ISO 13485 Certified Manufacturer

 Sunder's medical grade PVC compounds can be sterilized by both ETO and steam. For compliance with healthcare and environmental protection requirements,Sunder's products are conforms to USP, JP for safety assurance and with EN-71 part 3 for free-from-heavy metal inspection.To ensure excellence in product quality, to broaden application horizon and to fulfill low toxicity requirements in Europe and America, Sunder has began researching and developing medical grade PVC compounds using non-phthalate plasticizers. Medical grade PVC compounds that can be sterilized by steam and gamma ray are also being developed.


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 ShorePlasticizersSterilizationsApplications
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
‧Tubing connectors
‧Drip chamber component
High flow rigid injection Shore D Phthalates series /
Non-phthalates series
Ethylene Oxide (ETO) ‧Luer components
‧Drip chamber connectiors
‧IV components
Super elastic recovery Shore A 61-70 Phthalates series /
Non-phthalates series
Ethylene Oxide (ETO) ‧Peristaltic pump
‧Connection tubing






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