ISO/FDIS 15883-1

ISO/FDIS 15883-1:2024(E)
Date: 2024-03
ISO TC 198/WG 13
Secretariat: AAMI (for ANSI)
Washer-disinfectors — Part 1: General requirements, terms and definitions and
tests
Laveurs désinfecteurs — Partie 1: Exigences générales, termes et définitions et
essais

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ISO/FDIS 15883-1:2024(E)
© ISO 2024
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Published in Switzerland
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ISO/FDIS 15883-1:2024(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
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 for medical purposes, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 15883-1:2006), which has been technically
revised. It also incorporates ISO 15883-1:2006/Amd 1:2014.
The main changes compared to the previous edition are as follows:
— incorporation of ISO 15883-1:2006/Amd1:2014;
— alignment of terms and definitions with ISO 11139:2018;
— addition of requirements for load carrier(s);
— clarification of water quality requirements;
— relocation of former Annex C, Test methods for the detection and assessment of residual proteinaceous
contamination, to ISO 15883-5:2021;
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ISO/FDIS 15883-1:2024(E)
— redesignation of former Annex D, Microbiological recovery medium for estimation of bacterial
contamination of water, as Annex C;
— increase in the minimum temperature limit for thermal disinfection and calculation of A values from
0
65 °C to 70 °C (see Reference [48]);
— 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.
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ISO/FDIS 15883-1:2024(E)
Introduction
This document is the first part of the ISO 15883 series of standards specifying the performance of washer-
disinfectors (WDs) and specifies the general
...