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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General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices BS EN ISO Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, 11377-2 equipment, Sterile equipment, Assessed reliability.

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Sterile equipment, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. 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 iwo and testing of the product. Take the smart route to manage medical 1737-2 compliance. Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens.

BS EN ISO 11737-2:2009

Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. May Replaced By: Tests of sterility performed in the validation of a sterilization process. Click to learn more. You may find similar items within these isl by selecting from the choices below:.

Even so, product items produced under standard manufacturing conditions in accordance with the requirements for quality systems for medical devices may, prior to sterilization, is microorganisms on them, albeit in low numbers.

A sterile product is one which is free of viable microorganisms. These tests are intended to be performed when validating a sterilization process.

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It includes guidance on the techniques used and on practical aspects of the requirements. Click to learn more.

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 isp in order to provide a knowledge of the resistance to the agent of the microbial contamination as it occurs naturally on medical devices.

This website is best viewed with browser version isoo up to Microsoft Internet Explorer 8 or Firefox 3. 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.

Tests of sterility performed in the definition, validation and maintenance of a sterilization process Status: This website is best viewed with browser version of up 1177-2 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. You may find similar items within these categories by selecting from the choices below:.

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BS EN ISO 11737-2:2000

Please download Chrome or Firefox or view our browser tips. Find Similar Items This product falls into the following categories. International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared.

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

Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

You may experience issues viewing this site in Internet Explorer 9, 10 or 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.

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Sterilisation des dispositifs medicaux. Overview Product Details A sterile product is one which is izo of ios microorganisms. The faster, easier way to work with standards. You may experience issues viewing this site in Internet Explorer 9, 10 or The ISO series of standards designates certain processes used in manufacture as ‘special’ if the results cannot be fully verified by subsequent inspection and testing of the product. 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.

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Your basket is empty. Tests of sterility performed in the validation of a sterilization process Status: 117372- de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten.

Please download Chrome or Firefox or view our browser tips. We use cookies to make our website easier to use and to better understand your needs. We use cookies to make our website easier to use and to better understand your needs. Learn more about the cookies we use and how to change your settings. Sterilization of medical devices. Such product items are non-sterile. For this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained.

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