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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This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
Anyone responsible for sterilizing medical devices in both industrial and health care settings. It describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices. It tackles the need isk quality systems, staff training and proper safety measures and covers the following points:.
It also adds additional information.
BS EN ISO 11135:2014
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Who is this standard for? Why should you use this standard? It tackles the need for quality systems, staff training and proper safety measures and covers the following points: Your basket is empty.
Take the smart route to manage medical device compliance. 1113-51
The faster, easier way to work with standards. Symbols to be used with medical device labels, labelling and information to be supplied General requirements. You may experience issues viewing this site in Internet Explorer 9, 10 or Please download Chrome or Firefox or view our browser tips.
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ISO /Amd – Revision of Annex E, Single batch release
Sterilization of health-care products. 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.