Dublin, Sept. 29, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Training Course (Nov 17, 2025)" training has been added to ResearchAndMarkets.com's offering.
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.
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.
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
Please note that delegates will require access to a copy of ISO 11607-1 to gain the most from this training.
Who Should Attend:
- Quality Management System (QMS) specialists
- Quality, Packaging and Validation Engineers
- Regulatory Compliance specialists
- Internal Auditors
- Regulatory and Quality professionals
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Key Topics Covered:
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
- 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
For more information about this training visit https://www.researchandmarkets.com/r/ygvfxr
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