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S2W5-Alex
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S2W2
Assigned testing: Brinkley ISO 11135:2014 - Sterilization of healthcare products Specifications: Needs to be documented Tests: Products will be sterilized using the sterilizer and making sure that it meets the appropriate standards. Assigned to: Brinkley Aqueous testing Specifications: Materials should be monomer content, molecular weight, identification, and quantification. It must also be able to sustain the degradation of the product aging. Test: The valve will have fluid pass through it about 60 times with 1-50µl/min flowing through. Assigned to: Brinkley Must have waste disposal protocol Specification: Must be environmental friendly Test: Ensure to use materials that have lower impact on environment can be checked by looking up sources on different materials Assigned to: Brinkley Device needs to have shelf life of of about 7 years with success rates of 80% or more ...



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