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1. Applicable Standards
GB/T 15593‑2020 Polyvinyl chloride plastics for transfusion (infusion) equipment
GB/T 14233.1‑2008 Test methods for infusion, transfusion, injection equipment for medical use – Part 1: Chemical analysis methods
GB/T 16886 Biological evaluation of medical devices (series)
2. Raw 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 stabilizer; may be formulated without DEHP (bis(2‑ethylhexyl) phthalate), meeting the restricted‑substance requirements for medical materials.
• Characteristics: High elasticity and strong resilience; resistant to fatigue, deformation, and rupture under repeated squeezing; soft and comfortable to handle; withstands sterilization, low temperatures, and ageing; odourless and non‑irritating, with good biocompatibility; good mouldability and smooth, burr‑free surface.
3. Technical Requirements
(1) Appearance
The pellets shall be uniform in size, colourless transparent or light‑blue transparent, with consistent colour. No black spots, impurities, scorched particles, bubbles, elongated strings, or fines. Pellet size: 2.0–3.0 mm; no agglomeration.
(2) Physical Properties
• Shore hardness: A 65 ± 2
• Tensile strength: ≥ 13.0 MPa
• Water absorption (24 h): ≤ 0.1 %
• Elastic recovery rate: ≥ 90 % (after 100 repeated squeezes)
(3) 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
• Colour: clear, colourless or light blue; no turbidity, no odour
(4) Biocompatibility
• Cytotoxicity: ≤ grade 1
• Skin irritation: non‑irritating
• Delayed‑type hypersensitivity: non‑sensitizing
(5) Sterilization Adaptability
Tolerates ethylene oxide (EO) sterilization without discoloration, embrittlement, or cracking after sterilization; no leachable harmful substances; no significant loss of elasticity. Residual EO content in finished products: ≤ 10 μg/g (in accordance with GB 15980‑2009).
4. Reference Moulding Process
• Moulding temperature: injection/blow moulding temperature 130–170 ℃; do not exceed 175 ℃ to prevent decomposition of PVC and generation of toxic gases.
• Mold temperature: 25–40 ℃; use a water chiller for temperature control to ensure a smooth, burr‑free surface and uniform dimensions.
• Moulding speed: medium speed to avoid internal stress and preserve elasticity and resilience.
5. Packaging, Marking, Transport and Storage
(1) 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.
(2) Marking
Labels on both outer and inner packaging shall clearly indicate: product name, model, batch number, date of manufacture, net weight, manufacturer, applicable standard, “medical material”, and symbols for moisture protection, light protection, and keep away from heat sources. Each batch shall be accompanied by a product certificate.
(3) Transport
Transport vehicles shall be dry, clean, and enclosed. Do not transport together with toxic, harmful, odorous, corrosive substances or organic solvents. During transport, protect from sunlight, rain, moisture, heavy pressure, and severe impact to prevent pellet agglomeration.
(4) Storage
Store in a cool, dry, well‑ventilated, clean warehouse at a temperature of 0–30 ℃ and relative humidity ≤ 65 %. Keep away from heat sources, open flames, and organic solvents. Shelf life: 12 months from the date of manufacture; after expiry, the product shall be re‑tested and qualified before use.
6. Precautions
This product is a dedicated raw material for medical devices and is intended exclusively for the manufacture of disposable ear bulbs, ear suction bulbs, and similar medical products. It must not be used in non‑medical or non‑medical‑device applications.
Moulding shall be carried out in a clean room that meets the cleanliness requirements for medical‑device production to avoid product contamination.
Strictly control the moulding temperature; do not exceed 175 ℃ to prevent decomposition of PVC, which may release toxic gases and affect product safety and elasticity.
Finished ear bulbs must undergo strict sterilization after production; the sterilization process shall comply with ethylene oxide sterilization standards to ensure complete sterilization, residual levels within limits, and good elasticity.IX. Services and Support
7. 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
