Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices.
Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
- Designating products as sterile;
- Validating and routinely controlling the sterilization process; and
- Maintaining sterility over time with appropriate sterile barrier systems
This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Benefits of attending
- Gain a comprehensive overview of medical device sterilization
- Recognise the principles of the commonly applied methods of sterilization
- Learn the regulatory requirements for sterilization and how to comply
- Understand the portfolio of supporting standards and their interrelationships
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
