ISO 11137-2 PDF

May 14 2019

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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Performed early in product qualification, materials can be screened for compatibility with irradiation.

EN ISO – Sterilization of health care products – Radiation – Part 2: –

Send new samples for irradiation prior to sterility testing. Do I need a Biological Indicator? The radiation resistance of B. BIs also do not accurately represent natural form of bioburden on a product spore strip vs.

Your basket is empty. The faster, easier way to work with standards. Accept and continue Learn more about the cookies we use and how to change your settings. Sterilization of health care products-Radiation-Part 2: For both types of validations, the first step is identical: This website is best viewed with browser version of up 11137-2 Microsoft Internet Explorer 8 or Firefox 3.

Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose. In order to test a dose for SALone million products would need to be irradiated and sterility tested. Worldwide Standards We can source any standard from anywhere in the world. This standard contains guidelines to specify the methods jso can be used to determine the minimum iwo dose.

Its uso today has been discontinued. Overview Product Details What is this standard about? The unit of measurement is CFU: Do not sterility test the samples.

111137-2 Accelerated aging and package testing are additional tests to be considered for product irradiated at the maximum dose. Probability of a viable microorganism being present on a product unit after sterilization.

EN ISO 11137-2:2015

Take the smart route to manage medical device compliance. Find Similar Items This product falls into the following categories. Method 1 from determines the lowest sterilization dose necessary for the uso bioburden population.

This is considered an overdose. 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. Learn more about the cookies we use and how to change your settings.

Population of viable microorganisms on a product. Search all products by. Requirements for the development, validation and routine control of a sterilization process for medical devices BS EN 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.

If the sterility test exhibits a failing number of positive tests, the verification dose experiment can be performed again and samples re-tested. Each method has specific limitations and requirements that must be fully investigated before selection.

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

When gamma irradiation is selected for product sterilization, the dose at which the product is irradiated must be established and validated in accordance with appropriate AAMI standards. The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice and now includes significant technical changes such as: Sterilization of health care products-Radiation-Part 1: The number of samples required for this testing should be confirmed with the laboratory performing the testing usually These TIRs reflect common industry practices that evolve from an accumulated process knowledge base.

Setting the maximum dose as high as possible allows the greatest flexibility in processing schedules when product is ready for routine sterilization. Have bioburden testing performed on 10 products from three different batches, for a total of 30 products.

Guidance on dosimetric aspects of development, validation and routine control. Please download 111137-2 or Firefox or view our browser tips. Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms.

Bioburden counts must be CFU or less.

We use cookies to make our website easier to use and to better understand your needs. It is recommended that even without changes that the test be repeated every years to account for any changes in raw materials or suppliers. If one of these validations establishes my minimum dose, how do I establish a maximum dose?