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 describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbiocidal activity intended to sterilize medical devices.
This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.
You may find similar items within these categories by selecting from the choices below:. Anyone responsible for sterilizing medical devices in both industrial and health care settings. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
Your 1113-1 is empty. Find Similar Items This product falls into the following categories. Take the smart route to manage medical device compliance. Who is this standard for? 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.
Requirements for the development, validation and routine control of a sterilization process for medical devices Status: Sterilization of health-care products. You may experience issues viewing this site in Internet Explorer 9, 10 or Overview Product Details What is this standard about?
ISO /Amd – Revision of Annex E, Single batch release
Worldwide Standards We can source any standard from anywhere in the world. Search all products by. Requirements for the io, validation and routine control of a sterilization process for medical devices. It also adds additional information.
BS EN ISO 11135:2014
Why iao you use this standard? It tackles the need for quality systems, staff training and proper safety measures and covers the following points:. Click to learn more.
Symbols to be used with medical device labels, labelling and information to be supplied General requirements.
The faster, easier way to work with standards. It tackles the need for quality systems, staff training and proper safety measures and 111335-1 the following points: