Our services include validation of the packaging processes, such as the forming and sealing process of sterile barrier systems, pursuant to ISO 11607-2. In the course of a combined stability and packaging validation study, sterilized and final-packed test devices are subjected to both thermal and regular aging and to transport simulation, pursuant ISTA or ASTM standards.
According to ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life. Afterward, products can be subjected to various test systems in order to evaluate the performance of the packaging system, aseptic presentation and microbial barrier properties, as well as the performance of the containing medical device, functionality and biocompatibility.
The following test systems may be applicable for the packaging system:
- Dye test for seal integrity
- Peel test, burst test and bubble test
- Air permeability test and test for microbiological tightness
- Qualification of packaging materials
- Validation of the forming, sealing and assembly processes of packaging for terminally sterilized medical devices
- Validation of final packaging systems for sterile medical devices
- Evaluation of the shelf life of the sterile packed medical device
- Stressed medical devices are subjected to specific performance tests as well as to a biological evaluation test strategy
Global market acceptance
- We have been in operation since 1894.
- We operate in more than 143 countries.
- UL reports and certifications are recognized and accepted around the world.
- UL Marks appear on more than 22 billion products globally
Comprehensive testing and certification services
- We offer field evaluations, on-site training and can come to you for testing.
- Full compliance testing/evaluation to prescans and other preliminary testing.
- We have engineers that work with you throughout the production lifecycle.
- Our engineers possess an average more than 10 years in the industry.
- We possess more than 11 industries business units in the UL company portfolio.
Knowledge of global standards and regulatory requirements
- We cover many markets including the U.S. Food and Drug Administration, the South Korean Ministry of Food and Drug Safety, the European Union’s (EU) In Vitro Diagnostic (IVD) Directive, the EU Medical Devices Directive (MDD).
- We have helped to set more than 1,600 standards defining safety, security, quality and sustainability.
- Our engineers partner with standard committees, such as Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute (ANSI) and government bodies.
- We have an FDA-recognized consensus Standard, UL 2900, for cybersecurity.
- 159 UL laboratories are available for testing and certification worldwide.
- We offer tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles.
- We have more than 10 accredited UL laboratories around the world.