oSIST prEN ISO 15883-2:2023
(Main)Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1.
The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und semikritische Medizinprodukte (ISO/DIS 15883-2:2023)
Dieses Dokument legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Reinigung und thermische Desinfektion wiederverwendbarer Medizinprodukte wie chirurgische Instrumente, Anästhesiegeräte, Schüsseln, Schalen, Auffanggefäße, Utensilien und Glaswaren in einem einzigen Prozessablauf bestimmt sind.
Die in diesem Dokument festgelegten Anforderungen gelten zusätzlich zu den in ISO/DIS 15883 1:2020 festgelegten allgemeinen Anforderungen.
Die in diesem Dokument festgelegten Leistungsanforderungen stellen die Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von transmissiblen spongiformen Enzephalopathien möglicherweise nicht sicher.
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques (ISO/DIS 15883-2:2023)
L'ISO 15883-2:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection thermique, au cours d'un seul cycle standard, des dispositifs médicaux réutilisables tels que les instruments chirurgicaux, le matériel d'anesthésie, les bacs, plats, récipients, ustensiles, de la verrerie, etc.
Les exigences de l'ISO 15883-2:2006 sont applicables conjointement avec les exigences générales spécifiées dans l'ISO 15883-1.
Les exigences de performances spécifiées dans l'ISO 15883-2:2006 peuvent ne pas assurer l'inactivation ou l'élimination de l'agent ou des agents infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za kritične in polkritične medicinske pripomočke (ISO/DIS 15883-2:2023)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 15883-2:2023
01-julij-2023
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za kritične in polkritične
medicinske pripomočke (ISO/DIS 15883-2:2023)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und
semikritische Medizinprodukte (ISO/DIS 15883-2:2023)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques
(ISO/DIS 15883-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 15883-2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15883-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-24 2023-07-17
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-2:2023(E)
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
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
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
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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 15883-2:2023
ISO/DIS 15883-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . .3
4.1 General . 3
4.2 Cleaning . 4
4.3 Disinfecting . 5
4.4 Temperature of inner surfaces of processed devices . 5
4.5 Water quality . 5
5 Mechanical and control requirements . 5
5.1 Lumen and powered devices . 5
5.1.1 Irrigation . 5
5.1.2 Verification of flow through lumen and powered devices . 6
5.2 Control systems . 6
5.3 Process verification . 7
6 Testing for conformity .7
6.1 General . 7
6.2 Tests for soil removal from chamber walls, load carrier(s) and load . 7
6.3 Thermometric tests . 7
6.3.1 General . 7
6.3.2 Temperature of outer surfaces of devices . 7
6.3.3 Temperature of inner surfaces of devices . 8
6.4 Pressure and flow measurement . 9
7 Information to be supplied for the WD . 9
8 Information to be requested from the purchaser by the supplier of the WD .10
Annex A (informative) Summary of test programmes .11
Annex B (informative) Guidance on the designation of a medical device to a product family
for cleaning and thermal disinfection processes .12
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .15
Bibliography .19
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ISO/DIS 15883-2:2023(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 15883-2:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— change to title to reflect application to critical and semi-critical medical devices;
— addition of new terms defining critical and semi-critical medical devices, and non-critical devices;
— alignment of other terms and definitions with ISO 11139:2018;
— revision of cross-references to relevant clauses in ISO/DIS 15883-1:2020 and ISO 15883-5:2021;
— the upper limit of the washing temperature band reduced to +5 °C;
— addition of a clause on water quality (see 4.5);
— clarification of requirements for lumen and powered devices (see 5.1);
— addition of informative Annex B providing guidance on assigning a medical device to a product
family for cleaning and thermal disinfection processes;
— revision of references in 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.
iv
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ISO/DIS 15883-2:2023(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 second of a series of standards specifying the performance of washer-
disinfectors and specifies the general requirements for performance applicable to instrument washer-
disinfectors. The requirements given in this document apply to washer-disinfectors (WD) used for
cleaning and thermal disinfection of critical and semi-critical medical devices intended for reuse such
as:
— surgical instruments, which are divided into instrument product families based on design features,
e.g. instruments without hinges, cavities or lumens, with hinges, with sliding shafts, with lumens,
microsurgical instruments, and complex instruments (e.g. robotic);
— powered instruments;
— anaesthetic and respiratory equipment;
— medical devices comprised of glass components;
— any non-critical devices used in conjunction with critical and semi-critical medical devices.
Requirements for washer-disinfectors for other applications, such as for processing non-critical devices
and thermolabile endoscopes, are specified in other parts of the ISO 15883 series of standards.
When processed in the washer-disinfector, the medical devices can be intended for immediate use or
can be intended for further processing. In both cases, the efficacy of the cleaning and disinfection is of
major importance. In either case, this is for the well-being of the patient. In the latter case, it is also for
the safety of the staff who handles the instruments in the process of inspection, testing and packing as
well as ensuring that the sterilization process is not unduly challenged by residual soil.
The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the
disinfection process. Users should be aware that some medical devices can require pre-treatment, e.g.
soaking, brushing, ultrasonic pre-cleaning, lumen irrigation or any combination of these techniques.
Reference should be made to the medical device instructions for reprocessing (see also ISO 17664
series).
[4]
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 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 15883-2:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-2:2023(E)
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
1 Scope
This document specifies requirements for washer-disinfectors (WD) that are intended for use for
the cleaning and thermal disinfection, in a single operating cycle, of reusable medical devices such as
surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
The requirements specified in this document are applicable in conjunction with the general
requirements specified in ISO/DIS 15883-1:2020.
The specified performance requirements of this document might not ensure the inactivation or removal
of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
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 4017, Hexagon head screws — Product grades A and B
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 5361, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5362, Anaesthetic reservoir bags
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO/DIS 15883-1:2020, Washer-disinfectors — Part 1: General requirements, definitions and tests
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 15883-5:2021, Washer-disinfectors — Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip for general
purposes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/DIS 15883-1:2020 and the
following apply.
1
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ISO/DIS 15883-2:2023(E)
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]
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
critical medical device
item, processed in a washer-disinfector, intended to be introduced directly into,
or have contact with, the vascular system or normally sterile areas of the body
EXAMPLE Surgical instruments.
Note 1 to entry: Critical items will usually require sterilization before use.
Note 2 to entry: There can be national regulations with alternative wording of the definition for this term.
[SOURCE: ISO 11139:2018/DAmd 1:2023, 3.333]
3.4
lumen device
item that consists of tube(s) or pipe(s)
[SOURCE: ISO 11139:2018, 3.158]
3.5
non-critical device
item, processed in a washer-disinfector, whose surface(s) are intended to contact
intact skin of a body, but do not penetrate it, or device not intended for direct patient contact
EXAMPLE Human waste containers, blood pressure cuffs, wheelchairs, trays, bowls, dishes, glassware,
receivers, and containers for transit.
Note 1 to entry: There can be national regulations with alternative wording of the definition for this term when
applied to medical devices.
[SOURCE: ISO 11139:2018/DAmd 1:2023, 3.357]
3.6
powered device
surgical instrument which gives a rotating and/or oscillating movement to other
surgical instruments
EXAMPLE Dental hand pieces, orthopaedic saws, and drills.
Note 1 to entry: The power applied to the driven instrument can be mechanical (from a motor, either through
direct coupling, flexible axle, or belt) or by the flow of a pressurized fluid or compressed air.
[SOURCE: ISO 11139:2018, 3.199]
2
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ISO/DIS 15883-2:2023(E)
3.7
product family
group or subgroup of product characterized by similar attributes determined to be equivalent for
evaluation and processing purposes
Note 1 to entry: Design characteristics present specific challenges during the washing stage of medical devices in
a washer-disinfector.
[SOURCE: ISO 11139:2018, 3.218, modified – Note 1 to entry added]
3.8
rinsing
removing process residues through displacement by, and dilution with, water
[SOURCE: ISO 11139:2018, 3.237]
3.9
semi-critical medical device
item, processed in a washer-disinfector, that, during use, contacts mucous
membranes or non-intact skin of a body
EXAMPLE Some probes, some respiratory therapy equipment.
Note 1 to entry: There can be national regulations with alternative wording of the definition for this term.
[SOURCE: ISO 11139:2018/DAmd 1:2023, 3.369]
3.10
temperature band
range of temperatures expressed as the minimum and the maximum temperatures which prevail
during the specified period of a cycle
[SOURCE: ISO 11139:2018, 3.293]
3.11
washing
removal of contaminants from surfaces by means of an aqueous fluid
[SOURCE: ISO 11139:2018, 3.321]
3.12
washing temperature
minimum temperature of the washing temperature band
[SOURCE: ISO 11139:2018, 3.322]
3.13
washing time
period for which the cycle variables are maintained within the values specified for washing
EXAMPLE Temperature of the load, detergent concentration in the chamber.
[SOURCE: ISO 11139:2018, 3.323]
4 Performance requirements
4.1 General
4.1.1 The requirements of ISO/DIS 15883-1:2020 apply with the exception of:
— 4.3.2 (which refers to chemical disinfection, see Scope of this document);
3
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ISO/DIS 15883-2:2023(E)
— 5.7.5 (which refers to the accuracy of dosing systems; see 4.1.6 of this document).
4.1.2 The WD shall be designed to clean and thermally disinfect specified medical devices
that are intended to be reused and are designated as compatible with the WD process cycle [see
ISO/DIS 15883-1:2020, 8.1 b) 2)]. Processing of medical devices in the WD shall be in accordance with
the intended use of the WD and the instructions for processing the device as specified in accordance
with ISO 17664 series.
NOTE Some process chemicals or heat can promote fixation of proteinaceous or other soils to the devices to
be cleaned and can therefore interfere with the removal of soil.
4.1.3 The medical devices shall be cleaned and disinfected on the outer surfaces, including covered
surfaces and crevices, and where necessary for their safe use, safe handling and correct functioning,
the inner surfaces. Any necessary dismantling for processing the inner surfaces shall be conducted as
specified in accordance with ISO 17664-1.
4.1.4 If necessary for the process success or safety of load items, the WD shall be provided with
means to facilitate the correct alignment of the load and load carrier(s) in the WD chamber.
4.1.5 In order to process lumen devices or powered devices, the WD shall be provided with the load
carrier(s) and necessary connectors that shall be designed to ensure adequate irrigation with process
fluids through each device.
4.1.6 The means to control the volume of the process chemical(s) that is/are admitted (see
ISO/DIS 15883-1:2020, 5.7.2, 5.7.4 and 5.7.6) shall be adjustable by means of an access device and shall
deliver the set volume to an accuracy of ±5 % or better.
NOTE The volume of water admitted to the WD chamber affects the effective concentration of process
chemicals.
4.1.7 During any stage of the operating cycle, the pressure or flow inside the pipework system shall be
maintained above a specified minimum level for combination with the load, carrier(s), and if applicable,
inside the pipework for connectors, e.g. flow through hollow devices.
4.2 Cleaning
4.2.1 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.
The cleaning process shall also meet the requirements of the test specified in 6.2.
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 17664-1), or WD [see ISO/DIS 15883-1:2020, 8.1 a)].
4.2.2 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 first specified washing temperature band;
— 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.
NOTE A washing stage can include two or more washing temperatures.
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ISO/DIS 15883-2:2023(E)
4.3 Disinfecting
4.3.1 Each operating cycle shall include a thermal disinfection stage for which the time at which the
load is maintained at the disinfection temperature gives an A of at least 600 on all surfaces of the load
0
and load carrier(s) to be disinfected when tested in accordance with 6.3.
[12]
NOTE 1 See Kremer et al .
NOTE 2 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or
combination of the two.
4.3.2 The cycle shall include a thermal disinfection stage giving an A of at least 600 on all the inner
0
surfaces of the chamber when tested in accordance with 6.3.
4.3.3 The WD shall be capable of being set for disinfection stages that deliver an A of at least 3 000.
0
NOTE Attention is drawn to regional or national regulations.
4.3.4 If the disinfection is done with steam, the temperature on the surfaces of the load, chamber
walls, drain or the free chamber space shall remain below the boiling point of water corresponding
to the pressure in the WD chamber in order that water remains on the surface of the device to be
disinfected.
Conformity to this document shall be established by examination of the data obtained from
thermometric testing (see 6.3).
4.4 Temperature of inner surfaces of processed devices
For anaesthetic and respiratory tubing, lumen devices and powered devices, the temperature
requirements for the inner surfaces shall be deemed to have been achieved when:
— the temperature of the process fluids at the connection to, and the discharge from, the devices is
within the limits specified for the WD and conforms to 4.2 and 4.3;
— the flow of the process fluids at the connection to the instrument is within the limits specified when
tested in accordance with 5.1.2 and 6.3.3.
4.5 Water quality
The quality of water required for each processing stage shall be specified. The choice of water quality
shall ensure appropriate processing of the medical devices suitable for their specified intended use.
NOTE 1 For specific application, or for optimizing the process, specific grades of purified water are
recommended depending on the resulting risk.
NOTE 2 See ISO/DIS 15883-1:2020, ISO/TS 5111, and regional or national regulations or guidelines.
5 Mechanical and control requirements
5.1 Lumen and powered devices
5.1.1 Irrigation
5.1.1.1 For lumen devices, and powered devices, in which the inner surfaces are to be flushed,
means shall be provided to irrigate the medical device. Risk assessment shall be used to define critical
performance and usability parameters of the process. The effectiveness of the cleaning and disinfection
process employing the required means shall be demonstrated.
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ISO/DIS 15883-2:2023(E)
NOTE Performance and usability parameters can include, for example, damage of the device, wear,
connection error, pull-off force, disconnection, etc.
5.1.1.2 For powered devices, when required in accordance with validated device processing methods,
means shall be provided to drive the instrument during the cycle to ensure that all the inner surfaces
of axles, gears etc. come into contact with the process fluids for the specified times without causing
damage to the devices.
5.1.1.3 Validated means of connection shall be specified (see Clause 8) to conform with the
requirements of this document.
5.1.2 Verification of flow through lumen and powered devices
5.1.2.1 Durin
...
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