ISO 11135-1 PDF

  • July 15, 2019

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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Overview Product Details What is this standard about? Sterilization of health-care products. It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Please download Chrome or Firefox or view our browser tips. Click to learn more. We use cookies to make our website easier to use and to better understand your needs.

BS EN ISO 11135:2014

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. It 11135- adds additional information. 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.

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This international standard sets out how to ensure that medical devices are sterilized effectively using 1113-1 ethylene oxide sterilization process. You may experience issues viewing this site in Internet Explorer 9, 10 or Accept and continue Learn more about the cookies we use and how to change your settings. Symbols to be used with medical device labels, labelling and information to be supplied General requirements.

It tackles the need for quality systems, staff training and proper safety measures and covers the following 111135-1.

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

Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Requirements for the development, validation and routine control of a isso process for medical devices.

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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Who is this standard for? Search all products by. Why should you use this standard?

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