EN ISO 17664:2017

SLOVENSKI STANDARD
01-februar-2018
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SIST EN ISO 17664:2004
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Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices (ISO 17664:2017)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten
(ISO 17664:2017)
Traitement de produits de soins de santé - Informations devant être fournies par le
fabricant de l'appareil pour le traitement des dispositifs médicaux (ISO 17664:2017)
Ta slovenski standard je istoveten z: EN ISO 17664:2017
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
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17664:2004
English Version
Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices (ISO 17664:2017)
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 (ISO bereitzustellende Informationen für die Aufbereitung
17664:2017) von Medizinprodukten (ISO 17664:2017)
This European Standard was approved by CEN on 3 August 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4

European foreword
This document (EN ISO 17664:2017) 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 June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
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 17664:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), 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 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 14971:2012 ISO 14971:2007
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 17664:2017 has been approved by CEN as EN ISO 17664:2017 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a Commission's standardization request M/023
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this document is cited in the Official Journal of the European Union under that Directive,
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 Essential Requirements
of that Directive and associated EFTA regulations.
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 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
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 an Essential 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 Directive 93/42/EEC
Essential Requirements (ERs) Clause(s)/sub-clause(s) of this Remarks/Notes
of Directive 93/42/EEC EN
13.6h first and second 4,5,6,7
paragraphs only
13.6i 4,5,6,7 ER 13.6 i) is covered only for the
sterilization of devices supplied
non-sterile as a further
treatment prior to use.
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 products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 17664
Second edition
2017-10
Processing of health care products —
Information to be provided by the
medical device manufacturer for the
processing of medical devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif
Reference number
ISO 17664:2017(E)
©
ISO 2017
ISO 17664:2017(E)
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

ISO 17664:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
5 Risk analysis . 5
6 Information to be provided by the medical device manufacturer .6
6.1 General . 6
6.2 Processing instructions . 6
6.3 Limitations and restrictions on processing. 6
6.4 Initial treatment at the point of use . 7
6.5 Preparation before cleaning . 7
6.6 Cleaning . 7
6.6.1 General. 7
6.6.2 Automated cleaning . 7
6.6.3 Manual cleaning . 8
6.7 Disinfection . 9
6.7.1 General. 9
6.7.2 Automated disinfection . 9
6.7.3 Manual disinfection .
...