Sterilization Processes for Medical Device Manufacturers

Instructor-led Training2 DaysAdvancedInstructor-led or Virtual Classroom

In this training you will learn how to sterilize medical device safely. This course will cover essential aspects, focusing on standards such as ISO 17665-series, ISO 11135, ISO 11137-series, and ISO 14937. By the end of this training, you will be equipped to implement these standards and elevate your expertise in ensuring the safety and efficacy of medical devices.

With this seminar, participants will:

  • Understand microbiological data and be able to interpret it.
  • Be familiar with the requirements for the validation of sterilization processes and their documentation for medical devices.
  • Be familiar with the hygienic requirements for the production of medical devices.
  • Gain in-depth knowledge of sterilization in the manufacturing process of medical devices.
  • Learn about the requirements for the validation of sterilization processes.
  • Be familiar with the documentation requirements for validation reports for medical device sterilization.
  • Medical Device Manufacturers
  • Employees from controlled and clean areas
  • Persons responsible for the validation of sterilization
  • Persons responsible for the preparation of technical documentation
  • Employees from the development and quality assurance department
  • Product managers
  • Engineering managers
  • Medical Device consultants

Day 1:

  • Fundamentals of Microbiology
  • Where do microorganism occur and how are they transmitted?
  • Procedure for microbiological reduction
  • Cleanrooms and their operation according to EN ISO 14644 series.
  • Production Hygiene Monitoring
  • Program Method Validation Principles of sterilization validation according to EN ISO 14937

Day 2:

  • Specific Aspects of the Different Sterilization Procedures
  • Overview of (EN) ISO 17665-series, EN ISO 11135, EN ISO 11137-series, EN ISO 14937
  • Peculiarities of sterilization with moist heat
  • Special features of sterilization with ethylene oxide gas
  • Special features of radiation sterilization

The training program is intended to give a high-level view on the sterilization processes required to be conducted by medical device manufacturers.

Day one of this seminar conveys the essential requirements for the sterilization of medical devices as well as for hygiene monitoring as a basis for the production of sterile medical devices. You will get a good overview of the validation and documentation of sterilization processes in the medical device industry in order to ensure a valid manufacturing process in practice.

On day two of the training, you will learn the special aspects of the various sterilization procedures. Specifically, the following standards harmonised or adopted as state of the art under the Medical Devices Directive 93/42/EEC and/or Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices are discussed:

  • ISO 17665-series – Moist Heat Sterilization
  • ISO 11135 – Ethylene Oxide Sterilization
  • ISO 11137-series – Radiation Sterilization
  • ISO 14937 – Sterilization of Novel Sterilization Modalities

This 2-day training will teach you to sterilize medical devices safely.

This is an instructor-led training. Please note that we do offer this training program either as "In-person" training or as "Virtual classroom" training. Be sure to select the correct type of training to which you would like to register for in the booking table below.

All "in-person" events of this training, scheduled in our upcoming Public Calendar of events, will be held in our new state-of-the-art laboratory in New Brighton, Minnesota.
The new laboratory is accredited to ISO 17025 for the biological and chemical testing of medical devices and is part of TÜV SÜD’s ongoing commitment to providing high-quality medical device services that deliver precision with purpose to its customers.

TÜV SÜD America Inc.
141 14th ST NW
New Brighton, MN 55112

All other sessions will be held online as virtual classroom trainings.

FURTHER INFORMATION on the New Brighton Lab:

  • The seminar deals with internationally valid standards and is also suitable for implementation abroad. The contents of the seminar correspond to the current state of revision/harmonization.
  • Examination is hosted in an online platform andconsists of multiple-choice questions.
  • Exam duration: 90 minutes
  • Passing criteria: 70%
  • Participants will receive a Certificate of completion from the TÜV SÜD Academy.

Participants attending this course are preferred to have prior knowledge on medical devices.

Net Price (excl. TAX)
from$ 1,950.00

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From 30.Jul.2024
New Brighton, MN
$ 1,950.00 excl. TAX

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2 Days

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New Brighton, MN


Net price
$ 1,950.00
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Price (excl. TAX):
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Event No.

2 Days

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Net price
$ 1,950.00
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Price (excl. TAX):
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