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1. Applicable Standards
GB/T 15593-2020 Plastics — Poly(vinyl chloride) for transfusion (infusion) equipment
GB/T 14233.1-2008 Test methods for infusion, transfusion and injection equipment for medical use — Part 1: Chemical analysis methods
GB/T 16886 Biological evaluation of medical devices
GB 15980-2009 Hygienic standard for single-use medical supplies
2. Material Composition
Made from medical-grade PVC resin as the base material, combined with medical-grade environmentally friendly calcium-zinc stabilizers, medical-grade plasticizers, and processing aids. May be DEHP-free (di-(2-ethylhexyl) phthalate). All raw materials meet medical-grade requirements and contain no added toxic or hazardous substances.
3. Product Characteristics
Moderate rigidity; after molding, the product maintains high dimensional accuracy, is resistant to deformation, and can securely fix the female needle, preventing connection loosening, fluid leakage, and blood leakage
Excellent chemical stability; resistant to corrosion from blood and medicinal solutions, with no leaching of harmful substances, and does not affect blood components or medicinal potency
Resistant to ethylene oxide (EO) sterilization; does not discolor, become brittle, or crack after
sterilization, with all performance parameters remaining stable
Excellent biocompatibility; cytotoxicity ≤ Grade 1, no skin irritation, no sensitization reaction, meeting the requirements for blood-contact materials
Good injection molding performance, excellent flowability; free from black spots and impurities; after molding, the surface is smooth with no burrs or pores
4. Technical Requirements
(I) Appearance
Uniform pellets, colorless transparent or slightly transparent, with consistent color; free from black spots, impurities, scorched particles, bubbles, elongated strands, and fines; pellet size 2.0–3.0 mm, no agglomeration, fine texture.
(II) Physical and Mechanical Properties
- Shore Hardness: D 30 ± 5
- Tensile Strength: ≥20.0 MPa
- Water Absorption (24h): ≤0.1%
- Impact Strength: ≥15 kJ/m²
(III) Chemical Properties
- Reducing Substances (0.002 mol/L KMnO₄ consumption): ≤0.5 mL
- pH Difference: ≤0.5
- Heavy Metals (as Pb): ≤1.0 μg/mL
- Plasticizer Migration: Complies with GB/T 15593-2020 requirements
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Delayed-type Hypersensitivity: No sensitization
- Mucous Membrane Irritation: No irritation
- Hemolysis Test: Hemolysis rate ≤5%
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization. Sterilization parameters: temperature 50 ± 5℃, relative humidity 60% ± 10%,
EO concentration 800 ± 100 mg/L, sterilization time 6 hours. After sterilization, no hazardous substances are leached out, and the EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
5. Reference Molding Process
- Injection Temperature: Barrel Zone 1 (feed inlet): 130–140℃, Zone 2: 145–155℃, Zone 3: 155–165℃, Nozzle temperature: 150–160℃. Do not exceed 175℃ to prevent PVC degradation.
- Mold Temperature: 25–35℃, controlled by a water chiller to ensure stable dimensions, smooth surface, and no sink marks or burrs on the molded part
- Injection Speed: Medium speed (30–50 mm/s) to avoid internal stress generation and ensure the strength and sealing performance of the female needle hub base
- Cooling Time:15–25 s, adjusted according to the part thickness to ensure thorough cooling with no deformation
6. Packaging, Transportation, and Storage
(I) Packaging
- Inner packaging: Double-layer medical-grade PE vacuum bags, moisture-proof and contamination-proof, net weight 25 kg per bag
- Outer packaging: Paper-plastic composite bags
(II) Transportation
Transport vehicles must be dry, clean, and enclosed. Do not transport together with toxic, hazardous,
odorous, corrosive substances, or organic solvents. During transport, protect from sunlight, rain, moisture, heavy pressure, and severe impact to ensure packaging remains intact.
(III) Storage
Store in a cool, dry, well-ventilated, and clean warehouse, with temperature controlled at 0–30℃ and relative humidity ≤65%. Keep away from heat sources (at least 1 m away), open flames, and organic solvents. Under the specified storage conditions, the product has a shelf life of 12 months from the date of manufacture. After expiry, re-testing is required; the product may only be used if it meets the specifications.
7. Precautions
1. This product is a specialized raw material for medical devices, intended solely for the manufacture of female needle hub bases for single-use blood circuit tubes. It must not be used in non-medical or non-medical-device applications.
2. Molding processing must be carried out in a clean room that meets the requirements for medical device production, with controlled environmental cleanliness to avoid product contamination.
3. Strictly control the injection temperature and do not exceed 175℃. Exceeding this temperature may cause PVC degradation and the release of toxic gases, which may affect product safety and performance.
4. Dried material should be used within 4 hours. If left for too long, re-drying is required to prevent moisture absorption that may affect molding quality.
5. After opening, the product should be used as soon as possible. Remaining material should be sealed and stored to prevent moisture and contamination, and to avoid pellet moisture absorption and agglomeration.
6. After the finished female needle hub bases are produced, they must undergo strict sterilization treatment to ensure thorough sterilization and EO residue within acceptable limits before clinical use.
8. Services and Support
1. Website: www.kegfz.com
2. Email: kegfzxz@126.com / kechemxz@126.com
3. Telephone: 400 008 5899 00886-514-84634665 / 84661852
4. Fax: 00886-514-84661500
5. ISO 13485 Quality System Certification
6. MSDS provided upon request for product technology
7. 24-hour response to customer needs
