Register Early To Save
Enrol before 30 October to save 20% (Nov Course)
Discount has been applied to the price above. VAT, if applicable, will be added.
Sale
9 reviews for
Understanding Ethylene Oxide Sterilisation for Medical Devices
18 November 2025 | Short Online Course
Original price was: €415.€332Current price is: €332.
1 day live online training |Â Master ethylene oxide sterilisation for your devices with this 1-day course – Click Here to Download the Agenda
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Learn more about the course by toggling through the tabs below (Trainer, Agenda and Who Should Attend?)
Course Information
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
18 November 2025 | 14 April 2026 | 3 November 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.
Ethylene oxide sterilisation principles
- Microbiocidal principles of ETO
- ETO sterilisation process stages and critical parameters
- Product characteristics affecting / affected by ETO
Validation of ethylene oxide sterilisation
- Installation and operational qualification (IQ & OQ)
- Microbiological performance qualification (MPQ)
- Physical performance qualification (PPQ)
- Product adoption into existing validations
Session 2
120 mins | 1:00 PM UK
Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.
Routine monitoring and control
- Product release from sterilisation
- Assessment of change and revalidation
- Bioburden monitoring
Ethylene oxide residual control and testing
- Establishing limits
- Testing process and considerations
- Product release considerations
Jack Walters academic and industry research background is well suited to sterilisation and the associated technologies, having covered material science and engineering through to microbiology and toxicology. He was formally a member of BSI, CEN and ISO committees for sterilisation of healthcare products, as well as a subject matter expert on disinfection, packaging and sterilisation at a leading notified body. For the past number of years however he has focussed on provision of auditing, training and consultancy services via his own company founded in 2017 and selected partners, and remains an active member of a number of committees such as at the Institute of Decontamination Sciences as a member of the education committee.
Annette Callaghan A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
This short live online course is suitable for professionals involved with ethylene oxide sterilisation and includes:
- Quality assurance
- Regulatory affairs
- Production managers
- Engineers
- Supply chain managers
- Internal auditors
- Packaging and environmental engineering
9 reviews for Understanding Ethylene Oxide Sterilisation for Medical Devices
18 November 2025 | Short Online Course
Related products
-
Sale
This product has multiple variants. The options may be chosen on the product page
€587 €1,772Price range: €587 through €1,772Gathering Clinical Evidence for Medical Devices
11, 12 & 13 November 2025 | Hybrid Training | London
-
Sale
This product has multiple variants. The options may be chosen on the product page
Original price was: €1,890.€1,416Current price is: €1,416.Regulatory Affairs for Combination Products (Drug/Device and Device/Drug)
3 & 4 December 2025 | Hybrid Training | London
-
This product has multiple variants. The options may be chosen on the product page
€1,653US FDA Regulatory Strategies for Medical Devices & IVDs
22 September 2025 | 4-Day Live Online Course
Great Bear Healthcare (verified owner) –
The trainer was informative and knowledgeable of the subject and gave examples that helped understanding without too much jargon. Where there was technical jargon he explained it very well.
BIOCAPTIVA –
n/a
Pelican Healthcare Ltd (verified owner) –
n/a
Sterimedix –
n/a
Meditech Systems Limited –
The course was very informative and i really liked the fact that you could ask questions throughout.
Vernacare Internal Ltd (verified owner) –
Good course, helped me to understand the topic and the standards.
BIORA AB / Straumann Group –
The trainer had excellent knowledge of the area and the content was at the appropriate level. It was easy to understand the trainer also for me that don´t have English as native language. I can really recommend this course.
Peters Surgical International Co., Ltd –
na
Meditech Systems Limited –
The course was very interesting, and everybody involved was very professional.