DIN EN ISO 11737-2 : 2010现行
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
出版：German Institute for Standardisation (Deutsches Institut für Normung)
专家解读视频
This standard is included in DIN Handbook 263 and 268. Establishes the general requirements for tests on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.
ISO 11737-2 : 2009(R2015) - Identical
