Presented by
Management Forum
Sterilization of Medical Devices Training Course
A comprehensive introduction
Sterile devices are free of viable microorganisms and 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 is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
★★★★★ "Very structured training at perfect pace, covering all important point. Very good interaction."
19-20 October 2023
from £1299.00
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
- Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
- UK Conformity Assessed (UKCA) Marking for Medical Devices
- Sterilization of Medical Devices
- An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
- Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
- Non-Conformance and Corrective Action for Medical Device Manufacturers
Overview
Sterile devices are free of viable microorganisms and 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 is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards on:
- Designating products as sterile;
- Validating and routinely controlling the sterilization process; and
- Maintaining sterility over time with appropriate sterile barrier systems
This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits in attending
- Gain a comprehensive overview of medical device sterilization
- Recognise the principles of the commonly applied methods of sterilization
- Learn the regulatory requirements for sterilization and how to comply
- Understand the portfolio of supporting standards and their interrelationships
Who should attend
- Microbiologists and sterilization professionals
- Quality Management System (QMS) specialists
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
Please note that delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:
ISO 11135 - https://www.iso.org/standard/56137.html
ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.html
These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
The Sterilization of Medical Devices course will cover:
Introduction and welcome
The use of standards and overview of standards for sterilization
- Role of standards
- Interaction of standards and regulations for medical devices
- Portfolio of sterilization standards
General requirements
- ISO 14937 - Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- Structure of sterilization standards
- Common features of validation and routine control
Microbiology quality
- Introduction to microbiology
- Sources of microbial contamination
- Contamination control
Microbiology methods
- Bioburden estimation – EN ISO 11737-1 Sterilization of medical devices – Microbiological methods - Part 1: Determination of a population of microorganisms on products
- Test of sterility – EN ISO 11737-2 Sterilization of medical devices – Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Microbial inactivation
- Inactivation kinetics
- Sterility assurance
- EN 556-1 Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “Sterile”
Sterilization by irradiation
- Nature of ionizing radiation
- Sources of ionizing radiation
- Measurement of radiation dose
- Installation Qualification, Operational Qualification and Performance Qualification
- EN ISO 11137-1 1 Sterilization of health care products - Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- EN ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- EN ISO 11137-4 Sterilization of health care products — Radiation — Part 4: Guidance on process control
Q & A
Introduction and recap of day one
Sterilization by irradiation (cont.)
- Establishing the sterilization dose
- EN ISO 11137-2 Sterilization of health care products - Radiation – Part 2: Establishing the sterilization dose
- ISO/TS 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
Biological indicators
- EN ISO 11138 series - Sterilization of health care products — Biological indicators
Syndicate exercise - Radiation sterilization
- Feedback and discussion
Ethylene oxide sterilization
- EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Ethylene oxide sterilizaton (cont.)
- EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Syndicate exercise - Ethylene oxide sterilization
- Feedback and discussion
Moist heat sterilization
- EN ISO 17665-1 Sterilization of health care products - Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Wrap up and Q & A
Annette Callaghan
Sterile Management Systems
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).
Book Sterilization of Medical Devices Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
19-20 October 2023
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 12779
- GBP 1,299
- EUR 1,869
- USD 2,129
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
Reviews of IPI's Sterilization of Medical Devices training course
Very structured training at perfect pace, covering all important point. Very good interaction.
Jun 1 2023
Marijana Jelecevic Kakouros 
RA Manager, Beckton Dickinson
Jun 1 2023
An excellent webinar that delivered above and beyond. Eamonn would be a great contact to keep for the future. His knowledge is top class.
Kerry Poole 
Mercian Surgical Co Ltd
Sweden
- Bactiguard AB
- Oticon Medical
- Oticon Medical AB
France
- BD
- Beckton Dickinson
United Kingdom
- JenaValve
- Mercian Surgical Co Ltd
Belgium
- Nikkiso Belgium
Brazil
- Ul Solutions
Canada
- SterileCare Inc.
Finland
- Innokas Medical
Ireland
- SymPhysis Medical
Liechtenstein
- Ivoclar Vivadent AG
Poland
- Paul Hartmann Manufacturing Sp. z o.o.
Switzerland
- Gerresheimer
United States of America
- QIAGEN Sciences LLC
