STERILE TUBING WELDER , T - SPECS

2026-11-03

1 . Closed - System Sterile Welds . The device shall produce sterile welds without introducing particulates or chemical residues into the fluid path . 2 . Wet / Dry Flexibility . The device shall reliably connect PVC tubing in any combination of wet - to - wet , dry - to - dry , and wet - to - dry . 3 . Weld Strength . Welds shall meet or exceed the tensile strength requirements applicable to blood bag tubing ; vendor shall state the validated standard used . 4 . Weld Cycle Time . The typical weld cycle shall be ≤ 30 seconds from clamp engagement to completed weld ( or vendor - stated equivalent performance ), to support high - throughput operations . 5 . Weld Integrity Verification . Vendor shall provide recommended weld inspection criteria and / or an integrity test method or kit , or document compatibility with a standard integrity test procedure for closed - system welds . 6 . Tubing Material . Device shall be validated for PVC medical tubing commonly used in blood / component processing sets . 7 . Tubing Size Range . Device shall accommodate typical blood - bank PVC sizes , e . g ., OD ~ 3 . 9 – 4 . 5 mm and ID ~ 2 . 9 – 3 . 1 mm , or vendor ’ s equivalent validated range ; vendor shall specify the exact ranges supported . 8 . Sterile Heating Method . The heating element / wafer ( or equivalent ) shall operate at a validated temperature sufficient to cut / weld PVC while maintaining sterility ( e . g ., ~ 300 ° C ). Vendor shall state the validated operating temperature and sterility assurance rationale . 9 . Closed - Path Assurance . The device shall maintain a functionally closed system during weld operations . 10 . Electrical Safety / EMC . Device shall conform to applicable medical electrical safety / EMC standards ( e . g ., IEC 60601 - 1 and 60601 - 1 - 2 or vendor equivalent ). ( Vendor to list certifications .)

California

2026-05-10