SIST EN ISO 17664-1:2021

SLOVENSKI STANDARD
oSIST prEN ISO 17664-1:2021
01-junij-2021
Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi
proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih
pripomočkov - 1. del: Kritični in polkritični pripomočki (ISO/FDIS 17664-1:2020)
Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices - Part 1: Critical and semi-critical
medical devices (ISO/FDIS 17664-1:2020)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten -
Teil 1: Kritische und semi-kritische Medizinprodukte (ISO/FDIS 17664-1:2020)
Traitement de produits de soins de santé - Informations relatives au traitement des
dispositifs médicaux à fournir par le fabricant du dispositif - Partie 1 : Dispositifs
médicaux critiques et semi-critiques (ISO/FDIS 17664-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 17664-1
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
oSIST prEN ISO 17664-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 17664-1:2021

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oSIST prEN ISO 17664-1:2021
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17664-1
ISO/TC 198
Processing of health care products —
Secretariat: ANSI
Information to be provided by the
Voting begins on:
2021-02-25 medical device manufacturer for the
processing of medical devices —
Voting terminates on:
2021-05-20
Part 1:
Critical and semi-critical medical
devices
Traitement de produits de soins de santé — Informations relatives
au traitement des dispositifs médicaux à fournir par le fabricant du
dispositif —
Partie 1: Dispositifs médicaux critiques et semi-critiques
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 17664-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2021

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oSIST prEN ISO 17664-1:2021
ISO/FDIS 17664-1:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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oSIST prEN ISO 17664-1:2021
ISO/FDIS 17664-1:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Validation of the processes identified in the information provided by the medical
device manufacturer . 5
5 Risk analysis . 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 Initial treatment at the point of use . 7
6.5 Preparation before cleaning . 7
6.6 Cleaning . 8
6.6.1 General. 8
6.6.2 Automated cleaning . 8
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 .10
6.8 Drying .10
6.9 Inspection and maintenance .10
6.10 Packaging .11
6.11 Sterilization .11
6.12 Storage .12
6.13 Transportation .12
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.17
Annex C (informative) Classification of medical devices .19
Annex D (informative) Additional guidance on information to be provided by the medical
device manufacturer .22
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . .23
Bibliography .24
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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,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This first edition of ISO 17664-1 cancels and replaces ISO 17664:2017, of which it constitutes a minor
revision. The changes to ISO 17664:2017 are as follows:
— the title, introduction and scope have been editorially revised to reflect the addition of a second
part to the ISO 17664 series.
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.
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Introduction
This document applies to manufacturers of those medical devices that are intended to be cleaned,
disinfected, sterilized or a combination of all three by the processor 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 ready for their next use. This may include one or more of
cleaning, disinfection and sterilization.
— Single-use medical devices that require processing before use and are intended to be used in a clean,
disinfected or sterile state, or a combination of all three.
Significant advances in technology and knowledge have resulted in the development of complex medical
devices to support the delivery of health care to patients. These advances have led to medical devices
being designed that are potentially more difficult to clean, disinfect 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, sterilization or a combination of all three 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 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 the
surfaces of a medical device could compromise the correct functioning of the medical device, its safe
use and (if required) any subsequent disinfection process, sterilization process or both. 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 can 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, which can be used as a
guide to validate procedures.
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oSIST prEN ISO 17664-1:2021
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 17664-1:2021(E)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 1:
Critical and semi-critical medical devices
1 Scope
This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:—, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device.
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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
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
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
[SOURCE: ISO 11139:2018, 3.159]
3.5
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.]
3.6
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:
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— 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;
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 tissues, human tissues or both;
— 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 health care 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 health care product refers to a medical device.
3.9
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.]
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 11607-1:2019, 3.14]
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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.
[SOURCE: ISO 11139:2018, 3.236]
3.12
service life
number of processing (3.8) cycles, lifetime or both 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) designated or intended by the manufacturer (3.5) for one-time use only
Note 1 to entry: A single-use medical device is not intended to be further processed and used again.
3.14
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.15
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use
3.16
sterility assurance level
probability of a single viable microorganism occurring on an item after sterilization (3.17), expressed
as the negative exponent to the base 10
3.17
sterilization
process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival
of a microorganism on an individual item can be expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
3.18
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve
sterility under defined conditions
3.19
terminal process
final step of processing (3.8) to render a medical device (3.6) safe and ready for its intended use
3.20
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended
use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified — the notes to entry have been deleted.]
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3.21
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.]
3.22
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 Validation of the processes identified in the information provided by the
medical device manufacturer
4.1 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.
4.2 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, sterilized or all three when processed as directed.
NOTE 1 In addition to the duty of a manufacturer to demonstrate the validity of provided information, national
authorities can require the final effectiveness of the process to be verified by the processor.
NOTE 2 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.
4.3 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 See C.1.
5 Risk analysis
The medical device manufacturer shall undertake risk analysis to determine the content and detail of
the information to be provided to the user. 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:
— nature and design of the medical device;
— nature of the contamination on the medical device;
— intended use;
— life cycle of the medical device;
— foreseeable user error and misuse;
— user training;
— equipment required for processing;
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— accessories and consumables required for processing;
— necessary maintenance of the medical device;
— post-market information;
— limitation on number of reuses;
— necessary warnings.
These points can also be of benefit to those validating alternative processes in accordance with 4.2, NOTE 2.
NOTE 2 Annex C provides information on classification of medical devices which can assist with any risk
analysis process.
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
and its intended use.
6.1.2 Where disinfection is the terminal process, 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. 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.
6.1.3 Where sterilization is the terminal process, the medical device manufacturer shall specify
validated method(s) to achieve the required sterility assurance level. Medical device manufacturers
shall specify in their processing instructions any specific requirements 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 devi
...