The low-temperature vaporized hydrogen peroxide method is a vital sterilization alternative known for its effectiveness and material compatibility. By using vaporized hydrogen peroxide at lower temperatures, it ensures the safety of delicate items while effectively eliminating pathogens.
Similar to other sterilization process standards, ISO 22441 includes references outlining additional requirements for compliance. It follows the structure of ISO 9001 and ISO 13485, covering documentation, management responsibility, product realization, measurement, analysis, and improvement.
This report guides healthcare product manufacturers on qualifying materials like polymers, ceramics, and metals. These materials are used in healthcare products sterilized through methods such as radiation, ethylene oxide, steam, dry heat, and hydrogen peroxide.
This guidance outlines the process of transferring a healthcare product from one radiation sterilization modality to another or from one irradiator to another using the same radiation modality. It specifically addresses gamma, electron beam, and X-ray radiation sources.
The guidance focuses on evaluating differences between radiation sources, assessing sterilization and verification doses, and determining the maximum acceptable dose.