DIN Standards Committee Health Technologies
DIN EN ISO 11138-3
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017); German version EN ISO 11138-3:2017
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017); Deutsche Fassung EN ISO 11138-3:2017
Overview
ISO 11138-3 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in this part of ISO 11138-3 as dry saturated steam. While air-steam mixtures can be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138-3 might not be applicable for biological indicators used in such processes. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN). The responsible German committee is Working Committee NA 063-04-08 AA "Indikatoren" ("Indicators") at DIN Standards Committee Medicine.
Document: references other documents
Document: referenced in other documents
Responsible national committee
Responsible european committee
CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
