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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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It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Requirements for the development, validation and routine control of a sterilization process for medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. Your basket is empty.

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Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Take the smart route to manage medical device compliance. 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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BS EN ISO 11135:2014

Sterilization of health-care products. Accept and continue Learn more about the cookies we use and how to change your settings.

It tackles the need for quality systems, staff training and proper safety measures and covers the following points:. We use cookies to make our website easier to use and to better understand your needs.

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The faster, easier way to work with standards. Click to learn more. Anyone responsible for sterilizing medical devices in both industrial and health care settings.

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 international standard sets out how to ensure that medical io are sterilized effectively using an ethylene oxide sterilization process.

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