ISO 11607-1 Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems and packaging systems

The scope of ISO 11607-1 covers the protocol for testing sterile barrier systems (SBS) for maintained sterility when used for medical devices. This test is applicable to any medical device t hat is placed in an SBS for sterilization purposes. It is important to note this test does not apply to packaging materials that are used to transport a contaminated medical device on the way to reprocessing or disposal.

There are specific terms defined below that will help to more fully understand the standard.

  • Aseptic presentation- the transfer of sterile contents from it SBS using conditions and procedures that will minimize the risk of contamination
  • Bioburden- population of variable microorganisms on or in the product or its SBS
  • Medical device- instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in conjunction, for human beings, for one or more medical purposes
  • Microbial barrier- property of a sterile barrier system to minimize the risk of ingress of microorganisms
  • Protective packaging- configuration or materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
  • Seal- result of joining surfaces together by fusion to form a microbial barrier
  • Seal integrity- characteristics of a seal to minimize the ingress or microorganisms
  • Seal strength- mechanical capacity of the seal to withstand force
  • Service life- number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and safe for its intended use when used according to the labelling
  • Sterile- free from viable microorganisms
  • Sterile barrier system (SBS)- minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use
  • Sterile fluid-path packaging- system of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids
  • Sterilization compatibility- attributes of the packaging material and/or system that allow it both to withstand the sterilization process and attain the required conditions for sterilization within the packaging system
  • Sterilizing agent- physical or chemical entity or combination of entities having sufficient microbiocidal activity to achieve sterility under specified conditions
  • Terminal sterilization- process whereby a product is sterilized within its sterile barrier system

Prior to testing, the lab must receive the appropriate samples. Acceptable parameters should be determined prior to testing and will be used for evaluating the pass/fail standards. The specifications should be defined for temperature, pressure, humidity, maximum rate of change, exposure to sunlight or UV light, cleanliness, bioburden, and electrostatic properties. The test will then be performed according to the guidelines in ISO 11607. At the conclusion of testing, the laboratory will compile results and write a comprehensive report.

Keystone proud to provide customers with reliable testing and reports for sterile barrier systems and medical device packaging. With international accreditation, competitive pricing, and quick turnaround time, Keystone is the right testing partner. Our testing engineers are experienced and have thorough knowledge of industry standards. They are prepared to guide you through process and keep you informed. Let’s get started! Request a quote or contact us at (724) 657-9940.