Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

2021-03-17_JO_BT decision BT N 12427 ( Draft BT C037/2021)_ remove link to MDD and MDR
2019-08-21: enquiry period has been extended following modification of the perio in ISO.

Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für Prüfverfahren zum Nachweis der Reinigungswirksamkeit (ISO 15883-5:2021)

Dieses Dokument legt Verfahren und Prüfmethoden fest, die zum Nachweis der Reinigungswirksamkeit von Reinigungs-Desinfektionsgeräten (RDG) und ihres Zubehörs, die für die Reinigung von wiederverwendbaren Medizinprodukten eingesetzt werden, angewendet werden sollen.
ANMERKUNG 1 Die Anforderungen können auf Reinigungs-Desinfektionsgeräte angewendet werden, die zur Verwendung mit anderen Gegenständen bestimmt sind, die im Rahmen der medizinischen, zahnmedizinischen, labortechnischen, pharmazeutischen und veterinärmedizinischen Praxis verwendet werden.
ANMERKUNG 2 Dieses Dokument ist nicht anzuwenden für die Tätigkeiten, die von den Herstellern von wiederverwendbaren Medizinprodukten durchzuführen sind.

Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)

Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka čiščenja (ISO 15883-5:2021)

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Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
18-Aug-2021
Completion Date
18-Aug-2021

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SLOVENSKI STANDARD
SIST EN ISO 15883-5:2021
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
SIST EN ISO 15883-5:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 15883-5:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 15883-5:2021
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 15883-5:2021
EN ISO 15883-5:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 15883-5:2021
EN ISO 15883-5:2021 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 15883-5:2021
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SIST EN ISO 15883-5:2021
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
---------------------- Page: 7 ----------------------
SIST EN ISO 15883-5:2021
ISO 15883-5:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 15883-5:2021
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 2021 – All rights reserved iii
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SIST EN ISO 15883-5:2021
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
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SIST EN ISO 15883-5:2021
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 2021 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 15883-5:2021
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
---------------------- Page: 12 ----------------------
SIST EN ISO 15883-5:2021
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

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 2021 – All rights reserved 1
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SIST EN ISO 15883-5:2021
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
---------------------- Page: 14 ----------------------
SIST EN ISO 15883-5:2021
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 2021 – All rights reserved 3
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SIST EN ISO 15883-5:2021
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 i
...

SLOVENSKI STANDARD
oSIST prEN ISO 15883-5:2019
01-september-2019

Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka

čiščenja (ISO/DIS 15883-5:2019)

Washer disinfectors - Part 5: Performance requirements and test method criteria for

demonstrating cleaning efficacy (ISO/DIS 15883-5:2019)

Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für das

Prüfverfahren zum Nachweis der Reinigungswirkung (ISO/DIS 15883-5:2019)

Laveurs désinfecteurs - Partie 5 : Exigences de performance et critères de la méthode

dessai permettant de démontrer lefficacité de nettoyage (ISO/DIS 15883-5:2019)
Ta slovenski standard je istoveten z: prEN ISO 15883-5
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-5:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 15883-5:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 15883-5:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-5
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-06-10 2019-09-02
Washer disinfectors —
Part 5:
Performance requirements and test method criteria for
demonstrating cleaning efficacy
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-5:2019(E)
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 SUPPORTING DOCUMENTATION. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 15883-5:2019
ISO/DIS 15883-5:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 15883-5:2019
ISO/DIS 15883-5:2019(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 Test soil considerations ................................................................................................................................................................... 3

4.3 Load considerations ........................................................................................................................................................................... 3

4.4 Cleaning efficacy test criteria ..................................................................................................................................................... 4

4.4.1 General...................................................................................................................................................................................... 4

4.4.2 Visual examination ......................................................................................................................................................... 4

4.4.3 Assay criteria ....................................................................................................................................................................... 4

4.4.4 Process residuals ............................................................................................................................................................. 6

5 Testing for conformity .................................................................................................................................................................................... 6

5.1 Cleaning test method validation .............................................................................................................................................. 6

5.1.1 General...................................................................................................................................................................................... 6

5.1.2 Load soiling method ..................................................................................................................................................... 6

5.1.3 Detection method(s) ........................................................................................................................................... .......... 6

5.1.4 Analyte assay method .................................................................................................................................................. 6

5.2 Washer-disinfector requirements .......................................................................................................................................... 7

5.3 Cleaning type test ................................................................................................................................................................................. 7

5.3.1 Principle .................................................................................................................................................................................. 7

5.3.2 Reagents/materials ....................................................................................................................................................... 7

5.3.3 Procedure ............................................................................................................................................................................... 7

5.3.4 Acceptance criteria ........................................................................................................................................................ 7

5.4 Cleaning performance qualification test ........................................................................................................................... 8

5.4.1 Principle .................................................................................................................................................................................. 8

5.4.2 Reagents/materials ....................................................................................................................................................... 8

5.4.3 Procedure ............................................................................................................................................................................... 8

5.4.4 Acceptance criteria ........................................................................................................................................................ 8

5.5 Process residuals ................................................................................................................................................................................... 8

5.5.1 General...................................................................................................................................................................................... 8

5.5.2 Risk analysis ........................................................................................................................................................................ 8

5.5.3 Cytotoxicity considerations .................................................................................................................................... 8

5.5.4 Sampling methods .......................................................................................................................................................... 9

Annex A (informative) Examples of text soils ...........................................................................................................................................10

Annex B (normative) Test soil performance assessment.............................................................................................................13

Annex ZA (informative) Relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ....................................................34

Annex ZB (informative) Relationship between this European Standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered ......... ................................................................................................................................................................................................................35

Bibliography .............................................................................................................................................................................................................................37

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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 [or Project Committee] ISO/TC 198, Sterilization

of health care products.
This first edition cancels and replaces ISO/TS 15883-5:2005.
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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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 and can be

confirmed by performance qualification testing under clinical conditions.

Cleaning efficacy of washer-disinfectors has traditionally been demonstrated by referring to different

test soils and methods that had been used in several different countries. This part of ISO 15883

recommends the methods, including examples of test soils, to standardize these requirements.

The individual requirements for the various types of washer-disinfectors and device reprocessing

applications 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, soiling methods and test

surfaces/devices representative of design and intended applications;

— performance qualification testing under clinical conditions with load(s) soiled by the most

challenging load to be processed in normal practice.

NOTE This standard currently excludes the verification of cleaning of devices that might have been exposed to

prions, the causative agent in transmissible spongiform encephalopathies such as Creutzfeldt-Jakob disease (CJD).

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DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-5:2019(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 re-usable medical

devices and other items used in medical, dental, pharmaceutical and veterinary practice.

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.

I S O 158 83-1:20 06/A md1: 2014, Washer-disinfectors — Part 1: General requirements, terms and definitions

and tests (under review)

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

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
Note 1 to entry: This is the maximum value of analyte not to be exceeded.
[SOURCE: ISO 11139:2018, 3.5, modified — Note 1 to entry has been added.]
3.2
alert level

value from monitoring providing early warning of deviation from specified conditions

Note 1 to entry: This is the target value of analyte.
[SOURCE: ISO 11139:2018, 3.11, modified — Note 1 to entry has been added.]
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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
[SOURCE: ISO 11139:2018, 3.45]
3.5
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.6
load

product, equipment, or materials to be processed together within an operating cycle

[SOURCE: ISO 11139:2018, 3.155]
3.7
soil

natural or artificial contamination on a device or surface following its use or simulated use

[SOURCE: ISO 11139:2018, 3.257]
3.8
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]
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 below, (see 4.1.4 to 4.1.5), the relevant cleaning tests of the subsequent

parts of ISO 15883 that apply to the washer-disinfector type shall apply.

4.1.3 The conditions for cleaning, e.g. stages, temperatures, pressure, flow, chemicals, quality and

quantity of water, used to confirm conformance of the WD with the requirements of this standard shall

be defined.
NOTE Refer to ISO 15883-1:2006/Amd1: 2014, 5.23 for water quality.

4.1.4 For each specified cleaning stage, e.g. for different load(s), tests for cleaning efficacy shall be

performed (see 5.2.1). During tests of cleaning efficacy, the WD shall be operated without any disinfection

or drying stage.

If parts of the disinfection cycle are considered important for adequate cleaning (e.g. for rinsing), then

it shall be verified that this does not interfere with analyte detection, and should not affect the efficacy

or safety of the WD process.
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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).

4.2 Test soil considerations

4.2.1 The rationale for the choice of test soil and soiling method 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 devices in clinical practice. (See Annex A and Bibliography.)

4.2.2 The test soil shall conform to the performance criteria specified in Annex B.

NOTE Sample result sheets for data entry are provided in Annex 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 devices.

a) Composition of the test soil shall include at least the concentration of analyte(s) representative of

tissues/fluids, and if applicable, any associated procedural material(s) used on the device(s) during

its clinical use, that are intended to be cleaned (e.g. contrast media, lubricants, cements, etc.).

b) The method of test soil application shall simulate the conditions of use of the device(s), for example,

cauterization or heating that present a greater challenge to cleaning, and/or pressure gradients

that may facilitate the penetration of material into various parts of the device(s). Parts of the device

identified as the most difficult to clean shall be soiled (see 4.3).

c) After soiling of the device(s), consideration shall be given to transport and dwell time conditions

(e.g. temperature, time, humidity) for the device(s) from point of use to place of reprocessing, and if

applicable, any pre-treatment.

4.2.4 The method of test soil extraction (recovery) from devices, extraction efficiency, and detection of

analytes shall be validated.

NOTE An appropriate percent recovery is greater than 50%, unless otherwise justified (see 5.1.3.2).

4.3 Load considerations

Load(s), including their respective devices 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 residual type

testing and performance qualification tests [see also ISO 15883-1:2006/Amd1: 2014, 8.1b)]. The load(s)

shall be considered appropriate for the type of washer-disinfector being tested.

NOTE These devices can be surrogate devices, which could be used for some tests if they are shown to be

representative of the prescribed load.

Consideration shall be given to any applicable physical characteristics of the device type(s) and patient

contact area, including but not restricted to:
— lumens;
— valves;
— crevices;
— hinges and joints;
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— rough and irregular surfaces;
— material composition, including porosity;
— junctions and dead ends;
— internal moveable parts (e.g. cables).

These design characteristics are at a greater risk of accumulation and retention of soil and shall be

considered in the estimation of cleaning efficacy of the entire device.

Any necessary pre-treatment of the device(s), 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 Note 1). If applicable, at least one other validated quantitative analytical test

method shall be used to measure another analyte(s) in addition to protein.

NOTE 1 A validated qualitative method can be used for performance qualification and routine testing when

the detection level of this method is below the alert or action level assay criteria given in 4.4.3.

NOTE 2 Non-invasive devices, such as those that do not penetrate inside the body, either through a body

orifice or through the surface of the body, might only require visual examination. Some non-invasive devices can

represent higher levels of risk e.g. infant formula bottles, contact tonometers.
NOTE 3 Typical analytes are given in 4.4.3.3 (also see Bibliography).
[3]

NOTE 4 Refer to ISO I4971: 2007 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), including device(s) following cleaning stage(s). This requirement does not apply where visual

inspection of the surfaces of the device 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. gross magnification, boroscope);
— viewing distance.
[7]
Refer to EN 13018 for additional information on visual inspection.
4.4.3 Assay criteria
4.4.3.1 General

Acceptance criteria for analytes may be 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 and 4.4.4. Their action

levels are the maximum criteria for acceptable cleaning efficacy during testing, but the desired criteria

are given as the alert levels. If values are detected between the alert and action levels they shall be

investigated and considered to pass cleaning requirements, if justified.
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For the purpose of meeting the requirements of ISO 15883-1, the action level shall be used.

4.4.3.2 Protein assay criteria
The alert and action level criteria for the protein assay are:
— Alert level, ≥3 µg/cm².
— Action level, ≥6,4 µg/cm²

The maximum acceptable level of protein on a cleaned device shall be lower than the action level (see

[14] [27] [48] [52] [59]
references , , , , ) for each sample, as justified.

NOTE 1 Protein detection methods can include those specified in Annex C, or as otherwise validated.

NOTE 2 Alert and action levels relate to cleaning efficacy and performance and not necessarily clinical risk.

Clinical actions in response to adverse performance will depend on the types of instruments, procedures and

patient risk factors.
4.4.3.3 Assay criteria for other analytes

Other analytes and their acceptable levels, if used, on a cleaned device, include:

a) Total organic carbon (TOC)
[59]
1) Alert level ≥ 6 µg/cm² (see reference )
2 [44]
2) Action level ≥ 12 µg/cm (see reference )

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/cm²
2 [14] [15] [27]
2) Action level, ≥ 1,8 µg/cm (see references, , and )
c) Haemoglobin
2 [49]
1) Alert level, ≥ 1,0 µg/cm (see reference )
2 [13] [14] [15] [27]
2) Action level, ≥ 2,2 µg/cm (see references, , , and )
d) ATP
2 [17] [62]
1) Alert level, ≥ 10 femtomoles of ATP/cm (see references and )
2 [16] [17] [20]
2) Action level, ≥ 22 femtomoles of ATP/cm (see references , and )

NOTE Conversion of RLU to femtomoles can be obtained from the specific ATP monitoring equipment

supplier.
e) Endotoxin
2 ( [14]
1) Alert level, ≥ 2,2 EU/cm see reference )
[71] [72]
2) Action level, ≤20 EU/device (see references and )

NOTE The recommended endotoxin levels are ≤20 EU/device for implants and blood-contacting devices, and

[5] [72]

≤2.15 EU/device for a product having intrathecal patient contact (see references and ).

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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 15883-1:2006/Amd1: 2014, 4.6.
5 Testing for conformity
5.1 Cleaning test method validation
5.1.1 General

The cleaning test methods employed for both type testing (see 5.3) and performance qualification

testing (see 5.4) shall be validated.

NOTE 1 Cleaning test method includes the test soil, soiling method, recovery method, and endpoint analysis.

[6] [8]

NOTE 2 ISO 17025 requires test assay methods to be validated. Other references, such as ASTM E-2857,

[67] -[70] [38]

pharmacopoeias, ICH guidelines, 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 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 devices for

a defined time, temperature and humidity that will represent the use of the device(s) being processed

in the WD.
[41]
NOTE Refer to Köhnlein et al. 2008 as an example for conditioning.
5.1.3 Detection method(s)

5.1.3.1 The level 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 and an appropriate correction factor

applied (see 4.2.4).
[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 exclude 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.
6 © ISO 2019 – All righ
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