Shanghai SUNGO Lab
Hefei SUNGO Lab
Biological evaluation to the ISO 10993 and GB/T 16886 series
Biological evaluation is central to the safety assessment of medical devices. Working to the ISO 10993 and GB/T 16886 series, we provide the full test scope - cytotoxicity, skin irritation, sensitisation, systemic toxicity, haemocompatibility and implantation - to support product registration with sound scientific evidence.
Biological evaluation of medical devices (series)
Biological evaluation of medical devices (series)
United States Pharmacopeia Class VI plastics testing
Biocompatibility evaluation of breathing gas pathways in healthcare applications
MTT assay, agar diffusion and direct contact cytotoxicity testing
Skin irritation, intracutaneous reactivity and primary skin irritation testing
Skin sensitisation by the maximisation and closed-patch methods
Acute systemic toxicity, subchronic systemic toxicity and pyrogen testing
Haemolysis, thrombogenicity, coagulation and platelet activation
Local effects after subcutaneous, intramuscular and bone implantation