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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. All raw materials meet medical-grade requirements, contain no toxic or hazardous substances, and exhibit no adverse reactions upon contact with blood or medicinal solutions.
3. Product Characteristics
1. Combines rigidity and toughness; after molding, the sampling connector maintains high dimensional accuracy, is resistant to deformation and cracking, and can securely connect blood circuit tubes with sampling devices
2. Excellent sealing performance; no blood or fluid leakage after connection, ensuring safety during blood sampling and medicament infusion
3. Good chemical stability; resistant to corrosion from blood and medicinal solutions, with no leaching of harmful substances, and does not affect blood components or medicament potency
4. Resistant to ethylene oxide (EO) sterilization; does not discolor, become brittle, or crack after sterilization, with all performance parameters remaining stable
5. Excellent biocompatibility; cytotoxicity ≤ Grade 1, no skin irritation, no sensitization reaction, meeting the requirements for materials in contact with blood and medicinal solutions
6. Good injection molding performance, excellent flowability; after molding, the surface is smooth with no burrs or pores, suitable for insertion and withdrawal operations with sampling devices
4. Technical Requirements
(I) Appearance
Uniform pellets in red and blue colors, with consistent color; free from black spots, impurities, scorched particles, bubbles, elongated strands, and fines; pellet size 2.0–3.0 mm, no agglomeration, moderate texture.
(II) Physical and Mechanical Properties
- Shore Hardness: D 32 ± 2
- Tensile Strength: ≥18.0 MPa
- Water Absorption (24h): ≤0.1%
- Impact Strength: ≥16 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, the sealing performance and dimensional stability of the sampling connector show no significant degradation, 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℃.
- Mold Temperature: 25–35℃, controlled by a water chiller to ensure smooth surface, precise dimensions, and no sink marks or burrs on the sampling connector
- Injection Speed: Medium speed (30–50 mm/s) to ensure complete filling, with no short shots or bubbles, and to guarantee connection sealing performance
- Cooling Time: 15–25 s, adjusted according to sampling connector size to ensure thorough cooling with no deformation or mold sticking
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 sampling connectors 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℃ to prevent PVC degradation and the release of toxic gases, which may affect product safety and performance.
4. 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.
5. After the finished sampling connectors 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
