ISO 11135:2014 Ethylene Oxide Sterilization for Medical Devices

Level Specialist Duration 2 days

Available to book: Virtual classroom HK$5300 View dates and book now

This course is specifically designed for managers, product designers, system implementers, external sterilization packaging management personnel, and radiation sterilization personnel in the medical device industry related to sterile medical devices.

Participants will comprehensively study the content of ISO 11137-1:2013 (Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and ISO 11137-2:2013 (Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose) standards. They will master the characteristics of radiation sterilization, the qualification processes of IQ, OQ, and PQ in sterilization validation, routine control of sterilization, management of external sterilization providers, effective implementation of the sterilization process, as well as requirements for microbiological monitoring of sterilized products and clean production environments, to ensure the sterility assurance of sterile medical devices.

The course employs group activities, audit exercises, interactive discussions, and coaching-style sessions to deeply understand the principles, design, validation, routine control, and requirements for monitoring sterile products and environments in radiation sterilization.

Note: The training will be conducted in Chinese.

How will I benefit

Expert-led authoritative explanations by professional instructors
Comprehensive penetration of regulations and standards
Rich activities to facilitate understanding
More sharing of best practices

- Select the appropriate sterilization method based on the specific characteristics of the enterprise's products;
- Understand the definition of product families and their impact on the sterilization process;
- Master the design, validation, and routine control of radiation sterilization;
- Effectively monitor and control microorganisms in sterile products and the production environment;
- Standardize the management of external sterilization service providers and the control of sterilization processes.
- Product design personnel, process design personnel, and testing personnel for sterile medical devices;
- Managers, process personnel, and quality management personnel in sterilization factories;
- Personnel responsible for managing external sterilization service providers.
Participants who complete this course will receive a training certificate issued by the British Standards Institution (BSI).

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