ISO 11737-2 PDF

STANDARD. ISO. Second edition. Sterilization of medical devices —. Microbiological methods —. Part 2: Tests of sterility performed in the. ISO. /(R) Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and. BS EN ISO Sterilization of medical devices – Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of .

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Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

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May Replaced By: This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones. Worldwide Standards We can source any standard from anywhere in the world.

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Accept and continue Learn more about the cookies we use and how to change your settings. Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product.

It follows that the sterility of any one item in a population of items subjected to sterilization processing cannot be guaranteed, and the sterility of the processed population of items has to be defined in terms of the probability kso the existence of a non-sterile item in that population.

Click to learn more. Sterilisation des dispositifs medicaux. Find Similar Items This product falls into the following categories.

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Customers who bought this product also bought BS EN Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.

Overview Product Details A sterile product is one which is free of viable microorganisms. These tests are intended to be performed when validating a sterilization process. Take the smart route to manage medical device compliance. A sterile product is one which is free of viable microorganisms. Worldwide Standards We can source any standard from anywhere in the world.

BS EN ISO 11737-2:2000

For this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained. Tests of sterility performed in the validation of a sterilization process Status: You may find similar items within these categories by selecting from the choices below:.

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It includes guidance on the techniques used and on practical aspects of the requirements. Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens. The ISO series of standards designates certain processes used in isp as ‘special’ if the results cannot be fully verified by subsequent inspection and testing of the product. Click to learn more.

Learn more about the cookies we use and how to change your settings. You may find similar items within these categories by selecting from the choices below:. International Standards specifying procedures for the validation and routine control of the processes used for sterilization kso medical devices have been prepared. You may experience issues viewing this site in Internet Explorer 9, 10 or It specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process.

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Find Similar Items This product falls into the following categories. Such product items are non-sterile. Sterilization of medical devices.

Your basket is empty. Search all products by. Accept and ieo Learn more about the cookies we use and how to change your settings. An element of this validation may consist of exposing medical devices to the sterilizing agent when the extent of treatment has been reduced relative to that which will be used in routine processing in order to provide a knowledge of the resistance to the agent of the microbial contamination as it occurs naturally on medical devices.

Please download Chrome or Firefox or view our browser tips. Essais de sterilite uso en cours de validation d’un procede de izo. The International Standards for sterilization of medical devices require, when it is necessary to supply a sterile product item, that adventitious microbiological contamination of a medical device from all sources be minimized by all practical means.

Subsequent to this exposure, medical devices are subjected individually to tests of iwo as described in this part of BS EN ISO This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

An example of the use of such a test is in establishing a sterilizing dose for sterilization by radiation and for demonstrating the continued validity of this sterilization dose. Your basket is empty.