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

Why should you use this standard? Learn more about the cookies we use and how to change your settings. Requirements for the development, validation and routine control of a sterilization process for medical devices Status: 1135-1 tackles the need for quality systems, staff training and proper safety measures and covers the following points:.

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This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process. Overview Product Details Isoo is this standard about?

BS EN ISO 11135:2014

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

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The faster, easier way to work with standards. Click to learn more. Accept and continue Learn more about the cookies we use and how to change your settings. Who is this standard for?

Requirements for the development, validation and routine control of a sterilization process for medical devices. Worldwide Standards We can source any standard from anywhere in the world. Sterilization of health-care products. You may experience issues viewing this site in Internet Explorer 9, 10 or It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.

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It also adds additional information. Take the smart route to manage medical device compliance. Find Similar Isl This product falls into the following categories.

Search all products by. You may find similar items within these categories by selecting from the choices below:. Your basket is empty. Anyone responsible for sterilizing medical devices in both industrial and health care settings. Symbols to be used with medical device labels, labelling and information to be supplied General requirements.

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