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 17664-1:2021)

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 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device

Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten - Teil 1: Kritische und semi-kritische Medizinprodukte (ISO 17664-1:2021)

Dieses Dokument legt Anforderungen an die Informationen fest, die vom Hersteller zur Aufbereitung von kritischen und semikritischen Medizinprodukten (das heißt ein Medizinprodukt, das Kontakt zu sterilen Körperbereichen hat, oder ein Medizinprodukt, das Kontakt zu Schleimhaut oder krankhaft veränderter Haut hat) oder Medizinprodukten, die eine Sterilisation erfordern, bereitzustellen sind.
Das schließt Informationen zur Aufbereitung vor der Verwendung oder Wiederverwendung des Medizinprodukts ein.
In diesem Dokument sind keine Aufbereitungsanweisungen definiert. Dieses Dokument legt stattdessen Anforderungen fest, um Medizinprodukt-Hersteller darin zu unterstützen, ausführliche Aufbereitungs-anweisungen zur Verfügung zu stellen, die, sofern zutreffend, die folgenden Aktivitäten umfassen:
a) Erstbehandlung am Gebrauchsort;
b) Vorbereitung vor der Reinigung;
c) Reinigung;
d) Desinfektion;
e) Trocknung;
f) Kontrolle und Wartung;
g) Verpackung;
h) Sterilisation;
i) Lagerung;
j) Transport.
Dieses Dokument schließt die Aufbereitung von Folgendem aus:
- unkritischen Medizinprodukten, die nicht für die Sterilisation vorgesehen sind,
- Textilien zur Verwendung in Patientenabdeckungssystemen oder OP-Bekleidung,
- Medizinprodukten, die vom Hersteller nur zum Einmalgebrauch spezifiziert sind und gebrauchsfertig bereitgestellt werden.
ANMERKUNG Für weitere Hinweise zur Anwendung der ISO 17664-Reihe auf ein Medizinpodukt siehe ISO 17664-2:─, Anhang E.

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 17664-1:2021)

Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov - 1. del: Kritični in polkritični medicinski pripomočki (ISO 17664-1:2021)

General Information

Status
Published
Public Enquiry End Date
04-Jun-2021
Publication Date
08-Nov-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
13-Oct-2021
Due Date
18-Dec-2021
Completion Date
09-Nov-2021

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SLOVENSKI STANDARD
SIST EN ISO 17664-1:2021
01-december-2021
Nadomešča:
SIST EN ISO 17664:2018
Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi
proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih
pripomočkov - 1. del: Kritični in polkritični medicinski pripomočki (ISO 17664-
1:2021)

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 17664-1:2021)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-

Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten -

Teil 1: Kritische und semi-kritische Medizinprodukte (ISO 17664-1:2021)

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 17664-1:2021)
Ta slovenski standard je istoveten z: EN ISO 17664-1:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 17664-1:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 17664-1:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2021
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17664:2017
English Version
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 17664-1:2021)
Traitement de produits de soins de santé - Aufbereitung von Produkten für die

Informations relatives au traitement des dispositifs Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller

médicaux à fournir par le fabricant du dispositif - bereitzustellende Informationen für die Aufbereitung

Partie 1 : Dispositifs médicaux critiques et semi- von Medizinprodukten - Teil 1: Kritische und semi-

critiques (ISO 17664-1:2021) kritische Medizinprodukte (ISO 17664-1:2021)
This European Standard was approved by CEN on 28 June 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664-1:2021 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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

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

covered................................................................................................................................................................ 5

---------------------- Page: 4 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1:2021 (E)
European foreword

This document (EN ISO 17664-1:2021) has been prepared by Technical Committee ISO/TC 198

"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204

“Sterilization of medical devices” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by March 2022, and conflicting national standards shall

be withdrawn at the latest by March 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 17664:2017.

This document has been prepared under a Standardization Request given to CEN by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s) / Regulation(s).

For the relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral

part of this document.

Any feedback and questions on this document should be directed to the users’ national standards

body/national committee. A complete listing of these bodies can be found on the CEN websites.

This document is an adoption of an International Standard. The definitions in applicable regulatory

requirements differ from nation to nation and region to region. As a result, the definitions in this

document can differ in wording from those in European Regulations. For use in support of European

requirements, definitions in the European regulations for medical devices take precedence. For

relationship with EU Directive(s) and Regulations, see informative Annex ZA, which is an integral part

of this document.

The following referenced documents are indispensable for the application of this document. For

undated references, the edition of the referenced document (including any amendments) listed below

applies. For dated references, only the edition cited applies. However, for any use of this standard

within the meaning of Annex ZA, the user should always check that any referenced document has not

been superseded and that its relevant contents can still be considered the generally acknowledged

state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a

normative reference to the corresponding EN standard, if available, and otherwise to the dated version

of the ISO or IEC standard as listed below.

NOTE 1 The way in which these referenced documents are cited in normative requirements determines the

extent (in whole or in part) to which they apply.
---------------------- Page: 5 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1:2021 (E)
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 14971 EN ISO 14971:2019 ISO 14971:2019

NOTE 2 The standards normatively referred to by EN ISO 17664 Part 2:2019 are undated. These referred

standards also include normative references to other dated and undated standards. For undated normative

references, it should always be assumed that the latest edition applies.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 17664-1:2021 has been approved by CEN as EN ISO 17664-1:2021 without any

modification.
---------------------- Page: 6 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1:2021 (E)
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered

This European standard has been prepared under a Commission’s standardisation request to provide

one voluntary means of conforming to the General Safety and Performance Requirements of Regulation

(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].

Once this standard is cited in the Official Journal of the European Union under that Regulation,

compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding General Safety and

Performance Requirements of that Regulation, and associated EFTA regulations.

This document is an adoption of an International Standard. The definitions in applicable regulatory

requirements differ from nation to nation and region to region. As a result, the definitions in this

document can differ in wording from those in European Regulations. For use in support of European

requirements, definitions in the European regulations for medical devices take precedence.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be

‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,

‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as

possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance

Requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety

and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

Foreword, replacing the references in the core text.

NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is

not addressed by this European Standard.

Table ZA.1 – Correspondence between this European standard and Annex I of Regulation

(EU) 2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
23.4.i is covered only for the
disinfection, or sterilization of
23.4.i 4, 5, 6, 7
devices to make ready for first
use.
23.4.m 4, 5, 6, 7
23.4.n 4, 5, 6, 7
---------------------- Page: 7 ----------------------
SIST EN ISO 17664-1:2021
EN ISO 17664-1:2021 (E)

WARNING 1: Presumption of conformity stays valid only as long as a reference to this European

standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this

standard.
---------------------- Page: 8 ----------------------
SIST EN ISO 17664-1:2021
INTERNATIONAL ISO
STANDARD 17664-1
First edition
2021-07
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
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
Reference number
ISO 17664-1:2021(E)
ISO 2021
---------------------- Page: 9 ----------------------
SIST EN ISO 17664-1:2021
ISO 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 17664-1:2021
ISO 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

Bibliography .............................................................................................................................................................................................................................23

© ISO 2021 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 17664-1:2021
ISO 17664-1:2021(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,

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.
iv © ISO 2021 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 17664-1:2021
ISO 17664-1:2021(E)
Introduction

This document applies to manufacturers of those medical devices that are intended to be cleaned,

disinfected and/or sterilized 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

and/or disinfected and/or sterile state.

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 and/or sterilize.

Cleaning, disinfecting and sterilizing technologies have also undergone significant change in the past

decade, resulting in new systems and approaches that can be applied in the processing of medical

devices. This has led to a greater appreciation of the need for validation of processing, including

cleaning, disinfection and/or sterilization in order to ensure that medical devices are effectively

processed. These developments have led to the need to ensure that manufacturers of 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.
© ISO 2021 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 17664-1:2021
---------------------- Page: 14 ----------------------
SIST EN ISO 17664-1:2021
INTERNATIONAL STANDARD ISO 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 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a

medical device.
© ISO 2021 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 17664-1:2021
ISO 17664-1:2021(E)
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 and/or further processing.
[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
med
...

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.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 17664-1:2021
---------------------- Page: 2 ----------------------
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)
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© ISO 2021

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ii © ISO 2021 – All rights reserved
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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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oSIST prEN ISO 17664-1:2021
ISO/FDIS 17664-1:2021(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,

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