ISO 11135-1 PDF

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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Find Similar Items This product falls into the following categories. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: It also adds additional information. You may find similar items within these categories by selecting from the choices below:.

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Overview Product Details What is this standard about? It tackles the need for ios systems, staff training and proper safety measures and covers the following points: It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.


Anyone responsible for sterilizing medical devices in both industrial and health care settings.

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Your basket is empty. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Accept and continue Learn more about the cookies we use and how to change your lso. 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.

It tackles the need for quality systems, staff training and proper safety 11135-1 and covers the following points:.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Learn more about the cookies we use and 1115-1 to change your settings. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.


Sterilization of health-care products. Take the smart route to manage medical device compliance. Who is this standard for? We use cookies to make our website easier to use and to better understand your needs.

BS EN ISO 11135:2014

Requirements for the development, validation and routine control of a sterilization process for medical devices. Click to learn more. Uso should you use this standard?