醫療級PVC膠粒

ISO 13485認證製造商

善德生化科技生產品質穩定醫療級PVC膠粒，適合應用於以環氧乙烷滅菌之押、射出成型的醫療耗材；在安全及環保考量上，符合美國及日本藥典規範及EN-71不含八大重金屬。通過Class VI Test–USP (21 CFR, Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies) 生物相容性實驗。

 

Safety & Environmental Specifications

p pvc
1.Heavy metals （EN-71 Part 3）:
Lead (Pb), Barium (Ba), Cadmium (Cd), Chromium (Cr), Antimony (Sb), Mercury (Hg), arsenic (As) and Selenium (Se)（detecting limitation：0.25-1.5 ppm）Chromium
p pvc 8
2.Extractable substance tests（JPXVI）:
  1. Appearance
  2. Foaming test
  3. pH
  4. Potassium permanganate-reducing substances
  5. Residue on evaporation
  6. Absorption test
  7. Tin
p pvc 9
3.Biocompatiablity test (Class VI Test-USP, 21CFR,Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies）
  1. Systemic Injection Test
  2. Intracutaneous Injection and Implant Tests
  3. Intracutaneous Test Draize Scores
  4. Implant Test

Overall Specifications & Applications

SpecificationsHardness Shore PlasticizersSterilizationsApplications
Clear extrusion Shore A 61-100 Phthalates series /
Non-phthalates series		 Ethylene Oxide (ETO) ‧Soft medical tubings
‧Heart / lung bypasss kits
‧Blood tubings
‧Blood / IV containers
‧Endotracheal tubings
‧Drip chamber components
‧Stiff medical tubings
Clear injection Shore A 56-96 Phthalates series /
Non-phthalates series		 Ethylene Oxide (ETO) ‧Soft molding components
‧Face Masks
‧Enema Nozzles
‧Blood transfusion and
　 dialysis components
‧Blood transfusion set
　 components
‧Tubing connectors
‧Drip chamber component
High flow rigid injection Shore D Phthalates series /
Non-phthalates series		 Ethylene Oxide (ETO) ‧Luer components
‧Drip chamber connectiors
‧Filters
‧IV components
Super elastic recovery Shore A 61-70 Phthalates series /
Non-phthalates series		 Ethylene Oxide (ETO) ‧Peristaltic pump
‧Connection tubing

 

設備

 

 

 

認證

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