The ISO 11607 standard, developed by the International Organization for Standardization (ISO), consists of two sections under the main heading " Packaging for final sterilized medical devices":
In the ISO 11607-1 standard, the requirements for materials, pre-formed sterile barrier systems and packaging systems that are intended to maintain the sterility of sterilized medical devices until the point of use are explained and test methods are defined. This standard is complied with in industry, health institutions and wherever medical devices are placed in sterile barrier systems and sterilized. This standard does not cover all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Additional requirements are needed for drug and device combinations. This standard also does not define a quality assurance system for the control of all stages of production. This standard also does not apply to packaging materials or systems used to contain contaminated medical devices during transport of the material to the reprocessing or disposal site.
The ISO 11607-2 standard describes the requirements for developing and verifying processes for packaging medical devices that have been sterilized. These requirements include the creation, sealing, and assembly of pre-formed sterile barrier systems and packaging systems. This standard is applicable to industry, healthcare facilities, and any location where medical devices are packaged and sterilized. However, this standard does not cover all requirements for sterile barrier systems and packaging systems for aseptically produced medical devices. Additional requirements are needed for combinations of drugs and devices.
The concept of sterile barrier system is used to describe the minimum packaging required to perform the following functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow aseptic presentation.
Our organization also provides packaging testing services for sterilized medical devices within the scope of ISO 11607 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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