ISO/PRF 17664-2

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

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 17664-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-05-30 2019-08-22
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
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 17664-2:2019(E)
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. ISO 2019
---------------------- Page: 1 ----------------------
ISO/DIS 17664-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 17664-2:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

1.1 Inclusions ..................................................................................................................................................................................................... 1

1.2 Exclusions .................................................................................................................................................................................................... 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Risk analysis .............................................................................................................................................................................................................. 5

5 Validation of the processes identified in the information provided by the medical

device manufacturer ........................................................................................................................................................................................ 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.................................................................................................................... 7

6.4 Preparation before processing .................................................................................................................................................. 7

6.5 Cleaning ......................................................................................................................................................................................................... 7

6.5.1 General...................................................................................................................................................................................... 7

6.5.2 Manual cleaning ................................................................................................................................................................ 8

6.5.3 Automated cleaning ...................................................................................................................................................... 8

6.6 Disinfection ................................................................................................................................................................................................ 9

6.6.1 General...................................................................................................................................................................................... 9

6.6.2 Manual disinfection ....................................................................................................................................................... 9

6.6.3 Automated disinfection .............................................................................................................................................. 9

6.7 Drying ..........................................................................................................................................................................................................10

6.8 Inspection and maintenance ....................................................................................................................................................10

6.9 Packaging ..................................................................................................................................................................................................10

6.10 Storage ........................................................................................................................................................................................................10

6.11 Transportation .....................................................................................................................................................................................11

7 Presentation of the information .......................................................................................................................................................11

Annex A (informative) Commonly utilized processing methods ..........................................................................................12

Annex B (informative) Example processing instructions for non-critical reusable medical

devices ..........................................................................................................................................................................................................................15

Annex C (informative) Processing classification and grouping of medical devices ..........................................17

Annex D (informative) Additional guidance on information to be provided by the medical

device manufacturer .....................................................................................................................................................................................19

Annex E (informative) Examples of medical devices and their relationship to this document ...........20

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC on medical devices [OJ L 169] aimed to be

covered ......... ................................................................................................................................................................................................................24

Annex ZB (informative) Relationship between this European standard and the General

Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be

covered ......... ................................................................................................................................................................................................................25

Bibliography .............................................................................................................................................................................................................................26

© ISO 2019 – All rights reserved iii
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ISO/DIS 17664-2:2019(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 of 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 www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

A list of all parts in the ISO 17664- series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 17664-2:2019(E)
Introduction

This document applies to manufacturers of non-critical medical devices that are intended to be cleaned

and/or disinfected by the user or a third party to be made ready for use or reuse. 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 ready for their next use; and

— single-use medical devices that are supplied non-sterile but are intended to be used in a clean, and/

or disinfected state.

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 and/or disinfect.

Cleaning and disinfecting 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 and/or

disinfection 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 subsequent use. Failure to

remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from

surfaces of medical devices could compromise the correct functioning of the medical device, its safe

use and (if required) any subsequent disinfection process. 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 risk to safety 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 2019 – All rights reserved v
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DRAFT INTERNATIONAL STANDARD ISO/DIS 17664-2:2019(E)
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
1 Scope

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.

1.1 Inclusions

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) inspection and maintenance;
e) packaging;
f) storage;
g) transportation.
1.2 Exclusions
This document excludes processing of:
a) critical and semi-critical medical devices;
b) medical devices intended to be sterilized;
c) textile medical devices used in patient draping systems or surgical clothing;

d) medical devices specified by the manufacturer for single-use only and supplied ready for use.

NOTE See Annex E for further guidance on the application of either Part 1 or Part 2 of this series of documents

to a medical device.
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 2019 – All rights reserved 1
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ISO/DIS 17664-2:2019(E)
ISO 14971, Medical devices — Application of risk management to medical devices
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 https: //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.

[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]
3.2
cleaning agent

physical or chemical entity, or combination of entities, having activity to render an item clean

[SOURCE: ISO 11139:2018, 3.47]
3.3
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
disinfection

process to inactivate viable microorganisms to a level previously specified as being appropriate for a

defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.6
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
[SOURCE: ISO 11139:2018, 3.159]
3.7
medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or software

material or other similar related article, intended by the manufacturer 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;
2 © ISO 2019 – All rights reserved
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ISO/DIS 17664-2:2019(E)

— 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;

and does not achieve its primary intended action by pharmacological, immunological or metabolic

means, but which may be assisted in its intended 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:
— items specifically intended for cleaning, or sterilization of medical devices;

— pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for

sterilization;
— 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 11139:2018, 3.166]
3.8
medical device 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 11139:2018, 3.167, modified — Note 1 to entry has been added.]
3.9
non-critical medical device

item that is intended to come into contact with intact skin only or is a medical device not intended for

direct patient contact.

Note 1 to entry: For the purposes of this document, the classification as non-critical refers to the processing

aspect of the medical device only.
3.10
process chemical
formulation of substances intended for use in equipment
[SOURCE: ISO 11139:2018, 3.207]
3.11
processing

activity to prepare a new or used health care product for its

intended use

Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.

© ISO 2019 – All rights reserved 3
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ISO/DIS 17664-2:2019(E)
[SOURCE: ISO 11139:2018, 3.214, modified — Note 1 to entry has been added.]
3.12
processor

organization and/or individual with the responsibility of carrying

out actions necessary to prepare a new or reusable health care product for its intended use

Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]
3.13
reusable medical device

medical device designated or intended by the manufacturer as suitable for processing and reuse

Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single-use only.

[SOURCE: ISO 11139:2018, 3.236]
3.14
service life

number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and

safe for its intended use when used according to the labelling

Note 1 to entry: For the purposes of this document, a product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.251, modified — Note 1 to entry has been added.]
3.15
single-use medical device

medical device labelled or intended to be used on one individual during a single procedure

Note 1 to entry: A single-use medical device is not intended to be further processed and used again.

[SOURCE: ISO 11139:2018, 3.255, modified — Note 1 to entry has been added.]
3.16
terminal process

final step of processing to render a medical device safe and ready for its intended use

[SOURCE: ISO 11139:2018, 3.294]
3.17
validation

confirmation process, through the provision of objective evidence, that the requirements for a specific

intended use or application have been fulfilled

[SOURCE: ISO 11139:2018, 3.313, modified — The original Note 1, Note 2 and Note 3 to entry have been

deleted.]
3.18
verification

confirmation, through the provision of objective evidence, that specified requirements have been

fulfilled

[SOURCE: ISO 11139:2018, 3.314, modified — The original Note 1 and Note 2 to entry have been deleted.]

3.19
washer-disinfector
equipment designed to clean and disinfect product
Note 1 to entry: See ISO 15883- series.
4 © ISO 2019 – All rights reserved
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ISO/DIS 17664-2:2019(E)
[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]
4 Risk analysis

The medical device manufacturer shall undertake risk analysis to determine the content and detail of

the information to be provided. The risk management undertaken by the manufacturer of the medical

device shall conform with ISO 14971.

NOTE 1 Some of the points relevant to processing that any risk analysis can require (but not limited to) are:

— the likely points of contact with the user and/or the patient that might allow cross-contamination;

— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— service life;
— necessary warnings.

The points above can also be of benefit to those validating alternative processes in accordance with

Note 2 to 5.3.

NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk

analysis process.
5 Validation of the processes identified in the information provided by the
medical device manufacturer

5.1 The medical device manufacturer shall validate each process that is identified in the information

supplied with the medical device. Validation shall demonstrate that each process is suitable for processing

of the medical device.

5.2 Validation shall include the intended points of contact with the user and/or the patient that could

likely lead to cross-contamination. Validation may exclude those processes for parts of the medical device

that are unlikely to lead to cross contamination, based upon the risk analysis described in Clause 4.

5.3 The medical device manufacturer shall have objective evidence available that validation of the

processing procedures has been undertaken to confirm that the specific medical device will be clean

and/or disinfected, when processed as directed.

NOTE 1 A worst case approach, representing those areas of the medical device that are the intended points of

contact with the user and/or the patient and where there is opportunity for cross-contamination, can be used.

NOTE 2 In addition to the duty of a manufacturer to demonstrate the validity of provided information,

National Authorities can require the effectiveness of the final process to be verified by the processor.

© ISO 2019 – All rights reserved 5
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ISO/DIS 17664-2:2019(E)

NOTE 3 National Authorities can allow or require the use of an alternative process. In such cases they usually

require validation of those processes by the processor.

5.4 If a manufacturer supplies a number of different medical devices that share common attributes,

then validation studies may be performed as a product family. If this approach is taken, the medical device

manufacturer shall demonstrate commonality between the different medical devices and the validation

studies shall address the worst case attribute(s) of the product family.
NOTE See C.1.
6 Information to be provided by the medical device manufacturer
6.1 General

6.1.1 The information specified in this Clause shall take into account the nature of the medical device,

its intended location for use and processing and its intended use.

NOTE The location of processing can be at the point of use or within a processing department.

6.1.2 The medical device manufacturer shall specify validated method(s) to reduce the risk of

transmission of infectious agents to a level appropriate for the intended use of the medical device.

6.1.3 Medical device manufacturers shall specify in their processing instructions any special

techniques and accessories that will enable the processor to provide a medical device that is suitable for

its intended use.

6.1.4 When providing processing instructions, medical device manufacturers shall be aware of:

— available national and international standards and guidelines;
— the need for specific training;
— the processing equipment commonly available to the processor.

NOTE 1 Some national standards and regulations require cleaning and disinfection for all non-critical medical

devices.

NOTE 2 Annex A provides information which can assist with identifying the information required and the

processing equipment commonly available.

6.1.5 The equipment or materials required in the specified processes shall be identified by their

generic names or specification. Trade names may be added in cases where generic names do not provide

sufficient information (see D.2).
6.2 Processing instructions

6.2.1 At least one validated method shall be specified for each applicable stage of processing of the

medical device. Disinfection may be carried out concurrently with cleaning of the medical device.

NOTE 1 Annex A provides information on the commonly used processes available.

NOTE 2 The requirements for cleaning and disinfection are stated as separate clauses in this document.

However, when the steps are concurrent, the requirements of both stages can be considered as one. In such cases

a reduction in microorganisms and inactivation of viable microorganisms can be achieved as a result of the

combination of applying the disinfecting agent and a physical action.
6 © ISO 2019 – All rights reserved
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ISO/DIS 17664-2:2019(E)

NOTE 3 The range of medical devices included within this document is wide and varied. Many of these

medical devices (e.g. stethoscopes and blood pressure cuffs) are relatively simple medical devices which do not

necessarily require automated processes. There will be other medical devices where automated processing is

not possible or contra-indicated (e.g. some medical devices with electronic components). However, some medical

devices such as beds, wheelchairs and footwear can be,
...

INTERNATIONAL ISO
STANDARD 17664-2
First edition
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
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
PROOF/ÉPREUVE
Reference number
ISO 17664-2:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 17664-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 17664-2:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Risk analysis .............................................................................................................................................................................................................. 4

5 Validation of the processes identified in the information provided by the medical

device manufacturer ........................................................................................................................................................................................ 5

6 Information to be provided by the medical device manufacturer ....................................................................5

6.1 General ........................................................................................................................................................................................................... 5

6.2 Processing instructions ................................................................................................................................................................... 6

6.3 Limitations and restrictions on processing.................................................................................................................... 7

6.4 Preparation before processing .................................................................................................................................................. 7

6.5 Cleaning ......................................................................................................................................................................................................... 7

6.5.1 General...................................................................................................................................................................................... 7

6.5.2 Manual cleaning ................................................................................................................................................................ 7

6.5.3 Automated cleaning ...................................................................................................................................................... 8

6.6 Disinfection ................................................................................................................................................................................................ 8

6.6.1 General...................................................................................................................................................................................... 8

6.6.2 Manual disinfection ....................................................................................................................................................... 8

6.6.3 Automated disinfection .............................................................................................................................................. 9

6.7 Drying ............................................................................................................................................................................................................. 9

6.8 Inspection and maintenance ....................................................................................................................................................... 9

6.9 Packaging ..................................................................................................................................................................................................10

6.10 Storage ........................................................................................................................................................................................................10

6.11 Transportation .....................................................................................................................................................................................10

7 Presentation of the information .......................................................................................................................................................10

Annex A (informative) Commonly utilized processing methods ..........................................................................................11

Annex B (informative) Example processing instructions for non-critical reusable medical

devices ..........................................................................................................................................................................................................................15

Annex C (informative) Processing classification and grouping of medical devices ..........................................17

Annex D (informative) Additional guidance on information to be provided by the medical

device manufacturer .....................................................................................................................................................................................19

Annex E (informative) Examples of medical devices and their relationship to this document ...........20

Bibliography .............................................................................................................................................................................................................................24

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
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ISO 17664-2:2020(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 of 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 www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

A list of all parts in the ISO 17664 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 17664-2:2020(E)
Introduction

This document applies to manufacturers of non-critical medical devices that are intended to be cleaned,

disinfected or both by the processor to be made ready for use or reuse. 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 ready for their next use;

— single-use medical devices that require processing before use and are intended to be used in a clean

and/or disinfected state.

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 and disinfect.

Cleaning and disinfecting 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 and

disinfection in order to ensure that medical devices are effectively processed. These developments

have led to the need to ensure that manufacturers of 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 subsequent use. Failure to

remove contaminants (e.g. blood, tissues, microorganisms, cleaning agents and lubricants) from

surfaces of medical devices could compromise the correct functioning of the medical device, its safe

use and (if required) any subsequent disinfection process. 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 risk to safety 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 2020 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 17664-2:2020(E)
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
1 Scope

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.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;

4) medical devices specified by the manufacturer for single use only and supplied ready for use.

NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

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
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ISO 17664-2:2020(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 https:// 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 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, further processing or both.
[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]
3.2
cleaning agent

physical or chemical entity, or combination of entities, having activity to render an item clean

[SOURCE: ISO 11139:2018, 3.47]
3.3
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.4
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]
3.5
disinfection

process to inactivate viable microorganisms to a level previously specified as being appropriate for a

defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.6
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
[SOURCE: ISO 11139:2018, 3.159]
3.7
medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,

material or other similar related article, intended by the manufacturer 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;

2 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
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ISO 17664-2:2020(E)
— 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;

and does not achieve its primary intended action by pharmacological, immunological or metabolic

means, but which may be assisted in its intended 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:
— items specifically intended for cleaning or sterilization of medical devices;

— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for

sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal tissues, human tissues or both;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018, 3.166]
3.8
medical device manufacturer

natural or legal person with responsibility for design, manufacture or both of a medical device with

the intention of making the medical device available for use, under their name, whether or not such a

medical device is designed, manufactured or both by that person or on their 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 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1

to entry has been added.]
3.9
process chemical
formulation of substances intended for use in equipment
[SOURCE: ISO 11139:2018, 3.207]
3.10
processing

activity to prepare a new or used health care product for its

intended use

Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.214, modified — Note 1 to entry has been added.]
3.11
processor

organization or individual with the responsibility of carrying out

actions necessary to prepare a new or reusable health care product for its intended use

Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]
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ISO 17664-2:2020(E)
3.12
reusable medical device

medical device designated or intended by the manufacturer as suitable for processing and reuse

Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.

[SOURCE: ISO 11139:2018, 3.236]
3.13
service life

number of processing cycles, lifetime or both up to which a product is claimed to remain suitable and

safe for its intended use when used according to the labelling

Note 1 to entry: For the purposes of this document, a product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.251, modified — Note 1 to entry has been added.]
3.14
single-use medical device

medical device labelled or intended to be used on one individual during a single procedure

Note 1 to entry: A single-use medical device is not intended to be further processed and used again.

[SOURCE: ISO 11139:2018, 3.255, modified — Note 1 to entry has been added.]
3.15
validation

confirmation process, through the provision of objective evidence, that the requirements for a specific

intended use or application have been fulfilled

[SOURCE: ISO 11139:2018, 3.313, modified — Notes 1, 2 and 3 to entry have been deleted.]

3.16
verification

confirmation, through the provision of objective evidence, that specified requirements have been

fulfilled

[SOURCE: ISO 11139:2018, 3.314, modified — Notes 1 and 2 to entry have been deleted.]

3.17
washer-disinfector
equipment designed to clean and disinfect product
Note 1 to entry: See the ISO 15883 series.
[SOURCE: ISO 11139:2018, 3.319, modified — Note 1 to entry has been added.]
4 Risk analysis

The medical device manufacturer shall undertake risk analysis to determine the content and detail of

the information to be provided. The risk management undertaken by the manufacturer of the medical

device shall conform with ISO 14971.

NOTE 1 Some of the points relevant to processing that any risk analysis can require include:

— the likely points of contact with the user or the patient that might allow cross-contamination;

— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
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ISO 17664-2:2020(E)
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— service life;
— necessary warnings.

The points above can also be of benefit to those validating alternative processes in accordance with the

NOTE 2 to 5.2.

NOTE 2 Annex C provides information on classification of medical devices, which can assist with any risk

analysis process.
5 Validation of the processes identified in the information provided by the
medical device manufacturer

5.1 The medical device manufacturer shall validate each process that is identified in the information

supplied with the medical device and demonstrate that each process is suitable for processing of the

medical device. This shall include the intended points of contact with the user, the patient or both that

could likely lead to cross-contamination. Parts of the medical device that are unlikely to lead to cross

contamination may be excluded from validation, based upon the risk analysis described in Clause 4.

5.2 The medical device manufacturer shall have objective evidence available that validation of the

processing procedures has been undertaken to confirm that the specific medical device will be clean,

disinfected or both, when processed as directed.

NOTE 1 A worst-case approach, representing those areas of the medical device that are the intended points of

contact with the user, the patient or both and where there is opportunity for cross-contamination, can be used.

NOTE 2 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national

authorities can require the effectiveness of the final process to be verified by the processor.

NOTE 3 National authorities can allow or require the use of an alternative process. In such cases they usually

require validation of those processes by the processor.

5.3 If a manufacturer supplies a number of different medical devices that share common attributes,

then validation studies may be performed as a product family. If this approach is taken, the medical device

manufacturer shall demonstrate commonality between the different medical devices and the validation

studies shall address the worst-case attribute(s) of the product family.
NOTE For guidance on grouping of medical devices as product families, see C.1.
6 Information to be provided by the medical device manufacturer
6.1 General

6.1.1 The information specified in this clause shall take into account the nature of the medical device,

its intended location for use and processing and its intended use.

NOTE The location of processing can be at the point of use or within a processing department.

© ISO 2020 – All rights reserved PROOF/ÉPREUVE 5
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ISO 17664-2:2020(E)

6.1.2 The medical device manufacturer shall specify validated method(s) to reduce the risk of

transmission of infectious agents to a level appropriate for the intended use of the medical device.

6.1.3 Medical device manufacturers shall specify in their processing instructions any special

techniques and accessories that will enable the processor to provide a medical device that is suitable for

its intended use.

6.1.4 When providing processing instructions, medical device manufacturers shall be aware of:

— available national and international standards and guidelines;
— if applicable, the need for specific training;
— the processing equipment commonly available to the processor.

NOTE 1 Some national standards and regulations require cleaning and disinfection for all non-critical medical

devices.

NOTE 2 Annex A provides information which can assist with identifying the information required and the

processing equipment commonly available.

6.1.5 The equipment or materials required in the specified processes shall be identified by their

generic names or specification. Trade names may be added in cases where generic names do not provide

sufficient information (see Annex D).
6.2 Processing instructions

6.2.1 At least one validated method shall be specified for each applicable stage of processing of the

medical device. Disinfection may be carried out concurrently with cleaning of the medical device.

NOTE 1 Annex A provides information on the commonly used processes available.

NOTE 2 The requirements for cleaning and disinfection are stated as separate clauses in this document.

However, when the steps are concurrent, the requirements of both stages can be considered as one. In such cases

removal of soil, a reduction in microorganisms and inactivation of viable microorganisms can be achieved as a

result of the combination of applying the disinfecting agent and a physical action.

NOTE 3 The range of medical devices included within this document is wide and varied. Many of these

medical devices (e.g. stethoscopes and blood pressure cuffs) are relatively simple medical devices which do not

necessarily require automated processes. There will be other medical devices where automated processing is

not possible or contra-indicated (e.g. some medical devices with electronic components). However, some medical

devices such as beds, wheelchairs and footwear can be, and often are, subjected to automated processes. For this

final group of medical devices, a validated method of automated processing can be specified and is preferred.

6.2.2 The method shall be appropriate to the market in which the medical device is to be supplied.

6.2.3 The following information shall be stated where it is required for the maintenance of the intended

function of the medical device and the safety of the user(s) and the patient:
a) details of process steps;
b) a description of the equipment, the accessories or both;
c) specifications for process parameters and, if applicable, their tolerances.
NOTE For an example of an appropriate format see Annex B.
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ISO 17664-2:2020(E)
6.3 Limitations and restrictions on processing

6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s

instructions is known to lead to degradation that can limit the service life of the medical device, then the

medical device manufacturer shall provide such information regarding limitations and restrictions to the

processor.

6.3.2 If the service life of the medical device is limited by the number of processing cycles or some

other end of life indicator(s) this information shall also be provided.

6.3.3 Where an incompatibility of the medical device with a commonly used substance(s) or processing

condition(s) that can impact upon patient safety is known, this information shall be provided.

6.4 Preparation before processing

If preparation of a medical device is required prior to cleaning to ensure effective processing of that

medical device, then the following information shall be provided, where applicable:

a) a description of the process for disassembly of the medical device;

b) a description of the process and processing parameters for medical device preparation;

c) accessories and tools required.
NOTE For detailed guidance see Annex A.
6.5 Cleaning
6.5.1 General
At least one validated cleaning method shall be specified.
6.5.2 Manual cleaning

If a manual cleaning method is specified, the following information shall be included, where applicable:

a) a description of the m
...

PROJET DE NORME INTERNATIONALE
ISO/DIS 17664-2
ISO/TC 198 Secrétariat: ANSI
Début de vote: Vote clos le:
2019-05-30 2019-08-22
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

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
ICS: 11.080.01
CE DOCUMENT EST UN PROJET DIFFUSÉ POUR
OBSERVATIONS ET APPROBATION. IL EST DONC
SUSCEPTIBLE DE MODIFICATION ET NE PEUT
ÊTRE CITÉ COMME NORME INTERNATIONALE
AVANT SA PUBLICATION EN TANT QUE TELLE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE

Le présent document est distribué tel qu’il est parvenu du secrétariat du comité.

DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
Numéro de référence
LES DESTINATAIRES DU PRÉSENT PROJET
ISO/DIS 17664-2:2019(F)
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE. ISO 2019
---------------------- Page: 1 ----------------------
ISO/DIS 17664-2:2019(F)
ISO/DIS 17664-2:2019(F)
Sommaire Page

Avant-propos .................................................................................................................................................................. iv

Introduction.................................................................................................................................................................... vi

1 Domaine d’application .................................................................................................................................. 1

1.1 Informations à inclure ................................................................................................................................... 1

1.2 Exclusions........................................................................................................................................................... 1

2 Références normatives .................................................................................................................................. 2

3 Termes et définitions ..................................................................................................................................... 2

4 Analyse du risque ............................................................................................................................................ 6

5 Validation des procédés identifiés dans les informations fournies par le fabricant du

dispositif médical ............................................................................................................................................ 6

6 Informations à fournir par le fabricant du dispositif médical ........................................................ 7

6.1 Généralités ......................................................................................................................................................... 7

6.2 Instructions de traitement ........................................................................................................................... 7

6.3 Limites et restrictions du traitement ....................................................................................................... 8

6.4 Préparation avant le traitement ................................................................................................................ 8

6.5 Nettoyage ............................................................................................................................................................ 9

6.5.1 Généralités ......................................................................................................................................................... 9

6.5.2 Nettoyage manuel ............................................................................................................................................ 9

6.5.3 Nettoyage automatisé .................................................................................................................................... 9

6.6 Désinfection .................................................................................................................................................... 10

6.6.1 Généralités ...................................................................................................................................................... 10

6.6.2 Désinfection manuelle ................................................................................................................................ 10

6.6.3 Désinfection automatisée .......................................................................................................................... 11

6.7 Séchage ............................................................................................................................................................. 11

6.8 Contrôles et maintenance.......................................................................................................................... 12

6.9 Emballage ........................................................................................................................................................ 12

6.10 Stockage ........................................................................................................................................................... 12

6.11 Transport ........................................................................................................................................................ 12

7 Présentation des informations ................................................................................................................ 12

Annexe A (informative) Méthodes de traitement couramment utilisées ............................................. 13

Annexe B (informative) Exemples d’instructions de traitement pour les dispositifs

médicaux réutilisables non critiques .................................................................................................... 17

Annexe C (informative) Classification des traitements et groupes de dispositifs médicaux ......... 19

Annexe D (informative) Recommandations supplémentaires concernant les informations à

fournir par le fabricant du dispositif médical .................................................................................... 21

Annexe E (informative) Exemples de dispositifs médicaux et leur relation avec le présent

DOCUMENT PROTÉGÉ PAR COPYRIGHT

document ......................................................................................................................................................... 22

© ISO 2019 Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en oeuvre, aucune partie de cette essentielles concernées de la Directive 93/42/CEE relative aux dispositifs médicaux

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

[JO L 169] ......................................................................................................................................................... 25

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences

ISO copyright office
générales en matière de sécurité et de performances concernées du
Case postale 401 • Ch. de Blandonnet 8

Règlement (UE) 2017/745 ........................................................................................................................ 26

CH-1214 Vernier, Geneva
Tél.: [phone]

Bibliographie ................................................................................................................................................................ 27

Fax: [phone]
E-mail: [e-mail]
Website: www.iso.org
Publié en Suisse
© ISO 2019 – Tous droits réservés iii
ii © ISO 2019 – Tous droits réservés
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ISO/DIS 17664-2:2019(F)
Sommaire Page

Avant-propos .................................................................................................................................................................. iv

Introduction.................................................................................................................................................................... vi

1 Domaine d’application .................................................................................................................................. 1

1.1 Informations à inclure ................................................................................................................................... 1

1.2 Exclusions........................................................................................................................................................... 1

2 Références normatives .................................................................................................................................. 2

3 Termes et définitions ..................................................................................................................................... 2

4 Analyse du risque ............................................................................................................................................ 6

5 Validation des procédés identifiés dans les informations fournies par le fabricant du

dispositif médical ............................................................................................................................................ 6

6 Informations à fournir par le fabricant du dispositif médical ........................................................ 7

6.1 Généralités ......................................................................................................................................................... 7

6.2 Instructions de traitement ........................................................................................................................... 7

6.3 Limites et restrictions du traitement ....................................................................................................... 8

6.4 Préparation avant le traitement ................................................................................................................ 8

6.5 Nettoyage ............................................................................................................................................................ 9

6.5.1 Généralités ......................................................................................................................................................... 9

6.5.2 Nettoyage manuel ............................................................................................................................................ 9

6.5.3 Nettoyage automatisé .................................................................................................................................... 9

6.6 Désinfection .................................................................................................................................................... 10

6.6.1 Généralités ...................................................................................................................................................... 10

6.6.2 Désinfection manuelle ................................................................................................................................ 10

6.6.3 Désinfection automatisée .......................................................................................................................... 11

6.7 Séchage ............................................................................................................................................................. 11

6.8 Contrôles et maintenance.......................................................................................................................... 12

6.9 Emballage ........................................................................................................................................................ 12

6.10 Stockage ........................................................................................................................................................... 12

6.11 Transport ........................................................................................................................................................ 12

7 Présentation des informations ................................................................................................................ 12

Annexe A (informative) Méthodes de traitement couramment utilisées ............................................. 13

Annexe B (informative) Exemples d’instructions de traitement pour les dispositifs

médicaux réutilisables non critiques .................................................................................................... 17

Annexe C (informative) Classification des traitements et groupes de dispositifs médicaux ......... 19

Annexe D (informative) Recommandations supplémentaires concernant les informations à

fournir par le fabricant du dispositif médical .................................................................................... 21

Annexe E (informative) Exemples de dispositifs médicaux et leur relation avec le présent

document ......................................................................................................................................................... 22

Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences

essentielles concernées de la Directive 93/42/CEE relative aux dispositifs médicaux

[JO L 169] ......................................................................................................................................................... 25

Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences

générales en matière de sécurité et de performances concernées du

Règlement (UE) 2017/745 ........................................................................................................................ 26

Bibliographie ................................................................................................................................................................ 27

© ISO 2019 – Tous droits réservés iii
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ISO/DIS 17664-2:2019(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le

droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d’approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2

(voir www.iso.org/directives).

L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de

droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les

références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www.iso.org/brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant : www.iso.org/iso/fr/avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 198, Stérilisation des produits de

santé.

Une liste de toutes les parties de la série ISO 17664 se trouve sur le site web de l’ISO.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www.iso.org/fr/members.html.
iv © ISO 2019 – Tous droits réservés
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ISO/DIS 17664-2:2019(F)
Avant-propos européen

Le présent texte de l’ISO 17664-2:2019 a été rédigé par le Comité technique ISO/TC 198 « Stérilisation

des produits de santé » de l’Organisation internationale de normalisation (ISO) en collaboration avec le

Comité technique CEN/TC 204 « Stérilisation des dispositifs médicaux » dont le secrétariat est tenu par

le BSI.

Le présent document a été élaboré dans le cadre d’un mandat donné au CEN par la Commission

européenne et l’Association européenne de libre-échange et vient à l’appui des exigences essentielles

des Directives UE.

Pour la relation avec les Directives UE, voir les Annexes ZA et ZB, qui font partie intégrante du présent

document.

Les documents ci-après sont des références normatives indispensables à l’application du présent

document. Pour les références non datées, l’édition du document de référence indiquée ci-dessous

s'applique (y compris les éventuels amendements). Pour les références datées, seule l’édition citée

s’applique. Toutefois, pour toute utilisation de la présente norme au sens de l’Annexe ZA ou ZB, il est

recommandé à l’utilisateur de toujours vérifier que les documents de référence n’ont pas été annulés et

remplacés, et que leur contenu peut toujours être considéré comme représentant l’état de l’art

généralement reconnu.

Lorsque référence est faite à une norme ISO ou IEC dans le texte de la norme ISO, cette référence doit

s'entendre comme une référence normative à la norme EN correspondante, si celle-ci est disponible, ou

à défaut, à la version datée de ladite norme ISO ou IEC, telle qu'indiquée ci-dessous.

NOTE La façon dont ces documents de référence sont cités dans les exigences normatives détermine la

mesure dans laquelle ils s’appliquent (dans leur intégralité ou non).
Tableau — Correspondance entre les références normatives et les normes EN et ISO
datées
Références normatives Norme équivalente datée
mentionnées dans l'Article 2 de la
ISO
norme ISO
ISO 14971 EN ISO 14971:2012 ISO 14971:2007

Selon le Règlement Intérieur du CEN-CENELEC les instituts de normalisation nationaux des pays

suivants sont tenus de mettre cette Norme européenne en application : Allemagne, Ancienne

République yougoslave de Macédoine, Autriche, Belgique, Bulgarie, Chypre, Croatie, Danemark,

Espagne, Estonie, Finlande, France, Grèce, Hongrie, Irlande, Islande, Italie, Lettonie, Lituanie,

Luxembourg, Malte, Norvège, Pays-Bas, Pologne, Portugal, République tchèque, Roumanie,

Royaume-Uni, Serbie, Slovaquie, Slovénie, Suède, Suisse et Turquie.
Notice d’entérinement

Le texte de l’ISO 17664-2:2019 a été approuvé par le CEN comme EN ISO 17664-2:2019 sans aucune

modification.
© ISO 2019 – Tous droits réservés v
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ISO/DIS 17664-2:2019(F)
Introduction

Le présent document s’applique aux fabricants de dispositifs médicaux non critiques destinés à être

nettoyés et/ou désinfectés par l’utilisateur ou une tierce partie, afin de les rendre prêts à l'emploi ou au

réemploi. Sont inclus :

— les dispositifs médicaux destinés à être réutilisés et nécessitant un traitement pour les faire passer

de leur état « après utilisation clinique » à l’état « prêt à être réutilisé » ; et

— les dispositifs médicaux à usage unique fournis non stériles, mais destinés à être utilisés dans un

état « nettoyé et/ou désinfecté ».

Les importants progrès réalisés à la fois sur le plan des technologies et des connaissances ont permis de

développer des dispositifs médicaux complexes qui contribuent aux soins de santé des patients. Ces

avancées ont conduit à la conception de dispositifs médicaux potentiellement plus difficiles à nettoyer

et/ou désinfecter.

Les technologies de nettoyage et de désinfection ont également considérablement évolué au cours des

dix dernières années, aboutissant à de nouveaux systèmes et de nouvelles approches applicables au

traitement des dispositifs médicaux. Ces changements ont permis une meilleure prise en compte du

besoin de validation des procédés, notamment du nettoyage et/ou de la désinfection, afin de s’assurer

que les dispositifs médicaux sont traités efficacement. Ils ont également créé le besoin de s’assurer que

les fabricants de dispositifs médicaux réutilisables fournissent des instructions adéquates, aidant les

utilisateurs finaux à traiter efficacement et en toute sécurité les dispositifs médicaux, en utilisant les

équipements et procédés disponibles.

Un dispositif médical nécessitant un traitement est fourni avec des instructions de traitement détaillées

afin d’assurer que, si celles-ci sont suivies correctement, les risques de transmission d’agents infectieux

sont réduits au minimum. En outre, un traitement efficace réduit au minimum le risque d’autres effets

néfastes sur les dispositifs médicaux.

Le nettoyage est une étape importante pour permettre la réutilisation ultérieure en toute sécurité d’un

dispositif médical utilisé. Les contaminants (par exemple, sang, tissus, microorganismes, agent

nettoyant et lubrifiants) qui ne sont pas éliminés des surfaces des dispositifs médicaux pourraient

compromettre le fonctionnement correct des dispositifs médicaux, leur utilisation en toute sécurité (si

nécessaire) ainsi que tout procédé de désinfection ultérieur. Les dispositifs médicaux à usage unique

fournis par le fabricant de dispositifs médicaux de sorte qu’ils soient traités avant leur utilisation

peuvent également nécessiter un nettoyage avant toute poursuite du traitement.

Après le nettoyage, d’autres facteurs peuvent affecter l’utilisation sûre et efficace d’un dispositif

médical. Par exemple, les modes opératoires de contrôle et les essais de fonctionnement peuvent

s’avérer nécessaires pour s'assurer qu’un dispositif médical ne présente pas de risque pour la sécurité à

l’utilisation. Les fabricants de dispositifs médicaux peuvent aider les utilisateurs en leur fournissant des

instructions sur la manière dont il convient d’effectuer ces contrôles et essais.

Il est de la responsabilité des fabricants de dispositifs médicaux nécessitant un traitement de s’assurer

que la conception de ces dispositifs facilite la réalisation efficace dudit traitement. Cela inclut la prise en

compte des procédés validés les plus courants. Des exemples sont fournis dans l’Annexe A qui peut

servir de guide pour la validation des modes opératoires.
vi © ISO 2019 – Tous droits réservés
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PROJET DE NORME INTERNATIONALE ISO/DIS 17664-2:2019(F)
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
1 Domaine d’application

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.
1.1 Informations à inclure

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 contrôle et la maintenance ;
e) l'emballage ;
f) le stockage ;
g) le transport.
1.2 Exclusions
Le présent document exclut le traitement :
a) des dispositifs médicaux critiques et semi-critiques ;
b) des dispositifs médicaux destinés à être stérilisés ;

c) des dispositifs médicaux textiles utilisés dans les systèmes de drapage des patients ou les

vêtements de chirurgie ;

d) 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

Partie 1 ou 2 de cette série de documents à un dispositif médical.
© ISO 2019 – Tous droits réservés 1
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ISO/DIS 17664-2:2019(F)
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).

ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux.

3 Termes et définitions

Pour les besoins du présent document, les termes et définitions suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes :

— ISO Online browsing platform : disponible à l’adresse https://www.iso.org/obp ;

— IEC Electropedia : disponible à l’adresse http://www.electropedia.org/.
3.1
nettoyage

élimination des contaminants jusqu’à l’obtention de l’état nécessaire à la poursuite du traitement ou

jusqu’à obtention de l’état désiré

Note 1 à l’article : Le nettoyage consiste à éliminer, généralement à l’aide d’un détergent et d’eau, les souillures

adhérentes (par exemple, sang, substances protéiques et autres débris) des surfaces, fentes, cannelures, joints et

lumières d’un dispositif médical, par le biais d’un procédé manuel ou automatique qui prépare les articles à une

manipulation en toute sécurité et/ou à la poursuite du traitement.
[SOURCE : ISO 11139:2018, 3.46, modifiée — La Note 1 à l’article a été ajoutée]
3.2
agent nettoyant

entité physique, chimique ou combinaison d’entités, ayant une activité pour rendre un article propre

[SOURCE : ISO 11139:2018, 3.47]
3.3
utilisation clinique
utilisation d’un produit de santé au cours d’un protocole sur un patient
[SOURCE : ISO 11139:2018, 3.49]
3.4
agent désinfectant
agent physique ou chimique utilisé pour la désinfection
[SOURCE : ISO 11139:2018, 3.83]
3.5
désinfection

procédé visant à inactiver des microorganismes viables à un niveau préalablement spécifié comme

approprié pour une utilisation définie
[SOURCE : ISO 11139:2018, 3.84]
2 © ISO 2019 – Tous droits réservés
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ISO/DIS 17664-2:2019(F)
3.6
nettoyage manuel

élimination des contaminants d’un produit jusqu’à l’obtention de l’état nécessaire à la poursuite du

traitement ou jusqu’à obtention de l’état désiré sans utiliser de procédé automatique

[SOURCE : ISO 11139:2018, 3.159]
3.7
dispositif médical

instrument, appareil, équipement, machine, dispositif, implant, réactif destiné à une utilisation in vitro

ou logiciel, matériel ou autre article similaire ou associé, dont le fabricant prévoit qu’il soit utilisé seul

ou en association chez l’être humain pour une ou plusieurs fins médicales spécifiques suivantes :

— diagnostic, prévention, contrôle, traitement ou atténuation d’une maladie ;
— diagnostic, contrôle, traitement, atténuation ou compensation d’une blessure ;

— étude, remplacement, modification ou entretien de l’anatomie ou d’un processus physiologique ;

— entretien (artificiel) ou maintien de la vie ;
— maîtrise de la conception ;
— désinfection des dispositifs médicaux ;

— communication d’informations par un examen in vitro de spécimens (prélèvements) provenant du

corps humain ;
et dont l’action principale voulue n’est pas ob
...