ISO/AWI 11135 is a standard that specifies the requirements for the development, validation, and routine control of a sterilization process for medical devices using ethylene oxide. The standard is developed by the International Organization for Standardization (ISO), an independent, non-governmental international organization that develops and publishes standards for various industries, including healthcare.
The use of ethylene oxide is popular in the healthcare industry for its ability to sterilize medical devices without causing damage to the equipment. However, a downside of using ethylene oxide is its potential for toxicity. Therefore, the ISO/AWI 11135 standard provides guidelines to ensure the safety and effectiveness of the sterilization process using ethylene oxide.
ISO/AWI 11135 details the requirements for the development of a sterilization process that includes the selection of suitable process parameters, validation of the process, and routine control to ensure the process remains effective over time. The standard also includes requirements for the monitoring of ethylene oxide levels and residual levels of ethylene oxide and ethylene oxide derivatives in sterilized equipment.
A critical component of the sterilization process using ethylene oxide is the use of surfactants to improve the penetration of gas into hard-to-reach areas of medical devices. A popular surfactant used is Iso-Tridecanol and Ethylene Oxide Condensate, which is an effective wetting agent that enhances the penetration of ethylene oxide gas.
The inclusion of keywords Iso-Tridecanol and Ethylene Oxide Condensate in the blog improves the search engine optimization (SEO) for medical device manufacturers, distributors, and healthcare facilities interested in purchasing or using ethylene oxide sterilization services. Search engines use keywords to identify the relevance of web pages to specific search terms, therefore making it easy for potential customers to access the website.
In summary, the ISO/AWI 11135 standard is an essential guideline for the development, validation, and routine control of a sterilization process for medical devices using ethylene oxide. The inclusion of surfactants such as Iso-Tridecanol and Ethylene Oxide Condensate enhances the effectiveness of the sterilization process. Medical device manufacturers, distributors, and healthcare facilities using ethylene oxide sterilization services can use these keywords to optimize their SEO and attract potential customers.