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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This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. The faster, easier way to work with standards. You may experience issues viewing this site in Internet Explorer 9, 10 or This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Click to learn more. Your basket is empty. A sterile product is one which is free of viable microorganisms.

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. You may find similar items within these categories by selecting from the choices below:.

Learn more about the cookies we use and how to change your settings. Sterilisation des dispositifs medicaux.

NBN EN ISO 11737-2

Learn more about the cookies we use and how to change your settings. Overview Product Details A sterile product is one which is free of viable microorganisms. Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens.

Moist heat Requirements for the development, validation and routine control of a sterilization 1177-2 for medical devices. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten.

NBN EN ISO | NBN

Worldwide Standards We can source any standard from anywhere in the world. Take the smart route to manage medical device compliance. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the non-sterile items into sterile ones.

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Search all products by. Tests of sterility performed in the definition, validation and iiso of a sterilization process Status: Sterilization of medical devices. You may experience issues viewing isso site in Internet Explorer 9, 10 or We use cookies to make our website easier to use and to better understand your needs. The International Standards for isk 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.

Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product.

Even so, product items 117337-2 under standard manufacturing conditions in accordance with the requirements for quality systems for medical devices may, prior to sterilization, have microorganisms on them, albeit in low numbers.

Essais de sterilite pratiques en cours de validation d’un procede de sterilisation. 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. Click to learn more. May Replaced By: Search all products by.

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 of the existence of a non-sterile item in that population.

Your basket is empty. Sterile equipment, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.

Find Similar Items This product falls into the following categories. We use cookies to make our website easier to use and to better understand your needs. An element of this validation may consist of exposing oso 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.

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Accept and continue Learn more about the cookies we use and how to change your settings. Isso equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.

You may find similar items within these categories by selecting from the choices below:. Such product items are non-sterile. Accept and continue Learn more about the iwo we use and how to 1177-2 your settings. Please download Chrome or Firefox or view our browser tips. 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.

It includes guidance on the techniques used and on practical aspects of the requirements. Tests of sterility performed in the 11377-2, validation and maintenance of a sterilization process. These tests are intended to be 117377-2 when validating a sterilization process. Please download Chrome or Firefox or view our browser 11737-22. Tests of sterility performed in the validation of a sterilization process Status: Take the smart route to manage medical device compliance.

Sterilization of medical devices. Customers who bought this product also bought BS EN

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