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.

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)

General Information

Status
Published
Public Enquiry End Date
14-Nov-2023
Publication Date
08-Feb-2024
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Jan-2024
Due Date
30-Mar-2024
Completion Date
09-Feb-2024

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SLOVENSKI STANDARD
SIST EN ISO 17664-2:2024
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
SIST EN ISO 17664-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 17664-2:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 17664-2:2024


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.

---------------------- Page: 3 ----------------------
SIST EN ISO 17664-2:2024
EN ISO 17664-2:2023 (E)
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

2

---------------------- Page: 4 ----------------------
SIST EN ISO 17664-2:2024
EN ISO 17664-2:2023 (E)
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
...

SLOVENSKI STANDARD
oSIST prEN ISO 17664-2:2023
01-november-2023
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: prEN ISO 17664-2
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 17664-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 17664-2:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 17664-2:2023


DRAFT
EUROPEAN STANDARD
prEN ISO 17664-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2023
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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 204.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


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. prEN ISO 17664-2:2023 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN ISO 17664-2:2023
prEN ISO 17664-2:2023 (E)
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

2

---------------------- Page: 4 ----------------------
oSIST prEN ISO 17664-2:2023
prEN ISO 17664-2:2023 (E)
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 prEN ISO 17664-2:2023 by Technical Committee CEN/TC 204 “Sterilization of medic
...

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