YY/T 0573.4-2020 English PDF (YYT0573.4-2020)

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YY/T 0573.4-2020: Sterile hypodermic syringes for single use--Part 4: Syringes with re-use prevention frature
YY/T 0573.4-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.25
C 31
Replacing YY 0573.4-2010
Sterile hypodermic syringes for single use - Part 4:
Syringes with re-use prevention feature
(ISO 7886-4:2006, MOD)
ISSUED ON: FEBRUARY 26, 2020
IMPLEMENTED ON: MARCH 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 7 
2 Normative references ... 7 
3 Terms and definitions ... 8 
4 Naming and classification ... 8 
5 Physical requirements ... 10 
6 Chemical requirements ... 16 
7 Biological requirements ... 16 
8 Packaging ... 17 
9 Signs ... 18 
Appendix A (Normative) Test method for capacity tolerance and residual
capacity ... 22 
Appendix B (Normative) Test method for leakage at the connection between the
fixed needle tube and the needle seat, at the piston or sealing ring, when the
syringe is under positive pressure ... 25 
Appendix C (Normative) Test method for leakage at piston or sealing ring AND
separation of piston and core rod, when syringe is pumped under negative
pressure ... 27 
Appendix D (Normative) Test method for fit between jacket and piston assembly
... 30 
Appendix E (Normative) Test methods of re-use prevention features ... 31 
Appendix F (Normative) Preparation of extraction solution and test method . 33 
Appendix G (Informative) Guidelines for design and materials ... 35 
References ... 37 
Foreword
YY/T 0573 "Sterile hypodermic syringes for single use" consists of the following
parts:
- Part 2: Syringes for use with power-driven syringe pumps;
- Part 3: Auto-disable syringes for fixed dose immunization;
- Part 4: Syringes with re-use prevention feature.
This part is part 4 of YY/T 0573.
GB 15810 "Sterile syringes for single use" adopts, through modification, the ISO
7886-1 "Sterile hypodermic syringes for single use - Part 1: Syringes for manual
use". Therefore, the standard series of YY/T 0573 "Sterile hypodermic syringes
for single use" does not have part 1.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0573.4-2010 "Sterile hypodermic syringes for single use
- Part 4: Syringes with re-use prevention feature".
Compared with YY 0573.4-2010, the main technical changes in this part are as
follows:
- INTRODUCE the content of 15.4 "Performance after shipment" into 8.3
"Large package" (see 8.3);
- ADD the requirements for easy oxides and ethylene oxide residues, in the
chemical requirements (see 6.3, 6.4);
- ADD the requirements for sterility and bacterial endotoxins, in the biological
requirements (see 7.2, 7.3);
- MODIFY the requirements of "initial packaging or self-sealing packaging"
(see 8.1; Chapter 16 of the 2010 edition);
- ADD the Appendix A "Test methods for capacity tolerance and residual
capacity" (see Appendix A);
- ADD the Appendix B "Test method for leakage at the connection of the fixed
needle tube and the needle seat, at the piston or seal ring, when the syringe
is under positive pressure" (see Appendix B);
- ADD the Appendix C "Test method for leakage, at piston or sealing ring
AND separation of piston and core rod, when syringe is pumped under
negative pressure" (see Appendix C);
- ADD the Appendix D "Test method for fit between jacket and piston
assembly" (see Appendix D);
- ADD F.2 "Test method for residual ethylene oxide" (see Appendix F);
- ADD the Appendix G "Guidelines for design and materials" (see Appendix
G);
- DELETE the Appendix C "Environmental aspects" of the original standard
(see Appendix C of the 2010 edition).
This part uses the redrafting method to modify and adopt ISO 7886-4:2006
"Sterile hypodermic syringes for single use - Part 4: Syringes with re-use
prevention feature"
The technical differences between this part and ISO 7886-4:2006, as well as
the reasons, are as follows:
- Regarding normative references, this part has made adjustments with
technical differences, to adapt to China's technical conditions. The
adjustments are specifically reflected in Chapter 2 "Normative references";
the specific adjustments are as follows:
● DELETE the ISO 7000;
● DELETE the ASTM D999-01;
● DELETE the ASTM D5276-98;
● USE the GB/T 6682-2008, which modifies and adopts the international
standard, to replace ISO 3696:1987;
● USE the GB 15811-2016, which non-equivalently adopts the
international standard, to replace ISO 7864:1993 (see 5.6.2);
● USE the GB/T 18457-2015, which modifies and adopts the
international standard, to replace ISO 9626 (see 5.6.2);
● USE the GB/T 191-2008, which modifies and adopts the international
standard, to replace ISO 780 (see 9.1);
● USE the GB 15810, which modifies and adopts the international
standard, to replace ISO 7886-1:1993 (see Chapter 3);
● USE the YY/T 0497, which modifies and adopts the international
standard, to replace ISO 8537:1991 (see Chapter 3);
Sterile hypodermic syringes for single use - Part 4:
Syringes with re-use prevention feature
1 Scope
This part of YY/T 0573 specifies the terms and definitions, naming and
classification, physical requirements, chemical requirements, biological
requirements, packaging, markings, etc. of sterile hypodermic syringes for
single use (hereinafter referred to as syringes) with re-use prevention features.
This part applies to sterile hypodermic syringes for single use, which are made
of plastic materials, with or without needles, used for aspirating liquids OR for
injection immediately after aspirating liquids, designed to prevent re-use. It is
suitable for the re-use prevention performance of syringe, which can prevent
accidental needle stick injury. This part does not involve the performance of
preventing accidental needle stick injury of this type of syringe.
This part does not apply to glass syringes, self-destructive fixed-dose vaccine
syringes, syringes with prefilled liquid medicine. This part does not involve the
compatibility of the syringe and the injection liquid.
This part does not specify the design requirements for self-destructive features.
Note: When the syringe is used beyond the intended use, which is specified in this part,
other standards apply.
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) is applicable to this standard.
GB/T 191-2008 Packaging - Pictorial marking for handling of goods (ISO
780:1997, MOD)
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: Lock fittings (GB/T 1962.2-2001,
the needle seat.
When tested according to Appendix C, there shall be no gas leakage, at the
piston or sealing ring; meanwhile the reading of the pressure gauge shall not
continue to drop.
5.7.3 Re-use prevention features
In normal use OR when tested according to Appendix E, in accordance with the
manufacturer's instructions for use, once the re-use prevention feature is
activated, the syringe shall not be used again.
6 Chemical requirements
6.1 pH
When measuring with a potentiometric pH meter and the corresponding
universal electrode, the difference, BETWEEN the pH of the extract, which is
prepared according to F.1 of Appendix F AND the pH of the blank solution, shall
be ≤ 1.
6.2 Extractable metal content
Take the extract, which is prepared in F.1. Use a confirmed microanalysis
method (such as atomic absorption method OR inductively coupled plasma
emission spectrometry) to carry out the test. The total content of lead, tin, zinc,
iron in the syringe extract shall be ≤ 5 µg/mL; the cadmium content shall be ≤
0.1 µg/mL.
6.3 Easily oxidized substance
Take the 20 mL of extract, which is prepared in F.1. Test it according to the
second method in 5.2.2 of GB/T 14233.1-2008. When compared the syringe
extract with the same volume of the same batch of blank control solution, The
difference in the consumption of 0.002 mol/L potassium permanganate solution
shall be ≤ 0.5 mL.
6.4 Residual ethylene oxide
If ethylene oxide is used for sterilization, the control of residual ethylene oxide
shall be confirmed. When tested according to F.2, the residual amount of
ethylene oxide shall be ≤ 10 µg/g.
7 Biological requirements
7.1 General
It should refer to the guidelines, which are given in Appendix G, to select the
appropriate material of syringe. Meanwhile it shall conduct biocompatibility
evaluation.
7.2 Sterility
The syringe, in each initial package, shall be sterilized by an appropriate
method. The sterilization process shall be confirmed and routinely controlled,
to ensure that the survival probability of bacteria on the product is less than 10-
6. The confirmation of the sterilization process shall be documented.
Note: GB/T 14233.2 stipulates the sterility test method; this method is suitable for type
inspection BUT not for exit-factory inspection. For suitable sterilization and exit-factory
sterility inspection methods, see GB 18278.1, GB 18279.1 or GB 18280.1.
7.3 Bacterial endotoxin
When tested according to the method specified in GB/T 14233.2, the bacterial
endotoxin limit shall not exceed 20 EU per tube.
8 Packaging
8.1 Initial packaging or self-sealing packaging
The self-sealing syringe unit, which has needle cap and end cap, shall adopt
the self-sealing packaging. The syringe unit, without needle cap and end cap,
shall be packed in a single package.
When using ethylene oxide for sterilization, the initial packaging of non-self-
sealing syringes shall be made of air-permeable materials (such as dialysis
paper) on at least one side.
This part encourages the use of packaging materials with better ventilation
effects. Packaging materials must not have a harmful effect on the contents.
This packaging material and design shall ensure:
a) Under dry, clean and fully ventilated storage conditions, it shall ensure that
the contents are sterile;
b) When taken out of the package, the risk of contamination of the contents
is minimal;
c) During normal handling, transportation, storage, the contents are
adequately protected;
d) Once opened, the package cannot be easily resealed, meanwhile there
shall be obvious signs of tearing.