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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 Product Characteristics
1.Base Material: Medical-grade PVC resin with good flexibility and excellent moldability
2.Stabilization System: Medical-grade environmentally friendly calcium-zinc stabilization system; may be DEHP-free and free from other phthalate plasticizers
3.Characteristics: Excellent flexibility for conforming to facial contours, providing superior sealing performance to prevent anesthetic gas leakage; non-irritating, odorless, with good biocompatibility; resistant to sterilization and low temperatures, not prone to aging; moderate transparency for easy observation of facial condition and respiratory status
3. Technical Requirements
(I) Appearance
Uniform pellets, colorless transparent or light pink 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 and Mechanical Properties
- Shore Hardness: A 78 ± 5
- Tensile Strength: ≥15.0 MPa
- Elongation at Break: ≥320%
- Water Absorption (24h): ≤0.1%
- Light Transmittance (2 mm thickness): ≥82%
(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 pink, no turbidity, no odor
(IV) Biocompatibility
- Cytotoxicity: ≤ Grade 1
- Skin Irritation: No irritation
- Delayed-type Hypersensitivity: No sensitization
- Mucous Membrane Irritation: No irritation
(V) Sterilization Adaptability
Resistant to ethylene oxide (EO) sterilization; after sterilization, does not discolor, become brittle, or crack, with no leaching of hazardous substances; EO residue in the finished product is ≤10 μg/g (in compliance with GB 15980-2009).
4. Recommended Molding Process
- Barrel Temperature: Zone 1: 130–140℃, Zone 2: 145–155℃, Zone 3: 150–160℃, Nozzle temperature: 145–155℃ (do not exceed 175℃)
- Mold Temperature: 30–40℃
- Injection/Thermoforming Pressure: 50–70 MPa, Molding Speed: Medium, Cooling Time: 15–25 s
5. Packaging, Labeling, Transportation, and Storage
(I) Packaging
- Inner packaging: Double-layer medical-grade PE vacuum bags, 25 kg per bag
- Outer packaging: Paper-plastic composite bags
(II) Labeling
Labels on outer packaging shall clearly indicate: product name, model, batch number, production date, net weight, manufacturer, "medical-grade material," "moisture-proof," and "light-proof" markings.
(III) Transportation
Transport vehicles must be dry, clean, and enclosed. Do not transport together with toxic, hazardous, odorous, or corrosive substances. Protect from sunlight, rain, and heavy pressure.
(IV) Storage
Store in a cool, dry, well-ventilated, and clean warehouse, with temperature controlled at 0–30℃ and relative humidity ≤60%. Keep away from heat sources. Shelf life: 12 months.
6. Precautions
1. This product is intended solely for the manufacture of single-use anesthesia masks, and must not be used for non-medical purposes. Molding must be carried out in a clean room.
2. Strictly control the molding temperature to prevent PVC degradation and the release of toxic gases, which may affect product safety.
3. After opening, use as soon as possible. Remaining material should be sealed and stored to prevent moisture and contamination.
4. Finished products must be sterilized by EO before use. Ensure sealing performance meets requirements with no leakage.
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
