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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An element of this validation may consist of exposing medical devices to the sterilizing agent when ios 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.

Sterilization of medical devices.

Find Similar Items This product falls into the following categories. Tests of sterility performed in the validation of a izo process. Learn more about the cookies we use and how to change your settings. A sterile product is one which is free of viable microorganisms.

Sterilitaetspruefungen bei der Validierung eines Sterilisationsverfahrens. For this reason, sterilization processes have to be validated before use, the performance of 117337-2 process monitored routinely and the equipment maintained.

NBN EN ISO 11737-2

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. Please download Chrome or Firefox or view our browser tips. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

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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.

Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices. Learn more about the cookies we use and how to change your settings. Worldwide Standards We can source any standard from anywhere in the world.

Search all products by. Click to learn more. Take the smart route to manage medical device compliance. Tests of sterility performed in the validation of a sterilization process Status: Sterilisation des uso medicaux.

Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Your basket is empty. You may find similar items within these categories by selecting from the choices below:. Tests of sterility performed in the definition, validation and maintenance of a sterilization process Status: We use cookies to make our website easier to use and to better understand your needs.

NBN EN ISO | NBN

Sterilization of medical devices. We use cookies to make our website easier to use and to better understand your needs. You may experience issues viewing this site in Internet Explorer 9, 10 or The faster, easier way to work with standards.

Essais de sterilite pratiques en cours de validation d’un procede de sterilisation.

BS EN ISO 11737-2:2009

Worldwide Standards We can source any standard from anywhere in the world. 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 Tests of sterility kso in the definition, validation and maintenance of a sterilization process.

Overview Product Details A sterile product is one which is free of viable microorganisms.

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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. Such product items are non-sterile.

Find Similar Items This product falls into the following categories. Accept and continue Learn more about the cookies we use and how to change your settings. It includes guidance on the techniques used and on practical aspects of the requirements. This website is best viewed with browser version of up to 111737-2 Internet Explorer 8 or Firefox 3. Sterile equipment, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval iao, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.

Please download Chrome or Firefox or view our browser tips. 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 iao a test is in establishing a sterilizing dose for sterilization by radiation and for demonstrating the continued validity of this sterilization dose.

You may experience issues viewing this isi in Internet Explorer 9, 10 or Essais de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten.

Search all products by. May Replaced By: Customers who bought this product also bought BS EN Even so, product items 117377-2 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. Click to learn more.

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