EN ISO 17664-1:2021

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 (ISO 17664-1:2021)

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.

Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 1: Kritische und semi-kritische Medizinprodukte (ISO 17664-1:2021)

Dieses Dokument legt Anforderungen an die Informationen fest, die vom Hersteller zur Aufbereitung von kritischen und semikritischen Medizinprodukten (das heißt ein Medizinprodukt, das Kontakt zu sterilen Körperbereichen hat, oder ein Medizinprodukt, das Kontakt zu Schleimhaut oder krankhaft veränderter Haut hat) oder Medizinprodukten, die eine Sterilisation erfordern, 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 Aufbereitungs¬anweisungen zur Verfügung zu stellen, die, sofern zutreffend, die folgenden Aktivitäten umfassen:
a) Vorbehandlung am Gebrauchsort;
b) Vorbereitung vor der Reinigung;
c) Reinigung;
d) Desinfektion;
e) Trocknung;
f) Kontrolle und Wartung;
g) Verpackung;
h) Sterilisation;
i) Lagerung;
j) Transport.
Dieses Dokument schließt die Aufbereitung von Folgendem aus:
- unkritischen Medizinprodukten, sofern diese nicht für die Sterilisation vorgesehen sind,
- Textilien zur Verwendung in Patientenabdeckungssystemen oder OP Bekleidung,
- Medizinprodukten, die vom Hersteller nur zum Einmalgebrauch spezifiziert sind und gebrauchsfertig bereitgestellt werden.
ANMERKUNG Für weitere Hinweise zur Anwendung der ISO 17664-Reihe auf ein Medizinprodukt siehe ISO 17664 2:2021, Anhang E.

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 17664-1:2021)

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.

Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov - 1. del: Kritični in polkritični medicinski pripomočki (ISO 17664-1:2021)

General Information

• Status: Published
• Publication Date: 31-Aug-2021
• Withdrawal Date: 30-Mar-2022
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Sep-2021
• Completion Date: 01-Sep-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/571 - COMMISSION IMPLEMENTING DECISION of 19.11.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards personal protective equipment in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 17664-1:2021 - 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 (ISO 17664-1:2021)

Relations

• Replaces: EN ISO 17664:2017 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
• Effective Date: 08-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2021
Nadomešča:
SIST EN ISO 17664:2018
Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi
proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih
pripomočkov - 1. del: Kritični in polkritični medicinski pripomočki (ISO 17664-
1:2021)
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 (ISO 17664-1:2021)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten -
Teil 1: Kritische und semi-kritische Medizinprodukte (ISO 17664-1:2021)
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 17664-1:2021)
Ta slovenski standard je istoveten z: EN ISO 17664-1:2021
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 17664-1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17664:2017
English Version
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 (ISO 17664-1:2021)
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 1 : Dispositifs médicaux critiques et semi- von Medizinprodukten - Teil 1: Kritische und semi-
critiques (ISO 17664-1:2021) kritische Medizinprodukte (ISO 17664-1:2021)
This European Standard was approved by CEN on 28 June 2021.

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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664-1:2021 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. 5

European foreword
This document (EN ISO 17664-1:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with 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 March 2022, and conflicting national standards shall
be withdrawn at the latest by March 2022.
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 supersedes EN ISO 17664:2017.
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/national committee. A complete listing of these bodies can be found on the CEN websites.
This document is an adoption of an International Standard. The definitions in applicable regulatory
requirements differ from nation to nation and region to region. As a result, the definitions in this
document can differ in wording from those in European Regulations. For use in support of European
requirements, definitions in the European regulations for medical devices take precedence. For
relationship with EU Directive(s) and Regulations, see informative Annex ZA, which is an integral part
of this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the edition of the referenced document (including any amendments) listed below
applies. For dated references, only the edition cited applies. However, for any use of this standard
within the meaning of Annex ZA, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 14971 EN ISO 14971:2019 ISO 14971:2019

NOTE 2 The standards normatively referred to by EN ISO 17664 Part 2:2019 are undated. These referred
standards also include normative references to other dated and undated standards. For undated normative
references, it should always be assumed that the latest edition applies.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 17664-1:2021 has been approved by CEN as EN ISO 17664-1:2021 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 a Commission’s standardisation request 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].

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 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.

This document is an adoption of an International Standard. The definitions in applicable regulatory
requirements differ from nation to nation and region to region. As a result, the definitions in this
document can differ in wording from those in European Regulations. For use in support of European
requirements, definitions in the European regulations for medical devices take precedence.

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 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.

NOTE 4 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]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
23.4.i is covered only for the
disinfection, or sterilization of
23.4.i 4, 5, 6, 7
devices to make ready for first
use.
23.4.m 4, 5, 6, 7
23.4.n 4, 5, 6, 7
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 17664-1
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
ISO 17664-1:2021(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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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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ii © ISO 2021 – All rights reserved

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 .
...