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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Please download Chrome or Firefox or view our browser tips. Method 1 from determines the lowest sterilization dose necessary for the determined bioburden population.

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 changes in raw materials or suppliers.

Sterilization of health care products-Radiation-Part 3: Do I need a Biological Indicator? We use cookies to make our website easier to use and to better understand your needs. Furthermore, the validation is less expensive because fewer tests are necessary.

Gamma Sterilization Validations: VDmax 25 and Method 1 FAQ | STERIS AST

This standard contains guidelines to specify the methods that can be used to determine the minimum sterilisation dose. The faster, easier way to work with standards.

Probability of a viable microorganism being present on a product unit after sterilization. Accelerated aging and package testing are additional tests to be considered for product irradiated at the maximum dose. Setting the maximum dose as high as possible allows the greatest flexibility in processing schedules when product is ready for routine sterilization. Irradiating your product at a dose approximately 2. Have bioburden testing performed on 10 products from three different batches, for a total of 30 products.


BS EN ISO 11137-2:2015

Click to learn more. What are the basic steps? Sterilization of Medical devices-Microbiological methods-Part 1: BIs also do not accurately represent natural form of bioburden on a product spore strip vs. Bacillus pumilus, a spore-forming microorganism, served for iao years as a biological indicator to test for sterility.

Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms. Ieo may find similar items within these categories 11137–2 selecting from the choices below:. If one of these validations establishes my minimum dose, how do I establish a maximum dose? You may experience issues viewing this site in Internet Explorer 9, 10 or The standard has been systematically reviewed by experts to ensure its continued market relevance and 11137-2 to clinical best practice and now includes significant technical changes such as: Medical equipment, Sterilization hygieneRadiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Medical instruments, Sterile equipment, Mathematical calculations.

Overview Product Details What is this standard about?

Search all isk by. In the context of irradiation sterilization, bioburden is determined immediately prior to sterilization. The radiation resistance of B. Find Similar Items This product falls into the following categories. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

In order to test a dose for SALone million products would need to be irradiated and sterility tested. Take the smart route to manage medical device compliance. Establishing the sterilization dose Status: This must be retested if any changes are made to the isso. Are there other options for dose setting besides VDmax25 and Method 1? Which validation is right for me?

Who is this standard for? The unit of measurement is CFU: Requirements for the development, validation and routine control of a sterilization process for medical devices BS EN This part of ISO specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. 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.


Contained in and TIR 33 are additional methodsincluding Method 2 incremental dosing and VD max for selected doses of kGy in 2. Each method has specific limitations and requirements that must be fully investigated before selection. Send new samples for irradiation prior to sterility testing. Bioburden counts must be CFU or less. Sterilization of health care products-Radiation-Part 2: If the sterility test exhibits a failing number of positive tests, the verification dose experiment can be performed again and samples re-tested.

Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose. 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. These TIRs reflect common industry practices that evolve from an accumulated process knowledge base. Do not sterility test the samples. The number of samples required for this testing should be confirmed with the laboratory performing the testing usually This is considered an overdose.

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