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DIN 58921:2011 Edition

DIN 58921:2011 Edition

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Test method to demonstrate the suitability of a medical device simulator during steam sterilisation – Medical device simulator testing

Published By Publication Date Number of Pages
DIN 2011-01 41
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This standard specifies a test method with which can be demonstrated that a medical device simulator for use in sterilization processes of large steam sterilizers complying with DIN EN 285 and of small steam sterilizers complying with DIN EN 13060 (Type B Cycle) has a greater level of difficulty in achieving sterilization conditions in terms of air removal and steam penetration than the simulated medical device itself. A medical device simulator (MDS) qualified according to this standard is only valid for the examined medical device (MD). NOTE 1 Attention is drawn to the fact that similar looking medical devices can have different internal constructions. These differences can have an influence on the air removal and steam penetration capabilities. This can have an influence on the validity of the MDS. NOTE 2 A medical device simulator for which such evidence was provided, can be used during validation to present the original medical device only in terms of air removal and steam penetration. NOTE 3 A medical device simulator, qualified on the basis of this standard, can also be used for the development of sterilization processes. NOTE 4 A medical device simulator qualified according to this standard is not necessarily suitable to represent other requirements of the relevant medical device (see 8.2). This standard neither specifies requirements for the design of medical device simulators, nor material requirements for medical device simulators.

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