Use of a (proposed) standard protocol to validate Terumo TSCD-II connections between dissimilar blood bag tubing.
Vox Sang
; 91(3): 264-9, 2006 Oct.
Article
in En
| MEDLINE
| ID: mdl-16958840
ABSTRACT
BACKGROUND AND OBJECTIVES:
ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing. MATERIALS ANDMETHODS:
The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests.RESULTS:
All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N.CONCLUSION:
Successful connections have been made between dissimilar tube types and this work does not support the requirement for 'tight' tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Blood Preservation
/
Materials Testing
/
Sterilization
/
Blood Component Transfusion
Limits:
Humans
Language:
En
Journal:
Vox Sang
Year:
2006
Document type:
Article
Affiliation country:
United kingdom