ISO 10993 medical device

NJSILTM NJ-1802-20FA/B 20 shore A, 1 to 1 mix, molding and injection molding LSR   FEATURES High transparency Biocompatibility   Formulated to meet : FDA 21 CFR 177.2600 and BfR, XV ISO 10993 Cytotoxicity Sensitization Intracutaneous reactivity Systemic toxicity Hemocompatibility Genotoxicity    APPLICATION NJ-1802-20FA/B LSR has historically been used in a wide range of applications: Medical devices Food contact   DESCRIPTION: NJSILTM NJ 1802 20FA/B LSR are general purpose LSR developed to give excellent performances for various applications due to their high transparency and excellent mechanical properties.   MEDICAL APPLICATION: NJSILTM NJ-1802-20FA/B is qualified to address the tests described in ISO10993. Meets or exceeds acceptance criteria for Cytotoxicity (ISO10993 5: 2009), Sensitization (ISO10993 10: 2010), Irritation/Intracutaneous reactivity (ISO10993 10: 2019), Systemic toxicity (acute) and Subchronic toxicity (as tested by implantation) (ISO…