DIN Standards Committee Health Technologies
DIN EN ISO 11138-4
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 4: Biologische Indikatoren für Sterilisationsverfahren mit trockener Hitze (ISO 11138-4:2017); Deutsche Fassung EN ISO 11138-4:2017
Overview
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. Compared to DIN EN ISO 11138-4 from 2006, the requirement for the determination of resistance characteristics has been revised and Annex ZA on the relationship between the European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated. 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
