Overview

By decision of the CEN Technical Bureau (Resolution CEN/BT C52/2015), Annexes ZA, ZB and ZC and the European Preface have been updated and published in June 2015 as a new edition EN ISO 11137-2:2015. With this new edition of DIN EN ISO 11137-2, the foreword newly published by CEN, including Annexes Z, has been incorporated into the existing standard. The standard contains ISO 11137-1:2013 unchanged. The 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, Great Britain). On the national level, DIN 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