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 VD_max²⁵ or VD_max¹⁵." - 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  

Responsible international committee

ISO/TC 198/WG 2 - Radiation sterilization