DIN Standards Committee Quality Management, Statistics and Certification
DIN 58921
Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing; Text in German and English
Prüfverfahren zum Nachweis der Eignung eines Medizinproduktsimulators bei der Dampf-Sterilisation - Medizinproduktsimulatorprüfung; Text Deutsch und Englisch
Overview
The standard specifies a test method which serves to demonstrate the suitability of a test device developed for simulation of a medical device. Demonstration of suitability in accordance with this standard relates to achieving sterilization conditions in terms of air removal or steam penetration and applies to sterilization processes in large steam sterilizers complying with EN 285 and in small steam sterilizers complying with EN 13060 with Type B Cycle. In order for a medical device simulator (MDS) to be used for simulation of a medical device to be tested during steam sterilization processes, it shall be ensured that it demonstrates a greater level of difficulty in achieving sterilization conditions in terms of air removal or steam penetration in regards to the medical device to be simulated. This standard describes the modus operandi to prove that the MDS places corresponding demands on the sterilization process. This standard neither specifies requirements for the design of medical device simulators, nor material requirements. This standard has been prepared by Working Committee NA 063-04-08 AA "Indikatoren" ("Indicators") in cooperation with NA 063-04-01 AA "Dampf-Sterilisatoren" ("Steam sterilizers") at NAMed.
