Phoenix TPEs passed ISO 10993-5 and ISO 10993-10 Test

2016.04.12
Phoenix TPE  ISO10993-10 Skin Sensitization Test Report
Phoenix TPE ISO 10993-10  Intracutaneous Irritation Test Report
Modern-day development for medical devices is rapid-changing. More efficient, innovative technology, process, equipment, and more human friendly material are adopted for state-of-the-art medical devices. Thermoplastic Elastomers is just one kind of many.
 
According to the nature and duration of the anticipated contact with human tissues when in use medical device should be carefully tested for biocompatibility to avoid potential physiological damage by toxic, irritative or hypersensitive substances produced or contaminated during manufacturing. Therefore, material or medical device was subjected to in vitro cytotoxicity test to evaluate toxicity of
substances that could be extracted or released from the medical device or material constituents according to the ISO 10993 (2009) Biological evaluation of medical device-Part 5, as well as in vivo skin irritation and sensitization test according to ISO 10993 Part 10.
 
The TPEs specialist Phon Tech has submitted Phoenix 03, 04 series Thermoplastic Elastomers material for biocompatibility test. The test result indicated that Phoenix 03, 04 series material do not induce cytotoxic effect on L-929 fibroblast cells, nor produce skin irritation or sensitization. Phoenix 03, 04 series TPE material fulfill the basic requirement of biocompatibility for medical devices, such as syringe gasket, IV set tube, medical tube, and medical balloon tamponade. 
 
Contact our sales representative or send us e-mail for more details. Thank you.
 
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