TYGON® ND 100-65, one of the medical industry’s first non-DEHP tubing offerings, has been formulated specifically to meet the demanding challenges of applications such as dialysis, chemotherapy drug delivery and minimally invasive surgeries.
Characteristics
From open heart surgery to dialysis, ND 100-65 tubing has been specially formulated for medical device manufacturers that require a non-DEHP plasticized material. ND 100-65 sets the new standard for performance and durability in blood contact applications.
Based upon a unique chemistry developed by Saint-Gobain, TYGON® ND Series tubing was formulated to be Registration, Evaluation, Authorization and restriction of Chemical substances (REACH) compliant for DEHP. To ensure compliance, every individual compound lot is tested to ensure DEHP levels are <1000 ppm. During the extrusion process, individual product dimensions are maintained and monitored through in-line micrometers and off-line verification with computerized imaging equipment.
Consistent with many medical tubing requirements, ND-100-65 material can be effectively bonded/welded using the following methods: heat, electronic (RF)/ultrasonic, solvent and adhesive. Factors to be considered when selecting the components include: security of the bond required, effect on the integrity of the materials to be joined and presence of residues or extractables that may affect biocompatibility. When bonding procedures are not used, mechanical clamps are recommended to provide secure attachment.
Biocompatibility
TYGON® ND 100-65 is made from a biocompatible non-DEHP polymer material developed
specifically for blood contact medical device needs. It meets USP Class VI, ISO 10993, European Pharmacopoeia 3.1.1.2 and European REACH requirements. It is also non-hemolytic and non-pyrogenic.
Features/Benefits
• Crystal clear for easy visualization of fluid flow
• Ideal for contact with bodily fluids
• Non-wetting surface permits complete drainage
• Meets USP Class VI criteria
• REACH compliant
• Withstands ETO, gas and gamma sterilization
Typical Applications
• Minimally invasive devices
• Blood and IV solutions
• Dialysis equipment
• Inhalation equipment
• Chemotherapy drug delivery
• Kidney dialysis pumps
• Peristaltic pumps
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