Module 14 2022

22/03/2022

STERILISATION

ISO 14937: 2009 ● there is always a finite probability that a microorganism might survive regardless of the extent of treatment applied. – probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. ● Sterility of any one medical device cannot be guaranteed – Assessment is based on probability of a viable microorganisms being present

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

7

Factors affecting the success of sterilisation..(1)

• STATUS OF INCOMING RAW MATERIALS

• CLEANING AND DISINFECTION PROCEDURES • USED ON THE DEVICE • CONTROL OF THE MANUFACTURING ENVIRONMENT • CONTROL OF EQUIPMENT AND PROCESSES

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

8

4