contamination or damage.
15. Validated Cleaning and Sterilization
Procedure
This device is supplied non-sterile. Therefore, this device
must be sterilized by the users (healthcare professionals)
prior to surgery using validated sterilization processes in
accordance with guidelines stipulated by the government.
Proper sterilization and handling of this clip is important
for assuring that the clips meet sterile specifications prior
to surgery as an aid in minimizing the occurrence of
infection in the surgical patient.
Other procedures are also important in minimizing
contamination in an operating room including the use of
a surgical unit with laminar flow equipment at the
surgeonʼs discretion.
Sterilization equipment should be validated to assure that
it sterilizes specific load configurations properly. The end
user is responsible to validate the sterilization process in
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