EN ISO 17664-2:2023
(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: Unkritische 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
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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 .
...
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