SIST EN ISO 17664:2018
(Main)Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (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)
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of a medical device that requires cleaning followed by disinfection
and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions
of this document are applicable to medical devices that are intended for invasive or other direct or
indirect patient contact.
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 not intended for direct patient contact;
— 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.
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)
L'ISO 17664 :2017 spécifie les exigences relatives aux informations devant être fournies par un fabricant de dispositifs médicaux concernant le traitement d'un dispositif médical qui nécessite un nettoyage, puis une désinfection et/ou une stérilisation afin de s'assurer qu'il est sûr et efficace pour son utilisation prévue.
Elles incluent les informations de traitement avant l'utilisation ou la réutilisation du dispositif médical. Les dispositions du présent document s'appliquent aux dispositifs médicaux invasifs ou destinés à tout autre contact direct ou indirect avec le patient.
Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov (ISO 17664:2017)
Ta dokument določa zahteve za informacije, ki jih zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov, ki zahteva čiščenje, ki mu sledi razkuževanje in/ali sterilizacija, da se zagotovi, da je pripomoček varen in učinkovit za svojo predvideno uporabo.
To vključuje informacije za obdelavo pred uporabo ali ponovno uporabo medicinskega pripomočka. Določbe tega dokumenta se uporabljajo za medicinske pripomočke, ki so namenjeni invazivnim ali drugačnim neposrednim ali posrednim stikom z bolnikom.
Ta dokument ne določa navodil za obdelavo. Namesto tega ta dokument določa zahteve za pomoč proizvajalcem medicinskih pripomočkov pri zagotavljanju podrobnih navodil za obdelavo, ki po potrebi vsebujejo naslednje dejavnosti:
a) začetna obdelava na mestu uporabe;
b) priprava pred čiščenjem;
c) čiščenje;
d) razkuževanje;
e) sušenje;
f) pregledovanje in vzdrževanje;
g) pakiranje;
h) sterilizacija;
i) shranjevanje;
j) transport.
Ta dokument ne vključuje obdelave naslednjih proizvodov:
– nenujni medicinski pripomočki, ki niso namenjeni neposrednemu stiku z bolnikom;
– tekstilni pripomočki, ki se uporabljajo v sistemih za pokrivanje bolnikov ali operacijskih oblačilih;
– medicinski pripomočki, ki jih je proizvajalec določil za enkratno uporabo in so dobavljeni pripravljeni za takojšnjo uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 17664:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 17664:2004
3URFHVLUDQMHL]GHONRY]D]GUDYVWYHQRQHJR,QIRUPDFLMDNLMR]DJRWRYL
SURL]YDMDOHFPHGLFLQVNLKSULSRPRþNRY]DSRVWRSHNREGHODYHPHGLFLQVNLK
SULSRPRþNRY ,62
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
SIST EN ISO 17664:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 17664:2018
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SIST EN ISO 17664:2018
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.
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SIST EN ISO 17664:2018
EN ISO 17664:2017 (E)
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
2
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SIST EN ISO 17664:2018
EN ISO 17664:2017 (E)
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.
3
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SIST EN ISO 17664:2018
EN ISO 17664:2017 (E)
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.
4
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SIST EN ISO 17664:2018
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
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SIST EN ISO 17664:2018
ISO 17664:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 17664:2018
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 . 9
6.8 Drying .10
6.9 Inspection and maintenance .10
6.10 Packaging .10
6.11 Sterilization .11
6.12 Storage .11
6.13 Transportation .11
7 Presentation of the information .12
Annex A (informative) Commonly utilized processing methods .13
Annex B (informative) Example of processing instructions for reusable medical devices.18
Annex C (informative) Classification of medical devices .20
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .23
Bibliography .24
© ISO 2017 – All rights reserved iii
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SIST EN ISO 17664:2018
ISO 17664:2017(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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 17664:2004), which has been technically
revised. The scope has been increased to include medical devices requiring disinfection and/or
sterilization prior to use.
iv © ISO 2017 – All rights reserved
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SIST EN ISO 17664:2018
ISO 17664:2017(E)
Introduction
This document applies to manufacturers of those medical devices that are intended to be processed by
the user or a third party to be made ready for use. 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 cleaned, disinfected and/or sterilized and ready for their next
use, and
— single-use medical devices that are supplied non-sterile but are intended to be used in a clean,
disinfected and/or sterile state and therefore will require processing prior to use.
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, disinfect and/or sterilize.
Cleaning, disinfecting and sterilizing 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,
disinfection and/or sterilization in order to ensure that medical devices are effectively processed.
These developments have led to the need to ensure that manufacturers of reusable 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 reuse. Failure to remove
contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from both the
inside and outside surfaces of medical devices could compromise any subsequent disinfection
and/or sterilization process or the correct functioning of the medical device. 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 safety risk 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.
© ISO 2017 – All rights reserved v
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SIST EN ISO 17664:2018
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SIST EN ISO 17664:2018
INTERNATIONAL STANDARD ISO 17664:2017(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of a medical device that requires cleaning followed by disinfection
and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions
of this document are applicable to medical devices that are intended for invasive or other direct or
indirect patient contact.
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 not intended for direct patient contact;
— 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.
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 2017 – All rights reserved 1
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SIST EN ISO 17664:2018
ISO 17664:2017(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 http://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, usually with detergent and water, 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.
3.2
disinfecting agent
physical or chemical agent that is able to reduce the number of viable microorganisms
3.3
disinfection
process to reduce the number of viable microorganisms to a level previously specified as being
appropriate for a defined purpose
3.4
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
3.5
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 his name; whether or not such a medical
device is designed and/or manufactured by that person himself or on his 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 13485:2016, 3.10, modified - notes to entry not included]
3.6
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.5) 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;
— 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;
2 © ISO 2017 – All rights reserved
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SIST EN ISO 17664:2018
ISO 17664:2017(E)
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its 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:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11]
3.7
packaging system
combination of a sterile barrier system (3.15) and protective packaging (3.10)
3.8
processing
activity to prepare a new or used healthcare product for its
intended use
Note 1 to entry: For the purposes of this document, processing includes cleaning, disinfection and sterilization (if
necessary and applicable).
Note 2 to entry: For the purposes of this document, a healthcare product refers to a medical device.
3.9
processor
organization and/or individual with the responsibility for
carrying out actions necessary to prepare a new or reusable healthcare product for its intended use
Note 1 to entry: For the purposes of this document, a healthcare product refers to a medical device.
3.10
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.15) and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2006, 3.13]
3.11
reusable medical device
medical device (3.6) designated or intended by the manufacturer (3.5) as suitable for processing (3.8)
and reuse
Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single-use only.
3.12
service life
number of processing (3.8) cycles and/or life-time that a medical device (3.6) can be subjected to and
remain suitable and safe for its intended use
3.13
single-use medical device
medical device (3.6) desi
...
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