EN ISO 15883-5:2021

SLOVENSKI STANDARD
01-oktober-2021
Nadomešča:
SIST-TS CEN ISO/TS 15883-5:2006
Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka
čiščenja (ISO 15883-5:2021)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy (ISO 15883-5:2021)
Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für
Prüfverfahren zum Nachweis der Reinigungswirkung (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes
d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)
Ta slovenski standard je istoveten z: EN ISO 15883-5:2021
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-5
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2021
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes CEN ISO/TS 15883-5:2005
English Version
Washer-disinfectors - Part 5: Performance requirements
and test method criteria for demonstrating cleaning
efficacy (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de Reinigungs-Desinfektionsgeräte - Teil 5:
performance et critères des méthodes d'essai pour Leistungsanforderungen und Kriterien für
démontrer l'efficacité du nettoyage (ISO 15883- Prüfverfahren zum Nachweis der Reinigungswirkung
5:2021) (ISO 15883-5:2021)
This European Standard was approved by CEN on 28 February 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-5:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15883-5:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2022, and conflicting national standards
shall be withdrawn at the latest by February 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 15883-5:2005.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15883-5:2021 has been approved by CEN as EN ISO 15883-5:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 15883-5
First edition
2021-07
Washer-disinfectors —
Part 5:
Performance requirements and test
method criteria for demonstrating
cleaning efficacy
Laveurs désinfecteurs —
Partie 5: Exigences de performance et critères des méthodes d’essai
pour démontrer l’efficacité du nettoyage
Reference number
ISO 15883-5:2021(E)
©
ISO 2021
ISO 15883-5:2021(E)
© ISO 2021
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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . 3
4.1 General . 3
4.2 Test soil considerations . 3
4.3 Load considerations . 4
4.4 Cleaning efficacy test criteria . 5
4.4.1 General. 5
4.4.2 Visual examination . 5
4.4.3 Assay criteria . 5
4.4.4 Process residuals . 7
5 Testing for conformity . 7
5.1 Cleaning test method validation . 7
5.1.1 General. 7
5.1.2 Load soiling method . 7
5.1.3 Detection method(s) . . 7
5.1.4 Analyte assay method . 8
5.2 Washer-disinfector requirements . 8
5.3 Cleaning type test . 8
5.3.1 Principle . 8
5.3.2 Reagents/materials . 8
5.3.3 Procedure . 8
5.3.4 Acceptance criteria . 8
5.4 Cleaning performance qualification test . 9
5.4.1 Principle . 9
5.4.2 Reagents/materials . 9
5.4.3 Procedure . 9
5.4.4 Acceptance criteria . 9
5.5 Process residuals . 9
5.5.1 General. 9
5.5.2 Risk analysis .10
5.5.3 Cytotoxicity .10
5.5.4 Sampling methods .10
5.5.5 Acceptance criteria .10
Annex A (informative) Examples of test soils .11
Annex B (normative) Protein-based test soil performance assessment .16
Annex C (informative) Examples of test methods for the detection and assessment of
residual proteinaceous contamination .38
Annex D (informative) Examples of test methods for the detection of haemoglobin for the
assessment of cleaning efficacy .43
Annex E (informative) Test soil performance assessment – Sample results sheets .47
Bibliography .54
ISO 15883-5:2021(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 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;
iv © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
— 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.
ISO 15883-5:2021(E)
Introduction
Testing of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-
disinfector (WD). This testing includes type testing under simulated use conditions. In addition to type
testing, performance qualification testing is performed under clinical use conditions.
The cleaning efficacy of washer-disinfectors has historically been demonstrated by referring to
different test soils and methods that have been used in several different countries. This document gives
requirements for standardized methods for demonstration of cleaning efficacy, including examples of
test soils. The individual requirements for the various types of washer-disinfectors and processing
procedures can vary, but this document provides the basis for the demonstration of cleaning efficacy.
Cleaning efficacy testing is performed in the WD and with associated accessories in two phases:
— type testing, under simulated use conditions, with defined test soils and their analytes, soiling
methods and test surfaces/medical devices/product representative of design and intended
applications;
— performance qualification testing under clinical conditions with load(s) that are soiled with the
most challenging soil from clinical use.
This document excludes the verification of cleaning of product that could have been exposed to prions,
the causative agent in transmissible spongiform encephalopathies such as Creutzfeldt-Jakob disease
(CJD).
vi © ISO 2021 – All rights reserved

INTERNATIONAL STANDARD ISO 15883-5:2021(E)
Washer-disinfectors —
Part 5:
Performance requirements and test method criteria for
demonstrating cleaning efficacy
1 Scope
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of
washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical
devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the
context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable
medical devices.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
1)
ISO 15883-1:— , Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
action level
value from monitoring that necessitates immediate intervention
[SOURCE: ISO 11139:2018, 3.5]
1) Under preparation. Stage at the time of publication: ISO/DIS 15883-1:2020.
ISO 15883-5:2021(E)
3.2
alert level
value from monitoring providing early warning of deviation from specified conditions
[SOURCE: ISO 11139:2018, 3.11]
3.3
analyte
chemical substance that is the subject of chemical analysis
[SOURCE: ISO 11139:2018, 3.12]
3.4
clean
visually free of soil and below specified levels of analytes (3.3)
[SOURCE: ISO 11139:2018, 3.45]
3.5
clinical use
use of a health care product during a procedure on a patient
Note 1 to entry: This encompasses all steps prior to processing in a WD.
[SOURCE: ISO 11139:2018, 3.49, modified – Note 1 to entry has been added]
3.6
load
product, equipment, or materials to be processed together within an operating cycle
[SOURCE: ISO 11139:2018, 3.155]
3.7
product
tangible result of a process
EXAMPLE Raw material(s), intermediates(s), sub-assembly(ies), health care product(s)
[SOURCE: ISO 11139:2018, 3.217]
3.8
rinsing
removing process residues through displacement by, and dilution with, water
[SOURCE: ISO 11139:2018, 3.237]
3.9
simulated use
use that mimics the intended use of the medical device
3.10
soil
natural or artificial contamination on a device or surface following its use or simulated use
[SOURCE: ISO 11139:2018, 3.257]
3.11
surrogate product
item designed to represent product in process simulations and which is comparable with the actual
product
[SOURCE: ISO 11139:2018, 3.291]
2 © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
3.12
test soil
formulation designed for use as a substitute for a contaminant or debris found on a device after use
[SOURCE: ISO 11139:2018, 3.300]
3.13
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 In addition to the requirements below (see 4.1.3 to 4.1.5), the relevant cleaning performance
requirements of the subsequent parts of ISO 15883 that apply to the washer-disinfector type shall apply.
4.1.2 In addition to the tests specified in 4.1.4 and 4.1.5), the relevant cleaning tests of the subsequent
parts of ISO 15883 that apply to the washer-disinfector type shall apply.
[5]
NOTE See for example ISO 15883-7 .
4.1.3 The process conditions for cleaning, e.g. stages, temperatures, pressure, flow, process chemicals,
quality and quantity of water, used to confirm conformance of the WD with the requirements of this
standard shall be defined in accordance with ISO 15883-1:—, 4.1.12 and 8.2 b).
[4]
NOTE Refer to ISO 15883-1:—, 5.23 and ISO 15883-4 for water quality.
4.1.4 Tests of cleaning efficacy shall be performed on the defined cleaning stages, including, where
appropriate, flushing, rinsing, etc. (see 5.2). Cleaning stages shall be specified according to ISO 15883-1:—
, 4.1. It shall be verified and documented that the full cleaning stage does not interfere with analyte
detection. During tests of cleaning efficacy, the WD shall be operated without any disinfection or drying
stage and should not affect the efficacy and safety of the WD process.
4.1.5 Cleaning efficacy testing shall be performed in the WD and with accessories specified for the
particular load in two phases:
a) type testing under simulated use conditions with defined test soil(s), including the analyte(s) and
representative test load(s) (see 4.4.1),
b) performance qualification testing with worst-case load(s) soiled by clinical use (see 4.4.1), or if
justified (5.4.2), with surrogate product.
4.2 Test soil considerations
4.2.1 The rationale for the choice of test soil(s) and soiling method(s) shall be justified and documented.
Test soil formulations may be chosen or developed based on a review of the literature and demonstration
of its relevance based on the use of the medical device/product in clinical practice (see Annex A and the
Bibliography).
NOTE The test soils for the load, chamber walls and load carriers can be different.
4.2.2 The protein-based test soil shall conform to the performance criteria specified in B.2.
NOTE Sample result sheets for data entry are provided in Annex E.
ISO 15883-5:2021(E)
4.2.3 The choice of test soil, its method of application, and conditioning (e.g. drying) shall simulate
worst-case clinical use conditions of the load.
a) Composition of the test soil shall include the analyte(s) representative of soiling likely to be
encountered during intended use of the product at a quantity justified by 4.2.1, and if applicable,
any associated procedural material(s) used on the product during its clinical use, that are intended
to be cleaned (e.g. contrast media, lubricants, etc.).
b) The method of test soil application shall simulate the conditions of use of the product, for example,
cauterization or heating that present a greater challenge to cleaning, and/or pressure gradients
that could facilitate the penetration of material into various parts of the product. Parts of the
product identified as the most difficult to clean shall be soiled (see 4.3).
c) After application of the test soil on the product or test pieces, consideration shall be given to
transport and dwell time conditions (e.g. temperature, time, humidity) for the product from point
of use to place of processing, and if applicable, any pre-treatment (see 5.1.2.2).
d) The composition of the soil shall be characterized and the most difficult soil elements (e.g. lipids,
adhesives, insoluble proteins, etc.) shall be identified and considered in the validation strategy to
ensure that the validation activities demonstrate effective removal of the soil.
4.2.4 The method of test soil extraction, recovery efficiency, and detection of analytes shall be validated
and specified. Validation of the recovery shall demonstrate the ability to reduce analyte below the action
level.
An appropriate percent recovery is greater than 70 %, unless otherwise justified (see 5.1.3.2).
4.3 Load considerations
4.3.1 Load(s), including their respective product that represent typical and worst-case, clinical use
conditions, shall be defined and justified. Such load(s) shall be used for cleaning efficacy and process
residuals for type testing and performance qualification tests [see also ISO 15883-1:—, 8.1 b) and
[4]
ISO 15883-4 . The load(s) shall be considered appropriate for the type of washer-disinfector being
tested.
NOTE For type testing and performance qualification testing, when justified, the load can be surrogate
product, which could be used for tests if they are shown to be representative of the prescribed load.
4.3.2 Consideration shall be given to any applicable physical characteristics of the product type(s) and
patient contact area, including but not restricted to:
— lumens;
— valves;
— crevices;
— hinges and joints;
— rough and irregular surfaces;
— material composition, including porosity;
— junctions and dead ends;
— internal moveable parts (e.g. cables).
4 © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
These design characteristics are at a greater risk of accumulation and retention of soil and shall be
specifically considered in the estimation and risk assessment of cleaning efficacy and cleaning
endpoints of the entire product.
[18]
NOTE See ASTM F3357 for additional detail on medical device design and cleaning.
4.3.3 Any necessary pre-treatment of the product specified in its IFU, e.g. manual pre-cleaning or
disassembly, shall be included as part of the test procedure.
4.4 Cleaning efficacy test criteria
4.4.1 General
Cleaning efficacy shall be determined by visual examination (see 4.4.2) and by the quantitative
detection of protein (see 4.4.3.2, Note and Annex B).
For invasive medical devices, at least one other validated quantitative analytical test method shall be
used to measure another analyte(s) in addition to protein for type testing.
Non-invasive medical devices shall require visual examination only.
NOTE 1 Some non-invasive medical devices can represent higher levels of risk e.g. infant formula bottles,
contact tonometers.
NOTE 2 A validated qualitative method (see References [22],[52],[54],[70] and[88]) can be used for routine
testing when the detection level of this method is below the alert level assay criteria given in 4.4.3.
NOTE 3 Typical analytes are given in 4.4.3.2 and 4.4.3.3 (also see Bibliography).
[3]
NOTE 4 Refer to ISO 14971 for approach to risk assessment to support justification.
4.4.2 Visual examination
Visual examination shall demonstrate the absence of visible soil on all observable surfaces of the
load(s), following cleaning stage(s). This requirement does not apply where adequate visual inspection
of the surfaces of the product is not possible due to its configuration.
NOTE Adequate visual inspection requirements can include:
— defined instructions for inspection;
— adequate illumination;
— inspection aids, if applicable (e.g. lighted magnification boroscope);
— viewing distance.
[10] [16]
Refer to EN 13018 and ASTM E3106 for additional information on visual inspection.
4.4.3 Assay criteria
4.4.3.1 General
Acceptance criteria for analytes are specified in terms of both an alert level and an action level.
The alert and action levels for protein and other analytes are specified in 4.4.3.2 and 4.4.3.3. Their
action levels are the maximum criteria for acceptable cleaning efficacy during testing, but the target
values are given as the alert levels. When both alert and action levels are specified, if analytes are
detected at values between the two levels, they shall be investigated, but considered to pass cleaning
requirements.
ISO 15883-5:2021(E)
For the purpose of conforming to the requirements of 4.2 and 6.10 in ISO 15883-1:—, the action level
shall be used.
NOTE The analyte values in this document are expressed per unit area (cm ). Some regional and national
guidance specify maximum analyte values per medical device or per medical device side. It is not possible to
directly compare numerical values expressed per cm to those values expressed per medical device or per
medical device side, unless the surface area of the medical device or medical device side are known, and the
appropriate conversion made.
4.4.3.2 Protein assay criteria
The protein assay criteria are:
— Alert level ≥ 3 µg/cm
— Action level ≥ 6,4 µg/cm
The maximum acceptable level of protein on a cleaned product shall be lower than the action level (see
References [42],[51],[72],[76] and[85]), for each sample.
NOTE Protein detection methods can include those specified in Annex C, or as otherwise validated.
4.4.3.3 Assay criteria for other analytes
Other analytes, if used, and their acceptable levels on a cleaned product, include:
a) Total organic carbon (TOC)
1) Alert level ≥ 6 µg/cm (see Reference [85])
2) Action level ≥ 12 µg/cm (see Reference [67])
NOTE TOC is the quantity of carbon present in organic matter and determined as non-purgeable
organic carbon.
b) Carbohydrate
1) Alert level ≥ 0,9 µg/cm
2) Action level ≥ 1,8 µg/cm (see References [34],[40] and[53])
[53]
NOTE The method by Dubois et al. varies in its detection of monosaccharides and therefore the
level of detectable carbohydrate, depending on its composition. The alert and action levels provided
were based on this limitation.
c) Haemoglobin
1) Alert level ≥ 1,0 µg/cm (see Reference [73])
2) Action level ≥ 2,2 µg/cm (see References [34],[35],[42] and[51])
NOTE Haemoglobin detection methods can include those specified in Annex D, or as otherwise
validated.
d) Adenosine triphosphate (ATP)
1) Alert level ≥ 10 femtomoles (fmol) of ATP/cm (see References [37] and[89])
2) Action level ≥ 22 femtomoles (fmol) of ATP/cm (see References [36],[37] and[43])
NOTE Conversion of relative light units (RLU) to femtomoles can be obtained from the specific ATP
monitoring equipment supplier.
6 © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
e) Endotoxin
1) Alert level ≥ 2,2 EU/device (see References [12] and[33])
2) Action level ≥ 20 EU/device (see References [12],[32] and[33])
NOTE 1 Endotoxin is measured in endotoxin units (EU).
NOTE 2 The recommended endotoxin levels are ≤20 EU/device for implants and product that
directly or indirectly contact the cardiovascular system and lymphatic system, and ≤2,15 EU/device for
a product having intrathecal patient contact (see References [9],[12] and[33]).
NOTE 3 Additional endotoxin studies on medical devices can be found in References [41] and[50].
4.4.4 Process residuals
The cleaning stage(s), including any post-washing rinse(s) shall not leave any process residuals on the
load that are potentially harmful during subsequent use or impair the following process stages (see
5.5).
NOTE Refer to process chemicals in ISO 15883-1:—, 4.6.
5 Testing for conformity
5.1 Cleaning test method validation
5.1.1 General
The cleaning test methods employed for both type tests (see 5.3) and performance qualification tests
(see 5.4) shall be validated.
NOTE 1 Cleaning test method includes the test soil, soiling method, recovery method, and endpoint analysis.
[6]
NOTE 2 ISO/IEC 17025 requires test assay methods to be validated. Other references, such as
[15] [21] [26] [27] [28] [29]
ASTM E-2857, I.C.H guidelines , and pharmacopoeias , , , , give guidance on requirements for the
validation of various types of analytical test methods.
5.1.2 Load soiling method
5.1.2.1 The load soiling method, including its application and any treatment, shall simulate an
equivalent challenge to the WD cleaning stage(s) as that presented by worst-case clinically soiled load(s),
including the specified load carrier (see 4.2.3 and 5.2.1).
5.1.2.2 The load soiling method shall specify any conditioning, to include drying of soiled product for a
defined time, temperature and humidity (i.e. dwell time) that will represent the use of the product being
processed in the WD.
[62]
NOTE Refer to Köhnlein et al. 2008 as an example for conditioning.
5.1.3 Detection method(s)
5.1.3.1 The limit of detection, either directly or by extraction, shall be determined for each analyte and
each method used for cleaning validation studies.
5.1.3.2 The test soil recovery efficiency shall be determined. The corresponding correction factor shall
be calculated and applied to the results (see 4.2.4).
ISO 15883-5:2021(E)
[2]
NOTE ISO 11737-1 gives examples of methods of ascertaining bioburden recovery efficiencies and
application of bioburden correction factors. These principles and general methods can also be applied regarding
test soil recovery.
5.1.3.3 Negative and positive controls shall be conducted to identify interference of process conditions
with the detection method (see 5.2.2).
5.1.4 Analyte assay method
The chosen analyte assay method shall be validated for each analyte used for cleaning validation
studies.
5.2 Washer-disinfector requirements
5.2.1 The cleaning tests shall be performed on the defined washer-disinfector loads. The worst-case
load shall include representative product and specified load carrier(s). Each type of load carrier with
representative product shall be tested separately unless a justification is provided to do otherwise.
5.2.2 The WD cleaning stage(s) parameters and cleaning process chemicals shall be specified. Type
testing shall be conducted under the specified worst-case parameters (e.g. temperature, time, process
chemical concentration, services, pressure, and flow rate).
NOTE Services can include electricity, water, air, and steam supplies.
5.2.3 Cleaning validation shall be tested without any disinfection or drying stage (see ISO 15883-1:—,
6.10).
5.3 Cleaning type test
5.3.1 Principle
In addition to the requirements in this document, the relevant cleaning test requirements of the other
applicable parts of ISO 15883 shall apply.
5.3.2 Reagents/materials
Coagulating blood or an alternative test soil meeting the criteria in 4.2 shall be used.
5.3.3 Procedure
5.3.3.1 The test load, washer-disinfector chamber walls and load carrier shall be soiled with test soil
(see 4.2.1 and 4.3).
NOTE Refer to Annex A for examples of test soils.
5.3.3.2 Soiled surfaces shall be conditioned as described in 5.1.2.2.
5.3.3.3 Cleaning test stages shall be conducted in triplicate under the worst-case processing conditions
as defined for the WD (see 5.2.2).
5.3.4 Acceptance criteria
Cleaning efficacy shall conform with the absence of visible soil as specified in 4.4.2 and with the action
levels specified in 4.4.3 for the test load. Where practicable, cleaning efficacy should conform with the
8 © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
alert levels in 4.4.3 for the test load. Visual examination may be sufficient for chamber walls and load
carrier (see 4.4.2).
NOTE 1 The action levels are the acceptance criteria for cleaning efficacy during type testing, but the desired
criteria are given as the alert levels.
NOTE 2 Photographic records can assist by capturing visual examination outcomes.
5.4 Cleaning performance qualification test
5.4.1 Principle
Testing shall be conducted in conformance with ISO 15883-1:—, 6.10.3 and the applicable part of
ISO 15883.
5.4.2 Reagents/materials
The WD shall be tested using actual loads contaminated by clinical use. These loads shall be
representative of those the WD is intended to process and include product that are known as difficult
to clean.
For particular product, a surrogate product that simulates clinical use conditions may be used for
cleaning efficacy. The use of surrogate product and test soils shall be justified (see 5.1 and 4.2) for
applicability to clinical use conditions.
NOTE Surrogate product can be used to simulate product that are difficult to sample without destruction, or
for which the extraction efficiency of the sampling method cannot be determined.
5.4.3 Procedure
5.4.3.1 Soiled surfaces shall be held under dwell time conditions representative of worst-case practices
(e.g. time, temperature and humidity) prior to cleaning (see 5.1.2.2).
5.4.3.2 Cleaning tests shall be conducted on comparable loads in triplicate (see 5.2).
NOTE Based on a risk analysis, fewer replicates can be justified during requalification.
5.4.4 Acceptance criteria
Cleaning efficacy shall conform with the absence of visible soil specified in 4.4.2 and the action levels
specified in 4.4.3 for the test load. Where practicable, cleaning efficacy should conform with the alert
levels in 4.4.3 for the test load. Visual examination may be sufficient for chamber walls and load carrier
(see 4.4.2).
NOTE Photographic records can assist by capturing visual examination outcomes.
5.5 Process residuals
5.5.1 General
The acceptable amount of process residuals shall be specified as part of risk analysis and cytotoxicity
testing as part of type testing. Performance qualification requires periodic sampling of the product for
process residuals (see ISO 15883-1:—, Table A.1).
In the case of a change to the process or the process chemicals, type testing and performance
qualification shall be repeated.
ISO 15883-5:2021(E)
Compliance with this requirement shall be verified for all process chemicals intended to be used inside
the WD.
5.5.2 Risk analysis
A risk analysis shall be documented, demonstrating that the risk of process residuals has been reduced
to below harmful levels. The risk analysis shall consider the requirements of ISO 10993-1.
5.5.3 Cytotoxicity
Cytotoxicity tests shall be conducted on medical devices included in the WD load to demonstrate the
absence of potentially harmful residuals in conformance with ISO 10993-5 unless otherwise justified
as a result of the risk assessment (see 4.4 and 4.6 of ISO 15883-1:—). Any such risk assessment shall
include reference to the cytotoxicity of the process chemicals employed during validation. Refer to
References [45] and[47].
Additional biocompatibility testing can be required, based on the risk analysis as defined in ISO 10993-1.
5.5.4 Sampling methods
A sampling method for extraction of process residuals from the load and analytical method for detection
of process residuals in the samples shall be specified. These methods shall be capable of determining
the presence of process chemical(s) at concentrations below that specified as potentially harmful, i.e. as
the maximum acceptable (see ISO 15883-1:—, 6.10.4).
NOTE Refer to References [44] and [55].
Sampling shall be done at the end of the complete WD process.
5.5.5 Acceptance criteria
Based on the risk analysis or cytotoxicity test results, an action and alert level shall be specified.
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ISO 15883-5:2021(E)
Annex A
(informative)
Examples of test soils
Table A.1 provides condensed versions of examples of test soils that can be used for the testing of
cleaning efficacy to meet the requirements of 4.2.
No single test soil has been identified as being representative of all clinical practice.
Table A.1 — Examples of preparation methods for test soils
Examples of Test soil Preparation (condensed version) Reference
procedure
General surgery Coagulated bl
...