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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
2. Material Composition and Characteristics
• Base Material: Medical-grade high-elasticity PVC resin with excellent flexibility and good elastic recovery
• Stabilization System: Medical-grade environmentally friendly calcium-zinc stabilizers; may be DEHP-free (di-(2-ethylhexyl) phthalate), complying with hazardous substance control requirements for medical materials
• Characteristics:High elasticity and strong resilience; resistant to fatigue, deformation, and damage under repeated compression; soft hand feel for comfortable operation; resistant to sterilization, low temperatures, and aging; odorless and non-irritating, with excellent biocompatibility; good molding performance with a smooth, burr-free surface
3. Technical Requirements
(I) Appearance
Uniform pellets, colorless transparent or light blue 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.
(II) Physical Properties
- Shore Hardness: A 65 ± 2
- Tensile Strength: ≥13.0 MPa
- Water Absorption (24h): ≤0.1%
- Elastic Recovery Rate: ≥90% (after 100 repeated compressions)
(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
- Color: Clear and colorless or light blue, no turbidity, no odor
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Skin Irritation: No irritation
- Delayed-type Hypersensitivity: No sensitization
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization; after sterilization, does not discolor, become brittle, or crack, with no leaching of hazardous substances and no significant decrease in elasticity; EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
4. Packaging, Labeling, 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) Labeling
Labels on both outer and inner packaging shall clearly indicate: product name, model, batch number, production date, net weight, manufacturer, applicable standards, "medical-grade material," "moisture-proof," "light-proof," and "keep away from heat sources" markings. Each batch shall be accompanied by a product certificate.
(III) 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 prevent pellet agglomeration.
(IV) 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, 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.
5. Precautions
1. This product is a specialized raw material for medical devices, intended solely for the manufacture of single-use ear bulbs, ear syringes, and other medical products. It must not be used in non-medical or non-medical-device applications.
2. Molding must be carried out in a clean room that meets the cleanliness requirements for medical device production to avoid product contamination.
3. Strictly control the molding temperature and do not exceed 175℃ to prevent PVC degradation and the release of toxic gases, which may affect product safety and elasticity.
4. After the finished ear bulbs are produced, they must undergo strict sterilization treatment. The sterilization process shall comply with ethylene oxide sterilization standards to ensure thorough sterilization, residue levels within acceptable limits, and good elasticity.
6. 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
