Notes

• NOTE 1 A typical example is post degradation because of interaction of oxygen from air with ‘active’ centres generated during the sterilization process.
• NOTE 2 An indirect effect might not be observed immediately after sterilization, but can be manifested over longer duration, see also ‘long duration effect’.
• NOTE Typical examples include molecular contamination during chemical sterilization, formation of radiolysis gas during g-sterilization, bond breakage due to CTE mismatch during thermal sterilization. effect that is caused by the interaction with a non-process parameter after application of a sterilization process