Procurement Notice for Syringe Pistons for Single-Use Syringes (No.: JXHD202309001)

3.1 Scope

This technical requirement specifies the technical requirements, marking, packaging, transportation, and storage for pistons used in single-use sterile syringes.

3.2 Referenced or Cited Documents

3.2.1 The provisions contained in this technical document have been formulated in accordance with the relevant requirements set forth in YY/T 0243-2016, “Plungers for Single‑Use Sterile Syringes.”

3.2.2 Referenced Standard: GB 15810-2019, Single-use Sterile Syringes.

3.3 Appearance

3.3.1 The piston surface shall be clean and free of adhesive filaments, Hair , rubber crumbs and foreign matter; no blooming shall be observed.

3.3.2 The piston surface shall be free from visible bubbles, defects, and cracks.

3.3.3 The piston end shall have a clear datum line and shall be intact.

3.3.4 The piston side shall be equipped with a complete sealing ring;

3.3.5 The diameter of the piston trimming line shall not exceed the diameter of the piston sealing ring.

3.3.6 If a lubricant is applied to the piston surface, it must remain invisible under normal or corrected-to-normal vision. Obvious lubricant Gathering.

3.3.7 Conduct the yellowing resistance test in accordance with the test method specified in Appendix B of YY/T 0243-2016; the color of the piston shall not exhibit any significant change before and after aging.

3.4 Physical Properties

Project

Indicator

3.4.1 Hardness (Shore A)

57-65

3.4.2 Compression Set [Compression at (40±1)°C for 1200–2 h] Permanent compression set of the finished piston (test method参照YY/T 0243-2016, Appendix C)

≤40

3.4.3 Rate of change in tensile strength of the piston before and after aging, under conditions of 70°C for 72 hours.

Should not exceed ±20

3.4.4 The change rate of elongation at break of the piston before and after aging, under conditions of 70°C for 72 hours.

3.4.5 Piston permanent compression ratio (finished product), metal plug gauge, (%) (compressed for 24 h at 70°C; see Appendix C)

≤40

3.4.6 Piston Dimensions

It shall comply with the purchaser’s product drawing requirements.

3.5 Chemical Properties

3.5.1 Acidity/Alkalinity: The difference between the pH of the extract and that of the blank solution shall not exceed 1.0.

3.5.2 Extractable Metal Content: The test shall be conducted using an approved trace‑analysis method (e.g., atomic absorption spectroscopy). The total concentration of lead, tin, zinc, and iron in the extract shall not exceed 5 mg/L, and the cadmium concentration shall be less than 0.1 mg/L.

3.5.3 Reducing substances: When compared with an equal volume of the blank control solution from the same batch, the difference in the volume of 0.002 mol/L potassium permanganate solution consumed by the extract shall not exceed 0.4 mL.

3.5.4 UV Absorbance: Within the 220 nm to 360 nm range, the UV absorbance of the extract shall not exceed 0.2.

3.5.5 Ash: The residual ash shall not exceed 60%.

3.6 Biological Properties

3.6.1 The live vaccine shall be free of pyrogens.

3.6.2 The cytotoxicity of live cells shall not exceed Grade 2.

3.6.3 The hemolysis rate of the piston shall be less than 5%.

3.6.4 The live cold should not elicit any irritant response.

3.6.5 The live culture shall be non‑allergenic.

3.6.6 The piston shall exhibit no acute systemic toxicological reactions.

3.7 Service Performance

3.7.1 After the piston, barrel, and plunger rod are assembled into a syringe and sterilized by ethylene oxide, the residual volume of the syringe shall comply with the requirements specified in GB 15810-2019, clause 5.7.1.

3.7.2 After the piston, barrel, and plunger rod are assembled into a syringe and subjected to ethylene oxide sterilization, the seal integrity of the syringe body shall comply with the requirements specified in GB 15810-2019, clause 5.7.2.

3.7.3 After the piston, barrel, and plunger rod are assembled into a syringe and subjected to ethylene oxide sterilization, the syringe’s sliding performance shall comply with the requirements specified in GB 15810-2019, clause 5.7.3.

3.8 Marking, Packaging, Transportation, and Storage

3.8.1 Marking

1) The primary packaging of the product shall bear the manufacturer’s name and address, the product name, specifications and model, quantity, and batch number or date of manufacture, in accordance with the requirements of YY 0313-2014.

2) The product’s outer packaging shall bear the manufacturer’s name, address, trademark, product name, specifications and model, quantity, product standard number, production batch number or date, shelf life, gross weight, net weight, and dimensions, all in compliance with the provisions of YYO313-2014. Packaging and transportation marking symbols shall comply with the requirements of GB/T 191-2008.

3.8.2 Packaging

1) The product’s primary packaging is sealed in a double-layer medical-grade plastic bag.

2) The outer packaging shall be made of materials that provide adequate protection to the contents during normal handling, transportation, and storage; the packaging shall be intact and clean.

3.8.3 Transportation: During transportation, the product shall be protected from direct sunlight and exposure to rain and snow.

3.8.4 Storage: Packaged rubber stoppers shall be stored in a well-ventilated indoor environment free from corrosive gases, and shall be protected against…

The piston is fully protected.

3.9 Product Traceability Requirements

3.9.1 Winning Bid Product Supply Each Each month can have no more than 2 specifications. Production batch number.

3.9.2 The manufacturer’s factory inspection report for the winning bidder shall clearly indicate the batch of products. Batch numbers of major raw and auxiliary materials upon shipment.

3.9.3 The outer packaging of the product shall bear the manufacturer’s name, address, product name, specifications and model, quantity, the applicable product standard number, batch number or date of manufacture, shelf life, and other relevant information. QR code 。