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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BS EN ISO 11135:2014

Why should you use this standard? It tackles the need for quality systems, staff training and proper safety measures and covers 11135- following points: Medical equipment, Sterilization hygieneEthylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Isl approvalVerification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management.

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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Overview Product Details What is this standard about? Requirements for the development, validation and routine control of a sterilization process for lso devices Status: You may experience issues viewing this site in Internet Explorer 9, 10 or Take the smart route to manage medical device compliance.

It tackles the need for quality systems, staff training and proper safety measures and covers the following points:. 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. Accept and continue Learn more about the cookies we use and how to change your settings.

Who is this standard for? Worldwide Standards We can source any standard from anywhere in the world.

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Requirements for the development, validation and routine control of a sterilization process 11135- medical devices. Please download Chrome or Firefox or view our browser tips. Find Similar Items This product falls into the following categories.

This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. This international standard sets out how to ensure that medical devices are sterilized effectively using an ethylene oxide sterilization process.

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