ISO 17664-2:2021
(Main)Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Traitement de produits de soins de santé — Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif — Partie 2: Dispositifs médicaux non critiques
Le présent document spécifie les exigences applicables aux informations relatives au traitement des dispositifs médicaux non critiques et non destinés à être stérilisés, à fournir par le fabricant du dispositif (c'est-à-dire un dispositif médical destiné à entrer en contact avec la peau intacte uniquement ou un dispositif médical qui n'est pas destiné à un contact direct avec le patient). Ces exigences incluent les informations de traitement avant l'utilisation ou la réutilisation du dispositif médical. Les instructions de traitement ne sont pas définies dans le présent document. En revanche, le présent document spécifie des exigences visant à aider les fabricants de dispositifs médicaux à fournir des instructions de traitement détaillées qui comprennent, le cas échéant, les activités suivantes: a) la préparation avant le traitement; b) le nettoyage; c) la désinfection; d) le séchage; e) le contrôle et la maintenance; f) l'emballage; g) le stockage; h) le transport. Le présent document exclut le traitement: 1) des dispositifs médicaux critiques et semi-critiques; 2) des dispositifs médicaux destinés à être stérilisés; 3) des dispositifs médicaux textiles utilisés dans les systèmes de drapage des patients ou les vêtements de chirurgie; 4) des dispositifs médicaux spécifiés par le fabricant comme étant à usage unique et fournis prêts à l'emploi. NOTE Voir l'Annexe E pour obtenir des recommandations supplémentaires concernant l'application de la série de normes ISO 17664 relative aux dispositifs médicaux.
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INTERNATIONAL ISO
STANDARD 17664-2
First edition
2021-02
Processing of health care products —
Information to be provided by the
medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif —
Partie 2: Dispositifs médicaux non critiques
Reference number
ISO 17664-2:2021(E)
©
ISO 2021
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ISO 17664-2:2021(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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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ISO 17664-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Risk analysis . 4
5 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
6 Information to be provided by the medical device manufacturer .5
6.1 General . 5
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Preparation before processing . 7
6.5 Cleaning . 7
6.5.1 General. 7
6.5.2 Manual cleaning . 7
6.5.3 Automated cleaning . 8
6.6 Disinfection . 8
6.6.1 General. 8
6.6.2 Manual disinfection . 8
6.6.3 Automated disinfection . 9
6.7 Drying . 9
6.8 Inspection and maintenance . 9
6.9 Packaging .10
6.10 Storage .10
6.11 Transportation .10
7 Presentation of the information .10
Annex A (informative) Commonly utilized processing methods .11
Annex B (informative) Example processing instructions for non-critical reusable medical
devices .15
Annex C (informative) Processing classification and grouping of medical devices .17
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .19
Annex E (informative) Examples of medical devices and their relationship to this document .20
Bibliography .24
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ISO 17664-2:2021(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.
A list of all parts in the ISO 17664 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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ISO 17664-2:2021(E)
Introduction
This document applies to manufacturers of non-critical medical devices that are intended to be cleaned
and/or disinfected by the processor to be made ready for use or reuse. This includes:
— medical devices that are intended for reuse and require processing to take them from their state
after clinical use to the state of being ready for their next use;
— single-use medical devices that require processing before use and are intended to be used in a clean
and/or disinfected state.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of healthcare to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean and/or disinfect.
Cleaning and disinfecting technologies have also undergone significant change in the past decade,
resulting in new systems and approaches that can be applied in the processing of medical devices.
This has led to a greater appreciation of the need for validation of processing including cleaning and/
or disinfection in order to ensure that medical devices are effectively processed. These developments
have led to the need to ensure that manufacturers of medical devices provide adequate instructions
that support the end users to undertake safe and effective processing of medical devices, utilizing the
available equipment and processes.
A medical device requiring processing is supplied with detailed processing instructions in order to
ensure that, when followed correctly, the risks of transmission of infectious agents are minimized. In
addition, effective processing minimizes the risk of other adverse effects on medical devices.
Cleaning is an important step in rendering a used medical device safe for subsequent use. Failure to
remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from
surfaces of medical devices could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process. Single-use medical devices provided by the
medical device manufacturer for processing prior to use can also require cleaning prior to further
processing.
After cleaning, other factors can affect the safe and effective use of a medical device. For example,
procedures for inspection and functional testing might be necessary to ensure that a medical device
does not pose a risk to safety when used. Manufacturers of medical devices can assist users by providing
instructions on how this inspection and testing should be performed.
Manufacturers of medical devices that are to be processed have a responsibility to ensure that the
design of the medical devices facilitates achievement of effective processing. This includes consideration
of commonly available validated processes; examples are shown in Annex A. This annex can be used as
a guide to validate procedures.
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INTERNATIONAL STANDARD ISO 17664-2:2021(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e.
a medical device that is intended to come into contact with intact skin only or a medical device not
intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
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 14971, Medical devices — Application of risk management to medical devices
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ISO 17664-2:2021(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris)
from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process
that prepares the items for safe handling and/or further processing.
[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]
3.2
cleaning agent
physical or chemical entity, or combination of entities, having activity to render an item clean
[SOURCE: ISO 11139:2018, 3.47]
3.3
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.6
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended
use without the use of an automated process
[SOURCE: ISO 11139:2018, 3.159]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification or support of the anatomy or of a physiological process;
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ISO 17664-2:2021(E)
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means.
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal tissues and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018, 3.166]
3.8
medical device manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with
the intention of making the medical device available for use, under their name, whether or not such a
medical device is designed and/or manufactured by that person or on their behalf by another person(s)
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to
the definition of manufacturer.
[SOURCE: ISO 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1
to entry has been added.]
3.9
process chemical
formulation of substances intended for use in equipment
[SOURCE: ISO 11139:2018, 3.207]
3.10
processing
activity to prepare a new or used health care product for its
intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.214, modified — Note 1 to entry has been added.]
3.11
processor
organization and/or individual with the responsibility of carrying
out actions necessary to prepare a new or reusable health care product for its intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]
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ISO 17664-2:2021(E)
3.12
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.
[SOURCE: ISO 11139:2018, 3.236]
3.13
service life
number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
Note 1 to entry: For the purposes of this document, a product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.251, modified — Note 1 to entry has been added.]
3.14
single-use medical device
medical device labelled or intended to be used on one individual during a single procedure
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
[SOURCE: ISO 11139:2018, 3.255, modified — Note 1 to entry has been added.]
3.15
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
[SOURCE: ISO 11139:2018, 3.313, modified — Notes 1, 2 and 3 to entry have been deleted.]
3.16
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
[SOURCE: ISO 11139:2018, 3.314, modified — Notes 1 and 2 to entry have been deleted.]
3.17
washer-disinfector
WD
equipment designed to clean and disinfect product
Note 1 to entry: See the ISO 15883 series.
[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]
4 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided. The risk management undertaken by the manufacturer of the medical
device shall conform with ISO 14971.
NOTE 1 Some of the points relevant to processing that any risk analysis can require (but not limited to)
include:
— the likely points of contact with the user and/or the patient that might allow cross-contamination;
— nature and design of the medical device;
— nature of the contamination on the medical device;
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ISO 17664-2:2021(E)
— intended use;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— service life;
— necessary warnings.
The points above can also be of benefit to those validating alternative processes in accordance with the NOTE
2 to 5.2.
NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk
analysis process.
5 Validation of the processes identified in the information provided by the
medical device manufacturer
5.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device and demonstrate that each process is suitable for processing of the
medical device. This shall include the intended points of contact with the user and/or the patient that
could likely lead to cross-contamination. Parts of the medical device that are unlikely to lead to cross
contamination may be excluded from validation, based upon the risk analysis described in Clause 4.
5.2 The medical device manufacturer shall have objective evidence available that validation of the
processing procedures has been undertaken to confirm that the specific medical device will be clean
and/or disinfected, when processed as directed.
NOTE 1 A worst-case approach, representing those areas of the medical device that are the intended points of
contact with the user, the patient or both and where there is opportunity for cross-contamination, can be used.
NOTE 2 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the effectiveness of the final process to be verified by the processor.
NOTE 3 National authorities can allow or require the use of an alternative process. In such cases they usually
require validation of those processes by the processor.
5.3 If a manufacturer supplies a number of different medical devices that share common attributes,
then validation studies may be performed as a product family. If this approach is taken, the medical device
manufacturer shall demonstrate commonality between the different medical devices and the validation
studies shall address the worst-case attribute(s) of the product family.
NOTE For guidance on grouping of medical devices as product families, see C.1.
6 Information to be provided by the medical device manufacturer
6.1 General
6.1.1 The information specified in this clause shall take into account the nature of the medical device,
its intended location for use and processing and its intended use.
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ISO 17664-2:2021(E)
NOTE The location of processing can be at the point of use or within a processing department.
6.1.2 The medical device manufacturer shall specify validated method(s) to reduce the risk of
transmission of infectious agents to a level appropriate for the intended use of the medical device.
6.1.3 Medical device manufacturers shall specify in their processing instructions any special
techniques and accessories that will enable the processor to provide a medical device that is suitable for
its intended use.
6.1.4 When providing processing instructions, medical device manufacturers shall be aware of:
— available national and international standards and guidelines;
— if applicable, the need for specific training;
— the processing equipment commonly available to the processor.
NOTE 1 Some national standards and regulations require cleaning and disinfection for all non-critical medical
devices.
NOTE 2 Annex A provides information which can assist with identifying the information required and the
processing equipment commonly available.
6.1.5 The equipment or materials required in the specified processes shall be identified by their
generic names or specification. Trade names may be added in cases where generic names do not provide
sufficient information (see Annex D).
6.2 Processing instructions
6.2.1 At least one validated method shall be specified for each applicable stage of processing of the
medical device. Disinfection may be carried out concurrently with cleaning of the medical device.
NOTE 1 Annex A provides information on the commonly used processes available.
NOTE 2 The requirements for cleaning and disinfection are stated as separate clauses in this document.
However, when the steps are concurrent, the requirements of both stages can be considered as one. In such cases
removal of soil, a reduction in microorganisms and inactivation of viable microorganisms can be achieved as a
result of the combination of applying the disinfecting agent and a physical action.
NOTE 3 The range of medical devices included within this document is wide and varied. Many of these
medical devices (e.g. stethoscopes and blood pressure cuffs) are relatively simple medical devices which do not
necessarily require automated processes. There will be other medical devices where automated processing is
not possible or contra-indicated (e.g. some medical devices with electronic components). However, some medical
devices such as beds, wheelchairs and footwear can be, and often are, subjected to automated processes. For this
final group of medical devices, a validated method of automated processing can be specified and is preferred.
6.2.2 The method shall be appropriate to the market in which the medical device is to be supplied.
6.2.3 The following information shall be stated where it is required for the maintenance of the intended
function of the medical device and the safety of the user(s) and the patient:
a) details of process steps;
b) a description of the equipment, the accessories or both;
c) specifications for process parameters and, if applicable, their tolerances.
NOTE For an example of an appropriate format see Annex B.
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ISO 17664-2:2021(E)
6.3 Limitations and restrictions on processing
6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s
instructions is known to lead to degradation that can limit the service life of the medical device, then the
medical device manufacturer shall provide such information regarding limitations and restrictions to the
processor.
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some
other end of life indicator(s) this information shall also be provided.
6.3.3 Where an incompatibility of the medical device with a commonly used substance(s) or processing
condition(s) that can impact upon patient safety is known, this information shall be provided.
6.4 Preparation before processing
If preparation of a medical device is required prior to cleaning to ensure effective processing of that
medical device, then the following information shall be provided, where applicable:
a) a description of the process for disassembly of the medical device;
b) a description of the process and processing parameters for medical device preparation;
c) accessories and tools required.
NOTE For detailed guidance see Annex A.
6.5 Cleaning
6.5.1 General
At least one validated cleaning method shall be specified.
6.5.2 Manual cleaning
If a manual cleaning method is specified, the following information shall be included, where applicable:
a) a description of the manual method with step-by-step instructions and the sequence of each
individual process step;
b) a description
...
NORME ISO
INTERNATIONALE 17664-2
Première édition
2021-02
Traitement de produits de soins de
santé — Informations relatives au
traitement des dispositifs médicaux
à fournir par le fabricant du
dispositif —
Partie 2:
Dispositifs médicaux non critiques
Processing of health care products — Information to be provided
by the medical device manufacturer for the processing of medical
devices —
Part 2: Non-critical medical devices
Numéro de référence
ISO 17664-2:2021(F)
©
ISO 2021
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ISO 17664-2:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
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Publié en Suisse
ii © ISO 2021 – Tous droits réservés
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ISO 17664-2:2021(F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Analyse du risque . 5
5 Validation des procédés identifiés dans les informations fournies par le fabricant
du dispositif médical . 5
6 Informations à fournir par le fabricant du dispositif médical . 6
6.1 Généralités . 6
6.2 Instructions de traitement . 7
6.3 Limites et restrictions du traitement . 7
6.4 Préparation avant le traitement . 7
6.5 Nettoyage . 8
6.5.1 Généralités . 8
6.5.2 Nettoyage manuel . 8
6.5.3 Nettoyage automatisé . 8
6.6 Désinfection . 9
6.6.1 Généralités . 9
6.6.2 Désinfection manuelle. 9
6.6.3 Désinfection automatisée . 9
6.7 Séchage .10
6.8 Contrôles et maintenance .10
6.9 Emballage .11
6.10 Stockage .11
6.11 Transport .11
7 Présentation des informations .11
Annexe A (informative) Méthodes de traitement couramment utilisées .12
Annexe B (informative) Exemples d’instructions de traitement pour les dispositifs
médicaux réutilisables non critiques .16
Annexe C (informative) Classification des traitements et groupes de dispositifs médicaux .18
Annexe D (informative) Recommandations supplémentaires concernant les informations à
fournir par le fabricant du dispositif médical .21
Annexe E (informative) Exemples de dispositifs médicaux et leur relation avec le présent
document .22
Bibliographie .26
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ISO 17664-2:2021(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www .iso .org/ avant -propos.
Le présent document a été élaboré par le comité technique ISO/TC 198, Stérilisation des produits de santé.
Une liste de toutes les parties de la série ISO 17664 se trouve sur le site web de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2021 – Tous droits réservés
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ISO 17664-2:2021(F)
Introduction
Le présent document s’applique aux fabricants de dispositifs médicaux non critiques destinés à être
nettoyés et/ou désinfectés par l’opérateur de procédé, afin de les rendre prêts à l’emploi ou au réemploi.
Sont inclus:
— les dispositifs médicaux destinés à être réutilisés et requérant un traitement pour les faire passer
de leur état «après utilisation clinique» à l’état «prêt à être réutilisé»;
— les dispositifs médicaux à usage unique requérant un traitement avant utilisation et destinés à être
utilisés dans un état nettoyé et/ou désinfecté.
Les importants progrès réalisés à la fois sur le plan des technologies et des connaissances ont permis
de développer des dispositifs médicaux complexes qui contribuent aux soins de santé des patients. Ces
avancées ont conduit à la conception de dispositifs médicaux potentiellement plus difficiles à nettoyer
et/ou désinfecter.
Les technologies de nettoyage et de désinfection ont également considérablement évolué au cours des
dix dernières années, aboutissant à de nouveaux systèmes et de nouvelles approches applicables au
traitement des dispositifs médicaux. Ces changements ont permis une meilleure prise en compte du
besoin de validation des procédés, notamment du nettoyage et/ou de la désinfection, afin de s’assurer
que les dispositifs médicaux sont traités efficacement. Ils ont également créé le besoin de s’assurer que
les fabricants de dispositifs médicaux fournissent des instructions adéquates, aidant les utilisateurs
finaux à traiter efficacement et en toute sécurité les dispositifs médicaux, en utilisant les équipements
et procédés disponibles.
Un dispositif médical requérant un traitement est fourni avec des instructions de traitement détaillées
afin d’assurer que, si celles-ci sont suivies correctement, les risques de transmission d’agents infectieux
sont réduits au minimum. En outre, un traitement efficace réduit au minimum le risque d’autres effets
néfastes sur les dispositifs médicaux.
Le nettoyage est une étape importante pour permettre la réutilisation ultérieure en toute sécurité
d’un dispositif médical utilisé. Les contaminants (par exemple, sang, tissus, microorganismes, agent
nettoyant et lubrifiants) qui ne sont pas éliminés des surfaces des dispositifs médicaux pourraient
compromettre le fonctionnement correct des dispositifs médicaux, leur utilisation en toute sécurité
(si cela est exigé) ainsi que tout procédé de désinfection ultérieur. Les dispositifs médicaux à usage
unique fournis par le fabricant de dispositifs médicaux de sorte qu’ils soient traités avant leur utilisation
peuvent également requérir un nettoyage avant toute poursuite du traitement.
Après le nettoyage, d’autres facteurs peuvent affecter l’utilisation sûre et efficace d’un dispositif
médical. Par exemple, des modes opératoires de contrôle et des essais de fonctionnement peuvent
s’avérer nécessaires pour s’assurer qu’un dispositif médical ne présente pas de risque pour la sécurité
à l’utilisation. Les fabricants de dispositifs médicaux peuvent aider les utilisateurs en leur fournissant
des instructions sur la manière dont il convient d’effectuer ces contrôles et essais.
Il est de la responsabilité des fabricants de dispositifs médicaux nécessitant un traitement de s’assurer
que la conception de ces dispositifs facilite la réalisation efficace dudit traitement. Cela inclut la prise
en compte des procédés validés les plus courants. Des exemples sont fournis dans l’Annexe A qui peut
servir de guide pour la validation des modes opératoires.
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NORME INTERNATIONALE ISO 17664-2:2021(F)
Traitement de produits de soins de santé — Informations
relatives au traitement des dispositifs médicaux à fournir
par le fabricant du dispositif —
Partie 2:
Dispositifs médicaux non critiques
1 Domaine d’application
Le présent document spécifie les exigences applicables aux informations relatives au traitement
des dispositifs médicaux non critiques et non destinés à être stérilisés, à fournir par le fabricant du
dispositif (c’est-à-dire un dispositif médical destiné à entrer en contact avec la peau intacte uniquement
ou un dispositif médical qui n’est pas destiné à un contact direct avec le patient).
Ces exigences incluent les informations de traitement avant l’utilisation ou la réutilisation du dispositif
médical.
Les instructions de traitement ne sont pas définies dans le présent document. En revanche, le présent
document spécifie des exigences visant à aider les fabricants de dispositifs médicaux à fournir des
instructions de traitement détaillées qui comprennent, le cas échéant, les activités suivantes:
a) la préparation avant le traitement;
b) le nettoyage;
c) la désinfection;
d) le séchage;
e) le contrôle et la maintenance;
f) l’emballage;
g) le stockage;
h) le transport.
Le présent document exclut le traitement:
1) des dispositifs médicaux critiques et semi-critiques;
2) des dispositifs médicaux destinés à être stérilisés;
3) des dispositifs médicaux textiles utilisés dans les systèmes de drapage des patients ou les vêtements
de chirurgie;
4) des dispositifs médicaux spécifiés par le fabricant comme étant à usage unique et fournis prêts à
l’emploi.
NOTE Voir l’Annexe E pour obtenir des recommandations supplémentaires concernant l’application de la
série de normes ISO 17664 relative aux dispositifs médicaux.
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ISO 17664-2:2021(F)
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s’applique (y compris les
éventuels amendements).
ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
nettoyage
élimination des contaminants jusqu’à obtention de l’état nécessaire à la poursuite du traitement ou
jusqu’à obtention de l’état désiré
Note 1 à l'article: Le nettoyage consiste à éliminer les souillures adhérentes (par exemple, sang, substances
protéiques et autres débris) des surfaces, fentes, cannelures, joints et lumières d’un dispositif médical, par le
biais d’un procédé manuel ou automatique qui prépare les articles à une manipulation en toute sécurité et/ou à la
poursuite du traitement.
[SOURCE: ISO 11139:2018, 3.46, modifiée — La Note 1 à l’article a été ajoutée]
3.2
agent nettoyant
entité physique, chimique ou combinaison d’entités, ayant une activité pour rendre un article propre
[SOURCE: ISO 11139:2018, 3.47]
3.3
utilisation clinique
utilisation d’un produit de santé au cours d’un protocole sur un patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
agent désinfectant
agent physique ou chimique utilisé pour la désinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
désinfection
procédé visant à inactiver des microorganismes viables à un niveau préalablement spécifié comme
approprié pour une utilisation définie
[SOURCE: ISO 11139:2018, 3.84]
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ISO 17664-2:2021(F)
3.6
nettoyage manuel
élimination des contaminants d’un produit jusqu’à l’obtention de l’état nécessaire à la poursuite du
traitement ou jusqu’à obtention de l’état désiré sans utiliser de procédé automatique
[SOURCE: ISO 11139:2018, 3.159]
3.7
dispositif médical
instrument, appareil, équipement, machine, dispositif, implant, réactif destiné à une utilisation in vitro
ou logiciel, matériel ou autre article similaire ou associé, dont le fabricant prévoit qu’il soit utilisé seul
ou en association chez l’être humain pour une ou plusieurs fins médicales spécifiques suivantes:
— diagnostic, prévention, contrôle, traitement ou atténuation d’une maladie;
— diagnostic, contrôle, traitement, atténuation ou compensation d’une blessure;
— étude, remplacement, modification ou entretien de l’anatomie ou d’un processus physiologique;
— entretien (artificiel) ou maintien de la vie;
— maîtrise de la conception;
— désinfection des dispositifs médicaux;
— communication d’informations par un examen in vitro de spécimens (prélèvements) provenant du
corps humain;
et dont l’action principale voulue n’est pas obtenue par des moyens pharmacologiques ou
immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
Note 1 à l'article: Les produits susceptibles d’être considérés comme des dispositifs médicaux dans certaines
juridictions mais pas dans d’autres incluent:
— les articles spécifiquement destinés au nettoyage ou à la stérilisation des dispositifs médicaux;
— les sachets, les objets en bobine, les enveloppes de stérilisation et les récipients réutilisables pour emballer
les dispositifs médicaux en vue d’une stérilisation;
— les produits désinfectants;
— les aides pour les personnes handicapées;
— les dispositifs intégrant des tissus animaux et/ou humains;
— les dispositifs pour les technologies de fécondation in vitro et de reproduction assistée.
[SOURCE: ISO 11139:2018, 3.166]
3.8
fabricant du dispositif médical
personne physique ou morale responsable de la conception et/ou de la fabrication d’un dispositif
médical dans le but de le rendre disponible à l’utilisation, en son nom, que ce dispositif médical soit ou
non conçu et/ou fabriqué par cette personne ou en son nom par une ou plusieurs autres personnes
Note 1 à l'article: L’attention est attirée sur le fait que les dispositions de réglementations nationales ou régionales
peuvent s’appliquer à la définition du fabricant.
[SOURCE: ISO 11139:2018, 3.167, modifiée — Les Notes 1 à 7 à l’article ont été supprimées et une
nouvelle Note 1 à l’article a été ajoutée.]
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ISO 17664-2:2021(F)
3.9
procédé chimique
formulation de substances destinées à être utilisées dans un équipement
[SOURCE: ISO 11139:2018, 3.207]
3.10
traitement
activité visant à préparer un produit de santé neuf ou déjà en
service pour son utilisation prévue
Note 1 à l'article: Pour les besoins du présent document, un produit de santé désigne un dispositif médical.
[SOURCE: ISO 11139:2018, 3.214, modifiée — La Note 1 à l’article a été ajoutée]
3.11
opérateur de procédé
organisme et/ou personne chargé(e) d’effectuer les actions
nécessaires à la préparation d’un produit de santé neuf ou réutilisable pour son utilisation prévue
Note 1 à l'article: Pour les besoins du présent document, un produit de santé désigne un dispositif médical.
[SOURCE: ISO 11139:2018, 3.216, modifiée — La Note 1 à l’article a été ajoutée]
3.12
dispositif médical réutilisable
dispositif médical conçu ou défini par le fabricant pour pouvoir être traité et réutilisé
Note 1 à l'article: Il ne s’agit pas d’un dispositif médical conçu ou défini par le fabricant pour un usage unique.
[SOURCE: ISO 11139:2018, 3.236]
3.13
durée de vie en service
nombre de cycles de traitement et/ou durée de vie, ou nombre de cycles de traitement et durée de vie,
auxquels/à laquelle un produit est déclaré « rester adéquat et sûr » pour son utilisation prévue lorsqu’il
est utilisé conformément à l’étiquetage
Note 1 à l'article: Pour les besoins du présent document, un produit désigne un dispositif médical.
[SOURCE: ISO 11139:2018, 3.251, modifiée — La Note 1 à l’article a été ajoutée]
3.14
dispositif médical à usage unique
dispositif médical étiqueté ou défini pour être utilisé sur une personne pendant un seul mode opératoire
Note 1 à l'article: Un dispositif médical à usage unique n’est pas destiné à être traité et utilisé plus d’une fois.
[SOURCE: ISO 11139:2018, 3.255, modifiée — La Note 1 à l’article a été ajoutée]
3.15
validation
confirmation par des preuves objectives que les exigences pour une utilisation spécifique ou une
application prévue ont été satisfaites
[SOURCE: ISO 11139:2018, 3.313, modifiée — Les Notes 1, 2 et 3 à l’article ont été supprimées.]
3.16
vérification
confirmation par des preuves objectives que les exigences spécifiées ont été satisfaites
[SOURCE: ISO 11139:2018, 3.314, modifiée — Les Notes 1 et 2 à l’article ont été supprimées.]
4 © ISO 2021 – Tous droits réservés
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ISO 17664-2:2021(F)
3.17
laveur désinfecteur
équipement destiné à nettoyer et désinfecter un produit
Note 1 à l'article: Voir la série de normes ISO 15883.
[SOURCE: ISO 11139:2018, 3.319, modifiée — La Note 1 à l’article a été ajoutée.]
4 Analyse du risque
Le fabricant du dispositif médical doit réaliser une analyse du risque afin de déterminer le contenu et
les détails des informations à fournir. La gestion des risques mise en place par le fabricant doit être
conforme à l’ISO 14971.
NOTE 1 Toute analyse du risque peut exiger (mais sans s'y limiter) de prendre en compte certains des points
suivants liés au traitement, notamment:
— éventuels points de contact avec l’utilisateur et/ou le patient pouvant entraîner une contamination
croisée;
— nature et conception du dispositif médical;
— nature des contaminants du dispositif médical;
— utilisation prévue;
— erreur prévisible de l’utilisateur et mauvaise utilisation;
— formation des utilisateurs;
— équipements requis pour le traitement;
— accessoires et consommables requis pour le traitement;
— besoins en maintenance du dispositif médical;
— informations fournies après la mise sur le marché;
— durée de vie en service;
— avertissements nécessaires.
Les points ci-dessus peuvent également s’avérer utiles pour les entités qui valident des procédés
alternatifs conformément à la NOTE 2 du 5.2.
NOTE 2 L’Annexe C fournit des informations sur la classification des dispositifs médicaux pouvant faciliter
tout processus d’analyse du risque.
5 Validation des procédés identifiés dans les informations fournies par le
fabricant du dispositif médical
5.1 Le fabricant du dispositif médical doit valider chaque procédé identifié dans les informations
fournies avec le dispositif médical et démontrer que chaque procédé est adapté au traitement du
dispositif médical. La validation doit inclure les points de contact avec l’utilisateur et/ou le patient qui
sont prévus et susceptibles d’entraîner une contamination croisée. Les parties du dispositif médical qui
ne sont pas susceptibles d’entraîner une contamination croisée peuvent être exclues de la validation sur
la base de l’analyse du risque décrite à l’Article 4.
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ISO 17664-2:2021(F)
5.2 Le fabricant du dispositif médical doit disposer de preuves objectives démontrant que la validation
des modes opératoires de traitement a été effectuée, afin de confirmer que le dispositif médical concerné
sera propre et/ou désinfecté s’il est traité selon les instructions fournies.
NOTE 1 Une approche du cas le plus défavorable, représentant ces parties du dispositif médical qui sont
des points prévus de contact avec l’utilisateur et/ou le patient et pour lesquels il existe une possibilité de
contamination croisée, peut être utilisée.
NOTE 2 Outre l’obligation d’un fabricant de démontrer la validité des informations fournies, les autorités
nationales peuvent exiger que l’efficacité du procédé final soit vérifiée par l’opérateur de procédé.
NOTE 3 Les autorités nationales peuvent autoriser ou exiger l’utilisation d’un procédé alternatif. Dans ce cas,
elles exigent généralement la validation de ces procédés par l’opérateur de procédé.
5.3 Si un fabricant fournit plusieurs dispositifs médicaux différents partageant des caractéristiques
communes, alors des études de validation peuvent être effectuées sur une famille de produits. Si cette
approche est adoptée, le fabricant doit démontrer les points communs entre les différents dispositifs
médicaux et les études de validation doivent porter sur la ou les caractéristiques les plus défavorables de
la famille de produits.
NOTE Voir C.1 pour des recommandations relatives au regroupement des dispositifs médicaux en familles
de produits.
6 Informations à fournir par le fabricant du dispositif médical
6.1 Généralités
6.1.1 Les informations spécifiées dans le présent article doivent tenir compte de la nature du dispositif
médical, du lieu prévu pour son utilisation et son traitement, et de son utilisation prévue.
NOTE Le lieu du traitement peut se situer au point d’utilisation ou dans le service destiné au traitement.
6.1.2 Le fabricant du dispositif médical doit spécifier la ou les méthodes validées pour réduire le risque
de transmission d’agents infectieux à un niveau approprié pour l’utilisation prévue du dispositif médical.
6.1.3 Les fabricants de dispositifs médicaux doivent indiquer, dans leurs instructions de traitement,
toute technique particulière et tout accessoire spécifique permettant à l’opérateur de procédé de fournir
un dispositif médical approprié à son utilisation prévue.
6.1.4 Lorsqu’ils fournissent des instructions de traitement, les fabricants de dispositifs médicaux
doivent prendre en compte:
— les normes et lignes directrices nationales et internationales disponibles;
— le cas échéant, le besoin de formation spécifique;
— les équipements de traitement généralement à la disposition de l’opérateur de procédé.
NOTE 1 Certaines normes et réglementations nationales exigent un nettoyage et une désinfection pour tous
les dispositifs médicaux non critiques.
NOTE 2 L’Annexe A fournit des informations qui peuvent aider à l’identification des informations requises et
des équipements de traitement généralement disponibles.
6.1.5 Les équipements ou matériaux exigés pour les procédés spécifiés doivent être identifiés par leurs
noms génériques ou leurs spécifications. Des noms commerciaux peuvent être ajoutés dans les cas où les
noms génériques ne fournissent pas suffisamment d’informations (voir l’Annexe D).
6 © ISO 2021 – Tous droits réservés
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ISO 17664-2:2021(F)
6.2 Instructions de traitement
6.2.1 Au moins une méthode validée doit être spécifiée pour chaque étape de traitement appropriée
du dispositif médical. La désinfection peut être effectuée en même temps que le nettoyage du dispositif
médical.
NOTE 1 L’Annexe A fournit des informations sur les procédés couramment utilisés disponibles.
NOTE 2 Les exigences relatives au
...
INTERNATIONAL ISO
STANDARD 17664-2
First edition
Processing of health care products —
Information to be provided by the
medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif —
Partie 2: Dispositifs médicaux non critiques
PROOF/ÉPREUVE
Reference number
ISO 17664-2:2020(E)
©
ISO 2020
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ISO 17664-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
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ISO 17664-2:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Risk analysis . 4
5 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
6 Information to be provided by the medical device manufacturer .5
6.1 General . 5
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Preparation before processing . 7
6.5 Cleaning . 7
6.5.1 General. 7
6.5.2 Manual cleaning . 7
6.5.3 Automated cleaning . 8
6.6 Disinfection . 8
6.6.1 General. 8
6.6.2 Manual disinfection . 8
6.6.3 Automated disinfection . 9
6.7 Drying . 9
6.8 Inspection and maintenance . 9
6.9 Packaging .10
6.10 Storage .10
6.11 Transportation .10
7 Presentation of the information .10
Annex A (informative) Commonly utilized processing methods .11
Annex B (informative) Example processing instructions for non-critical reusable medical
devices .15
Annex C (informative) Processing classification and grouping of medical devices .17
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .19
Annex E (informative) Examples of medical devices and their relationship to this document .20
Bibliography .24
© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
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ISO 17664-2:2020(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.
A list of all parts in the ISO 17664 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
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ISO 17664-2:2020(E)
Introduction
This document applies to manufacturers of non-critical medical devices that are intended to be cleaned,
disinfected or both by the processor to be made ready for use or reuse. This includes:
— medical devices that are intended for reuse and require processing to take them from their state
after clinical use to the state of being ready for their next use;
— single-use medical devices that require processing before use and are intended to be used in a clean
and/or disinfected state.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of healthcare to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean and disinfect.
Cleaning and disinfecting technologies have also undergone significant change in the past decade,
resulting in new systems and approaches that can be applied in the processing of medical devices.
This has led to a greater appreciation of the need for validation of processing including cleaning and
disinfection in order to ensure that medical devices are effectively processed. These developments
have led to the need to ensure that manufacturers of medical devices provide adequate instructions
that support the end users to undertake safe and effective processing of medical devices, utilizing the
available equipment and processes.
A medical device requiring processing is supplied with detailed processing instructions in order to
ensure that, when followed correctly, the risks of transmission of infectious agents are minimized. In
addition, effective processing minimizes the risk of other adverse effects on medical devices.
Cleaning is an important step in rendering a used medical device safe for subsequent use. Failure to
remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from
surfaces of medical devices could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process. Single-use medical devices provided by the
medical device manufacturer for processing prior to use can also require cleaning prior to further
processing.
After cleaning, other factors can affect the safe and effective use of a medical device. For example,
procedures for inspection and functional testing might be necessary to ensure that a medical device
does not pose a risk to safety when used. Manufacturers of medical devices can assist users by providing
instructions on how this inspection and testing should be performed.
Manufacturers of medical devices that are to be processed have a responsibility to ensure that the
design of the medical devices facilitates achievement of effective processing. This includes consideration
of commonly available validated processes; examples are shown in Annex A. This annex can be used as
a guide to validate procedures.
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INTERNATIONAL STANDARD ISO 17664-2:2020(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e.
a medical device that is intended to come into contact with intact skin only or a medical device not
intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
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 14971, Medical devices — Application of risk management to medical devices
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ISO 17664-2:2020(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris)
from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process
that prepares the items for safe handling, further processing or both.
[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]
3.2
cleaning agent
physical or chemical entity, or combination of entities, having activity to render an item clean
[SOURCE: ISO 11139:2018, 3.47]
3.3
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.6
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended
use without the use of an automated process
[SOURCE: ISO 11139:2018, 3.159]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification or support of the anatomy or of a physiological process;
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ISO 17664-2:2020(E)
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal tissues, human tissues or both;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018, 3.166]
3.8
medical device manufacturer
natural or legal person with responsibility for design, manufacture or both of a medical device with
the intention of making the medical device available for use, under their name, whether or not such a
medical device is designed, manufactured or both by that person or on their behalf by another person(s)
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to
the definition of manufacturer.
[SOURCE: ISO 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1
to entry has been added.]
3.9
process chemical
formulation of substances intended for use in equipment
[SOURCE: ISO 11139:2018, 3.207]
3.10
processing
activity to prepare a new or used health care product for its
intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.214, modified — Note 1 to entry has been added.]
3.11
processor
organization or individual with the responsibility of carrying out
actions necessary to prepare a new or reusable health care product for its intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]
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ISO 17664-2:2020(E)
3.12
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.
[SOURCE: ISO 11139:2018, 3.236]
3.13
service life
number of processing cycles, lifetime or both up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
Note 1 to entry: For the purposes of this document, a product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.251, modified — Note 1 to entry has been added.]
3.14
single-use medical device
medical device labelled or intended to be used on one individual during a single procedure
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
[SOURCE: ISO 11139:2018, 3.255, modified — Note 1 to entry has been added.]
3.15
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
[SOURCE: ISO 11139:2018, 3.313, modified — Notes 1, 2 and 3 to entry have been deleted.]
3.16
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
[SOURCE: ISO 11139:2018, 3.314, modified — Notes 1 and 2 to entry have been deleted.]
3.17
washer-disinfector
equipment designed to clean and disinfect product
Note 1 to entry: See the ISO 15883 series.
[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]
4 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided. The risk management undertaken by the manufacturer of the medical
device shall conform with ISO 14971.
NOTE 1 Some of the points relevant to processing that any risk analysis can require include:
— the likely points of contact with the user or the patient that might allow cross-contamination;
— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
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— foreseeable user error and misuse;
— user training;
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— service life;
— necessary warnings.
The points above can also be of benefit to those validating alternative processes in accordance with the
NOTE 2 to 5.2.
NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk
analysis process.
5 Validation of the processes identified in the information provided by the
medical device manufacturer
5.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device and demonstrate that each process is suitable for processing of the
medical device. This shall include the intended points of contact with the user, the patient or both that
could likely lead to cross-contamination. Parts of the medical device that are unlikely to lead to cross
contamination may be excluded from validation, based upon the risk analysis described in Clause 4.
5.2 The medical device manufacturer shall have objective evidence available that validation of the
processing procedures has been undertaken to confirm that the specific medical device will be clean,
disinfected or both, when processed as directed.
NOTE 1 A worst-case approach, representing those areas of the medical device that are the intended points of
contact with the user, the patient or both and where there is opportunity for cross-contamination, can be used.
NOTE 2 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the effectiveness of the final process to be verified by the processor.
NOTE 3 National authorities can allow or require the use of an alternative process. In such cases they usually
require validation of those processes by the processor.
5.3 If a manufacturer supplies a number of different medical devices that share common attributes,
then validation studies may be performed as a product family. If this approach is taken, the medical device
manufacturer shall demonstrate commonality between the different medical devices and the validation
studies shall address the worst-case attribute(s) of the product family.
NOTE For guidance on grouping of medical devices as product families, see C.1.
6 Information to be provided by the medical device manufacturer
6.1 General
6.1.1 The information specified in this clause shall take into account the nature of the medical device,
its intended location for use and processing and its intended use.
NOTE The location of processing can be at the point of use or within a processing department.
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6.1.2 The medical device manufacturer shall specify validated method(s) to reduce the risk of
transmission of infectious agents to a level appropriate for the intended use of the medical device.
6.1.3 Medical device manufacturers shall specify in their processing instructions any special
techniques and accessories that will enable the processor to provide a medical device that is suitable for
its intended use.
6.1.4 When providing processing instructions, medical device manufacturers shall be aware of:
— available national and international standards and guidelines;
— if applicable, the need for specific training;
— the processing equipment commonly available to the processor.
NOTE 1 Some national standards and regulations require cleaning and disinfection for all non-critical medical
devices.
NOTE 2 Annex A provides information which can assist with identifying the information required and the
processing equipment commonly available.
6.1.5 The equipment or materials required in the specified processes shall be identified by their
generic names or specification. Trade names may be added in cases where generic names do not provide
sufficient information (see Annex D).
6.2 Processing instructions
6.2.1 At least one validated method shall be specified for each applicable stage of processing of the
medical device. Disinfection may be carried out concurrently with cleaning of the medical device.
NOTE 1 Annex A provides information on the commonly used processes available.
NOTE 2 The requirements for cleaning and disinfection are stated as separate clauses in this document.
However, when the steps are concurrent, the requirements of both stages can be considered as one. In such cases
removal of soil, a reduction in microorganisms and inactivation of viable microorganisms can be achieved as a
result of the combination of applying the disinfecting agent and a physical action.
NOTE 3 The range of medical devices included within this document is wide and varied. Many of these
medical devices (e.g. stethoscopes and blood pressure cuffs) are relatively simple medical devices which do not
necessarily require automated processes. There will be other medical devices where automated processing is
not possible or contra-indicated (e.g. some medical devices with electronic components). However, some medical
devices such as beds, wheelchairs and footwear can be, and often are, subjected to automated processes. For this
final group of medical devices, a validated method of automated processing can be specified and is preferred.
6.2.2 The method shall be appropriate to the market in which the medical device is to be supplied.
6.2.3 The following information shall be stated where it is required for the maintenance of the intended
function of the medical device and the safety of the user(s) and the patient:
a) details of process steps;
b) a description of the equipment, the accessories or both;
c) specifications for process parameters and, if applicable, their tolerances.
NOTE For an example of an appropriate format see Annex B.
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6.3 Limitations and restrictions on processing
6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s
instructions is known to lead to degradation that can limit the service life of the medical device, then the
medical device manufacturer shall provide such information regarding limitations and restrictions to the
processor.
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some
other end of life indicator(s) this information shall also be provided.
6.3.3 Where an incompatibility of the medical device with a commonly used substance(s) or processing
condition(s) that can impact upon patient safety is known, this information shall be provided.
6.4 Preparation before processing
If preparation of a medical device is required prior to cleaning to ensure effective processing of that
medical device, then the following information shall be provided, where applicable:
a) a description of the process for disassembly of the medical device;
b) a description of the process and processing parameters for medical device preparation;
c) accessories and tools required.
NOTE For detailed guidance see Annex A.
6.5 Cleaning
6.5.1 General
At least one validated cleaning method shall be specified.
6.5.2 Manual cleaning
If a manual cleaning method is specified, the following information shall be included, where applicable:
a) a description of the m
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