YY/T 1768.2-2021 English PDF (YYT1768.2-2021)

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YY/T 1768.2-2021: Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles
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 d...