Sterilisering av medicintekniska produkter - Disk- och spoldesinfektorer - Del 5: Provnedsmutsning och metoder för att visa rengöringseffektivitet (ISO/TS 15883-5:2005)
This Technical Specification includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards.
The inclusion of the test soils and methods in this Technical Specification does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy.
Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil.
NOTE 1 The test soils and methods included in this Technical Specification are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing this Technical Specification.
They have been edited only to provide a uniform format within this Technical Specification.
NOTE 2 An example of this is the use of the peroxidase test (see Annex J) to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in Annex G). See also
ISO 15883-1:2005, Annex D.