YY/T 0497-2018 English PDF (YY/T0497-2018)

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YY/T 0497-2018: Sterile insulin syringe for single use
YY/T 0497-2018
Sterile insulin syringe for single use
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0497-2005
Sterile insulin syringe for single use
(ISO 8537.2007, MOD)
2018-04-11 released
2019-05-01 Implementation
Issued by the State Drug Administration
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0497-2005 "Sterile Insulin Syringe for Single Use", compared with YY 0497-2005, mainly
The technical changes are as follows.
---Modified the normative references in Chapter 2;
---Modified Chapter 3 terms and definitions;
--- Deleted 4.3 materials in the original standard and moved to Chapter 5 of this standard;
--- Deleted the distance from 5.2 coat curling to hand pressing in the original standard;
--- Deleted the 5.3 piston in the original standard;
--- Deleted Figure 3 "Example of quantity value indication" in the original standard;
--- Deleted 5.11.3 in the original standard, there should be no hemolytic reaction;
--- Deleted 5.11.4 in the original standard should have no acute systemic toxicity.
---Modified the 6.4 scale ruler;
---Added the specifications in Table 1 with a nominal capacity of 0.3mL and a scale interval of 0.5;
---Added 6.6.1 general rules of piston/core rod assembly;
--- Added 6.8.2 needle leakage;
--- Deleted Chapter 6 test methods in the original standard;
---Modified 8.2 aseptic;
---Modified 8.3 bacterial endotoxin;
--- Deleted the instruction manual and product certificate in Chapter 8 of the original standard;
---Added in 9.1 "Type 1, Type 3, Type 5 and Type 7 use dialysis paper on one side and plastic material on the other side
Claim";
--- Deleted the "license number required by regulations", "sterilization method, sterilization validity period, sterilization certificate" in Chapter 8 of the original standard;
---Adjusted Appendix A in the original standard to Appendix B and made modifications;
--- Added Appendix A "Test Method for Force Required to Operate Core Rod";
---Adjusted Appendix B in the original standard to Appendix G and modified the preparation method of easy oxides;
---Adjust and modify Appendix C in the original standard to Appendix D;
--- Deleted Appendix D of the original standard;
--- Deleted Appendix E of the original standard;
--- Added Appendix E "Test Method for Air Leakage at the Connection of Syringe Cone/Needle Seat or Needle/Jacket under Negative Pressure";
---Adjusted Appendix F in the original standard to Appendix I and modified it;
---Added Appendix F "Test Method for Air Leakage at Piston when Syringe Pumping Negative Pressure";
---Adjusted Appendix G in the original standard to Appendix J and modified it;
--- Deleted Appendix H in the original standard;
--- Added Appendix H "Test Method for Residual Ethylene Oxide";
This standard uses the redrafting method to modify and adopt ISO 8537.2007 "Single-use sterile insulin syringes with or without needles".
The technical differences between this standard and ISO 8537.2007 and the reasons are as follows.
---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is specifically reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 9626 (see 6.8.2) with GB/T 18457 modified to adopt international standards;
● Replace ISO 594-1 (see 6.7.1) with GB/T 1962.1 which is equivalent to adopting international standards;
● Replace ISO 7864 with the non-equivalent international standard GB 15811 (see 6.8.1, 6.8.2);
● Added reference to GB 15810 (see 6.4.1.2);
● Added reference to GB/T 6682 (see 7.4);
● Added reference to GB/T 14233.2 (see 8.2);
● Added reference to GB 18278.1 (see 8.2);
● Added reference to GB 18279.1 (see 8.2);
● Added reference to GB 18280.1 (see 8.2);
● Added reference to YY/T 0466.1 (10.3.4).
---Added "Chapter 5 Materials" to standardize material requirements;
---Added in 6.4.2 for 1.0mL and 2.0mL syringes, numbers can be marked on the 5-unit scale capacity line
Requirements;
---Modified the requirement of "extractable metal content";
---Added "7.3 Easy Oxidation";
--- Added "7.4 Residual Ethylene Oxide";
---Added "Chapter 8 Biological Properties" to standardize the biological requirements of products;
---Added 9.1 "Type 1, Type 3, Type 5 and Type 7 packaging materials with dialysis paper on one side and plastic material on the other side";
---Modified the packaging requirements;
---Modified the requirements of the logo;
---Modify Appendix A in ISO 8537.2007 and move it to Appendix G of this standard;
--- Move Appendix B of ISO 8537.2007 to Appendix F of this standard;
--- Move Appendix C of ISO 8537.2007 to Appendix A of this standard;
---Modify Appendix D in ISO 8537.2007 and move it to Appendix B of this standard;
--- Move Appendix E in ISO 8537.2007 to Appendix C of this standard;
--- Move Appendix F in ISO 8537.2007 to Appendix D of this standard;
--- Move Appendix G of ISO 8537.2007 to Appendix E of this standard;
--- Deleted Appendix H in ISO 8537.2007;
--- Move Appendix I of ISO 8537.2007 to Appendix J of this standard;
---Added Appendix H "Methods for Detection of Residual Ethylene Oxide";
---Added Appendix I "Biological Evaluation";
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Syringe (Needle) Standardization Technical Committee (SAC/TC95).
Drafting organizations of this standard. Shandong Xinhua Ande Medical Products Co., Ltd., Suzhou Bidi Medical Devices Co., Ltd., Shanghai Medical Devices
Testing institute.
The main drafters of this standard. Nie Yucai, Tian Xiaolei, Du Qin, Li Meng, Hua Songhe.
This standard was first published in.2005.
Sterile insulin syringe for single use
1 Scope
This standard specifies the requirements and test methods for single-use sterile insulin syringes (hereinafter referred to as syringes).
One-time use, for human injection immediately after inhaling insulin.
This standard applies to syringes that inject 40 units per milliliter (U-40) and 100 units per milliliter (U-100) of insulin.
This standard does not apply to syringes for long-term storage of insulin.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Luer) tapered joints Part 1.General requirements
(ISO 594-1.1986, IDT)
GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)
GB/T 14233.1-2008 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment-Part 2.Biological test methods
GB 15810-2001 Sterile syringes for single use (ISO 7886-1.1993, EQV)
GB 15811 Sterile injection needles for single use (ISO 7864.1993, MOD)
GB/T 16886.1 Biological evaluation of medical devices. Part 1.Evaluation and testing in the risk management process (ISO 10993-1.
2009, IDT)
GB 18278.1-2015 Sterilization Moisture Heat of Medical and Healthcare Products Part 1.Development, Validation and Routine of the Sterilization Process of Medical Devices
Control requirements (ISO 17665-1.2006, IDT)
GB 18279.1-2015 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and verification of the sterilization process of medical devices
General control requirements (ISO 11135-1.2007, IDT)
GB 18280.1-2015 Medical and health care products sterilization radiation Part 1.Medical device sterilization process development, confirmation and routine
Control requirements (ISO 11137-1.2006, IDT)
GB/T 18457 Manufacturing of stainless steel needle tubes for medical devices (ISO 9626.1991.2001, MOD)
GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems
(ISO 11607-1.2006, IDT)
ISO 7000.2014 Graphical Signs for Equipment-Registered Symbols
ISO 81714-1.2010 Design of Graphic Symbols Technical Documents Used in Products---Part 1.Basic Rules
YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements
(ISO 15233-1.2012, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Graduatedcapacity
The reference line of the piston moves one or several given volume intervals to determine the discharge from the syringe at 20℃±3℃ or 27℃±
The volume of water at 3°C.
3.2
Needlecap
A cap used to keep the needle tube sterile and protect the needle tube and needle seat (if there is a needle seat) from physical damage.
3.3
Needlesheath
A sleeve used to protect the needle tube from physical damage.
3.4
Protectiveendcaps
It is used to close the protruding part of the core rod and the pressing hand, the cone and (or) the cap of the needle tube part.
4 Product Classification
4.1 The structure of the syringe and the names of its components are shown in Figure 1.
Description.
1---Needle cap/needle sheath;
2---end cap;
3---cone hole;
4---cone head;
5---coat;
6---Piston;
7---seal ring;
8---core rod;
9 --- Laying of hands;
10---end cap;
11---Coat curling;
12---baseline;
13---Nominal capacity line;
14---scale capacity line;
15---Zero tick mark.
Note. Figure 1 is only a schematic diagram of each part of the syringe. Removable or non-removable injection needles are not part of this standard and are not shown. Piston/core rod
The combination may or may not be an integral structure, and may also include more than one sealing ring.
Figure 1 Example of an insulin syringe
4.2 The types of syringe products are as follows.
The type of syringe should be determined by the combination of packaging and needle, classified as follows.
Type 1.6% (Luer) outer conical connector, without needle, packed in a single package.
Type 2.6% (Luer) outer cone connector, without needle, with end cap.
Type 3.6% (Luer) outer conical connector, with removable or removable needle, packed in a single package.
Type 4.6% (Luer) outer cone connector with removable injection needle and end cap.
Type 5.Non-6% (Luer) connector, with a non-removable injection needle, packed in a single package.
Type 6.Non-6% (Luer) connector with non-removable injection needle and end cap.
Type 7.With a fixed needle tube, packed in a single package.
Type 8.With fixed needle tube, with end cap.
5 materials
The materials used to manufacture the syringe and its components shall meet the requirements of Chapter 6.The parts in contact with the chemical liquid should also meet the requirements of Chapter 7 and Chapter 8.
Claim.
6 Physical properties
6.1 Appearance
Observe with normal or corrected vision without magnification. The surfaces of syringes and needles in contact with insulin should be clean and free of foreign matter.
6.2 Lubricants
If lubricant is used on the inner surface of the syringe (including the piston) and the outer surface of the needle tube, observe with normal or corrected vision without magnification,
The inner surface of the syringe, the outer surface of the needle tube and the needle hole must not have any visible accumulation of lubricant.
6.3 Size range
The size range and scale range of the syringe should meet the requirements of Table 1.
Table 1 Syringe size range, scale ruler and scale capacity tolerance
Unit ruler
Nominal capacity
mL
Minimum standard
Ruler length
mm
Ruler
interval
unit
Scale capacity tolerance
Volume less than half of the nominal capacity
Equal to or greater than nominal
Half the volume
U-100
U-40
0.3 41 0.5
0.3 41 1
0.5 43 1
1.0 57 1
1.0 57 2
0.5 43 0.5
0.5 43 1
1.0 50 1
2.0 60 1
2.0 60 2
±(1.5% of nominal capacity
2% of discharge volume)
±5% of discharge volume
6.4 Scale ruler
6.4.1 Ruler
6.4.1.1 The ruler of the syringe is indicated by the scale of insulin unit, which can only indicate one intensity of insulin unit, and expressed in milliliters (mL)
Nominal capacity.
6.4.1.2 The tolerance of the scaled capacity of the syringe is tested in accordance with 6.7 of GB 15810-2001 and should meet the requirements of Table 1.
Note. The scale capacity can be easily determined by weighing the discharged liquid. See 3.1.
6.4.1.3 The scale capacity line should be uniform in thickness, between 0.2mm and 0.4mm, and should be at right angles to the long axis of the jacket.
6.4.1.4 The scale capacity line shall be evenly distributed along the longitudinal axis between the zero line and the total scale capacity line along the vertical axis.
6.4.1.5 When holding the syringe vertically, the ends of all equal-length graduated volume lines should be aligned with each other in the vertical direction, and the deviation should not exceed
0.5mm.
6.4.1.6 The length of the secondary scale capacity line is approximately one-half of the main scale capacity line.
6.4.1.7 The scale and numbers should be clearly identifiable, and the color should be clearly contrasted with the syringe.
6.4.2 Value of the scale
For the 0.3mL and 0.5mL syringes, the scale should be marked with the value of the amount on each 5 unit graduation line. For 1.0mL
And 2.0mL syringes, the ruler should be marked with the value of the amount on the scale capacity line of 5 units or 10 units.
The value height is not less than 3mm.
Hold the syringe vertically, with the zero scale line up and the ruler forward, the value should be perpendic...