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ISO 11607 Testing
ISO 11607-1 specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
Our services in ISO 11607-1 Testing include:
- Protocol and Test Plan generation
- Sampling Programs
- Transportation Testing
- Accelerated and Real Time Aging
- Integrity Testing:
- Bubble Leak Test
- Tensile /Peel Test
- Dye Penetration Test
- Vacuum Decay Test
- Burst Test
- Microbial Challenge
- Final Reports
ISO 11607-2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves and the packaging systems.
Our services in this area include:
- Consultancy
- Process development
- IQ – OQ – PQ
- Test Plans and Protocols
- Sampling
- Validation Testing
- Technical and Regulatory Files
- Comparative performance studies
- Packaging system analysis
Back To Package Integrity Testing
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ISO11607 Test Flow
Useful Resource
Useful Resource – Why Considering Packaging Early in the Design Process can Save Time and Money
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