The EN ISO 15883 series, jointly developed under the Vienna agreement by ISO/TC 198 and CEN/TC 102, describes the design and functionality of washer-disinfectors (WD), used to disinfect medical tools. Part 1 of the series specifies general design requirements, process specifications and validation methods for all kinds of washer-disinfectors. The subsequent parts focus on the design of particular devices, processing special load including particular specifications of the processing process, such as requirements for the thermal processing of surgical instruments or the chemo-thermal processing of flexible endoscopes.
Part 5 of this series, which was previously published as a technical specification, originally differed from the other standards as it described the requirements for test soils and methods for testing the cleaning efficacy of WD for different types of load. In order to incorporate the experience gained in the application of this standard series over the last 15 years, as well as publications about validation methods of WD and medical devices, this already outdated technical specification has now been completely updated and it has been published as EN ISO 15883-5 ‘Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy’.
The new EN ISO 15883-5 comprises cleaning performance and conformity testing requirements originally described in EN ISO 15883-1 (currently under revision), but also includes significant revisions in the international harmonisation of the cleaning performance criteria for washer-disinfectors to become a reference standard for cleaning efficacy testing.
In addition to the specification of various test soils for different applications, the corresponding analysis methods are also specified and explained in detail. For each element analysed, alert and action level values are given to evaluate the performance of the WD process in question. If user-specific test methods are required, a dedicated annex specifies how a new test method can be implemented and validated. Finally, the standard also provides requirements and methods for testing and evaluating the maximum amount of process residues on the processed devices, for which the process does not lead to any damage.
Therefore, EN ISO 15883-5 provides an extensive toolkit that can be used for testing and validation of WD processes within the scope of type testing and performance qualification, as well as for routine testing. Thanks to this new standard, cleaning efficacy testing in different regions now becomes more unified and results are more comparable to each other, so that processes and the effectiveness of cleaning medical devices are further improved, thus ensuring a high level of safety for both users and patients.
EN ISO 15883-5 was developed by CEN/TC 102 ‘Sterilizers and associated equipment for processing of medical devices’, whose Secretariat is held by DIN, the German National Standardization Institute.
Jennifer OGBONNA
jogbonna@cencenelec.eu
