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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Test equipment, Sterilization hygieneSamples, Microbiological analysis, Microbiology, Approval testing, Process control, Biological analysis and testing, Specimen preparation, Medical equipment, Sterile equipment, Assessed reliability.
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BS EN ISO 11737-2:2000
It follows that the sterility of any one item in 117372- 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. May Replaced By: Your basket is empty. You may find similar items within these categories by selecting from the choices below:. Such product items are non-sterile.
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Tests of sterility performed in the validation of a sterilization process. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of BS EN ISO Overview 117737-2 Details A sterile product is one which is free of viable microorganisms. Learn more about the cookies we use and how to change your settings. International Standards specifying procedures for the validation and routine control of the processes used for sterilization of medical devices have been prepared.
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Sterilization of medical devices. 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. Tests of sterility performed in the validation of a sterilization process Status: 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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Sterilization is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. You may find similar items within these 117737-2 by selecting from the choices below:.
NBN EN ISO 11737-2
The ISO series of standards designates certain processes used in manufacture as ‘special’ if the results io be fully verified by subsequent inspection and testing of the product.
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. 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.
Please download Chrome or Firefox or view our browser tips. Sterile 11737–2, Sterilization hygieneMedical equipment, Microbiological analysis, Process control, Approval testing, Biological analysis and testing, Microbiology, Assessed reliability, Test equipment, Samples, Specimen preparation.
Take the iwo route to manage medical device compliance. Sterilisation des dispositifs medicaux. 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.
The faster, easier way to work with standards. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. 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.
Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices.
NBN EN ISO | NBN
Find Similar Items This product falls into the following categories. These tests are intended to be performed when validating a sterilization process.