Medical Grade PVC Pellets

Item

Content

Main Parameters

1. Base Material: Medical-grade PVC resin

2. Hardness: Soft (Shore A 50–90) / Rigid (Shore D 60–85)

3. Density: 1.25–1.40 g/cm³

4. Melt Flow Rate: 0.5–3.0 g/10min

5. Volatile Matter: ≤0.3%

6. Ash Content: ≤0.1%

Key Performance

1. Biocompatibility: Complies with ISO 10993 / USP Class VI

2. Low Migration: Non-phthalate plasticizer, low heavy metal, low exudation

3. Sterilization Resistance: Withstands EO/gamma irradiation/steam sterilization

4. High Clarity, No Black Speckles, Low Odor

5. Low-Temperature Resistance, Stable Processing

Compliance Standards

YY/T 1628, T/CAMDI 047, ISO 10993, REACH/RoHS

Main Applications

Soft: Infusion/transfusion/dialysis tubing, blood bags, breathing circuits, masks

Rigid: Connectors, three-way valves, housings, sampling tubes

Identification Methods

1. Visual Inspection: High clarity, uniform particles, no impurities

2. Document Verification: Biocompatibility & migration test reports

3. Performance Test: Sterilization resistance, no irritating odor

4. Qualification Check: Medical certification & clean production proof