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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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 Microsoft Internet Explorer 8 or Firefox 3. Accept and continue Learn more about the cookies we use and how to change your settings. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices.

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An example of the use of 11737–2 a test is in establishing a sterilizing dose for sterilization iwo radiation and for demonstrating the continued validity of this sterilization dose. 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 Search all products by. Overview Product Details A sterile product is one which is free of viable microorganisms.

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BS EN ISO 11737-2:2000

ieo Even so, product items produced 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.

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11773-2 this reason, sterilization processes have to be validated before use, the performance of the process monitored routinely and the equipment maintained. Sterilization of medical devices.

Tests of sterility performed in the definition, validation and maintenance of a sterilization process. 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 1173-2 from all sources be minimized by all practical means.

NBN EN ISO 11737-2

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

You may experience issues viewing this site in Internet Explorer 9, 10 or Click to learn more. May Ieo By: Test equipment, Sterilization islSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.

You may experience issues viewing this site in Internet Explorer 9, 10 or A sterile product is one which is free of viable microorganisms.

Sterilization of medical devices. You may find similar items within these categories by selecting from the choices below:. Your basket is empty. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation. Find Similar Items This product falls into the following categories. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Please download Chrome or Firefox or view our browser tips.

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NBN EN ISO | NBN

International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared. Such product items are non-sterile. Essais de sterilite pratiques en cours de validation d’un procede de sterilisation Title in German Sterilisation von Medizinprodukten. The ISO series ixo standards designates certain processes used in manufacture as ‘special’ if the results cannot be fully verified by subsequent inspection and testing of the product.

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Tests of sterility performed in the definition, validation and maintenance of a sterilization process Status: Please download Chrome or Firefox or view our browser tips.