DIN Standards Committee Health Technologies
DIN EN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2013); Deutsche Fassung EN ISO 11137-2:2013
Overview
The International Standard which has been published in March 2012 had to be revised during a Minor Revision due to identified errors with regard to formulations used to describe the requirements for the interpretation of results during a verification dose experiment. The following is corrected in this new edition DIN EN ISO 11137-2:2012-07: - correction of the requirement in 9.1, second paragraph, third sentence, by addition of the word "and" so it states: "a particular bioburden level and sterilization dose" - correction of requirement in 10.3.4.1, third paragraph, by addition of the word "not" so it states: "dose should not be less than 90 % of VDmax25 or VDmax15." - linguistic correction for the purpose of description of the requirements for interpretation of the results during verification dose experiment in every clause of 7.2.6.2, 7.3.7.2, 9.2.6.3, 9.3.7.3, 9.4.6.3 and 9.5.7.3. The International Standard specifies methods for determining the sterilization dose and methods applied for checking continued effectiveness of the determined sterilization dose. This includes criteria for defining product families and the selection and testing of products used for determination of the sterilization dose. Methods for determination of a product-specific sterilization dose include - methods serving for demonstration that with a preselected sterilization dose of 25 kGy or 15 kGy a sterility assurance level (SAL) of at least 10-6 is achieved. The standard contains detailed examples for the individual methods. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA), in collaboration with CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom). On the national level, Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at NAMed is responsible.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204 - Sterilization of medical devices