oSIST prEN ISO 15883-3:2023
(Main)Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/DIS 15883-3:2023)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/DIS 15883-3:2023)
ISO 15883-3:2006 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für Behälter für menschliche Ausscheidungen (ISO/DIS 15883-3:2023)
Dieses Dokument legt Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Entleerung, Ausspülung, Reinigung und thermische Desinfektion von Behältern für menschliche Ausscheidungen zur Entsorgung innerhalb eines Betriebszyklus angewandt werden.
Die in diesem Dokument festgelegten Anforderungen gelten zusätzlich zu den in ISO/DIS 15883 1:2020 und ISO 15883 5:2021 festgelegten allgemeinen Anforderungen.
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à déjections humaines (ISO/DIS 15883-3:2023)
L'ISO 15883-3:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour vider, rincer, nettoyer et désinfecter thermiquement les récipients employés pour contenir les déjections humaines afin de pouvoir les réutiliser après un cycle standard.
L'ISO 15883-3:2006 s'applique conjointement avec l'ISO 15883-1.
Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov (ISO/DIS 15883-3:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 15883-3:2023
01-julij-2023
Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov
(ISO/DIS 15883-3:2023)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers (ISO/DIS 15883-3:2023)
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für Behälter für
menschliche Ausscheidungen (ISO/DIS 15883-3:2023)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique de récipients à déjections humaines (ISO/DIS
15883-3:2023)
Ta slovenski standard je istoveten z: prEN ISO 15883-3
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15883-3:2023
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oSIST prEN ISO 15883-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-24 2023-07-17
Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
Laveurs désinfecteurs —
Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à
déjections humaines
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NATIONAL REGULATIONS.
ISO/DIS 15883-3:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
Laveurs désinfecteurs —
Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à
déjections humaines
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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WHICH REFERENCE MAY BE MADE IN
Reference number
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15883-3:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . .2
4.1 General . 2
4.2 Chemical dosing systems . 3
4.3 Emptying . 3
4.4 Cleaning . 4
4.5 Disinfecting . 4
4.6 Drying . 5
4.7 Cooling . 5
5 Mechanical and control requirements . 5
5.1 Instrumentation and control . 5
5.2 Process . 5
5.3 Venting, draining, and purging . 6
5.4 Water quality . 6
6 Testing for conformity .6
6.1 General . 6
6.2 Test for drain seal integrity . 6
6.3 Test for flushing of non-absorbent materials . 6
6.4 Test for flushing of absorbent material (toilet tissue) . 7
6.5 Test for loading/emptying of human waste containers . 7
6.5.1 Automatic emptying . 7
6.5.2 Manual emptying . 7
6.6 Tests for soil removal from load, load carrier(s) and chamber walls . 7
7 Information to be supplied . 7
8 Information to be requested from the purchaser by the supplier of the WD .8
Annex A (informative) Summary of test programmes . 9
Annex B (normative) Specification for toilet tissue for use in tests on washer-disinfectorsfor
human waste containers .10
Annex C (informative) Measurement of water absorbency of toilet tissue by the basket
method .11
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .12
Bibliography .16
iii
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(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.
This second edition cancels and replaces the first edition (ISO 15883-3:2006), which has been
technically and editorially revised.
The main changes compared to the previous edition are as follows:
— revision of clauses cross-referencing clauses in ISO/DIS 15883-1:2020 and ISO 15883-5:2021;
— alignment of terms and definitions with ISO 11139:2018;
— addition of clause 4.1.2 listing exemptions from the requirements of ISO/DIS 15883-1:2020;
— alignment of text in clauses on cleaning and disinfecting with revised clauses of ISO 15883-2;
— addition of rinsing from former 4.6 to 4.4 Cleaning and 4.5 Disinfection
— addition of 4.7 Cooling;
— deletion of references in Bibliography already referenced in ISO/DIS 15883-1:2020 or
ISO 15883-5:2021.
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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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
Introduction
It is recommended that this Introduction be read in conjunction with the introduction to
ISO/DIS 15883-1:2020.
This part of ISO 15883 is the third of a series of standards specifying the performance of washer-
disinfectors and specifies the general requirements for performance applicable to washer-disinfectors
for human waste containers. The requirements given in this document apply to washer-disinfectors
used for emptying, flushing, washing, and thermally disinfecting human waste containers intended for
reuse such as:
— portable sanitary pans;
— supports for single-use bedpans;
— hospital bowls for containment of human waste;
— urine collection containers;
— suction bottles;
— products similar to the above and used for similar purposes.
Fields of application within the scope of the ISO 15883 series of standards can include laboratory,
veterinary, dental and pharmaceutical applications, and other specific applications, such as washer-
disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for
use with immunologically compromised patients.
Requirements for washer-disinfectors for other applications are specified in other parts the ISO 15883
series of standards.
In order to reduce the risk of spillage and the generation of aerosols most machines incorporate means
to empty human waste containers automatically, e.g. by the action of closing the WD door.
Where equipment does not provide automatic emptying facilities, extra care is needed by the user to
avoid exposure to human waste and contamination of the work environment including the generation
of aerosols.
The reliability of a human waste container washer-disinfector can be adversely affected if the
machine is connected to a poorly designed or constructed drainage system. The purchaser is therefore
recommended to ensure that the drainage system complies with the manufacturer’s recommendations
in all respects.
Safety requirements for washer-disinfectors are given in IEC 61010-2-040.
In respect of the potential adverse effects on the quality of water intended for human consumption or
environmental impacts caused by the washer-disinfector and its intended use, it is noteworthy that the
ISO 15883 series of standards provides no information as to whether the washer-disinfectors may be
used without restrictions in any of the ISO member states.
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oSIST prEN ISO 15883-3:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-3:2023(E)
Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
1 Scope
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for
emptying, flushing, washing and thermal disinfection of containers used to hold human waste for
disposal by one operating cycle.
The requirements of this document apply in addition to the general requirements specified in
ISO/DIS 15883-1:2020 and ISO 15883-5:2021.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11139:2018, Sterilization of health care products — Vocabulary of terms used in sterilization and
related equipment and process standards
ISO/DIS 15883-1:2020, Washer-disinfectors — Part 1: General requirements, terms and definitions and
tests
ISO 15883-5:2021, Washer-disinfectors — Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
A
0
measure of microbiological lethality delivered by a moist heat disinfection process expressed in terms
of the equivalent time in seconds at 80 °C with reference to a microorganism with a z value of 10 K
Note 1 to entry: See also ISO/DIS 15883-1:2020, Annex B.
[SOURCE: ISO 11139:2018, 3.1, modified – Note 1 to entry has been added]
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
3.2
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[SOURCE: ISO 11139:2018, 3.46]
3.3
flushing
purging
removing by displacement with a fluid
[SOURCE: ISO 11139:2018, 3.121]
3.4
human waste
body fluids and excretions
EXAMPLE Faeces, urine, blood, pus, vomit, mucus.
[SOURCE: ISO 11139:2018, 3.134]
3.5
human waste container
vessel for holding and transporting human waste
[SOURCE: ISO 11139:2018, 3.135]
3.6
washing
removal of contaminants from surfaces by means of an aqueous fluid
[SOURCE: ISO 11139:2018, 3.321]
4 Performance requirements
4.1 General
4.1.1 The requirements of ISO/DIS 15883-1:2020 apply with the exception of
— 4.1.13 (which refers to pressure inside the pipework during the washing stage);
— 4.3.2 (which refers to chemical disinfection, see Scope of this document);
— 5.7.4 (which refers to verification of the dose of process chemical admitted);
— 5.7.5 (which specifies the accuracy and reproducibility of chemical dosing systems);
— 5.8 (which refers to load temperature protection);
— 5.9 (which refers to control of temperatures on the load and chamber walls, see 4.5.3 and 4.5.4 of
this document);
— 5.21 b) (which refers to microprocessor control systems);
— 6.8.5 (which refers to tests for load temperature protection);
— 6.10.3 (which refers to protein residue tests, see also ISO/DIS 15883-1:2020, Table A.1 (load, 6.10.3),
ISO 15883-5:2021, Annex A (RAMS), and Annex A of this document).
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
4.1.2 The requirements of ISO 15883-5:2021 apply with the exception of
— 4.1.4 (requirement that verification and documentation of the full cleaning stage does not interfere
with analyte detection, is not applicable);
— 4.4.3 (which refers to assay criteria);
— 5.1.1 (which refers to validation of test methods);
— 5.1.3 (which refers to validation of detection methods);
— 5.1.4 (which refers to analyte assay methods);
— 5.3.4 (requirements that action levels specified in 4.4.3 for the load, and conformance of cleaning
efficacy for the test load with the alert levels in 4.4.3, are not applicable);
— 5.4.4 (requirements that action levels specified in 4.4.3 for the load, and conformance of cleaning
efficacy for the test load with the alert levels in 4.4.3, are not applicable.
4.1.3 The WD shall be designed to process one or more human waste containers in an operating cycle.
NOTE This can require the use of a variety of types of load carrier(s).
4.1.4 The temperature attained on the surfaces of the load during the disinfection stage shall not be
less than the disinfection temperature.
4.2 Chemical dosing systems
4.2.1 Provision shall be made for the installation of a chemical dosing system, when specified by the
purchaser, to allow for the injection of a descalant, detergent and/or rinse aid.
4.2.2 The means to control the volume of process chemical(s) admitted shall be adjustable and shall
deliver the set volume to an accuracy of ±10 % or better.
4.2.3 The WD shall either be fitted with means to ensure that a fault is indicated when insufficient
process chemical(s) has/have been admitted, or it shall be possible for the operator to visually verify
that the required amount of process chemical(s) has/have been used.
4.3 Emptying
4.3.1 The manufacturer shall require the purchaser to specify whether the human waste containers
are required to be emptied manually or automatically.
Manual emptying of human waste containers should be avoided whenever possible.
4.3.2 When the human waste container(s) are to be emptied automatically the emptying system shall
ensure that there is no spillage of the human waste container contents or discharge of aerosols of the
contents of human waste containers during automatic emptying.
Check for conformance in accordance with 6.5.1.
4.3.3 When the human waste container(s) are to be emptied manually into the WD the door aperture
and load support system shall be designed to enable the human waste container to be emptied and then
located in the load carrier without spillage or splashing.
Check for conformance in accordance with 6.5.2.
3
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
4.4 Cleaning
4.4.1 Cleaning shall be tested in accordance with the requirements of ISO/DIS 15883-1:2020 and the
performance requirements and test method criteria specified in ISO15883- 5: 2021.
NOTE Some suitable test soils for human waste containers are described in the Bibliography of
ISO 15883-5:2021, Reference [63] and Reference [64].
The cleaning process shall also meet the requirements of the test specified in 6.6.
Where applicable, any treatment required prior to cleaning in the WD shall be performed in accordance
with the instructions for use for the load (see ISO 17664-2), or WD [see ISO/DIS 15883-1:2020, 8.1 a)].
4.4.2 Pre-wash (flushing)
The human waste containers shall be flushed with sufficient water to remove the gross soiling.
4.4.3 Washing
The human waste containers shall be washed on both their inner and outer surfaces.
NOTE The water used to wash the human waste containers can be discharged without recirculation or be
recirculated during a single washing stage within one operating cycle.
During the washing stage:
— the washing time shall start when the temperature at the control sensor of the WD reaches the
lower limit of the temperature profile;
— the temperatures recorded on the surface of the load and load carrier(s) for the washing stage follow
the temperature profile defined for this stage and are within + 5 °C of the relevant set temperature
for each holding time of the stage (see ISO/DIS 15883-1:2020, 4.2.3).
NOTE A washing stage can include two or more washing temperatures and washing temperature bands.
4.5 Disinfecting
4.5.1 When tested in accordance with the method specified in ISO/DIS 15883-1:2020, 6.8.2, 6.8.3
and 6.8.4, each operating cycle shall include a thermal disinfection stage during which the specified
minimum temperature for the specified minimum (holding) time, or the equivalent lethality of an A of
0
at least 60 is achieved on all surfaces which are required to be disinfected.
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or
combination of the two.
4.5.2 Higher A values than 60 may be specified for the inner surface of the human waste container,
0
the outer surfaces of the human waste container or the walls of the WD chamber.
4.5.3 The temperature on the surface of the load shall be within 0 °C to 15 °C of the disinfection
temperature throughout the time specified for disinfection when this has been specified as a time–
temperature relationship.
4.5.4 The temperature recorded on the surface of the chamber wall shall be within 0 °C to 15 °C of the
set temperature throughout the time specified for disinfection when this has been specified as a time–
temperature relationship.
4.5.5 If rinsing between cleaning and disinfection is omitted, then the requirements of 4.2.4 of
ISO/DIS 15883-1:2020 apply.
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
4.5.6 If there is a final rinsing after the disinfection stage, then 4.4 of ISO/DIS 15883-1:2020 applies.
4.6 Drying
The provision of a separate drying stage within the operating cycle is optional.
Hot air or compressed air used for drying shall be of a quality which shall not impair the cleanliness of,
nor introduce microbial contamination to, the load.
NOTE ISO 8573-1, ISO 29463-1 and EN 1822-1 provide guidance and specifications on air quality.
4.7 Cooling
The provision of a separate cooling stage within the operating cycle is optional. Means used to cool the
load shall not impair the cleanliness of, nor introduce microbial contamination to, the load.
5 Mechanical and control requirements
5.1 Instrumentation and control
5.1.1 The WD shall either be fitted with a display showing chamber temperature [see
ISO/DIS 15883-1:2020, 5.11.4 a)] or an indicating light to show attainment of a pre-set disinfection
temperature. The sensor shall be located as specified in ISO/DIS 15883-1:2020, 5.12.6.
5.1.2 Provision shall be made for the installation of a temperature recorder when specified by the
purchaser. When a recorder is fitted this shall be deemed to meet the requirements of 5.1.1.
5.2 Process
5.2.1 The inner surfaces of the chamber shall be cleaned and disinfected during the process.
5.2.2 Means shall be provided to pre-set the washing temperature and time over a specified range.
Adjustment shall be by means of an access device.
5.2.3 Means shall be provided to pre-set the disinfection temperature and time over a specified
range. Adjustment shall be by means of an access device.
NOTE The facility to adjust the pre-set time and temperature over the ranges specified is to allow for
disinfection for short time periods at high temperature or, to obtain equivalent effect, prolonged times at lower
temperatures; this can be required for processing human waste containers which will not withstand higher
temperatures.
The combination of disinfection time and disinfection temperature shall be set to achieve the specified
A value.
0
5.2.4 If process fluid is recirculated, means shall be provided to prevent the spread of contaminants
and microorganisms to a subsequent process step.
NOTE The water used to wash the human waste containers can be discharged without recirculation or be
recirculated during a single flushing stage within one operating cycle.
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oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(E)
5.3 Venting, draining, and purging
5.3.1 For free standing and single door WD the drainage outlet shall be placed towards the rear of the
WD.
This should be done in such a manner that it is possible to make connection with a drainage outlet in
any position within a horizontal angle of 180°.
5.3.2 When tested in accordance with 6.2, the water seal in the trap between the ch
...
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