ISO 11135:2014 – Ethylene Oxide (EO) Sterilisation Training

Our Training Content

The aim of this training is to comprehensively convey the requirements of the ISO 11135:2014 standard for the sterilisation of medical devices with ethylene oxide (EO) to participants in a practical manner. The training aims to provide technical competence in the development, validation, routine monitoring and control of the EO sterilisation process.

Participants who successfully complete the training will acquire the knowledge and skills to manage EO sterilisation processes using a risk-based approach and to plan and evaluate validation and re-qualification activities in accordance with the standard.

Fundamental Principles and Objectives of the Standard

• Scope of the ISO 11135 Standard
• Fundamental Principles of Ethylene Oxide Sterilisation
• Process Development and Validation Requirements
• Routine Monitoring and Control Activities
• Management of Health, Safety and Environmental Risks

Training Method

• Interactive Presentations: Technical explanations specific to EO sterilisation
• Application-Focused Content: Validation, biological indicators, and process examples
• Case Studies: Participants learn to apply the knowledge gained during the training
• Assessment: Measurement tools that support the correct understanding of standard items

Who is it suitable for?

• Technical and quality personnel working in medical device manufacturers
• Sterilisation and validation specialists
• Quality Assurance/Quality Control personnel
• Internal and external auditors, technical specialists
• Managers and engineers responsible for EO sterilisation processes

Training Dates and Registration

Our training courses are conducted online. For registration and detailed information, please visit our website or contact us at support@pcatrainings.com.tr.

What Do You Gain from Training?

• Full technical mastery of ISO 11135:2014 requirements
• Competence in the development and validation of EO sterilisation processes
• Ability to plan and evaluate IQ-OQ-PQ studies
• Effective management of routine monitoring, control, and re-qualification processes
• Ability to establish sterilisation processes compliant with regulations and ISO 13485