Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

ISO 17664:2017 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 ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

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 relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif (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

Status
Withdrawn
Publication Date
05-Dec-2017
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
01-Sep-2021

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 17664:2018
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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.

---------------------- Page: 5 ----------------------
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.
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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
---------------------- Page: 14 ----------------------
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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