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Testing under ISO 11607 standard

What is ISO 11607?

ISO 11607-1 is a standard that 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 sterilised medical devices until the point of use.

ISO 11607-1 compliant Testing services include:

  • 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.

ISO 11607: Worst Case Parameters for medical devices, sealing parameters and configuration.

Our services in this area include:

  • Technical support
    •   Process Development
    •   IQ – OQ – PQ
  • Test Plans and Protocols
  • Sampling Programs
  • Validation Testing
  • Technical and Regulatory Files
  • Comparative Performance Studies
  • Packaging System Analysis

Read an informative article by our experts on ISO 11607 and Packaging Testing.

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Case Study – Emerson Network Power

Case Study

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How Anecto developed a number of innovative solutions for the leading multinational Emerson Network Power.