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ISO 11737-2:2009Withdrawn

Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Stérilisation des dispositifs médicaux — Méthodes microbiologiques — Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation

This edition has been replaced by ISO 11737-2:2019.

Abstract / scope

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Life cycle

Replaces

ISO 11737-2:1998WithdrawnSterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization processInternational Standard · Published 9 Jul 1998 · ISO/TC 198

Replaced by

ISO 11737-2:2019PublishedSterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processInternational Standard · Published 2 Dec 2019 · ISO/TC 198