Overview

In 2012, CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices" (secretariat: DIN, Germany), CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, Great Britain) and ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA) agreed to harmonize the terminology in the field of sterilization of health care products. Based on ISO/TS 11139, Sterilization of health care products - Vocabulary, and the portfolio of standards prepared by the three technical committees, the TCs have compiled their terminology in a joint standard, DIN EN ISO 11139 "Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards", and harmonized it where necessary. At national level the relevant mirror committees have also actively supported the preparation of this terminology standard. Amendment 1 to DIN EN ISO 11139:2019-05 adapts some definitions and adds new terms and definitions. The responsible national standardization committee is Working Committee NA 176-03-09 AA "Sterilisation und Aufbereitung von Medizinprodukten" "Sterilization and processing of medical devices".

Document: references other documents

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices  

Responsible european committee

CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices  

Responsible international committee

ISO/TC 198/WG 5 - Terminology