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YY 0285.1-2017 English PDF (YY0285.1-2017)

YY 0285.1-2017 English PDF (YY0285.1-2017)

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YY 0285.1-2017: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
This part of YY 0285 specifies the general requirements for intravascular catheters of various uses with sterile supply and single-use. This part does not apply to intravascular catheter accessories, such as YY 0450.1.
YY 0285.1-2017
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing YY 0285.1-2004, YY 0285.2-1999
Intravascular catheters - Sterile and single-use catheters
- Part 1. General requirements
(ISO 10555-1.2013, MOD)
ISSUED ON. JULY 17, 2017
IMPLEMENTED ON. JANUARY 1, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Requirements ... 9
5 Logo of nominal size ... 11
6 Information provided by manufacturers ... 12
Foreword
YY 0285 “Intravascular catheters - Sterile and single-use catheters” consists of four parts.
- Part 1. Intravascular catheters - Sterile and single-use catheters - Part 1. General requirements;
- Part 3. Intravascular catheters - Sterile and single-use catheters - Part 3. Central venous catheters;
- Part 4. Intravascular catheters - Sterile and single-use catheters - Part 4. Balloon dilatation catheters;
- Part 5. Intravascular catheters - Sterile and single-use catheters - Part 5. Trocar peripheral catheter.
This part is the first part of YY 0285.
This part was drafted in accordance with the rules in GB/T 1.1-2009.
This part replaces YY 0285.1-2004 "Sterile, single-use intravascular catheters. Part 1. General requirements" and YY 0285.2-9 "Sterile, single-use intravascular catheters - Part 2. Angiographic catheter."
Compared with YY 0285.1-2004 and YY 0285.2-1999, the main technical changes in this part are as follows.
- revise the requirements and test methods of angiographic catheter;
- revise flow requirements;
- modify some verbal expressions. This part uses the redrafted law revision using IS0 10555-1. 2013 "Intravascular catheters - Sterile and single-use catheters - Part 1. General requirements".
The technical differences and the reasons between this part and ISD 10555-1. 2013 are as follows.
- With regard to the normative references, this part has made adjustments with technical differences so as to adapt to the technical conditions in our country. The adjustments are mainly reflected in Chapter 2 "Normative References". The specific adjustments are as follows.
• Replace ISD 594-1 with identical international standard GB/T 1962.1;
Intravascular catheters - Sterile and single-use catheters
- Part 1. General requirements
1 Scope
This part of YY 0285 specifies the general requirements for Intravascular catheters of various uses with sterile supply and single-use. This part does not apply to Intravascular catheter accessories, such as YY 0450.1.
2 Normative references
The following document for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. 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 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. - Part 2. Locking joints (ISO/IEC 1962.2-2001, ISO 594-2. 1998, IDT)
GB 15810 Sterile hypodermic syringes for single-use (GB15810-2001, eqv ISO 7886-1. 1993)
GB/T 30515 Petroleum products. Transparent and opaque liquids. Determination of kinematic viscosity and calculation of dynamic viscosity (GB/T 30515- 2014, ISO 3104.1994, MOD)
YY/T 0466.1 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, ISO 5223-1.2012, IDT)
YY/T 0586 Medical polymer products-Test methods of radiopacity
ISO 3105.1994 Glass capillary kinematic viscometers. Specifications and operating instructions second edition (Glass capillary kinematic viscometers-Specifications and operating instructions)
3.7
Outside diameter
It is the maximum diameter of a catheter or hydration catheter that can be inserted into blood vessel in ante-hydration and post-hydration.
3.8
Junction
It is the connection of one or more pipelines where the pipe connections are capable of withstanding mechanical tension or mechanical stress during clinical use. 3.9
Hydratable intravascular catheter
Intravascular catheters that contain a material that exhibits clinically significant hydration after touch an aqueous medium.
3.10
Post-hydration
The hydratable intravascular catheter is immersed into (37 ± 2) ° C water and maintained for the state after the clinically expected period of use.
3.11
Clinically significant hydration
The effective length of post-hydration is 1% greater than the effective length of ante-hydration, or the outside diameter of post-hydration is 10% greater than or equal to the outside diameter of ante-hydration.
3.12
Power injection
It is the rapid injection of liquid under high pressure.
3.13
Primary packaging
It is the packaging that directly contacts with instruments and / or keep products sterile.
mm, the flow of each cavity shall be no less than 80% of the nominal value of manufacturers; as for the catheter having a nominal outside diameters greater than or equal to 1.0 mm, the flow of each cavity shall be no less than 90% of the nominal value of manufacturers. If measuring the flow of hydration catheter, the post-hydration flow shall be measured.
4.10 Power injection
If the catheter is marked for power injection, the burst pressure measured in accordance with Appendix F shall be greater than the peak pressure at the maximum flow measured in accordance with Appendix G.
4.11 Side hole
The design, number and position of side holes shall minimize adverse effects on the catheter and damage to the tissue.
4.12 Distal end and head end
To reduce damage to the blood vessels during use, the distal end and head end of the catheter shall be rounded, tapered or treated similarly.
5 Logo of nominal size
5.1 General rules
The nominal size of the catheter shall be identified as specified in 5.1 and 5.2. 5.2 Outside diameter
Unless otherwise specified in the standard for a particular type of catheter, the outside diameter shall be expressed in millimeters1) and sent to the nearest 0.01 mm or 0.1 mm.
For the instrument whose cross-section designs non-circular, the specifications shall be marked with the maximum shaft diameter. In this case, the manufacturer may choose to provide additional information related to the profile of the instrument, such as the minor axis dimension of the elliptical section.
5.3 Nominal effective length
When effective length is less than 100 mm, it shall be expressed in millimeters; when effective length is greater than or equal to 100 mm, it shall be expressed in millimeters or centimeters.
1 Appendix H shows the measurement unit system which can be additionally used except for the provisions of this section.
Appendix B
(Normative)
Peak tension test method
B.1 Principle
Select the test section of the catheter or entire catheter so that each connection between each tubular portion, catheter adapter or connector and the pipeline, and connections between each tubular portion are tested. Put tension on each test section until the pipeline is broken or the connection is separated. When testing hydration catheters, consider the state of ante-hydration and post-hydration, report the worst outcome.
B.2 Instrument
Tension tester can exert a force greater than 15N.
B.3 steps
B.3.1 Assemble the catheter according to the manufacturer's instructions. The test is carried out by selecting a section of the catheter under test, including the hub or the connector (if any) and the connections between the sections, for example, the connection between the pipeline and the end-head end. The end-head end with less than 3mm in length shall not be included in the test section. For hydration catheters, prepare the test specimen of the same position from both catheters. One specimen is adjusted according to B.3.2, another specimen is not adjusted but conducted directly according to B.3.3 ~ B.3.8.
B.3.2 Place the test specimen in a suitable aqueous medium, keep the temperature of (37 ± 2) °C to the corresponding clinical use of time (see B.3.1), conduct the state adjustment, and then conduct a test immediately according to B3.3 ~ B.3.8. B.3.3 Fix the test section to the tension tester, if hub or connector is available, use appropriate clamps to prevent the hub or the connector from deforming.
B.3.4 Measuring the gauge length of the test section, that is, the distance of test section among the fixtures of tension tester, or the distance between the hub or connector and the fixture of the other end of the test section.
B.3.5 Stretch at a unit strain rate (see Table B.1) at a millimeter gauge length of 20 mm / min until the test section is separated into two or more sections. Appendix C
(Normative)
Test methods for liquid leakage under pressure
C.1 principle
Connect the catheter to the syringe through a leak-proof connection, put some water pressure on the catheter and catheter adapter (if any) and the catheter tubing, check for leaking. When testing hydration catheters, consider the state of ante- hydration and post-hydration, report the worst outcome.
C.2 Reagents
Distilled water or deionized water.
C.3 Instrument
C.3.1 leak-proof connector, connect the catheter to the syringe or pressure instrument (C.3.3) and assemble a pressure gauge that can measure at least 300 kPa pressure with a small internal cavity.
C.3.2 connector used for leak-proof connection between syringe or pressure instrument (C.3.3) and non-h...
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