ISO 11137-2 PDF

Buy EN ISO STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO. ISO Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. ANSI/AAMI/. ISO Sterilization of health care products — Radiation —. Part 2: Establishing the sterilization dose. American. National. Standard.

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Sterilization of Medical devices-Microbiological methods-Part 1: The number 1137-2 samples required for this testing should be confirmed with the laboratory performing the testing usually Bioburden counts must be CFU or less. Have bioburden testing performed on 10 products from three different batches, for a total of 30 products.

Probability of a viable microorganism being present on a product unit after sterilization. If the sterility test exhibits a failing number of positive tests, the verification dose experiment can be performed again and samples re-tested.

BS EN ISO 11137-2:2015

Worldwide Standards We can source any standard from anywhere in the world. You may find similar items within these categories by selecting from the choices below:. Your basket is empty. Do I need a Biological Indicator? This Method should be used when the lowest possible sterilization dose is desired due to cost considerations, use of gamma sensitive materials, or when the bioburden count is above CFU.


Send new samples for irradiation prior to sterility testing. Which validation is right for me?

The unit of measurement is CFU: Bacillus pumilus, a spore-forming microorganism, served for many years as a biological indicator to 1137-2 for sterility. Why is the verification dose experiment performed at a lower SAL than the sterilization dose? If one of these validations establishes my minimum dose, how do I establish a maximum dose?

Please download Chrome or Firefox or view our browser tips. Each method has specific limitations and requirements that must be fully investigated before selection. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Who is this standard for? Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose. Learn more about the cookies we use and how to change your settings.

Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms. For both types of validations, the first step is identical: Establishing the sterilization dose Status: Find Similar Items This product falls into the following categories. This standard contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose.


Sterilization of health care products-Radiation-Part 1: Are there other options for ido setting besides VDmax25 and Method 1?

ANSI/AAMI/ISO – Sterilization of Health Care Products Package

In order to test a dose for SALone million products would need to be irradiated and sterility tested. Click to learn more. A correction of the language used to describe the requirements for interpretations of results during a verification dose experiment Amendments to methods of dose establishment and means of substantiation Changes to the incremental increases in the bioburden values have been included in Table 6.

It is recommended that even without changes that the test be repeated every years to account for any is in raw materials or suppliers. Measure of the ability of a specified technique to remove microorganisms from product. Its use today has been discontinued. Accept and continue Learn more about the cookies we use and how to change your settings.