What is ISO 15883-5 about?
ISO 15883-5 is one of a series of documents for Washer-disinfectors that specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical, and veterinary practice.
Note: ISO 15883-5 does not apply to the activities to be performed by the manufacturers of reusable medical devices.
Who is ISO 15883-5 for?
ISO 15883-5 is applicable to-
- Manufacturers of Washer-disinfectors
- Washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical, and veterinary practice
Why should you use ISO 15883-5?
Cleaning efficacy is a key aspect of establishing the satisfactory performance of a washer-disinfector (WD). This testing includes type testing under simulated use conditions. In addition to type testing, performance qualification testing is performed under clinical use conditions.
ISO 15883-5 gives requirements for standardized methods for demonstration of cleaning efficacy, including examples of test soils. The individual requirements for the various types of washer-disinfectors and processing procedures can vary, but this document provides the basis for the demonstration of cleaning efficacy.
Cleaning efficacy testing is performed in the WD and with associated accessories in two phases, type testing, under simulated use conditions, with defined test soils and their analytes, soiling methods, and test surfaces/medical devices/product representative of design and intended applications and performance qualification testing under clinical conditions with load(s) that are soiled with the most challenging soil from clinical use.
What’s changed since the last update?
BS EN ISO 15883-5:2021 supersedes ISO 15883-5:2018, which has been withdrawn. BS EN ISO 15883-5:2021 has some significant technical changes with respect to ISO 15883-5:2018, these include:
- New and previous terms and definitions were harmonized with ISO 11139:2018
- Considerations for the selection of an appropriate test soil and test load have been included
- Performance requirements to demonstrate cleaning efficacy of a washer-disinfector were consolidated and specified
- Cleaning efficacy test and acceptance criteria for the type test and performance qualification test have been specified for a variety of analytes
- Alert and action levels were introduced for analytes to facilitate interpretation of cleaning validation data
- Examples of test soils relevant to certain procedures, as referenced in published literature, and suitable assay methods for detection or quantification of certain soil residuals have been included in Annex A