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

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

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

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

Equipment

Certification