differences, to adapt to the technical conditions of China. The adjustments are mainly reflected in clause 2 “Normative
References”. The specific adjustments are as follows.
• USE the GB/T 1962.1 which equivalently adopts international standards to substitute ISO 594-1;
• USE the GB/T 18457 which equivalently adopts international standards to substitute ISO 9626;
• USE the GB/T 0285.1 which adopts international standards through
Intravascular catheters - Sterile and single-use
catheters - Part 5. Over-needle peripheral catheters
1 Scope
This part of YY 0285 specifies the requirements for over-needle peripheral catheters for insertion into the peripheral vasculature that are supplied sterile and in single-use.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1. General requirement (GB/T
1962.1-2015, ISO 594-1.1986, IDT)
GB/T 18457 Stainless steel needle tubing for the manufacture of medical devices (GB/T 18457-2015, ISO 9626.1991, MOD)
YY 0285.1 Intravascular catheters - Sterile and single-use catheters - Part 1. General requirements (YY 0285.1-2017, ISO 10555-1.2013, MOD)
3 Terms and definitions
The terms and definitions as defined in YY 0285.1 and the following terms and definitions apply to this document.
3.1
Over-needle peripheral intravascular catheter
A catheter for introducing in or withdrawing out a fluid or instrument from a peripheral vascular system.
3.2
Needle
Appendix A
(Normative)
Determination of connection strength between needle hub and needle
tube
A.1 Principle
Apply tension and compression to the needle tube and the needle hub, then check for loose connections between the needle tube and the needle hub. A.2 Instrument
The tensile tester can apply a force of 20 N with an accuracy of ±1%.
A.3 Test procedure
A.3.1 Condition the needle for 2 h under conditions of relative humidity of 40% ~ 60% and temperature of 22 °C ± 2 °C, immediately perform the test.
A.3.2 Clamp the needle tube and the needle hub on the fixture of the tensile tester, then apply the tension and pressure one time at the speed of 100 mm/min in accordance with the following force values.
- The test needle with a nominal outer diameter less than 0.6 mm. 10 N; - The test needle with the nominal outer diameter greater than or equal to 0.6 mm. 20 N.
A.3.3 Check the connection between the needle tube and the needle hub,
record whether the needle is loose.
A.4 Test report
The test report shall include the following information.
a) Identification of the needle;
b) The outer diameter of the needle, expressed in mm;
c) The applied force (i.e. 10 N or 20 N);
d) Whether the needle in the needle hub loosens.
Appendix D
(Normative)
Determination of liquid leakage from vent fittings
D.1 Principle
The catheter is connected to a simulated blood source under hydrostatic pressure. Allow liquid to flow into the needle and measure the time it takes for the liquid to leak through the vent fitting.
D.2 Test solution
D.2.1 Dissolve 9 g of analytically pure sodium chloride in distilled or deionized water to prepare 1 L sodium chloride solution [0.9% (mass concentration)]. D.2.2 Mix 550 mL of sodium chloride solution (D.2.1) and 450 mL of USP grade or higher glycerin to prepare test solution.
Note. To improve the observability, a coloring agent such as a red or blue food coloring agent may be added.
D.3 Instrument
D.3.1 Constant liquid level container, capable of providing 400 mm ± 20 mm static pressure head, equipped with a liquid supply pipeline with an inner diameter of not less than 3 mm, the liquid supply pipeline is equipped with a clip or valve, the end has a puncture membrane such as latex cover). An example of this device is shown in Figure D.1.
D.3.2 Stopwatch, or similar device.
D.4 Procedure
D.4.1 Fill the test solution (D.2) at 23 °C ± 2 °C into a constant liquid level container (D.3.1).
D.4.2 Discharge all air in the supply line and close the clamp or valve. D.4.3 Insert the needle tip into the membrane to ensure that the needle is maintained at ±5° from the horizontal plane.
D.4.4 Open the clamp or valve to allow liquid to flow into the needle tube and measure the time it takes for the first drop to drop at the vent fitting. D.5 Test report