Presented by
Management Forum
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices.
Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization by Ethylene Oxide is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
Please note that delegates will require access to a copy of ISO 11135 to gain the most from this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 11135 - https://www.iso.org/standard/56137.html
This standard is also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc
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).
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
11 November 2024
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14310
Not ready to book yet?
for 7 days, no obligation
1 May 2025
Live online
13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14663
Until 27 Mar
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for 7 days, no obligation
10 November 2025
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 15059
Until 06 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
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Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: