ISO 17665:2024 – Wet Heat (Steam) Sterilisation Training

Our Training Content

The purpose of this training is to comprehensively convey the requirements of the ISO 17665:2024 standard for the sterilisation of medical devices using moist heat (steam) to participants in a practical manner. The training covers the development, validation, routine monitoring and control of the sterilisation process, as well as post-sterilisation product release processes.

Participants who successfully complete the training will acquire the knowledge and competence to manage moist heat sterilisation processes using a risk-based approach and to plan and evaluate validation, requalification and change management activities in accordance with the standard.

Fundamental Principles and Objectives of the Standard

• Scope and Application Area of the ISO 17665:2024 Standard
• Characterisation of moist heat as a sterilisation agent
• Process and equipment characterisation
• Product and product family definition (Annex G)
• Definition of the sterilisation process
• Validation approach: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
• Routine monitoring and control activities
• Post-sterilisation product release
• Maintaining process effectiveness, requalification and change management

Training Method

• Interactive Presentations: Systematic and technical explanations based on standard materials
• Application-Focused Content: Process types, validation examples, and decision-making mechanisms
• Case Studies: Participants learn to apply the knowledge gained during training
• Assessment: Measurement tools that support the correct understanding of standard requirements

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 experts
• Engineers and managers responsible for moist heat 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 Will You Gain from the Training?

• Full technical mastery of ISO 17665:2024 requirements
• Competence in developing and validating moist heat sterilisation processes
• The ability to plan and evaluate IQ/OQ/PQ studies
• Effective management of routine monitoring, product release, and re-qualification processes
• Ability to establish processes compliant with ISO 13485 and relevant sterilisation standards