Some standard content:
Preface
YY/T0243—2003
This standard is a revised version of YY/T0243-1996, and supplements and improves the original standard. The main differences between this standard and YY/T0243-1996 are as follows:
- Add piston aging performance index,
The original standard's easy oxidation index: from ≤0.5mL to ≤0.4mL, - Add the test method for yellowing of rubber stopper,
In the inspection rules, type inspection is added.
From the date of implementation, this standard will replace YY/T0243—1996. Appendix A of this standard is a normative appendix. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Syringes (Needles). The drafting unit of this standard: Shanghai Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. The main drafter of this standard: Ding Biao.
The previous versions of the standards replaced by this standard are: YY/T0243—1996.
1 Scope
Disposable Sterile Syringe Pistons
YY/T0243—2003
This standard specifies the classification and naming, requirements, test methods, inspection rules and markings, instructions for use, packaging, transportation and storage of disposable sterile syringe pistons (hereinafter referred to as pistons). This standard applies to disposable sterile syringe pistons, which are used to match disposable sterile syringes. 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard. GB/T191-2000 Pictorial marking for packaging, storage and transportation GB3512-2001 Accelerated aging and heat resistance test for vulcanized rubber or thermoplastic rubber in hot air GB9969.1-1998 General provisions for instructions for use of industrial products GB/T2828-1987 Sampling procedures and sampling tables for batch inspection (applicable to inspection of continuous batches) GB/T2829-2002 Sampling procedures and sampling tables for periodic inspection (applicable to inspection of production process stability) GB/T7759-1996 Determination of compression set of vulcanized rubber or thermoplastic rubber at room temperature, high temperature and low temperature GB/T14233.1-1998 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB/T14233.2-1993 Inspection methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods GB/T 16886.1—2001
Biological evaluation of medical devices Part 1: Evaluation and testing (idtISO10993.1:1997) YY/T0313—1998 Packaging, marking, transportation and storage of medical polymer products 3 Requirements
3.1 Appearance requirements
3.1.1 The piston surface shall not have rubber threads, rubber scraps, foreign impurities and frost. 3.1.2 The appearance color of the piston shall be uniform, and there shall be no obvious bubbles, lack of glue, cracks, cuts and eccentricity on the surface. 3.1.3 There shall be a clear edge reference line on the top of the side of the piston seal ring, the reference line shall be complete, and the contact with the inner surface of the syringe jacket shall be close. 3.1.4 The diameter of the trimmed part of the piston shall not be greater than the diameter of the piston seal ring. 3.1.5 The rubber plug shall not be yellowed according to the method in Appendix A. 3.2 Physical properties
The physical and mechanical properties of the piston material shall comply with the provisions of Table 1. Table 1 Physical and mechanical properties of piston materials
Hardness (Shore A type)
Compression set/(%)
After aging
(70℃ ×72 h)/(%)
Change rate of tensile strength
Change rate of elongation at break
Note: Compression set condition is compression at 40℃±1℃ for 120_2h. Index
YY/T0243—2003
3.3 Chemical properties
3.3.1 Extractable metal content
The total content of heavy metals such as lead, zinc, tin and iron in the piston leaching solution should be ≤5μg/mL, and the content of cadmium should be ≤0.1μg/mL. 3.3.2 Acidity
The pH value of the piston leaching solution should be compared with the blank solution of the same batch, and the difference in pH value should not exceed 1.0. 3.3.3 Oxidizing agent
Compared with the same batch of blank control solution, the difference in volume of 0.002mol/L potassium permanganate solution consumed by 20mL piston leaching solution should be ≤0.4mL.
3.4 Biological properties
3.4.1 The piston should not release any substances that have side effects on patients. The toxicity of the piston material should be evaluated according to GB/T16886.1--2001, and the test results should show no toxicity. 3.4.2 The piston should be non-pyrogenic.
3.4.3 The hemolysis rate of the piston should be ≤5%.
3.4.4 The piston should have no systemic acute toxicity.
4 Test method
4.1 Piston appearance
Observe visually, it shall meet the requirements of 3.1. 4.2 Physical and mechanical properties of piston material
4.2.1 Hardness (Shore A type)
Perform according to the method specified in GB/T531-1999, it shall meet the requirements of 3.2. 4.2.2 Compression permanent deformation
Perform according to the method specified in GB/T7759-1996, it shall meet the requirements of 3.2. 4.2.3 Performance change rate after aging
Perform according to the method specified in GB3512-2001, it shall meet the requirements of 3.2. 4.3 Chemical property test
4.3.1 Preparation of leaching solution
Calculate the piston surface area according to the piston drawing or the actual object, take a piston with a surface area of not less than 150cm2 without external pollution, add 2ml of water (pure water or water for injection) per 1cm2, place it in a glass container, keep the temperature at 37℃±1℃ for 8h (1h for easy oxidation), separate the sample from the liquid, cool to room temperature, and use it as the test solution. At the same time, take the same volume of water and place it in a glass container, and prepare a blank control solution in the same way.
4.3.2 Extractable metal content
Take the leaching solution and conduct the test according to the method specified in 5.6 of GB/T14233.1-1998. The cadmium content shall be tested according to the method specified in 5.9.1 of GB/T14233.1-1998, which shall meet the requirements of 3.3.1. 4.3.3 pH
Take the leaching solution and carry out the test according to the method specified in 5.4 of GB/T14233.1-1998, which shall comply with the provisions of 3.3.2. 4.3.4 Oxidizing agent
Take 20mL of leaching solution and carry out the test according to the method specified in 5.2.2 of GB/T14233.1-1998, which shall comply with the provisions of 3.3.3. 4.4 Biological performance test
4.4.1 Pyrogen test
Put the piston into a sterile, non-pyrogenic stoppered vessel, add 1mL.0.9g/L sterile non-pyrogenic sodium chloride injection solution for every 3cm2 of piston surface area, shake for several minutes until the piston is completely immersed, and place in a 60℃±2℃ constant temperature box for 2h. Before the test, place the leaching solution in a pressure steam sterilizer at 115℃ for 30min, and the leaching solution shall not be stored for more than 2h. The test is to be carried out in accordance with the method in Chapter 32 of GB/T14233.2-1993 and shall comply with the provisions of 3.4.2. 4.4.2 Hemolysis test The test is to be carried out in accordance with the method in GB/T14233.2-1993 and shall comply with the provisions of 3.4.3. 4.4.3 Systemic acute toxicity test The test is to be carried out in accordance with the method in GB/T0243-2003 The test is to be carried out in accordance with the method in GB/T14233.2-1993 and shall comply with the provisions of 3.4.4. 5 Inspection rules 5.1 Acceptance The piston shall be inspected by the quality inspection department of the manufacturer and shall be submitted for acceptance only after it has passed the inspection 5.2 Batch rules The piston shall be submitted for inspection in batches, and the inspection is divided into factory inspection (batch inspection) and type inspection (periodic inspection). A production batch is composed of products manufactured under the same conditions of materials, processes, equipment and production time. Each production batch constitutes an inspection batch. 5.3 Factory inspection (batch inspection) (recommended) 5.3.1 It should be carried out in accordance with the provisions of GB/T2828-1987. 5.3.2 Sampling plan type adopts one-time sampling, starting from normal inspection sampling, and its non-conforming classification, inspection items, inspection level and qualified quality level are in accordance with the provisions of Table 2.
Table 2 Factory inspection (batch inspection)
Non-conforming product classification
Inspection items
Inspection level
All qualified
Note: The physical and mechanical properties of the piston material can be tested according to the same raw material batch. 5.4
Type inspection (periodic inspection)
Type inspection should be carried out in the following cases: a)
Before new products are put into production (including old products transferred to the factory for production); at least once a year in continuous production;
When the interval is more than half a year, it is put into production again;
When there are major changes in design, process or materials; When the national quality supervision and inspection agency proposes a type test requirement. Inspection items
Should be in accordance with all the requirements of Chapter 3.
All qualified
5.4.3 Type inspection (periodic inspection) shall be carried out in accordance with the provisions of GB/T2829-2002. 5.4.4 Sampling method
3.1.1, 3.1.2
3.1.3, 3.1.4
Random sampling shall be conducted from the batches that have passed the factory inspection. The number of samples shall be in accordance with the provisions of Table 3. Type inspection (periodic inspection) adopts a single sampling plan. Its unqualified classification, test group, inspection items, discrimination level, RQL (unqualified quality level) and sampling plan shall be in accordance with the provisions of Table 3. Table 3 Type inspection (periodic inspection)
Classification of non-conforming products
Inspection items
Discrimination level
Sampling plan
All qualified
All qualified
3.1.1, 3.1.2
3.1.3, 3.1.4
12(1,2)
YY/T 0243-—2003
6 Classification and marking
6.1 Classification
The type and basic size of the piston shall comply with the user's drawing requirements. 6.2 Piston material
The material of the piston shall be a polymer material that has no toxic side effects on the human body. If the outer surface of the piston is coated with a lubricant, it shall meet the medical requirements (except for viscosity). 7 Marking, Instructions for Use
7.1 MarkingbzxZ.net
7.1.1 General requirements
Should meet the requirements of YY/T0313-1998. 7.1.2 Primary packaging marking
The following markings should be on the primary packaging:
a) manufacturer's name, address and trademark;
b) product name, model or specification;
c) quantity;
d) production batch number or date.
7.1.3 Outer packaging markings
Outer packaging shall have the following markings:
Manufacturer name, address and trademark,
b) Product name, model or specification,
Quantity,
d) Product standard number, registration number;
Production batch number or date,
Expiration date;
g) Gross weight, net weight;
h) Volume (length × width × height);
i) Packaging storage and transportation graphic markings shall comply with the provisions of GB/T191-2000. 7.2
Instructions for use
Each outer packaging shall be accompanied by a product instruction manual and a certificate of inspection. 7.2.1 The format of the instruction manual shall comply with GB9969.1-1998, and the instruction manual shall contain at least the following contents: a) Scope of application; b) Storage and transportation conditions; Instructions for use and precautions; Warnings; Others: manufacturer's guarantee, after-sales service matters, contact methods, other matters that need to be explained to the user; e) Instruction manual version number or publication date. 7.2.2 The certificate shall contain the following contents: a) Manufacturer's name; b) Product name and specifications; c) Product standard number, d) Inspection date and inspector code. 8 Packaging, transportation and storage 8.1 Packaging 8.1.1 Primary packaging Sealed packaging with double-layer plastic bags.
8.1.2 Outer packaging
Material that can fully protect the contents during normal transportation and storage should be used. Transportation
During transportation, it should be protected from direct sunlight and rain and snow. 8.3 Purchase and storage
YY/T0243-—2003
The packaged rubber plugs should be stored in a clean room with a relative humidity not exceeding 80%, no corrosive gases and good ventilation. 5
YY/T 0243--2003
Appendix A
(Normative Appendix)
Test method for yellowing of rubber plugs
20 rubber plugs/batch
Apply silicone oil to the outer surface of the rubber plugs
Put 4 rubber plugs on the syringe body and seal them in a small
packaging bag
Put them in an oven
70℃ for one week (168 h)
Judgment method: The bottom of the rubber plug (the outer surface of the cone) shall not be yellowed. 62 The certificate of conformity shall contain the following information:
a) manufacturer's name;
b) product name and specifications;
c) product standard number,
d) inspection date and inspector code.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Primary packaging
Use double-layer plastic bags for sealed packaging.
8.1.2 Outer packaging
Material that can fully protect the contents during normal transportation and storage. Transportation
During transportation, it should be protected from direct sunlight and rain and snow. 8.3 Purchase and storage
YY/T0243-—2003
The packaged rubber plugs should be stored in a clean room with a relative humidity not exceeding 80%, no corrosive gases and good ventilation. 5
YY/T 0243--2003
Appendix A
(Normative Appendix)
Test method for yellowing of rubber plugs
20 rubber plugs/batch
Apply silicone oil to the outer surface of the rubber plugs
Put 4 rubber plugs on the syringe body and seal them in a small
packaging bag
Put them in an oven
70℃ for one week (168 h)
Judgment method: The bottom of the rubber plug (the outer surface of the cone) shall not be yellowed. 62 The certificate of conformity shall contain the following information:
a) manufacturer's name;
b) product name and specifications;
c) product standard number,
d) inspection date and inspector code.
8 Packaging, transportation and storage
8.1 Packaging
8.1.1 Primary packaging
Use double-layer plastic bags for sealed packaging.
8.1.2 Outer packaging
Material that can fully protect the contents during normal transportation and storage. Transportation
During transportation, it should be protected from direct sunlight and rain and snow. 8.3 Purchase and storage
YY/T0243-—2003
The packaged rubber plugs should be stored in a clean room with a relative humidity not exceeding 80%, no corrosive gases and good ventilation. 5
YY/T 0243--2003
Appendix A
(Normative Appendix)
Test method for yellowing of rubber plugs
20 rubber plugs/batch
Apply silicone oil to the outer surface of the rubber plugs
Put 4 rubber plugs on the syringe body and seal them in a small
packaging bag
Put them in an oven
70℃ for one week (168 h)
Judgment method: The bottom of the rubber plug (the outer surface of the cone) shall not be yellowed. 6
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.