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Regulatory and Safety Overview

 TR HT 200TR 90GV-5HLV-3H
ISO 10993✓✓✓ 
USP Class VI✓✓✓✓
Animal free✓✓✓ 
Phthalate free✓✓✓✓
Bisphenol free✓✓✓✓

Bio-compatibility

 TR HT 200TR 90GV-5HLV-3H
Cytotoxicity
ISO 10993-5
✓✓✓ 
Sensitization
ISO 10993-10
✓✓✓ 
Irritation
ISO 10993-10
✓✓✓ 
Acute systemic toxicity
ISO 10993-11
 ✓✓ 
Drug master file FDA 30462