What is ISO 11135 All About?
ISO 11135:2014 is an international standard that provides guidelines for the sterilization of medical devices using ethylene oxide (EtO). The standard is intended to be used by manufacturers of medical devices, as well as by organizations that perform sterilization services.
The standard is divided into several sections, each of which covers a specific aspect of the sterilization process.
Design and development of the sterilization process:
The first section of the standard provides guidelines on how to design and develop a sterilization process that is appropriate for the intended use of the medical device and that can effectively sterilize the device. This includes identifying the requirements for sterilization, performing a risk assessment, selecting the appropriate sterilization method, and establishing the sterilization conditions. Additionally, the manufacturers have to consider the compatibility of the materials of the medical device with the sterilization agent.
Validation of the sterilization process:
The second section of the standard provides guidelines on how to validate the sterilization process to ensure that it is capable of effectively sterilizing the medical device. This includes establishing the conditions for sterilization, such as temperature, humidity, pressure, and time, as well as performing microbial and product testing to demonstrate that the sterilization process is effective.
Routine control of the sterilization process:
The third section of the standard provides guidelines on how to implement and maintain routine control of the sterilization process to ensure that it continues to be effective. This includes monitoring the process conditions, such as temperature, humidity, EtO concentration, and pressure, as well as performing regular microbial and product testing to ensure that the sterilization process is still effective.
Revalidation of the sterilization process:
The fourth section of the standard provides guidelines on how to revalidate the sterilization process after any changes that could affect the process's effectiveness, such as equipment changes or changes in the production process.
Handling and storage of items before, during, and after sterilization:
The fifth section of the standard provides guidelines on how to handle and store medical devices before, during, and after sterilization to ensure that they remain sterile and safe for use. This includes guidelines for packaging, labeling, and storage.
Packaging, labeling and documentation:
The sixth section of the standard provides guidelines for packaging, labeling and documentation of the sterilized product. It also covers the requirement for product release, that is the process of determining that the product has been properly sterilized and is safe for use.
Overall, the standard provides a comprehensive set of guidelines for the sterilization of medical devices using EtO. It covers the entire process of sterilization, including design and development, validation, routine control, revalidation, and the handling and storage of items before, during, and after sterilization. Additionally, it includes requirements for packaging, labeling, and documentation, as well as product release. By following the guidelines set out in ISO 11135:2014, manufacturers and sterilization service providers can ensure that the medical devices they produce or sterilize are safe and effective for their intended use.
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ISO 11135:2014 - Sterilization of health-care products