Fundamentals, common methods, and practical pitfalls
Two-day practical course
Sterilisation of medical devices to protect patients and users is a central element in the development, manufacture, use, and reprocessing of medical devices. When applied correctly, it enables safe medical devices and improves product quality.
It is important to distinguish between products that are manufactured under aseptic conditions and sterilised, and medical devices that are sterilised on site by the user.
Gain an understanding of the validation workflow for sterilisation processes and learn the normative foundations according to DIN EN ISO 11135, DIN EN ISO 11137, and DIN EN ISO 17665.
Learn how to select suitable methods, process parameters, and service providers; which tasks and responsibilities you have as a manufacturer, service provider, or test laboratory; and how to maintain sterility over the long term.
- Content
- Regulatory and legal requirements for the sterilisation of medical devices
- Fundamentals of medical device sterilisation
- Requirements for packaging used for sterilisation
- Sterilisation methods
- Ethylene oxide (EO) sterilisation
- Radiation sterilisation (gamma and electron beam)
- Moist heat (steam) sterilisation
- Demonstration of sterilisation/sterility
- Labelling of sterile products
- Your Benefits
- You will learn the various requirements for sterilising medical devices.
- You will understand the different sterilisation methods.
- You will know how to implement the requirements for validation and qualification of sterilisation processes.
- You will receive practical, company-ready tips.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Medical device manufacturers
- Manufacturers of sterile products
- Professionals in product management
- Professionals in Quality Assurance and Quality Management
- Research and Development
