SIST EN ISO 17664-2:2024
(Main)Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 2: Nicht kritische Medizinprodukte (ISO 17664-2:2021)
Dieses Dokument legt Anforderungen an die Informationen fest, die vom Medizinprodukt-Hersteller zur Aufbereitung von unkritischen Medizinprodukten, für die keine Sterilisation vorgesehen ist (d. h. Medizinprodukte, die nur für den Kontakt mit intakter Haut oder nicht für direkten Patientenkontakt bestimmt sind), bereitzustellen sind.
Das schließt Informationen zur Aufbereitung vor der Verwendung oder Wiederverwendung des Medizinprodukts ein.
In diesem Dokument sind keine Aufbereitungsanweisungen definiert. Dieses Dokument legt stattdessen Anforderungen fest, um Medizinprodukt-Hersteller darin zu unterstützen, ausführliche Aufbereitungsanweisungen zur Verfügung zu stellen, die gegebenenfalls die folgenden Aktivitäten umfassen:
a) Vorbereitung vor der Aufbereitung;
b) Reinigung;
c) Desinfektion;
d) Trocknung;
e) Kontrolle und Wartung;
f) Verpackung;
g) Lagerung;
h) Transport.
Dieses Dokument ist nicht anwendbar für die Aufbereitung von Folgendem:
1) kritischen und semikritischen Medizinprodukten;
2) Medizinprodukten, die für die Sterilisation vorgesehen sind;
3) textilen Medizinprodukten zur Verwendung in Patientenabdeckungssystemen oder OP-Bekleidung;
4) Medizinprodukten, die vom Hersteller nur zum Einmalgebrauch spezifiziert sind und gebrauchsfertig bereitgestellt werden.
ANMERKUNG Weitere Leitlinien zur Anwendung der Normenreihe ISO 17664 auf Medizinprodukte finden sich in Anhang E.
Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2: Dispositifs médicaux non critiques (ISO 17664-2:2021)
Le présent document spécifie les exigences applicables aux informations relatives au traitement des dispositifs médicaux non critiques et non destinés à être stérilisés, à fournir par le fabricant du dispositif (c'est-à-dire un dispositif médical destiné à entrer en contact avec la peau intacte uniquement ou un dispositif médical qui n'est pas destiné à un contact direct avec le patient).
Ces exigences incluent les informations de traitement avant l'utilisation ou la réutilisation du dispositif médical.
Les instructions de traitement ne sont pas définies dans le présent document. En revanche, le présent document spécifie des exigences visant à aider les fabricants de dispositifs médicaux à fournir des instructions de traitement détaillées qui comprennent, le cas échéant, les activités suivantes:
a) la préparation avant le traitement;
b) le nettoyage;
c) la désinfection;
d) le séchage;
e) le contrôle et la maintenance;
f) l'emballage;
g) le stockage;
h) le transport.
Le présent document exclut le traitement:
1) des dispositifs médicaux critiques et semi-critiques;
2) des dispositifs médicaux destinés à être stérilisés;
3) des dispositifs médicaux textiles utilisés dans les systèmes de drapage des patients ou les vêtements de chirurgie;
4) des dispositifs médicaux spécifiés par le fabricant comme étant à usage unique et fournis prêts à l'emploi.
NOTE Voir l'Annexe E pour obtenir des recommandations supplémentaires concernant l'application de la série de normes ISO 17664 relative aux dispositifs médicaux.
Proizvodnja izdelkov za zdravstveno nego - Informacije za obdelavo medicinskih pripomočkov, ki jih zagotovi proizvajalec - 2. del: Nenujni medicinski pripomočki (ISO 17664-2:2021)
Ta dokument določa zahteve za informacije, ki jih zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave nenujnih medicinskih pripomočkov, ki jih ni treba sterilizirati (tj. medicinski pripomoček, ki je namenjen samo stiku z nepoškodovano kožo, ali medicinski pripomoček, ki ni namenjen neposrednemu stiku s pacientom).
To vključuje informacije za obdelavo pred uporabo ali ponovno uporabo medicinskega pripomočka.
Ta dokument ne določa navodil za obdelavo. Namesto tega določa zahteve
za pomoč proizvajalcem medicinskih pripomočkov pri zagotavljanju podrobnih navodil za obdelavo, ki po potrebi vsebujejo naslednje dejavnosti:
a) priprava pred obdelavo;
b) čiščenje;
c) razkuževanje;
d) sušenje;
e) pregledi in vzdrževanje;
f) pakiranje;
g) shranjevanje;
h) prevoz.
Ta dokument ne vključuje obdelave naslednjih izdelkov:
1) nujni in delno nujni medicinski pripomočki;
2) medinski pripomočki, ki jih je treba sterilizirati;
3) tekstilni medicinski pripomočki, ki se uporabljajo v sistemih za pokrivanje bolnikov ali operacijskih oblačilih;
4) medicinski pripomočki, ki jih je proizvajalec določil za enkratno uporabo in so dobavljeni pripravljeni za takojšnjo uporabo.
OPOMBA: Glej dodatek E za dodatne smernice o uporabi skupine standardov ISO 17664 za medicinski pripomoček.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Proizvodnja izdelkov za zdravstveno nego - Informacije za obdelavo medicinskih
pripomočkov, ki jih zagotovi proizvajalec - 2. del: Nenujni medicinski pripomočki
(ISO 17664-2:2021)
Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
(ISO 17664-2:2021)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten -
Teil 2: Nicht kritische Medizinprodukte (ISO 17664-2:2021)
Traitement de produits de soins de santé - Informations relatives au traitement des
dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2: Dispositifs médicaux
non critiques (ISO 17664-2:2021)
Ta slovenski standard je istoveten z: EN ISO 17664-2:2023
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17664-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2023
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices - Part 2: Non-critical medical
devices (ISO 17664-2:2021)
Traitement de produits de soins de santé - Aufbereitung von Produkten für die
Informations relatives au traitement des dispositifs Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller
médicaux à fournir par le fabricant du dispositif - bereitzustellende Informationen für die Aufbereitung
Partie 2: Dispositifs médicaux non critiques (ISO von Medizinprodukten - Teil 2: Nicht kritische
17664-2:2021) Medizinprodukte (ISO 17664-2:2021)
This European Standard was approved by CEN on 17 December 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664-2:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
The text of ISO 17664-2:2021 has been prepared by Technical Committee ISO/TC 198 "Sterilization of
health care products” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 17664-2:2023 by Technical Committee CEN/TC 204 “Sterilization of medical devices”
the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2024, and conflicting national standards shall be
withdrawn at the latest by June 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral
part of this document.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 17664-2:2021 has been approved by CEN as EN ISO 17664-2:2023 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail. In this context, the definition of ‘medical device’ in EN ISO 17664-2 is a modified
version of the definition prepared by the Global Harmonization Task Force with modification to the
Note in the definition.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation (EU) this EN
2017/745
23.4.i 4,5,6,7 23.4.i is covered only for the
disinfection of devices to make
ready for first use.
23.4.n 4,5,6,7
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 14971 ISO 14971:2019 Medical devices — EN ISO 14971:2019
Application of risk
EN ISO 14971:2019+A11:2021
management to medical
devices
The documents listed in the Column 1 of table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 17664-2
First edition
2021-02
Processing of health care products —
Information to be provided by the
medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif —
Partie 2: Dispositifs médicaux non critiques
Reference number
ISO 17664-2:2021(E)
©
ISO 2021
ISO 17664-2:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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
ISO 17664-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Risk analysis . 4
5 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
6 Information to be provided by the medical device manufacturer .5
6.1 General . 5
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 7
6.4 Preparation before processing . 7
6.5 Cleaning . 7
6.5.1 General. 7
6.5.2 Manual cleaning . 7
6.5.3 Automated cleaning . 8
6.6 Disinfection . 8
6.6.1 General. 8
6.6.2 Manual disinfection . 8
6.6.3 Automated disinfection . 9
6.7 Drying . 9
6.8 Inspection and maintenance . 9
6.9 Packaging .10
6.10 Storage .10
6.11 Transportation .10
7 Presentation of the information .10
Annex A (informative) Commonly utilized processing methods .11
Annex B (informative) Example processing instructions for non-critical reusable medical
devices .15
Annex C (informative) Processing classification and grouping of medical devices .17
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .19
Annex E (informative) Examples of medical devices and their relationship to this document .20
Bibliography .24
ISO 17664-2:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
A list of all parts in the ISO 17664 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO 17664-2:2021(E)
Introduction
This document applies to manufacturers of non-critical medical devices that are intended to be cleaned
and/or disinfected by the processor to be made ready for use or reuse. This includes:
— medical devices that are intended for reuse and require processing to take them from their state
after clinical use to the state of being ready for their next use;
— single-use medical devices that require processing before use and are intended to be used in a clean
and/or disinfected state.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of healthcare to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean and/or disinfect.
Cleaning and disinfecting technologies have also undergone significant change in the past decade,
resulting in new systems and approaches that can be applied in the processing of medical devices.
This has led to a greater appreciation of the need for validation of processing including cleaning and/
or disinfection in order to ensure that medical devices are effectively processed. These developments
have led to the need to ensure that manufacturers of medical devices provide adequate instructions
that support the end users to undertake safe and effective processing of medical devices, utilizing the
available equipment and processes.
A medical device requiring processing is supplied with detailed processing instructions in order to
ensure that, when followed correctly, the risks of transmission of infectious agents are minimized. In
addition, effective processing minimizes the risk of other adverse effects on medical devices.
Cleaning is an important step in rendering a used medical device safe for subsequent use. Failure to
remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from
surfaces of medical devices could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process. Single-use medical devices provided by the
medical device manufacturer for processing prior to use can also require cleaning prior to further
processing.
After cleaning, other factors can affect the safe and effective use of a medical device. For example,
procedures for inspection and functional testing might be necessary to ensure that a medical device
does not pose a risk to safety when used. Manufacturers of medical devices can assist users by providing
instructions on how this inspection and testing should be performed.
Manufacturers of medical devices that are to be processed have a responsibility to ensure that the
design of the medical devices facilitates achievement of effective processing. This includes consideration
of commonly available validated processes; examples are shown in Annex A. This annex can be used as
a guide to validate procedures.
INTERNATIONAL STANDARD ISO 17664-2:2021(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 2:
Non-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e.
a medical device that is intended to come into contact with intact skin only or a medical device not
intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664-2:2021(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris)
from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process
that prepares the items for safe handling and/or further processing.
[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]
3.2
cleaning agent
physical or chemical entity, or combination of entities, having activity to render an item clean
[SOURCE: ISO 11139:2018, 3.47]
3.3
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.6
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended
use without the use of an automated process
[SOURCE: ISO 11139:2018, 3.159]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification or support of the anatomy or of a physiological process;
2 © ISO 2021 – All rights reserved
ISO 17664-2:2021(E)
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means.
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal tissues and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018, 3.166]
3.8
medical device manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with
the intention of making the medical device available for use, under their name, whether or not such a
medical device is designed and/or manufactured by that person or on their behalf by another person(s)
Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to
the definition of manufacturer.
[SOURCE: ISO 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1
to entry has been added.]
3.9
process chemical
formulation of substances intended for use in equipment
[SOURCE: ISO 11139:2018, 3.207]
3.10
processing
activity to prepare a new or used health care product for its
intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.214, modified — Note 1 to entry has been added.]
3.11
processor
organization and/or individual with the responsibility of carrying
out actions necessary to prepare a new or reusable health care product for its intended use
Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]
ISO 17664-2:2021(E)
3.12
reusable medical device
medical device designated or intended by the manufacturer as suitable for processing and reuse
Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.
[SOURCE: ISO 11139:2018, 3.236]
3.13
service life
number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
Note 1 to entry: For the purposes of this document, a product refers to a medical device.
[SOURCE: ISO 11139:2018, 3.251, modified — Note 1 to entry has been added.]
3.14
single-use medical device
medical device labelled or intended to be used on one individual during a single procedure
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
[SOURCE: ISO 11139:2018, 3.255, modified — Note 1 to entry has been added.]
3.15
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
[SOURCE: ISO 11139:2018, 3.313, modified — Notes 1, 2 and 3 to entry have been deleted.]
3.16
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
[SOURCE: ISO 11139:2018, 3.314, modified — Notes 1 and 2 to entry have been deleted.]
3.17
washer-disinfector
WD
equipment designed to clean and disinfect product
Note 1 to entry: See the ISO 15883 series.
[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]
4 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided. The risk management undertaken by the manufacturer of the medical
device shall conform with ISO 14971.
NOTE 1 Some of the points relevant to processing that any risk analysis can require (but not limited to)
include:
— the likely points of contact with the user and/or the patient that might allow cross-contamination;
— nature and design of the medical device;
— nature of the contamination on the medical device;
4 © ISO 2021 – All rights reserved
ISO 17664-2:2021(E)
— intended use;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— service life;
— necessary warnings.
The points above can also be of benefit to those validating alternative processes in accordance with the NOTE
2 to 5.2.
NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk
analysis process.
5 Validation of the processes identified in the information provided by the
medical device manufacturer
5.1 The medical device manufacturer shall validate each process that is identified in the information
supplied with the medical device and demonstrate that each process is suitable for processing of the
medical device. This shall include the intended points of contact with the user and/or the patient that
could likely lead to cross-contamination. Parts of the medical device that are unlikely to lead to cross
contamination may be excluded from validation, based upon the risk analysis described in Clause 4.
5.2 The medical device manufacturer shall have objective evidence available that validation of the
processing procedures has been undertaken to confirm that the specific medical device will be clean
and/or disinfected, when processed as directed.
NOTE 1 A worst-case approach, representing those areas of the medical device that are the intended points of
contact with the user, the patient or both and where there is opportunity for cross-contamination, can be used.
NOTE 2 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the effectiveness of the final process to be verified by the processor.
NOTE 3 National authorities can allow or require the use of an alternative process. In such cases they usually
require validation of those processes by the processor.
5.3 If a manufacturer supplies a number of different medical devices that share common attributes,
then validation studies may be performed as a product family. If this approach is taken, the medical device
manufacturer shall demonstrate commonality between the different medical devices and the validation
studies shall address the worst-case attribute(s) of the product family.
NOTE For guidance on grouping of medical devices as product families, see C.1.
6 Information to be provided by the medical device manufacturer
6.1 General
6.1.1 The information specified in this clause shall take into account the nature of the medical device,
its intended location for use and processing and its intended use.
ISO 17664-2:2021(E)
NOTE The location of processing can be at the point of use or within a processing department.
6.1.2 The medical device manufacturer shall specify validated method(s) to reduce the risk of
transmission of infectious agents to a level appropriate for the intended use of the medical device.
6.1.3 Medical device manufacturers shall specify in their processing instructions any special
techniques and accessories that will enable the processor to provide a medical device that is suitable for
its intended use.
6.1.4 When providing processing instructions, medical device manufacturers shall be aware of:
— available national and international standards and guidelines;
— if applicable, the need for specific training;
— the processing equipment commonly available to the processor.
NOTE 1 Some national standards and regulations require cleaning and disinfection for all non-critical medical
devices.
NOTE 2 Annex A provides information which can assist with identifying the information required and the
processing equipment commonly available.
6.1.5 The equipment or materials required in the specified processes shall be identified by their
generic names or specification. Trade names may be added in cases where generic names do not provide
sufficient information (see Annex D).
6.2 Processing instructions
6.2.1 At least one validated method shall be specified for each applicable stage of processing of the
medical device. Disinfection may be carried out concurrently with cleaning of the medical device.
NOTE 1 Annex A provides information on the commonly used processes available.
NOTE 2 The requirements for cleaning and disinfection are stated as separate clauses in this document.
However, when the steps are concurrent, the requirements of both stages can be considered as one. In such cases
removal of soil, a reduction in microorganisms and inactivation of viable microorganisms can be achieved as a
result of the combination of applying the disinfecting agent and a physical action.
NOTE 3 The range of medical devices included within this document is wide and varied. Many of these
medical devices (e.g. stethoscopes and blood pressure cuffs) are relatively simple medical devices which do not
necessarily require automated processes. There will be other medical devices where automated processing is
not possible or contra-indicated (e.g. some medical devices with electronic components). However, some medical
devices such as beds, wheelchairs and footwear can be, and often are, subjected to automated processes. For this
final group of medical devices, a validated method of automated processing can be specified and is preferred.
6.2.2 The method shall be appropriate to the market in which the medical device is to be supplied.
6.2.3 The following information shall be stated where it is required for the maintenance of the intended
function of the medical device and the safety of the user(s) and the patient:
a) details of process steps;
b) a description of the equipment, the accessories or both;
c) specifications for process parameters and, if applicable, their tolerances.
NOTE For an example of an appropriate format see Annex B.
6 © ISO 2021 – All rights reserved
ISO 17664-2:2021(E)
6.3 Limitations and restrictions on processing
6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s
instructions is known to lead to degradation that can limit the service life of the medical device, then the
medical device manufacturer shall provide such information regarding limitations and restrictions to the
processor.
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some
other end of life indicator(s) this information shall also be provided.
6.3.3 Where an incompatibility of the medical device with a commonly used substance(s) or processing
condition(s) that can impact upon patient safety is known, this information shall be provided.
6.4 Preparation before processing
If preparation of a medical device is required prior to cleaning to ensure effective processing of that
medical device, then the following information shall be provided, where applicable:
a) a description of the process for disassembly of the medical device;
b) a description of the process and processing parameters for medical device preparation;
c) accessories and tools required.
NOTE For detailed guidance see Annex A.
6.5 Cleaning
6.5.1 General
At least one validated cleaning method shall be specified.
6.5.2 Manual cleaning
If a manual cleaning method is specified, the following information shall be included, where applicable:
a) a description of the manual method with step-by-step instructions and the sequence of each
individual process step;
b) a description of the process and processing parameters and, if applicable, any limits the medical
device can withstand;
c) a description of the accessories required;
d) identification and concentration of process chemicals required;
e) the contact time of any cleaning agents used;
f) the quality of water to be used;
g) methods to be used for rinsing (including the need for rinsing between cleaning and subsequent
steps where the process residues could interact adversely with the disinfecting agent);
h) if known, identification of any incompatibilities of cleaning agents with the medical device.
The medical device manufacturer's instructions for use may direct the processor to refer to the cleaning
product manufacturer's instructions for use.
ISO 17664-2:2021(E)
6.5.3 Automated cleaning
6.5.3.1 If the automated cleaning process recommends the use of a washer-disinfector meeting the
requirements of the ISO 15883 series, the information regarding the automated process may be limited to
those parameters that are specific for the medical device, such as specific load configuration, positioning,
connection, accessories, process chemicals, water quality, pressures or temperature limit(s) and a statement
confirming the recommendation to use a washer-disinfector conforming with the ISO 15883 series.
6.5.3.2 If the specific cleaning requirements of the medical device do not allow a generic claim of
compatibility with a washer-disinfector meeting the requirements of the ISO 15883 series then the
following information shall be included, where applicable:
a) a description of the process and processing parameters including any limits the medical device can
withstand;
b) a description of the accessories required;
c) identification and concentration of process chemicals required;
d) the contact time of any cleaning agents used;
e) the quality of water to be used;
f) methods to be used for rinsing (including the need for rinsing between cleaning and subsequent
steps where the process residues could interact adversely with the disinfecting agent);
g) if known, identification of any incompatibilities of cleaning agents with the medical device.
The medical device manufacturer's instructions for use may direct the processor to refer to the cleaning
product manufacturer's instructions for use.
NOTE Additional information conforming with 6.5.3.2 can be provided when the requirements of 6.5.3.1 are
met if the medical device manufacturer chooses to do so.
6.6 Disinfection
6.6.1 General
If disinfection is required, at least one validated disinfection method shall be specified.
NOTE When using chemical disinfection, carry-over residue from the cleaning process can interact adversely
with the disinfecting agent.
6.6.2 Manual disinfection
If a manual disinfection method is specified, the following information shall be included, where
applicable:
a) a description of the manual metho
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