ISO 17664-1:2021
(Main)Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. 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) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, 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 1: Dispositifs médicaux critiques et semi-critiques
Le présent document spécifie les exigences relatives aux informations à fournir par le fabricant du dispositif médical pour le traitement des dispositifs médicaux critiques ou semi-critiques (c’est-à-dire un dispositif médical qui pénètre dans des sites normalement stériles du corps humain ou un dispositif médical qui entre en contact avec des muqueuses ou une peau lésée) ou des dispositifs médicaux destinés à être stérilisés. Il concerne les informations de traitement avant la première utilisation du dispositif médical et sa réutilisation. Les instructions de traitement ne sont pas définies dans le présent document. Le présent document spécifie plutôt des exigences visant à aider les fabricants de dispositifs médicaux à fournir des instructions de traitement détaillées, qui comprennent les opérations suivantes, le cas échéant: a) traitement initial au point d’utilisation; b) préparation avant le nettoyage; c) nettoyage; d) désinfection; e) séchage; f) contrôles et maintenance; g) emballage; h) stérilisation; i) stockage; j) transport. Le présent document exclut le traitement des éléments suivants: — les dispositifs médicaux non critiques, à moins qu’ils ne soient destinés à être stérilisés; — les dispositifs textiles utilisés dans les systèmes de drapage des patients ou les vêtements de chirurgie; — les dispositifs médicaux spécifiés par le fabricant comme étant à usage unique et fournis prêts à l’emploi. NOTE Voir l’ISO 17664-2:2021, Annexe E, pour des recommandations supplémentaires relatives à l’application de la série ISO 17664 à un dispositif médical.
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INTERNATIONAL ISO
STANDARD 17664-1
First edition
2021-07
Processing of health care products —
Information to be provided by the
medical device manufacturer for the
processing of medical devices —
Part 1:
Critical and semi-critical medical
devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif —
Partie 1: Dispositifs médicaux critiques et semi-critiques
Reference number
ISO 17664-1:2021(E)
©
ISO 2021
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ISO 17664-1:2021(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
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Published in Switzerland
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ISO 17664-1:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
5 Risk analysis . 5
6 Information to be provided by the medical device manufacturer .6
6.1 General . 6
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Initial treatment at the point of use . 7
6.5 Preparation before cleaning . 7
6.6 Cleaning . 8
6.6.1 General. 8
6.6.2 Automated cleaning . 8
6.6.3 Manual cleaning . 8
6.7 Disinfection . 9
6.7.1 General. 9
6.7.2 Automated disinfection . 9
6.7.3 Manual disinfection .10
6.8 Drying .10
6.9 Inspection and maintenance .10
6.10 Packaging .11
6.11 Sterilization .11
6.12 Storage .12
6.13 Transportation .12
7 Presentation of the information .12
Annex A (informative) Commonly utilized processing methods .13
Annex B (informative) Example of processing instructions for reusable medical devices.17
Annex C (informative) Classification of medical devices .19
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .22
Bibliography .23
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ISO 17664-1:2021(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 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This first edition of ISO 17664-1 cancels and replaces ISO 17664:2017, of which it constitutes a minor
revision. The changes to ISO 17664:2017 are as follows:
— the title, introduction and scope have been editorially revised to reflect the addition of a second
part to the ISO 17664 series.
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 17664-1:2021(E)
Introduction
This document applies to manufacturers of those medical devices that are intended to be cleaned,
disinfected and/or sterilized by the processor to be made ready for use. 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. This may include one or more of
cleaning, disinfection and sterilization.
— Single-use medical devices that require processing before use and are intended to be used in a clean
and/or disinfected and/or sterile state.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of health care to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean, disinfect and/or sterilize.
Cleaning, disinfecting and sterilizing 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, disinfection and/or sterilization 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 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 the
surfaces of a medical device could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process, sterilization process or both. 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 can be necessary to ensure that a medical device
does not pose a safety risk 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, which can be used as a
guide to validate procedures.
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INTERNATIONAL STANDARD ISO 17664-1:2021(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 1:
Critical and semi-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
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) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device.
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ISO 17664-1:2021(E)
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
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
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
3.4
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]
3.5
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the medical device manufacturer (3.6) 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;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
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ISO 17664-1:2021(E)
— 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, in or on the human body, but which may be assisted in its 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:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11]
3.6
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.]
3.7
packaging system
combination of a sterile barrier system (3.15) and protective packaging (3.10)
3.8
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, processing includes cleaning, disinfection and sterilization (if
necessary and applicable).
Note 2 to entry: For the purposes of this document, a health care product refers to a medical device.
3.9
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.]
3.10
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.15) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2019, 3.14]
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ISO 17664-1:2021(E)
3.11
reusable medical device
medical device (3.5) designated or intended by the medical device manufacturer (3.6) as suitable for
processing (3.8) 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]
3.12
service life
number of processing (3.8) cycles and/or lifetime that a medical device (3.5) can be subjected to and
remain suitable and safe for its intended use
3.13
single-use medical device
medical device (3.5) designated or intended by the medical device manufacturer (3.6) for one-time use
only
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
3.14
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.15
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use
3.16
sterility assurance level
probability of a single viable microorganism occurring on an item after sterilization (3.17), expressed
as the negative exponent to the base 10
3.17
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
3.18
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve
sterility under defined conditions
3.19
terminal process
final step of processing (3.8) to render a medical device (3.5) safe and ready for its intended use
3.20
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified — the notes to entry have been deleted.]
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ISO 17664-1:2021(E)
3.21
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.]
3.22
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 — abbreviated term WD removed and Note 1 to entry
added.]
4 Validation of the processes identified in the information provided by the
medical device manufacturer
4.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device. Validation shall demonstrate that each process is suitable for processing
of the medical device.
4.2 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 and/or sterilized when processed as directed.
NOTE 1 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the final effectiveness of the process to be verified by the processor.
NOTE 2 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.
4.3 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 See C.1.
5 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided to the user. 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 (but are not
limited to):
— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
— life cycle of the medical device;
— foreseeable user error and misuse;
— user training;
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ISO 17664-1:2021(E)
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— limitation on number of reuses;
— necessary warnings.
These points can also be of benefit to those validating alternative processes in accordance with 4.2, NOTE 2.
NOTE 2 Annex C provides information on classification of medical devices which can assist with any risk
analysis process.
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
and its intended use.
6.1.2 Where disinfection is the terminal process, 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. 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.
6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify
validated method(s) to achieve the required sterility assurance level. Medical device manufacturers
shall specify in their processing instructions any specific requirements 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;
— the need for specific training;
— the processing equipment commonly available to the processor.
NOTE Annex A and Annex C provide information on classification of medical devices which can assist with
identifying the information required.
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. The method shall be relevant to the market in which the medical device is to be supplied.
NOTE Annex A provides information on the commonly used processes available.
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ISO 17664-1:2021(E)
6.2.2 The following information shall be stated where it is critical to 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, accessories or both;
c) specifications for process parameters and their tolerances.
NOTE For an example of appropriate text see Annex B.
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 might limit the service life of the medical device, for
example functionality, biocompatibility or suitability for effective processing, 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.
NOTE For example, this information if applicable, can provide a method to monitor the actual number of
processing cycles.
6.3.3 Where an incompatibility of the medical device with a substance(s) or processing condition(s) is
known, this information shall be provided.
6.4 Initial treatment at the point of use
If treatment of a medical device at the point of use is required to ensure effective processing of that
medical device, then the following information shall be provided, where applicable:
a) a description of initial treatment techniques;
b) any checks that need to be undertaken;
c) the time between medical device use, the initial treatment and/or the next step of the process;
d) a description of the support systems, containers for transportation or both;
e) a description of the transportation steps.
6.5 Preparation before cleaning
If preparation of a medical device
...
NORME ISO
INTERNATIONALE 17664-1
Première édition
2021-07
Traitement de produits de soins de
santé — Informations relatives au
traitement des dispositifs médicaux
à fournir par le fabricant du
dispositif —
Partie 1:
Dispositifs médicaux critiques et
semi-critiques
Processing of health care products — Information to be provided
by the medical device manufacturer for the processing of medical
devices —
Part 1: Critical and semi-critical medical devices
Numéro de référence
ISO 17664-1:2021(F)
©
ISO 2021
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ISO 17664-1:2021(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
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
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Publié en Suisse
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ISO 17664-1:2021(F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Validation des procédés identifiés dans les informations fournies par le fabricant
du dispositif médical . 5
5 Analyse du risque . 5
6 Informations devant être fournies 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 Traitement initial au point d’utilisation . 7
6.5 Préparation avant le nettoyage . 7
6.6 Nettoyage . 8
6.6.1 Généralités . 8
6.6.2 Nettoyage automatisé . 8
6.6.3 Nettoyage manuel . 9
6.7 Désinfection . 9
6.7.1 Généralités . 9
6.7.2 Désinfection automatisée . 9
6.7.3 Désinfection manuelle.10
6.8 Séchage .10
6.9 Contrôles et maintenance .11
6.10 Emballage .11
6.11 Stérilisation .11
6.12 Stockage .12
6.13 Transport .12
7 Présentation des informations .12
Annexe A (informative) Méthodes de traitement couramment utilisées .13
Annexe B (informative) Exemple d’instructions de traitement pour les dispositifs
médicaux réutilisables .18
Annexe C (informative) Classification des dispositifs médicaux .20
Annexe D (informative) Recommandations supplémentaires relatives aux informations à
fournir par le fabricant du dispositif médical .23
Bibliographie .24
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ISO 17664-1:2021(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, en collaboration avec le comité technique CEN/TC 204, Stérilisation des dispositifs médicaux, du
Comité européen de normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO
et le CEN (Accord de Vienne).
La première édition de l’ISO 17664-1 annule et remplace l’ISO 17664:2017, dont elle constitue une
révision mineure. Par rapport à l’ISO 17664:2017, les modifications sont les suivantes:
— le titre, l’introduction et le domaine d’application ont fait l’objet d’une révision rédactionnelle pour
refléter l’ajout de la deuxième partie de la série ISO 17664.
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.
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ISO 17664-1:2021(F)
Introduction
Le présent document s’applique aux fabricants de dispositifs médicaux prévus pour être soumis à un
procédé de nettoyage, de désinfection et/ou de stérilisation par l’opérateur de procédé, afin de les
rendre « prêts à l’emploi ». Sont inclus:
— les dispositifs médicaux destinés à être réutilisés et requérant un traitement pour les faire passer
de leur état « après une utilisation clinique » à l’état « prêt à être réutilisé ». Cela peut inclure une ou
plusieurs opérations de nettoyage, désinfection et stérilisation;
— les dispositifs médicaux à usage unique requérant un traitement avant utilisation et destinés à être
utilisés dans un état « nettoyé et/ou désinfecté et/ou stérile ».
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,
désinfecter et/ou stériliser.
Les technologies de nettoyage, de désinfection et de stérilisation 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, de la désinfection, et/ou de la
stérilisation, afin d’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
négatifs sur les dispositifs médicaux.
Le nettoyage est une étape importante pour permettre la réutilisation en toute sécurité d’un dispositif
médical utilisé. Les contaminants (par exemple, sang, tissus, micro-organismes, agents de nettoyage
et lubrifiants) qui ne sont pas éliminés des surfaces du dispositif médical sont susceptibles de
compromettre le fonctionnement correct du dispositif médical, son utilisation en toute sécurité et (le
cas échéant) tout procédé de désinfection ou de stérilisation, ou les deux. Les dispositifs médicaux à
usage unique fournis par le fabricant de dispositifs médicaux de sorte qu’ils soient traités avant leur
utilisation peuvent également exiger 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 procédures de contrôle et des essais de fonctionnement peuvent s’avérer nécessaires
pour 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 requérant un traitement d’assurer que
leur conception facilite l’obtention dudit traitement avec efficacité. Cela inclut la prise en compte des
procédés validés communément disponibles; des exemples sont fournis dans l’Annexe A, qui peut être
utilisée comme guide pour valider des modes opératoires.
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NORME INTERNATIONALE ISO 17664-1:2021(F)
Traitement de produits de soins de santé — Informations
relatives au traitement des dispositifs médicaux à fournir
par le fabricant du dispositif —
Partie 1:
Dispositifs médicaux critiques et semi-critiques
1 Domaine d’application
Le présent document spécifie les exigences relatives aux informations à fournir par le fabricant du
dispositif médical pour le traitement des dispositifs médicaux critiques ou semi-critiques (c’est-à-dire
un dispositif médical qui pénètre dans des sites normalement stériles du corps humain ou un dispositif
médical qui entre en contact avec des muqueuses ou une peau lésée) ou des dispositifs médicaux
destinés à être stérilisés.
Il concerne les informations de traitement avant la première utilisation du dispositif médical et sa
réutilisation.
Les instructions de traitement ne sont pas définies dans le présent document. Le présent document
spécifie plutôt des exigences visant à aider les fabricants de dispositifs médicaux à fournir des
instructions de traitement détaillées, qui comprennent les opérations suivantes, le cas échéant:
a) traitement initial au point d’utilisation;
b) préparation avant le nettoyage;
c) nettoyage;
d) désinfection;
e) séchage;
f) contrôles et maintenance;
g) emballage;
h) stérilisation;
i) stockage;
j) transport.
Le présent document exclut le traitement des éléments suivants:
— les dispositifs médicaux non critiques, à moins qu’ils ne soient destinés à être stérilisés;
— les dispositifs textiles utilisés dans les systèmes de drapage des patients ou les vêtements de
chirurgie;
— les dispositifs médicaux spécifiés par le fabricant comme étant à usage unique et fournis prêts à
l’emploi.
NOTE Voir l’ISO 17664-2:2021, Annexe E, pour des recommandations supplémentaires relatives à
l’application de la série ISO 17664 à un dispositif médical.
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ISO 17664-1:2021(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 l’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 produits à une manipulation en toute sécurité, à la
poursuite du traitement ou les deux.
[SOURCE: ISO 11139:2018, 3.46, modifiée — La Note 1 à l’article a été ajoutée.]
3.2
agent désinfectant
agent physique ou chimique qui permet de réduire le nombre de micro-organismes viables
3.3
désinfection
procédé visant à réduire le nombre de micro-organismes viables à un niveau préalablement spécifié
comme approprié pour son utilisation définie
3.4
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]
3.5
dispositif médical
instrument, appareil, équipement, machine, dispositif, implant, réactif destiné à une utilisation in
vitro, logiciel, matériel ou autre article similaire ou associé, dont le fabricant du dispositif médical (3.6)
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;
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ISO 17664-1:2021(F)
— 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, dans le corps humain ou à la surface de celui-ci, mais dont la
fonction peut être assistée par de tels moyens
Note 1 à l'article: Les produits pouvant être considérés comme des dispositifs médicaux dans certaines
juridictions mais pas dans d’autres incluent:
— les produits désinfectants;
— les aides pour les personnes handicapées;
— les dispositifs intégrant des tissus animaux et/ou des tissus humains;
— les dispositifs pour les technologies de fécondation in vitro et de reproduction assistée.
[SOURCE: ISO 13485:2016, 3.11]
3.6
fabricant du dispositif médical
personne physique ou morale responsable de la conception ou de la fabrication, ou de la conception et
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 ou fabriqué, ou conçu et fabriqué, par cette personne ou en
son nom par une ou plusieurs autres personnes
Note 1 à l'article: L’attention est appelée sur le fait que les exigences réglementaires, nationales ou régionales,
peuvent s’appliquer à la définition de fabricant.
[SOURCE: ISO 11139:2018, 3.167, modifiée — Les Notes 1 à 7 ont été supprimées et une nouvelle Note 1
à l’article a été ajoutée.]
3.7
système d’emballage
combinaison d’un système de barrière stérile (3.15) et d’un emballage de protection (3.10)
3.8
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, le traitement comprend le nettoyage, la désinfection et la
stérilisation (si nécessaire et applicable).
Note 2 à l'article: Pour les besoins du présent document, un produit de santé désigne un dispositif médical.
3.9
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.]
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ISO 17664-1:2021(F)
3.10
emballage de protection
configuration de matériaux conçue pour éviter tout dommage au système de barrière stérile (3.15) et à
son contenu depuis leur assemblage jusqu’au point d’utilisation
[SOURCE: ISO 11607-1:2019, 3.14]
3.11
dispositif médical réutilisable
dispositif médical (3.5) conçu ou défini par le fabricant du dispositif médical (3.6) pour pouvoir être
soumis à un traitement (3.8) 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, modifiée — « pour pouvoir être traité » a été remplacé par « pour
pouvoir être soumis à un traitement ».]
3.12
durée de vie en service
nombre de cycles de traitement (3.8) et/ou durée de vie, auxquels/à laquelle un dispositif médical (3.5)
peut être soumis en restant adéquat et sûr pour son utilisation prévue
3.13
dispositif médical à usage unique
dispositif médical (3.5) conçu ou défini par le fabricant du dispositif médical (3.6) pour une utilisation
une seule fois
Note 1 à l'article: Un dispositif médical à usage unique n’est pas destiné à être traité et utilisé plus d’une fois.
3.14
stérile
exempt de microorganismes viables
[SOURCE: ISO 11139:2018, 3.271]
3.15
système de barrière stérile
emballage minimal empêchant la pénétration des micro-organismes et permettant une présentation
aseptique du produit à son point d’utilisation
3.16
niveau d’assurance de la stérilité
probabilité de présence d’un microorganisme viable sur un produit après la stérilisation (3.17), exprimée
en base 10 avec un exposant négatif
3.17
stérilisation
procédé utilisé pour obtenir un produit exempt de micro-organismes viables
Note 1 à l'article: Dans un procédé de stérilisation, la nature de l’inactivation microbienne est exponentielle, par
conséquent la survie d’un microorganisme sur une unité individuelle peut être exprimée en termes de probabilité.
Cette probabilité peut être réduite à un nombre très faible, mais elle ne peut jamais être nulle.
3.18
agent stérilisant
entité physique ou chimique, ou combinaison d’entités, ayant une activité microbicide suffisante pour
obtenir la stérilité dans des conditions définies
3.19
procédé terminal
dernière étape du traitement (3.8) visant à obtenir un dispositif médical (3.5) sûr et prêt à son utilisation
prévue
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ISO 17664-1:2021(F)
3.20
validation
confirmation par des preuves objectives que les exigences pour une utilisation spécifique ou une
application prévues ont été satisfaites
[SOURCE: ISO 9000:2015, 3.8.13, modifiée — Les notes à l’article ont été supprimées.]
3.21
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.]
3.22
laveur désinfecteur
équipement destiné à nettoyer et désinfecter un produit
Note 1 à l'article: Voir la série ISO 15883.
[SOURCE: ISO 11139:2018, 3.319, modifiée — L'abréviation LD a été supprimée et la Note 1 à l’article a
été ajoutée.]
4 Validation des procédés identifiés dans les informations fournies par le
fabricant du dispositif médical
4.1 Le fabricant du dispositif médical doit valider chaque procédé identifié dans les informations
fournies avec le dispositif médical. La validation doit démontrer que chaque procédé convient au
traitement du dispositif médical.
4.2 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, désinfecté et/ou stérilisé s’il est traité selon les instructions fournies.
NOTE 1 Outre l’obligation d’un fabricant de démontrer la validité des informations fournies, les autorités
nationales peuvent exiger que l’efficacité finale du procédé soit vérifiée par l’opérateur de procédé.
NOTE 2 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.
4.3 Si un fabricant fournit plusieurs dispositifs médicaux différents partageant des caractéristiques
communes, alors les études de validation peuvent être effectuées sur des familles 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.
5 Analyse du risque
Le fabricant du dispositif médical doit réaliser une analyse du risque pour déterminer le contenu et les
détails des informations à fournir à l’utilisateur. 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 de prendre en compte les points suivants (mais n'est pas limitée
à):
— nature et conception du dispositif médical;
— nature des contaminants du dispositif médical;
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ISO 17664-1:2021(F)
— utilisation prévue;
— cycle de vie du dispositif médical;
— 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;
— limitation du nombre de réutilisations;
— avertissements nécessaires.
Ces points peuvent également s’avérer utiles pour les entités qui valident des procédés alternatifs
conformément à 4.2, NOTE 2.
NOTE 2 L’Annexe C fournit des informations sur la classification des dispositifs médicaux, qui peut faciliter
tout processus d’analyse du risque.
6 Informations devant être fournies 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 et de son utilisation prévue.
6.1.2 Lorsqu’une désinfection constitue le procédé terminal, 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. Les fabricants de dispositifs médicaux
doivent indiquer dans leurs instructions de traitement toute technique et tout accessoire spécifique
permettant à l’opérateur de procédé de fournir un dispositif médical approprié à son utilisation prévue.
6.1.3 Lorsqu’une stérilisation constitue le procédé terminal, le fabricant du dispositif médical doit
spécifier la ou les méthodes validées pour atteindre le niveau d’assurance de la stérilité exigé. Les
fabricants de dispositifs médicaux doivent indiquer dans leurs instructions de traitement toute exigence
spécifique permettant à l’opérateur de procédé de fournir un dispositif médical approprié à son
utilisation prévue.
6.1.4
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17664-1
ISO/TC 198
Processing of health care products —
Secretariat: ANSI
Information to be provided by the
Voting begins on:
2021-02-25 medical device manufacturer for the
processing of medical devices —
Voting terminates on:
2021-05-20
Part 1:
Critical and semi-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 1: Dispositifs médicaux critiques et semi-critiques
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 17664-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 17664-1:2021(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
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ISO/FDIS 17664-1:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
5 Risk analysis . 5
6 Information to be provided by the medical device manufacturer .6
6.1 General . 6
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Initial treatment at the point of use . 7
6.5 Preparation before cleaning . 7
6.6 Cleaning . 8
6.6.1 General. 8
6.6.2 Automated cleaning . 8
6.6.3 Manual cleaning . 8
6.7 Disinfection . 9
6.7.1 General. 9
6.7.2 Automated disinfection . 9
6.7.3 Manual disinfection .10
6.8 Drying .10
6.9 Inspection and maintenance .10
6.10 Packaging .11
6.11 Sterilization .11
6.12 Storage .12
6.13 Transportation .12
7 Presentation of the information .12
Annex A (informative) Commonly utilized processing methods .13
Annex B (informative) Example of processing instructions for reusable medical devices.17
Annex C (informative) Classification of medical devices .19
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .22
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .23
Bibliography .24
© ISO 2021 – All rights reserved iii
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ISO/FDIS 17664-1:2021(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 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This first edition of ISO 17664-1 cancels and replaces ISO 17664:2017, of which it constitutes a minor
revision. The changes to ISO 17664:2017 are as follows:
— the title, introduction and scope have been editorially revised to reflect the addition of a second
part to the ISO 17664 series.
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 © ISO 2021 – All rights reserved
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ISO/FDIS 17664-1:2021(E)
Introduction
This document applies to manufacturers of those medical devices that are intended to be cleaned,
disinfected, sterilized or a combination of all three by the processor to be made ready for use. 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. This may include one or more of
cleaning, disinfection and sterilization.
— Single-use medical devices that require processing before use and are intended to be used in a clean,
disinfected or sterile state, or a combination of all three.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of health care to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean, disinfect or sterilize.
Cleaning, disinfecting and sterilizing 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, disinfection, sterilization or a combination of all three 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 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 the
surfaces of a medical device could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process, sterilization process or both. 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 can be necessary to ensure that a medical device
does not pose a safety risk 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, which can be used as a
guide to validate procedures.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 17664-1:2021(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 1:
Critical and semi-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
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) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:—, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device.
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ISO/FDIS 17664-1:2021(E)
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
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
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
3.4
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]
3.5
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.]
3.6
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.5) to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
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ISO/FDIS 17664-1:2021(E)
— 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;
— 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, in or on the human body, but which may be assisted in its 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:
— 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 13485:2016, 3.11]
3.7
packaging system
combination of a sterile barrier system (3.15) and protective packaging (3.10)
3.8
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, processing includes cleaning, disinfection and sterilization (if
necessary and applicable).
Note 2 to entry: For the purposes of this document, a health care product refers to a medical device.
3.9
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.]
3.10
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.15) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2019, 3.14]
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ISO/FDIS 17664-1:2021(E)
3.11
reusable medical device
medical device (3.6) designated or intended by the manufacturer (3.5) as suitable for processing (3.8)
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]
3.12
service life
number of processing (3.8) cycles, lifetime or both that a medical device (3.6) can be subjected to and
remain suitable and safe for its intended use
3.13
single-use medical device
medical device (3.6) designated or intended by the manufacturer (3.5) for one-time use only
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
3.14
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.15
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use
3.16
sterility assurance level
probability of a single viable microorganism occurring on an item after sterilization (3.17), expressed
as the negative exponent to the base 10
3.17
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
3.18
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve
sterility under defined conditions
3.19
terminal process
final step of processing (3.8) to render a medical device (3.6) safe and ready for its intended use
3.20
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified — the notes to entry have been deleted.]
4 © ISO 2021 – All rights reserved
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ISO/FDIS 17664-1:2021(E)
3.21
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.]
3.22
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 Validation of the processes identified in the information provided by the
medical device manufacturer
4.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device. Validation shall demonstrate that each process is suitable for processing
of the medical device.
4.2 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, sterilized or all three when processed as directed.
NOTE 1 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the final effectiveness of the process to be verified by the processor.
NOTE 2 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.
4.3 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 See C.1.
5 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided to the user. 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:
— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
— life cycle of the medical device;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
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ISO/FDIS 17664-1:2021(E)
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— limitation on number of reuses;
— necessary warnings.
These points can also be of benefit to those validating alternative processes in accordance with 4.2, NOTE 2.
NOTE 2 Annex C provides information on classification of medical devices which can assist with any risk
analysis process.
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
and its intended use.
6.1.2 Where disinfection is the terminal process, 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. 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.
6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify
validated method(s) to achieve the required sterility assurance level. Medical device manufacturers
shall specify in their processing instructions any specific requirements 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;
— the need for specific training;
— the processing equipment commonly available to the processor.
NOTE Annex A and Annex C provide information on classification of medical devices which can assist with
identifying the information required.
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. The method shall be relevant to the market in which the medical device is to be supplied.
NOTE Annex A provides information on the commonly used processes available.
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ISO/FDIS 17664-1:2021(E)
6.2.2 The following information shall be stated where it is critical to 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, accessories or both;
c) specifications for process parameters and their tolerances.
NOTE For an example of appropriate text see Annex B.
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 might limit the service life of the medical device, for
example functionality, biocompatibility or suitability for effective processing, 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
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17664-1
ISO/TC 198
Processing of health care products —
Secretariat: ANSI
Information to be provided by the
Voting begins on:
2020-12-23 medical device manufacturer for the
processing of medical devices —
Voting terminates on:
2021-03-17
Part 1:
Critical and semi-critical medical
devices
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 17664-1:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 17664-1:2020(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
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 2020 – All rights reserved
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ISO/FDIS 17664-1:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
5 Risk analysis . 5
6 Information to be provided by the medical device manufacturer .6
6.1 General . 6
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Initial treatment at the point of use . 7
6.5 Preparation before cleaning . 7
6.6 Cleaning . 8
6.6.1 General. 8
6.6.2 Automated cleaning . 8
6.6.3 Manual cleaning . 8
6.7 Disinfection . 9
6.7.1 General. 9
6.7.2 Automated disinfection . 9
6.7.3 Manual disinfection .10
6.8 Drying .10
6.9 Inspection and maintenance .10
6.10 Packaging .11
6.11 Sterilization .11
6.12 Storage .12
6.13 Transportation .12
7 Presentation of the information .12
Annex A (informative) Commonly utilized processing methods .13
Annex B (informative) Example of processing instructions for reusable medical devices.17
Annex C (informative) Classification of medical devices .19
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .22
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .23
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .24
Bibliography .25
© ISO 2020 – All rights reserved iii
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ISO/FDIS 17664-1:2020(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,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This first edition of ISO 17664-1 cancels and replaces ISO 17664:2017, of which it constitutes a minor
revision. The changes to ISO 17664:2017 are as follows:
— the title, introduction and scope have been editorially revised to reflect the addition of a second
part to the ISO 17664 series.
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 © ISO 2020 – All rights reserved
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ISO/FDIS 17664-1:2020(E)
Introduction
This document applies to manufacturers of those medical devices that are intended to be cleaned,
disinfected, sterilized or a combination of all three by the processor to be made ready for use. 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. This may include one or more of
cleaning, disinfection and sterilization.
— Single-use medical devices that require processing before use and are intended to be used in a clean,
disinfected or sterile state, or a combination of all three.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of health care to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean, disinfect or sterilize.
Cleaning, disinfecting and sterilizing 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, disinfection, sterilization or a combination of all three 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 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 the
surfaces of a medical device could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process, sterilization process or both. 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 can be necessary to ensure that a medical device
does not pose a safety risk 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, which can be used as a
guide to validate procedures.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 17664-1:2020(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 1:
Critical and semi-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
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) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:—, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device.
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ISO/FDIS 17664-1:2020(E)
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
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
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
3.4
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]
3.5
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.]
3.6
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.5) to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
2 © ISO 2020 – All rights reserved
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ISO/FDIS 17664-1:2020(E)
— 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;
— 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, in or on the human body, but which may be assisted in its 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:
— 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 13485:2016, 3.11]
3.7
packaging system
combination of a sterile barrier system (3.15) and protective packaging (3.10)
3.8
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, processing includes cleaning, disinfection and sterilization (if
necessary and applicable).
Note 2 to entry: For the purposes of this document, a health care product refers to a medical device.
3.9
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.]
3.10
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.15) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2019, 3.14]
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ISO/FDIS 17664-1:2020(E)
3.11
reusable medical device
medical device (3.6) designated or intended by the manufacturer (3.5) as suitable for processing (3.8)
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]
3.12
service life
number of processing (3.8) cycles, lifetime or both that a medical device (3.6) can be subjected to and
remain suitable and safe for its intended use
3.13
single-use medical device
medical device (3.6) designated or intended by the manufacturer (3.5) for one-time use only
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
3.14
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.15
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use
3.16
sterility assurance level
probability of a single viable microorganism occurring on an item after sterilization (3.17), expressed
as the negative exponent to the base 10
3.17
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
3.18
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve
sterility under defined conditions
3.19
terminal process
final step of processing (3.8) to render a medical device (3.6) safe and ready for its intended use
3.20
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified — the notes to entry have been deleted.]
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3.21
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.]
3.22
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 Validation of the processes identified in the information provided by the
medical device manufacturer
4.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device. Validation shall demonstrate that each process is suitable for processing
of the medical device.
4.2 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, sterilized or all three when processed as directed.
NOTE 1 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the final effectiveness of the process to be verified by the processor.
NOTE 2 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.
4.3 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 See C.1.
5 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided to the user. 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:
— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
— life cycle of the medical device;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
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— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— limitation on number of reuses;
— necessary warnings.
These points can also be of benefit to those validating alternative processes in accordance with 4.2, NOTE 2.
NOTE 2 Annex C provides information on classification of medical devices which can assist with any risk
analysis process.
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
and its intended use.
6.1.2 Where disinfection is the terminal process, 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. 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.
6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify
validated method(s) to achieve the required sterility assurance level. Medical device manufacturers
shall specify in their processing instructions any specific requirements 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;
— the need for specific training;
— the processing equipment commonly available to the processor.
NOTE Annex A and Annex C provide information on classification of medical devices which can assist with
identifying the information required.
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. The method shall be relevant to the market in which the medical device is to be supplied.
NOTE Annex A provides information on the commonly used processes available.
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6.2.2 The following information shall be stated where it is critical to 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, accessories or both;
c) specifications for process parameters and their tolerances.
NOTE For an example of appropriate text see Annex B.
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 might limit the service life of the medical device, for
example functionality, biocompatibility or suitability for effective processing, then the medical device
manufacturer shall provide such information regarding limitations and restrictions to the processor.
6.3.2 If the service
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