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An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Training Course

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

21 May 2024
+ 18 November 2024 »

from £299

Need help?  Enrol or reserve

Course Overview

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including maintaining this state for a defined period of time. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriate and stable sterile barrier system is important and expected when demonstrating conformity with the regulations. 

These requirements are supported by a series of standards for maintaining sterility over time with appropriate sterile barrier systems.

This course provides an introduction to these regulatory requirements, as they relate to typical sterile barrier systems used for single-use and reusable medical devices, 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.

Benefits of Attending

  • Gain an overview of the types of sterile barrier systems used for medical devices
  • Understand the principles of sterile barrier system validation
  • Learn the regulatory requirements for sterile barrier systems and how to comply
  • Gain an awareness of the ISO 11607 series of standards

Who Should Attend

  • Quality Management System (QMS) specialists
  • Quality, Packaging and Validation Engineers
  • Regulatory Compliance specialists
  • Internal Auditors
  • Regulatory and Quality professionals

Please note that delegates will require access to a copy of ISO 11607-1 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 11607-1 - https://www.iso.org/standard/70799.html

This standard is also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.

Enrol or reserve

The An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices course will cover:

The ISO 11607 Series of Standards

  • Background and reference to EN 868 and AAMI TIR22
  • Definitions
  • Types of packaging systems
  • Packaging materials

ISO 11607 Part 1

  • General requirements
  • Material requirements

ISO 11607 Part 1 (continued)

  • Designing a sterile barrier system
  • Packaging system performance and stability testing

ISO 11607 Part 2

  • Sterile barrier system manufacturing
  • Equipment validation
  • Process validation
  • Process control and ongoing monitoring

Enrol or reserve

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).

More details

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

21 May 2024

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 14311

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 16 Apr

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Not ready to book yet?

for 7 days, no obligation

18 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 14312

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 14 Oct

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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.

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy