Fluid Technology Solutions Validation guide and performance testing summary ReNu SU Technology cartridge

1 Introduction2 Irradiation Stability3 Materials, manufacturing and regulatory compliance statements a. Materials of construction e. Compliance declaration summary h. Declaration of minimised risk of TSE/BSE 4 Compendial and non compendial testing a. Summary table f. Kligman maximisation test 1. Introduction Watson-Marlow’s ReNu SU Technology™ cartridge comprises of polyurethane tubing installed on a high density polyethylene (HDPE) manifold with nylon collets. All components are manufactured and assembled in ISO 14644 class 7 (class 10,000, Grade C) cleanrooms of production facilities operating...

4. Compendial and non compendial testing 3e. Compliance declaration summary 3g RoHS Table 1: List of compliance statements for the ReNu SU Technology cartridge and substances not found in the processing of or raw materials for the ReNu SU Technology cartridge Named substance/compliance statement Raw material Manufacturing process Final product Table 2: A summary of the compendial and ISO tests performed on the ReNu SU Technology cartridge The ReNu SU Technology cartridge has passed a number of compendia and ISO testing, a summary of the results are disclosed within. Results: ReNu SU Technology...

4e ISO 10993-6 Biological evaluation of medical devices, implantation The purpose of this test is to evaluate the solid material in direct contact with living tissue. Strips of the ReNu SU Technology cartridge (1mm x 1mm x 10 mm) and the negative control plastics were tested. The test sites were examined for inflammation, encapsulation, necrosis, haemorrhage and discolouration macroscopically. Results: The ReNu SU Technology cartridge did not demonstrate any remarkable difference as compared to the control implant sites. Therefore the ReNu SU Technology cartridge passed the requirements for ISO...

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