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| Sterilization is one of the key processes in the production of sterile medical devices. Among the different sterilization types, each has its advantages and disadvantages. Evidence of successful sterilization is important and expected when demonstrating conformity with regulatory requirements. |
IntentionThe workshop will address the following topics related to medical device sterilization: microorganisms and their characteristics, bioburden determination for medical devices, controlled environments, clean rooms in the production of medical devices, cleaning and sterility assurance for reprocessed medical devices, and sterile barrier systems. Through the presentation of practical examples, the attendees will learn the details of compliance assurance and get the knowledge for competent performance of medical device sterilization. |
Content
- Basic sterility – microorganisms and their characteristics, medical devices’ bioburden, controlled environments and cleanrooms, cleaning and sterility assurance processes with a sterile barrier system.
- Requirements for the sterility of medical devices according to medical device directives and regulations, ISO 17665-1, and other harmonized standards regarding the sterilization of medical devices.
- Presentation of the different sterilization types (steam, dry, gas, radiation)
- The importance of contamination control of work environments and sterilization processes in relation to ISO 13485
- Procedures for the confirmation of successful sterilization of medical devices (control, validation, sterility)
- Packaging and release of sterile medical devices
- Review of the most important sterilization methods used in the medical device industry – practical cases
Methodology
The workshop will cover the theoretical basics and requirements through practical examples and exchange of experience.
Course and materials will be in English language.
| | Lecturer Marjetka Kralj Kunčič PhD is a Doctor of Science in microbiology with more than 17 years of experience in quality management systems. Her previous wor with a medical device manufacturer included not only laboratory management and quality control, but also active involvement in the development, production and regulatory compliance of medical devices, as well as quality management system compliance. Currently, she works as an SIQ auditor and a consultant in the field of medical devices and a member of the technical group for the preparation of health protection standards. |
The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.
Certification procedure
Main steps in the process of obtaining the CE mark and more about certification procedure according to Regulation (EU) 2017/745 and ISO 13485 you can find HERE.
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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