ISO/FDIS 15883-1
(Main)Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
Laveurs désinfecteurs — Partie 1: Exigences générales, termes et définitions et essais
General Information
Relations
Buy Standard
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS 15883-1
ISO/TC 198
Washer-disinfectors —
Secretariat: ANSI
Part 1:
Voting begins on:
2024-03-19
General requirements, terms and
definitions and tests
Voting terminates on:
2024-06-11
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 15883-1:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 15883-1:2024(en)
International
Standard
ISO/FDIS 15883-1
ISO/TC 198
Washer-disinfectors —
Secretariat: ANSI
Part 1:
Voting begins on:
General requirements, terms and
2024-03-19
definitions and tests
Voting terminates on:
Laveurs désinfecteurs —
2024-06-11
Partie 1: Exigences générales, termes et définitions et essais
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 15883-1:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 15883-1:2024(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements . .10
4.1 General .10
4.2 Cleaning .14
4.2.1 General .14
4.2.2 Pre-wash stage .14
4.2.3 Washing stage .
...
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
---------------------- Page: 1 ----------------------
ISO/FDIS 15883-1:2024(E)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no
part of this publication may be reproduced or utilized otherwise in any form or by any means,
electronic or mechanical, including photocopying, or posting on the internet or an intranet, without
prior written permission. Permission can be requested from either ISO at the address below or
ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
2 © ISO 2024 – All rights reserved
ii © ISO 2024 – All rights reserved
---------------------- Page: 2 ----------------------
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;
© ISO 2024 – All rights reserved 3
© ISO 2024 – All rights reserved iii
---------------------- Page: 3 ----------------------
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.
4 © ISO 2024 – All rights reserved
iv © ISO 2024 – All rights reserved
---------------------- Page: 4 ----------------------
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.