YY/T 0285.6-2020 PDF English
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Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports
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YY/T 0285.6-2020: PDF in English (YYT 0285.6-2020) YY/T 0285.6-2020
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.25
C 31
Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports
(ISO 10555-6:2015, NEQ)
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions... 5
Figure 1 -- Subcutaneous implanted port ... 6
Figure 2 -- Subcutaneous implanted port connected to catheter ... 6
4 Requirements ... 7
4.1 General ... 7
4.2 Biochemical properties ... 7
4.3 Distance mark ... 8
4.4 Nominal dimensions of subcutaneous implanted port ... 9
4.5 Physical requirements ... 9
4.6 Flow ... 10
4.7 Burst pressure for subcutaneous implanted ports and catheters ... 11
5 Magnetic resonance imaging (MRI) compatibility ... 12
6 Information provided by the manufacturer ... 12
6.1 General ... 12
6.2 Initial packaging ... 12
6.3 Traceability label ... 12
6.4 Instruction manual ... 13
Annex A (Normative) Test method for no gas leakage ... 14
Annex B (Informative) Detection limit of different matrix specimens ... 16
Annex C (Informative) Further characterization test guidelines: needle penetration and
extraction ... 18
Annex D (Normative) Test method for no leakage after multiple punctures ... 20
Annex E (Normative) Puncture chips ... 22
Annex F (Normative) Peak tension ... 24
Annex G (Normative) Bending test ... 25
Figure G.1 -- Installation drawing of bending test tool and catheter ... 25
Figure G.2 -- Bending test system ... 27
Bibliography... 28
Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports
1 Scope
This Part of YY/T 0285 specifies the relevant performance and safety requirements for
sterile and single-use subcutaneous implanted ports. This Part applies to the
subcutaneous implanted ports intended for long-term or persistent intravascular use,
consisting of a subcutaneously implanted infusion port and catheter.
NOTE 1: The known subcutaneous implanted ports are also used for non-endovascular indications
such as intraperitoneal, intrathecal and epidural access. The implanted ports based on risk
assessment and for non-endovascular applications only may refer to this Part. All subcutaneous
implanted ports for non-endovascular applications are encouraged to implement the requirements
of this Part.
This Part does not specify the performance and safety requirements related to the non-
coring needle for the implanted ports (hereinafter referred to as the non-coring needle).
NOTE 2: See YY 0881 for the requirements for the non-coring needle.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008, Test methods for infusion transfusion injection equipment for
medical use - Part 1: Chemical analysis methods
GB 15810, Sterile syringes for single use
YY 0285.1-2017, Intravascular catheters - Sterile and single-use catheters - Part 1:
General requirements
YY 0285.3-2017, Intravascular catheters - Sterile and single-use catheters - Part 3:
Central venous catheters
YY 0334-2002, General specification for surgical implants made of silicone
elastomer
Pharmacopoeia of the People's Republic of China, Edition 2015
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in YY 0285.1-2017
as well as the followings apply.
3.1 catheter
single or multi-lumen tubing that allows its end to enter a point in the body
3.2 connection
a system that connects the catheter to the subcutaneous implanted port
3.3 effective surface area
the area that can be pierced by the needle
3.4 flushing volume
the volume of the solution required to completely replace one solution with another in
subcutaneous implanted ports and catheters
3.5 non-coring needle
the needle that is not prone to chipping when puncturing the septum
NOTE: Chips are debris that can be created when the needle pierces the septum.
3.6 outlet tube
a cannula connected to a catheter at the port outlet
3.7 priming volume
the total volume of space that subcutaneous implanted ports and catheters can be filled
with solution
3.8 priming volume of the subcutaneous implanted port
the total volume of the subcutaneous implanted port that can be filled with the solution,
wherein the space consists of the reservoir and the outlet tube
3.9 priming volume of the catheter
the total volume of space in the effective length of catheter that can be filled with
solution
4 Requirements
4.1 General
Unless otherwise specified in this Part, subcutaneous implanted ports and catheters
shall comply with the requirements of YY 0285.1-2017.
4.2 Biochemical properties
4.2.1 Biocompatibility
4.2.1.1 General
The subcutaneous implanted port shall be free of biological hazards (source).
NOTE 1: See GB/T 16886.1 for biological evaluation.
NOTE 2: Prove that the implant material meets the corresponding standards (such as YY 0334, ISO
5832, YY/T 1557 and YY/T 0660) is helpful to support the biological evaluation requirements of
GB/T 16886.1.
4.2.1.2 Bacterial endotoxin
Inject no more than 10mL of water for bacterial endotoxin test from each set of
subcutaneous implanted ports. Extract at (37±1)°C for (1±0.1)h. Carry out the test
according to the bacterial endotoxin inspection method in “Pharmacopoeia of the
People's Republic of China, Edition 2015”. The bacterial endotoxin content shall be
less than 0.5EU/mL.
NOTE: See YY/T 0618 for the requirements for routine detection of bacterial endotoxin.
4.2.2 Chemical properties
4.2.2.1 Silicone rubber elastic parts
The silicone rubber elastic parts on the subcutaneous implanted port shall meet the
requirements of 5.3 and 5.4 in YY 0334-2002.
4.2.2.2 Other components (excluding silicone rubber elastic parts)
4.2.2.2.1 Test solution preparation
According to the ratio of 0.2g of sample plus 1mL of experimental water in accordance
with GB/T 6682, set it at (37±1)°C for 72h leaching as the test solution. Prepare the
blank control solution in the same method.
4.2.2.2.2 pH
When tested according to the method given in 5.4.1 of GB/T 14233.1-2008, the pH
difference between the test solution and the blank control solution shall not exceed 1.0.
4.2.2.2.3 Metal ions
When tested according to the method given in 5.9.1 or 5.6.1 of GB/T 14233.1-2008,
use atomic absorption spectrophotometry (AAS) or equivalent method to determine.
The total content of barium, chromium, copper, lead and tin in the test solution shall
not exceed 1μg/mL. The content of cadmium shall not exceed 0.1μg/mL.
The color of the test solution shall not exceed the color of the standard control solution
with mass concentration ρ(Pb2+)=1μg/mL.
4.2.2.2.4 Reducing substances (easy oxides)
When tested according to 5.2.2 indirect titration method in GB/T 14233.1-2008, the
difference between the volume of potassium permanganate [c(KMnO4)=0.002mol/L]
consumed by the test solution and the control solution shall not exceed 2.0mL.
4.2.2.2.5 UV absorbance
When tested according to the method given in 5.7 of GB/T 14233.1-2008, measure the
absorbance in the wavelength range of 250nm~320nm. The absorbance of the test
solution shall not be greater than 0.1.
4.2.2.2.6 Evaporation residue
When tested according to the method given in 5.5 of GB/T 14233.1-2008, the
evaporation residue shall not exceed 2mg.
4.2.2.3 Residual amount of ethylene oxide
If the subcutaneous implanted port is sterilized by ethylene oxide, it shall be tested
according to the method specified in Chapter 9 Determination of ethylene oxide residue
(gas chromatography) in GB/T 14233.1-2008, the residual amount of ethylene oxide in
each subcutaneous implanted port shall not be greater than 0.5mg.
4.3 Distance mark
If the catheter provides distance mark, it shall be marked as follows:
a) For split catheter, indicate the distance from the end of the catheter;
b) For pre-connected catheter, indicate the distance from the adjacent end of the
catheter.
Starting from the first mark, the distance between the marks shall not be greater than
5cm.
4.5.5.2 Self-sealing after puncture
When the test is carried out according to the method given in Annex D, the septum of
the subcutaneous implanted port shall have no gas leakage.
4.5.5.3 Puncture chips
When tested according to Annex E, after each injection seat is punctured by 1000
times/cm2 or the nominal puncture times (whichever is greater), the number of chips
shall not exceed 30.
4.5.6 Connection properties or catheter properties
4.5.6.1 Peak tension
When tested in accordance with Annex F, the minimum peak tensile force of the
connection between the subcutaneous implanted port and the catheter shall be 5N.
The minimum peak tensile force of all other parts of the catheter shall meet the
requirements of 4.4 of YY 0285.3-2017.
4.5.6.2 Bending resistance
When tested according to Annex G, the liquid flow rate of the curved catheter shall not
be less than 50% of the liquid flow rate of the straight catheter.
4.5.6.3 Dynamic breaking strength
The connection between the subcutaneous implanted port and the catheter, as well as
each connection of the catheter, shall be subjected to a dynamic breaking strength test
at a frequency of (1 ± 0.2) Hz. It shall be stretched in the flow direction to a duct
elongation of 10%, or a maximum tensile force of 5N. Take whichever arrives first.
Repeat 100,000 times. During the test, no component shall break or crack.
For split catheters, the above requirements shall also be met after the subcutaneous
implanted port is connected to the catheter in accordance with the manufacturer's
instructions.
4.6 Flow
4.6.1 General
If marked with nominal flow, when the subcutaneous implanted port not used for power
injection and the subcutaneous implanted port used for power injection are tested
according to the methods of Annex E and Annex G of YY 0285.1-2017, for the catheters
with a nominal outer diameter of less than 1.0mm, the flow rate of each lumen shall not
be less than 80% of the manufacturer's nominal value; for the catheters with a nominal
outer diameter greater than or equal to 1.0mm, the flow rate of each lumen shall not be
less than 90% of the manufacturer's nominal value.
If the flow rate of the hydration catheter is measured, the flow rate after hydration shall
be measured.
4.6.2 Subcutaneous implanted port indicated not to be used for power injection
When conducting the test according to the method given in Annex E of YY 0285.1-
2017, the following modifications shall be made to the test instrument:
- 6% (Luer) male conical connector (component 6 of Figure E.1 in YY 0285.1-2017)
shall be connected to the needle seat of the non-coring needle;
- The non-coring needle shall be placed through the septum of the subcutaneous
implanted port;
- The subcutaneous implanted port shall be connected to the test catheter (component
7 of Figure E.1 in YY 0285.1-2017) according to the manufacturer's instructions;
- The inline pressure sensor shall be connected to the proximal end of the non-coring
needle.
The test shall be done with the non-coring needle. Use the minimum and maximum
flows under gravity to express. Needle gauge (G) and length shall be recorded.
4.6.3 Subcutaneous implanted port indicated to be used for power injection
When conducting the test according to the method given in Annex G of YY 0285.1-
2017, the following modifications shall be made to the test instrument:
- The locking device (component 4 of Figure G.1 in YY 0285.1-2017) shall be
connected to the needle seat of the non-coring needle used for power injection;
- The non-coring needle shall be placed through the septum of the subcutaneous
implanted port;
- The subcutaneous implanted port shall be connected to the test catheter (component
6 of Figure G.1 in YY 0285.1-2017) according to the manufacturer's instructions.
4.7 Burst pressure for subcutaneous implanted ports and catheters
4.7.1 General
When conducting the test according to the method given in Annex F of YY 0285.1-
2017, the following modifications shall be made to the test instrument:
- As appropriate risk-based clinical justification, the locking device accessories
(F.2.3 in YY 0285.1-2017 and component 3 in Figure F.1) shall be connected to
the needle seat of the non-coring needle;
Annex A
(Normative)
Test method for no gas leakage
A.1 Principle
Apply air pressure to the connection between the subcutaneous implanted port and the
catheter AND the subcutaneous implanted port. Determine if gas leaks are found.
A.2 Instruments
A.2.1 Leak-proof connectors.
A.2.2 Syringe, or constant pressure source.
A.2.3 Pressure gauge, which is capable of measuring pressures up to 300kPa.
A.2.4 Test chamber, which can be filled with liquid and the temperature can be
controlled.
A.3 Steps
A.3.1 Bring the test chamber liquid (A.2.4) to a temperature of (37±2)°C. Maintain this
temperature throughout the test.
A.3.2 If the catheter is a split catheter, connect it to a subcutaneous implanted port.
A.3.3 Cut the catheter away from the port end. Leave a length of tubing long enough
(up to 10cm) for the connection to the pressure gauge and pressure source.
A.3.4 Connect the end of the catheter to a pressure source and a pressure gauge through
a leak-proof connector.
A.3.5 Immerse the subcutaneous implanted port in a temperature-controlled chamber.
A.3.6 Allow the subcutaneous implanted port to reach thermal equilibrium.
A.3.7 Adjust the pressure to at least 200kPa and wait 2min.
A.3.8 Check the assembled subcutaneous implanted port for gas leaks (pressure drop
of more than 2.65kPa within 2min or failure to reach 200kPa level).
A.4 Test report
The test report shall include the following information:
Annex B
(Informative)
Detection limit of different matrix specimens
B.1 Principle
Fill the subcutaneous implanted port and the catheter with colored solutions. Rinse by
continuous bolus until color disappears.
B.2 Reagents
B.2.1 Glycerin.
B.2.2 9g/L NaCl solution.
B.2.3 Patent Blue V colorant (λ=635nm).
NOTE: Patent Blue V is an example of a suitable commercial product. This information is given
for the convenience of users of this Part and does not imply an endorsement of this product.
B.3 Instruments
B.3.1 Non-coring needle.
B.3.2 Syringe.
B.3.3 Spectrophotometer, which is capable of measuring absorbance at 635nm.
B.4 Procedures
B.4.1 Prepare 400mL of NaCl solution (9 g/L) as flushing solution.
B.4.2 Prepare 100mL of colored solution [100mL contains 45% glycerol, 2mg of patent
blue V colorant, and 9g/L NaCl solution to constant volume (simulating blood viscosity
coefficient)].
B.4.3 Cut X cm of catheter (for example, X = 25cm + length of outlet tube). Connect it
to the subcutaneous implanted port according to the manufacturer's instructions for use.
B.4.4 Fill the subcutaneous implanted port and catheter with sufficient colored solution.
B.4.5 Use 2mL of bolus-dose flushing solution to rinse each subcutaneous implanted
port without shaking.
B.4.6 Collect the flushing solution into a test tube. Use a spectrophotometer to measure
Annex C
(Informative)
Further characterization test guidelines: needle penetration and extraction
C.1 Principle
Use the non-coring needle to puncture the septum. Record the peak penetration and
extraction forces.
C.2 Instruments
C.2.1 Tensile/compression testing machine.
C.2.2 A clamp, which holds the needle so that the needle is perpendicular to the
subcutaneous implanted port.
C.3 Steps
C.3.1 Place the test piece in a suitable aqueous medium at (37±2)°C. The state is
adjusted to the appropriate clinical time. After the state adjustment, immediately carry
out the test in accordance with C.3.2 and C.3.3.
C.3.2 Needle penetration force test
C.3.2.1 Set the test speed of the testing machine to 50 mm/min in compression mode.
C.3.2.2 Place the subcutaneous implanted port on the support plate of the testing
machine.
C.3.2.3 Insert the clamp that is holding the needle perpendicular to the surface of the
injector into the upper jaw.
C.3.2.4 Place the needle over the puncturing surface.
C.3.2.5 Insert the needle into the septum of the subcutaneous implanted port. Pass the
needle through the septum without touching the bottom of the subcutaneous implanted
port.
C.3.2.6 Record the peak penetration force.
C.3.3 Needle extraction force test
C.3.3.1 Set the test speed of the testing machine to 50 mm/min in the tensile mode.
C.3.3.2 Completely withdraw the needle from the septum of the subcutaneous
Annex D
(Normative)
Test method for no leakage after multiple punctures
D.1 Principle
Use the needle to randomly distribute the appropriate number of punctures in the
effective area of the septum. Carry out the leak test for the implanted port according to
Annex A.
D.2 Instruments
D.2.1 Apparatus: in accordance with the requirements of Annex A.
D.2.2 The non-coring needle: recommended by the manufacturer.
D.2.3 Test equipment: used to perform puncture.
D.3 Steps
D.3.1 Make the temperature of the test chamber liquid (A.2.4) reach (37±2)°C.
Maintain this temperature throughout the test.
D.3.2 Immerse the subcutaneous implanted port in a temperature-controlled chamber.
Allow it to reach thermal equilibrium.
D.3.3 Puncture. At the same time, keep the subcutaneous implanted port in a
temperature-controlled chamber.
The number of punctures shall be as follows:
Conduct a minimum of 1000 punctures per cm2 of effective surface area of the septum.
If the manufacturer claims to withstand a higher number of punctures, this number shall
be considered for this test. The punctures are randomly distributed among the effective
surface area of the septum. Make sure that the tip of the non-coring needle completely
penetrates the septum for each puncture. Each needle shall have a maximum of 50
punctures. Double check that the needle tip does not tip or wobble after leaving the
septum. If this happens, replace this non-coring needle.
D.3.4 Carry out the leak test in accordance with Annex A.
D.4 Test report
The test report shall contain the following information:
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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