YY/T 1768.2-2021 PDF in English
YY/T 1768.2-2021 (YY/T1768.2-2021, YYT 1768.2-2021, YYT1768.2-2021)
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Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles
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Standards related to: YY/T 1768.2-2021
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YY/T 1768.2-2021: PDF in English (YYT 1768.2-2021) YY/T 1768.2-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
YY/T 1768.2-2021
Needle-based injection systems for medical use -
Requirements and test methods - Part 2: Needles
(ISO 11608-2:2012, NEQ)
ISSUED ON: MARCH 09, 2021
IMPLEMENTED ON: APRIL 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Material requirements ... 7
5 Physical requirements ... 7
5.1 Size ... 7
5.2 Needle flow ... 8
5.3 Connection between needle seat and needle tube ... 8
5.4 Needle tip ... 8
5.5 Straight ... 9
5.6 Lubricant ... 9
5.7 Patient end measurement ... 9
5.8 Functional compatibility with needle-based injection system ... 9
5.9 Easy to assemble and disassemble ... 9
6 Chemical requirements ... 10
6.1 Test solution preparation ... 10
6.2 pH ... 10
6.3 Heavy metal content (metal ions) ... 10
7 Biological requirements ... 10
7.1 Sterility... 10
7.2 Bacterial endotoxin ... 10
7.3 Biocompatibility ... 10
8 Packaging ... 11
9 Information provided by the manufacturer ... 11
9.1 General ... 11
9.2 Marks ... 12
9.3 Instructions for use ... 13
Annex A (normative) Standard atmosphere and test apparatus ... 15
Annex B (normative) Pretreatment of needles ... 17
Annex C (normative) Radial runout determination method at patient end measurement
point ... 18
Annex D (normative) Determination of the flow through the needle ... 20
Annex E (normative) Method for determination of connection between needle seat and
needle tube ... 22
Annex F (normative) Test method for confirming the suitability of needles and injection
systems ... 23
Bibliography ... 26
Needle-based injection systems for medical use -
Requirements and test methods - Part 2: Needles
1 Scope
This Part of YY/T 1768 specifies the requirements and test methods for single-use
double-ended sterile needles.
This Part applies to needles used in conjunction with the needle-based injection system
(NIS) of YY/T 1768.1.
This Part does not apply to dental needles, prefilled injection needles, needles pre-
assembled by the manufacturer, and needles that do not require assembly or connection
to the NIS.
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 2423.4-2008, Environmental testing for electric and electronic products - Part
2: Test method - Test Db: Damp heat, cyclic (12 h + 12 h cycle) (IEC 60068-2-
30:2005, IDT)
GB/T 6682, Water for analytical laboratory use - Specification and test methods
(GB/T 6682-2008, ISO 3696:1987, MOD)
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for
medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005, Test methods for infusion, transfusion, injection equipment for
medical use - Part 2: Biological test methods
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1:2009,
IDT)
GB/T 18457-2015, Stainless steel needle tubing for the manufacture of medical
devices (ISO 9626:1991, MOD)
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels,
6 - Needle tube;
7 - Binder (if used).
NOTE 1: The needle container can be used as a needle sheath.
NOTE 2: The illustrated right end of the needle is the patient end. The left end is the cartridge end
for puncturing the cartridge.
Figure 1 -- Example of needle assembly for NIS
3.3 seal
A removable barrier expected to keep the needle sterile within the needle container.
3.4 unit packaging
The needle container and seal together make up this device packaging, so as to keep the
needle sterile.
3.5 user packaging
A package used by the manufacturer to provide the user with one or more identical
devices (in their single package) from the same production batch.
4 Material requirements
The needle tube used to manufacture the needle shall meet the requirements of GB/T
18457-2015.
5 Physical requirements
5.1 Size
5.1.1 General
The size of the connecting part of the needle assembly shall be such that the needle can
be used in conjunction with the NIS specified in YY/T 1768.1.
5.1.2 Needle size
Use the test apparatus that complies with A.1 in Annex A. In the standard atmosphere
specified in A.2, when testing needles without pretreatment in Annex B, it shall be
adapted to the test gauge specified in Annex C. The size shall meet the requirements of
Table 1.
6 Chemical requirements
6.1 Test solution preparation
Immerse 25 needles with the sheath removed into 250mL of freshly prepared grade two
water that meets the requirements of GB/T 6682. Keep temperature constant for 1h at
(37±1)℃. Take out the needle to get the test solution. At the same time, prepare the
blank control solution according to the same method as above without putting the
needle.
6.2 pH
When tested according to the method specified in GB/T 14233.1-2008, the pH
difference between the test solution prepared in 6.1 and the blank control solution shall
not be greater than 1.
6.3 Heavy metal content (metal ions)
When measured by atomic absorption spectrophotometry (AAS) or an equivalent
method, the total content of barium, chromium, copper, lead and tin in the test solution
shall not exceed 5μg/mL. The content of cadmium shall not exceed 0.1μg/mL.
When tested according to the method specified in 5.6.1 of GB/T 14233.1-2008, the
color of the test solution shall not exceed the color of the standard control solution with
a concentration of 5μg/mL.
7 Biological requirements
7.1 Sterility
The needles in the unit packaging shall meet the requirements of YY/T 0615.1.
7.2 Bacterial endotoxin
When tested according to the method specified in GB/T 14233.2-2005, the bacterial
endotoxin content shall be less than 20EU/piece.
7.3 Biocompatibility
Carry out the biological evaluation of materials and/or final products on the basis of
material characterization according to the evaluation procedures specified in GB/T
16886.1.
NOTE: For the consideration of animal protection, the evaluation procedure given in GB/T 16886.1
is recommended for biological evaluation. When using such an evaluation procedure, if it can be
confirmed that the material of the needle tube under evaluation is equivalent to the material specified
in GB/T 18457-2015, and the production process of the product is equivalent to the production
process of similar products on the market; if the human intake in clinical use is lower than the
tolerable limit (TI) of the substance, it can confirm that the product has good biocompatibility
without the need for corresponding biological tests.
8 Packaging
Each needle shall be sealed in a unit packaging. One or more unit packaging shall be
placed in the user packaging.
Materials used in the unit packaging shall not adversely affect the contents. The material
and design of this packaging shall ensure that:
a) Maintain the sterility of the contents during normal handling and storage;
b) The risk of contamination of contents during removal from packaging is minimal;
c) When the seal is removed, it will not affect the subsequent assembly of the needle
and NIS;
d) Conduct appropriate protection of the contents during normal handling, transport
and storage;
e) Once opened, the package shows signs that the package has been opened and the
package cannot be resealed.
9 Information provided by the manufacturer
9.1 General
The needles shall be accompanied by information sufficient for safe use. It shall also
consider the training and knowledge of potential users. This information shall include
the manufacturer's identification.
The instructions for use shall be included in the user packaging unless the needle is safe
to use without instructions.
The flow rate determined in accordance with 5.2 shall be provided on the label.
Annex B
(normative)
Pretreatment of needles
B.1 Pretreatment in hot, dry atmosphere
Put the needles in the unit packaging into the test chamber under the following
conditions for at least 96h:
- Temperature: (70±2)℃;
- Relative humidity: (50±10)%.
B.2 Pretreatment in a refrigerated environment
Put the needles in the unit packaging into the test chamber under the following
conditions for at least 96h:
- Temperature: (-40±3)℃.
B.3 Pretreatment in periodic atmospheric environment
Place the needles in the unit packaging into the test chamber. Process according to GB/T
2423.4-2008 and the following requirements:
- Change 1 [see Figure 2a) in GB/T 2423.4-2008];
- Lower limit of temperature: (25±3)℃ (no humidity requirement);
- Upper limit of temperature: (55±2)℃;
- 6 cycles.
NOTE: The corresponding chapters in GB/T 2423.4-2008 are Chapter 4 (Test chamber), Chapter 7
(Conditional test) and Chapter 9 (Recovery).
Distilled water.
D.3 Instruments
D.3.1 Test fixture
The sample needle is mounted on it.
D.3.2 Water tank
Connect to the test fixture. It is pressurized with (1.1±0.01) bar compressed air.
NOTE: 1bar=100kPa. A pressure of 1.1 bar is considered to best simulate the average situation of
the user.
D.4 Steps
Add (23±2)℃ water to the water tank. Connect or screw the test needle into the test
fixture attached to the tank.
Make water flow through the needle for at least (15±0.25)s. Collect the effluent in a
suitable container.
Convert the effluent to its volume by weighing the effluent. The density of water is
assumed to be equal to 1.000g/mL.
NOTE: Tolerances for temperature, pressure and time have been chosen to consider what is usually
achievable, although they are believed to have different effects on the overall tolerance.
D.5 Result expression
Test results are reported in milliliters per minute (mL/min).
The water temperature in the fluid path shall not exceed 25°C.
Annex F
(normative)
Test method for confirming the suitability of needles and injection systems
F.1 Principle
Apply the specified torque to the needle and connect it to the NIS for at least 10s. Use
dose test to determine the integrity of clinically relevant fluid pathways. (In the settings
of NIS Vhigh and Vlow, where Vlow is less than or equal to 10% of NIS maximum dose,
and Vhigh is greater than or equal to 90% of NIS maximum dose.)
Finally, measure and record the removal torque of the needle seat.
F.2 Instruments and devices
F.2.1 Torque tester
It is capable of holding needles and NIS securely (for threaded needles). The instrument
shall be able to apply (0.07±0.01) N·m of assembly torque (clockwise). The resolution
is ±0.001N·m. This instrument shall also be able to apply disassembly torque (counter-
clockwise) and record the peak results. If the needle has no thread, the relevant
assembly and disassembly tests shall meet the relevant requirements.
F.2.2 Timer
It is capable of timing 10s with ±1s resolution.
F.2.3 Dose accuracy instrument
It is capable of collecting and weighing NIS liquids from tests. The resolution is
0.0001g. The instrument shall include a laboratory balance with a protective frame and
weighing pan (for information on the accuracy of dose determination, see YY/T 1768.1).
F.3 Steps
F.3.1 Needle seat - Assembly
NOTE: This is a prerequisite for the torque teardown test.
F.3.1.1 Fill the applicable cartridge into the reusable NIS (if applicable). For injection
devices with integral containers and non-replaceable containers, cartridges are not used
because NIS itself contains liquid.
F.3.1.2 Prime NIS with an additional needle as needed until a stream of fluid emerges
from the needle tip. This is to ensure that the pusher assembly of the NIS is in contact
with the piston, that is, the NIS is pre-drained. Remove the additional needle.
F.3.1.3 Insert the NIS into the needle seat torque tester.
F.3.1.4 Connect the test needle to the NIS. Apply a torque of (0.07±0.01) N·m. Record
the peak assembly torque (twist on) measurement result.
F.3.1.5 Start a 10s timer. Let the assembly hold for at least 10s. Carefully remove the
pen assembly from the torque tester.
F.3.2 Needle dose accuracy
F.3.2.1 Perfuse the NIS (if not already perfused) according to the manufacturer's
instructions for use.
F.3.2.2 Select and set the first target dose of the NIS. This is Vlow or Vhigh set in random
or alternating dose order.
F.3.2.3 Zero the balance.
F.3.2.4 Apply and maintain pressure on the NIS propulsion unit, so as to deliver the
liquid dose to the measuring equipment.
F.3.2.5 Deliver the dose according to the manufacturer's instructions for use.
F.3.2.6 Stabilize the mass on the balance. Observe and record the first stable mass value
within 5s after the holding time specified in the instructions for use.
Make sure the balance is zeroed before each dose. When a new weighing pan is required,
add a portion of the liquid. Put it on the balance and tare it.
F.3.3 Needle seat removal torque
F.3.3.1 Carefully replace the NIS in the torque test apparatus. Unscrew the needle thread
holder from the NIS test gauge described in D.1. Record the peak disassembly torque
(twist down).
F.3.3.2 Repeat the above steps (from F.3.1.4) with the new needle for the second target
dose of NIS. This is another dose (Vlow or Vhigh) set in a random or alternating dose
order.
F.3.3.3 Repeat the above steps (starting from F.3.1.4) with the same syringe and
cartridge (needle syringe with replaceable container) or needle injection device with
integral non-replaceable container. Complete another required parallel test.
F.4 Acceptance criteria
F.4.1 Needle seat - Assembly guidelines
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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