Foreword

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This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This first edition of ISO 15883‑5 cancels and replaces ISO/TS 15883‑5:2005, which has been technically revised. The main changes compared to the previous edition are as follows:

— new and previous terms and definitions were harmonized with ISO 11139:2018;
— considerations for 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;
— the immersion test protocol resulting from interlaboratory tests to evaluate cleaning performance of a protein-based test is specified in Annex B, together with examples of worksheets to assist laboratories performing the test in an Annex E;
— examples of protein detection methods were revised and transferred across from ISO 15883‑1:2006 to informative Annex C;
— examples of haemoglobin detection methods were added to informative Annex D;
— extensive revision of the Bibliography.

A list of all parts in the ISO 15883 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

BS EN ISO 15883-5:2021

Washer-disinfectors - Performance requirements and test method criteria for demonstrating cleaning efficacy

Published:

31 Aug 2021

Withdrawn:

7 Feb 2022