CEN ISO/TS 17664-3:2026

• Abstract:

  This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.; The cleaning classification category is comprised of two parts:; designate medical devices to a product family;; designate product families to cleaning processes.; NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.; This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.; This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.; NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.; NOTE 3 Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.

• Status: Published
• Publication Date: 07-Jul-2026
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 08-Jul-2026
• Completion Date: 08-Jul-2026
• Ref Project: SIST-TS CEN ISO/TS 17664-3:2026 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a cleaning classification (ISO/TS 17664-3:2026)

• Referred By: EN ISO 11638:2022 - Resilient floor coverings - Heterogeneous poly(vinyl chloride) flooring on foam - Specification (ISO 11638:2020, including corrected version 2021-09)
• Effective Date: 28-Jan-2026
• Consolidated By: ISO/TS 17664-3:2026 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 3: Guidance on the designation of a reusable medical device to a cleaning classification
• Effective Date: 12-Feb-2026

CEN ISO/TS 17664-3:2026 is a CEN Technical Specification for processing of health care products, published by CEN and based on ISO/TS 17664-3:2026. It gives guidance for assigning reusable medical devices to cleaning classification categories and for linking product families to cleaning processes. It is written for medical device manufacturers and for processing facilities that clean reusable medical devices.

What does CEN ISO/TS 17664-3:2026 specify?

CEN ISO/TS 17664-3:2026 specifies how to group reusable medical devices for cleaning, what attributes to use when forming a product family, and how to designate a cleaning process for that family. In practice, it helps the manufacturer describe cleaning in the instructions for use (IFU) and helps the processing facility choose a suitable cleaning workflow.

The scope covers two linked steps:

• designate medical devices to a product family
• designate product families to cleaning processes

The document applies to manufacturers devising cleaning methods and processing instructions, and to any processing facility where medical devices are cleaned. It excludes processing of single-use medical devices provided as sterile before use and textile devices. Its scope also excludes microbiocidal processes such as sanitization, disinfection and sterilization.

Annex	What it covers
Annex A	Guidance on product families, including geometric design features, materials, clinical-use considerations and evaluation questions

The document is organized into clauses on scope, terms and definitions, risk analysis, product families, cleaning classification categories, application of the categories, and processing resources for different device categories.

What are the key requirements of CEN ISO/TS 17664-3:2026?

CEN ISO/TS 17664-3:2026 is guidance rather than a test method, but it sets out the main factors to consider when classifying reusable medical devices for cleaning. The practical aim is to make cleaning instructions more realistic for the device design and for the facility that will process the device.

1) Use risk analysis as the starting point

Clause 4 says the medical device manufacturer should undertake risk analysis in accordance with ISO 17664-1 or ISO 17664-2, as applicable. If a processing facility uses an alternative method not specified by the manufacturer, the facility should also undertake risk analysis. In practice, this means the cleaning approach should be justified for the specific device and setting, not copied blindly from another product.

2) Build product families from four main attributes

Clause 5 says product families are based on geometric design features, materials of construction, clinical use, and type of cleaning process. The document adds that devices with similar cleaning behavior may be grouped together, even across different product families in the same cleaning classification category. For manufacturers, this means the product family should reflect how the device actually behaves during cleaning, not just how it looks on paper.

3) Pay special attention to difficult design features

Clause 5.2 and Annex A highlight design features that affect cleanability, such as cavities, hinges, joints, pivot points, valves, blind slots, mated surfaces, springs, screws, buttons, O-rings, rough surfaces, sliding shafts, lumens, channels, containers, racks and tray systems. These features can trap soil, limit brush access, reduce visual inspection and encourage biofilm formation. In practice, the manufacturer should identify the hardest-to-clean locations and make sure the IFU addresses them.

4) Consider material compatibility and degradation

Clause 5.3 says the product family designation should consider cleaning-agent compatibility and the possible effects of repeated cleaning cycles on materials. Annex A adds that material properties can change over time and that heat sensitivity, accessory wear and surface damage also matter. This is important because a device can be cleanable at first use but degrade after repeated processing.

5) Use clinical use to judge soil type and challenge

Clause 5.4 says medical devices in the same product family should have similar clinical use, and the master product should represent the most difficult soiling expected in that family. The clause notes that soils may include blood, protein, secretions and procedure-related substances such as cement, lubricants, gels, iodine, simethicone and radiopaque dyes. For users, this means the chosen representative device should match the worst realistic contamination.

6) Classify devices by manual and automated cleaning access

Clause 6 defines six cleaning classification categories:

• M1, M2 and M3 for manual cleaning
• A1, A2 and A3 for automated cleaning

The categories are based on surface accessibility and whether specialized equipment, accessories or customized parameters are needed. A device may qualify for more than one category. In practice, this tells the facility whether a device can be cleaned directly, needs manual pre-cleaning, or needs special connectors, accessories or cycles.

7) Use the categories to support validation and workflow design

Clause 7 says processing facilities can use the cleaning classification categories to identify the cleaning process, while product families can be used to define master products and validate the cleaning process. If a facility departs from the manufacturer’s validated instructions, the alternative process should be validated by the facility with suitable equipment, materials and trained staff. This links the manufacturer’s instructions to real-world processing and verification.

8) Match resources to the category

Clause 8 explains that M1/A1 devices are readily accessible, M2/A2 devices are harder to access but usually do not need specialized equipment, and M3/A3 devices require the greatest resources. For M3/A3 devices, the document points to specialized equipment, ongoing training, competency checks and monitoring of cleaning effectiveness. In practice, the higher the category number, the more support the facility needs to clean the device reliably.

What terms does CEN ISO/TS 17664-3:2026 define?

• Cleaning - removal of contaminants enough for further processing or intended use.
• Cleaning agent - a physical or chemical entity, or combination of entities, used to make an item clean.
• Cleaning classification category - a grouping system in which devices share cleaning processes, equipment and accessories that are considered suitable.
• Instructions for use (IFU) - the part of the accompanying information needed for safe and effective intended use.
• Master product - the product or procedure set used to represent the most difficult-to-clean item in a product family or processing category.
• Product family - a group or subgroup of products with similar attributes that are equivalent for evaluation and processing.
• Reusable medical device - a medical device intended by the manufacturer for processing and reuse.
• Validation - confirmation, through objective evidence, that requirements for a specific intended use have been met.

Who uses CEN ISO/TS 17664-3:2026?

CEN ISO/TS 17664-3:2026 is used by medical device manufacturers, cleaning-process developers, and processing facilities that clean reusable medical devices. It is relevant to people preparing IFU content, selecting representative master products, and deciding how to group devices into families for cleaning validation.

It is also useful for quality, regulatory and validation teams that need to justify a cleaning strategy for complex devices. In health care settings, it supports the staff and managers who set up cleaning workflows, select equipment, train operators and verify that the cleaning process works for the device family they handle.

Which standards are used with CEN ISO/TS 17664-3:2026?

The document points readers to several related standards and guidance documents:

• ISO 11139 - provides the vocabulary source for many of the terms used in the document.
• ISO 17664-1 - gives the parallel framework for critical and semi-critical medical devices and is cited for risk analysis and compatibility-related information.
• ISO 17664-2:2021 - gives the parallel framework for non-critical medical devices and is cited for risk analysis and for compatibility and end-of-life information.
• ISO 15883-5 - defines cleaning requirements and acceptance criteria for washer-disinfectors.
• ISO 17665 - is cited as an example of a standard that gives designation guidance for moist-heat sterilization, but not for cleaning.
• AAMI TIR12 and ANSI/AAMI ST98 - are mentioned as documents that use product family and master product terminology and relate to device processing and cleaning validation.
• ASTM F3357 - is cited for examples of reusable medical device design features that affect cleanability.

What does the CEN ISO/TS 17664-3:2026 document contain?

CEN ISO/TS 17664-3:2026 contains definitions, a risk-analysis clause, guidance for building product families, and a six-category cleaning classification system split between manual and automated cleaning. It also explains how the categories are used in practice to choose a process, define a master product, and support validation.

Annex A adds practical guidance with examples of difficult geometric design features and their cleaning challenges. It also discusses material considerations and includes evaluation questions that help a manufacturer or processing facility judge whether a device belongs in a harder cleaning category.

SLOVENSKI STANDARD
01-september-2026
Proizvodnja izdelkov za zdravstveno nego - Informacije za obdelavo medicinskih
pripomočkov, ki jih zagotovi proizvajalec - 3. del: Navodilo za določitev razreda
čiščenja ponovno uporabnih medicinskih pripomočkov (ISO/TS 17664-3:2026)
Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices - Part 3: Guidance on the
designation of a reusable medical device to a cleaning classification (ISO/TS 17664-
3:2026)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten -
Teil 3: Leitfaden für die Einstufung eines wiederverwendbaren Medizinprodukts in eine
quantitative Reinigungsklasse (ISO/TS 17664-3:2026)
Traitement de produits de soins de santé - Informations relatives au traitement des
dispositifs médicaux à fournir par le fabricant du dispositif - Partie 3: Recommandations
sur la désignation d'un dispositif médical réutilisable dans une classification de nettoyage
(ISO/TS 17664-3:2026)
Ta slovenski standard je istoveten z: CEN ISO/TS 17664-3:2026
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 17664-3
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
July 2026
TECHNISCHE SPEZIFIKATION
ICS 11.080.01
English Version
Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices - Part 3: Guidance on the
designation of a reusable medical device to a cleaning
classification (ISO/TS 17664-3:2026)
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 3: Recommandations sur la désignation d'un von Medizinprodukten - Teil 3: Leitfaden für die
dispositif médical réutilisable dans une classification Einstufung eines wiederverwendbaren
de nettoyage (ISO/TS 17664-3:2026) Medizinprodukts in eine quantitative Reinigungsklasse
(ISO/TS 17664-3:2026)
This Technical Specification (CEN/TS) was approved by CEN on 6 June 2026 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, Türkiye 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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 17664-3:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 17664-3:2026) 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.
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.
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 website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 17664-3:2026 has been approved by CEN as CEN ISO/TS 17664-3:2026 without any
modification.
Technical
Specification
ISO/TS 17664-3
First edition
Processing of health care
2026-06
products — Information to be
provided by the medical device
manufacturer for the processing of
medical devices —
Part 3:
Guidance on the designation of
a reusable medical device to a
cleaning classification
Traitement de produits de soins de santé — Informations
relatives au traitement des dispositifs médicaux à fournir par le
fabricant du dispositif —
Partie 3: Recommandations sur la désignation d'un dispositif
médical réutilisable dans une classification de nettoyage
Reference number
ISO/TS 17664-3:2026(en) © ISO 2026

ISO/TS 17664-3:2026(en)
© ISO 2026
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
ISO/TS 17664-3:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Risk analysis . 4
5 Product families . 4
5.1 General .4
5.2 Geometric design features .5
5.3 Materials of construction .5
5.4 Clinical use .5
5.5 Type of cleaning process .5
6 Cleaning classification categories . 5
6.1 General .5
6.2 Manual cleaning . .6
6.2.1 Category M1 medical devices .6
6.2.2 Category M2 medical devices.6
6.2.3 Category M3 medical devices.6
6.3 Automated cleaning .6
6.3.1 Category A1 medical devices .6
6.3.2 Category A2 medical devices.6
6.3.3 Category A3 medical devices.6
7 Application of cleaning classification category . 6
7.1 General .6
7.2 Medical device complexity .7
7.3 Cleaning risk mitigation .7
8 Processing resources for categories and families of medical devices. 7
8.1 General .7
8.2 Category M1 and A1 medical devices .7
8.3 Category M2 and A2 medical devices.7
8.4 Category M3 and A3 medical devices .7
Annex A (informative) Guidance on product families . 9
Bibliography .12

iii
ISO/TS 17664-3:2026(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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).
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/TS 17664-3:2026(en)
Introduction
ISO 17664-1 and ISO 17664-2 address the medical device manufacturer’s labelling requirements. Typically,
these requirements are mandated by law or government regulation to be validated to demonstrate effective
processes. This document is intended to bridge the gap between the manufacturer of reusable medical
devices and the facility responsible for medical device processing.
ISO 17664-1 and ISO 17664-2 specify requirements for the information to be provided by the medical device
manufacturer for processing. ISO 17665 gives specificity for designation to a product family or master
product, but this is for moist heat sterilization and not for cleaning.
Product family and master product are used within a number of documents (i.e. ISO 17664-1 and ISO 17664-2,
AAMI TIR12 and ANSI/AAMI ST98). These documents use the terminology, but do not provide guidance to
inform the medical device manufacturer as to how to define product family or designate the master product
using objective evidence.
The connection between the medical device manufacturer and the processing facility is intended to be
communicated through the instructions for use (IFU). In addition to providing guidance to the manufacturer,
this document provides the guidance to the processing facility to establish cleaning workflows based on
medical device cleaning classification category within the clinical setting. This allows verification that the
cleaning instructions can be performed effectively for all reusable medical devices.
As the variability in design features for reusable medical devices continues to increase, guidance is needed
to establish appropriate medical device cleaning classification.

v
Technical Specification ISO/TS 17664-3:2026(en)
Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices —
Part 3:
Guidance on the designation of a reusable medical device to a
cleaning classification
1 Scope
This document gives guidance on designating medical devices to cleaning classification categories, attributes
used for medical device cleaning classification category, and designation of a cleaning process.
The cleaning classification category is comprised of two parts:
a) designate medical devices to a product family;
b) designate product families to cleaning processes.
NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and
identification of master products during cleaning validation.
This document is applicable to manufacturers devising cleaning methods and instructions for processing. It
also applies to any processing facility where medical devices are cleaned.
This document does not cover processing of single-use medical devices provided as sterile before use and
textile devices.
NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use
treatment that can be specified.
NOTE 3 Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device
cleaning classification categories.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

ISO/TS 17664-3:2026(en)
3.1
cleaning
removal of contaminants to the extent necessary for further processing (3.10) or for intended use
Note 1 to entry: Cleaning consists of the removal of adherent soil (3.13) (e.g. blood, protein substances and other
debris) from the surfaces, crevices, serrations, joints and lumens of a medical device (3.8) 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
cleaning classification category
grouping system of the included medical devices (3.8) wherein cleaning (3.1) processes, equipment and
accessories are considered suitable
Note 1 to entry: Different product families can be combined in the same cleaning classification category.
Note 2 to entry: Cleaning processes include washer-disinfector, equipment and accessories, etc.
3.4
clinical use
use of a health care product during a procedure on a patient
[SOURCE: ISO 11139:2018, 3.49]
3.5
instructions for use
IFU
portion of the accompanying information that is essential for the safe and effective intended use of a medical
device (3.8) or accessory directed to the user of the medical device
Note 1 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or its
accessory.
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.342]
3.6
manual cleaning
removal of contaminants from an item to the extent necessary for further processing (3.10) or for intended
use without the use of an automated process
[SOURCE: ISO 11139:2018, 3.159]
3.7
master product
health care product or procedure set used to represent the most difficult to clean item in a product family
(3.11) or processing (3.10) category
[SOURCE: ISO 11139:2018, 3.160, modified — The term “clean” has replaced “sterilize”.]
3.8
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;

ISO/TS 17664-3:2026(en)
— 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 which 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 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;
— medical devices incorporating animal tissues and/or human tissues;
— medical devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.166]
3.9
medical device manufacturer
natural or legal person with responsibility for design or manufacture, or both, of a medical device (3.8) with
the intention of making the medical device available for use, under their name, whether or not such a medical
device is designed or 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:
...