Status: Published. Publication date: Edition: 1. Number of pages: 4. Technical Committee.: ISO/TC Sterilization of health care products. ICS. ISO INTERNATIONAL. STANDARD. ISO. First edition. Sterilization of health care products —. Ethylene oxide —. Part 1. Permission can be requested from either ISO at the address below or ISO’s ISO cancels and replaces ISO and.

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BS EN ISO 11135:2014

Sterilization of health-care products. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. We use cookies to make our website easier to use and to better understand your needs. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process. You may experience issues viewing this site in Internet Explorer 9, 10 or Requirements for the development, validation and routine control of a sterilization process for medical devices.

Medical equipment, Sterilization hygieneEthylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance approvalVerification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management. Click to learn more.

ISO /Amd – Revision of Annex E, Single batch release

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Overview Product Details What is this standard about? Learn more about the cookies we use and how to change your settings. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.

Worldwide Standards We can source any standard from anywhere in the world. Take the smart route to manage medical device compliance. Your basket is empty. It tackles the need for quality systems, staff training and proper safety measures and covers the following points:.

Anyone responsible for sterilizing medical devices in both industrial and health care settings. Why should you use this standard?

The faster, easier way to work with standards. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Please download Chrome or Firefox or view our browser tips. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: It also adds additional information.