Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage or handling. Many device regulators require medical device shelf-life and package testing to the ISO 11607 series of standards to ensure devices remain sterile until the barrier system is opened. In this free webinar, we will outline how to comply with requirements in ISO 11607 and Transport simulation as per ISTA 2A including:
- Key terms and definitions
- Simulation of life cycle of a medical device- Typical life cycle
- Regulations and Standards
- Packaging validation test -ISTA 2 A (International Safe Transit Association)
- Package Integrity Test
- Shelf-life study design
Who should watch this pre-recorded webinar:
Professionals involved in design, manufacturing or packaging of sterile medical devices.
This webinar will NOT cover the detailed individual testing requirements.
Register to view the recording:
Kushalappa M. D., Project Engineer – Medical Device Testing , UL
Kushalappa.M.D has over 9 years of experience in the field of Medical device testing with respect to ISTA 2 A and ISO 11607 requirements. He has also trained many engineers and technicians over the years. He has been instrumental in setting up the package validation lab at UL, he is also an expert in project handling and laboratory testing.