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: 29-Jun-2026
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198 - Sterilization of health care products
• Current Stage: 6060 - International Standard published
• Start Date: 30-Jun-2026
• Due Date: 27-Feb-2026
• Completion Date: 30-Jun-2026

• Consolidates: ISO 23999:2021 - Resilient floor coverings — Determination of dimensional stability and curling after exposure to heat
• Effective Date: 17-Jun-2023

Overview

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, is an essential technical specification developed by ISO. This document delivers clear guidance for medical device manufacturers and processing facilities regarding the classification and cleaning of reusable medical devices.

The specification supports the designation of devices to cleaning classification categories and helps group devices into product families, aligning them with appropriate cleaning processes. This ensures consistent, validated cleaning methods are defined in manufacturers’ instructions for use (IFU) and implemented during actual cleaning operations.

Key Topics

• Cleaning Classification Categories: Outlines processes for categorizing medical devices based on their design, material, clinical use, and cleaning process type.

  • Manual cleaning (Categories M1–M3): From accessible surfaces to those necessitating specialized equipment.
  • Automated cleaning (Categories A1–A3): From simple surfaces to complex devices requiring specialized accessories and customized parameters.

• Product Family Designation: Provides the basis for grouping devices with similar attributes, ensuring collective validation, and efficient processing.

  • Attributes considered:
    • Geometric design features (e.g., surfaces, crevices, lumens)
    • Materials of construction
    • Clinical use
    • Type of cleaning process

• Master Product Identification: Establishes protocols for identifying the most challenging device within a product family to ensure cleaning efficacy is validated for all group members.

• Risk Analysis: Advises manufacturers and processing facilities to conduct risk assessments, especially when alternative cleaning processes are used.

• Instructions for Use (IFU): Emphasizes robust, validated cleaning instructions to guarantee effective decontamination and reduce risk across the product lifecycle.

Applications

ISO/TS 17664-3:2026 is highly relevant for:

• Medical Device Manufacturers: Assists in developing, validating, and documenting cleaning methods for reusable medical devices. Enhances product family grouping and supports regulatory compliance.
• Healthcare Processing Facilities: Enables standardized workflows, risk mitigation, and proper allocation of resources for cleaning diverse medical devices.
• Quality Assurance and Risk Management Teams: Facilitates process validation, equipment selection, and staff training according to the cleaning complexity of device categories.
• Regulatory and Compliance Officers: Assists in meeting global requirements for reusable medical device processing and traceability.

Practical Benefits:

• Improved Cleaning Outcomes: By grouping devices and matching them to the correct cleaning process, the risk of residual contamination is minimized.
• Efficiency in Validation: Identifying master products streamlines the demonstration of cleaning efficacy for device families.
• Resource Management: Categorization informs the required level of equipment, training, and ongoing competency evaluation, especially for high-complexity device categories.
• Enhanced Communication: Clear manufacturer instructions and established cleaning categories support reliable and safe processing in clinical environments.

Related Standards

Implementation of ISO/TS 17664-3:2026 is closely connected to:

• ISO 17664-1: Outlines the requirements for information to be provided by the medical device manufacturer for processing of medical devices.
• ISO 17664-2: Specifies requirements for processing instructions for health care products not intended to be sterilized.
• ISO 11139: Provides foundational terms and definitions for sterilization and related equipment.
• ISO 15883-5: Establishes cleaning requirements and acceptance criteria for washer-disinfectors.
• AAMI TIR12 / ANSI/AAMI ST98: Offer additional guidance and terminology related to medical device reprocessing.

Conclusion

ISO/TS 17664-3:2026 serves as a key resource for ensuring that reusable medical devices are effectively cleaned, safely reused, and compliant with international best practices. By establishing clear cleaning classification categories, product family groupings, and robust validation protocols, the standard empowers manufacturers and healthcare facilities to safeguard patient safety and optimize device reprocessing.

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 2026
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ISO copyright office
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Published in Switzerland
ii
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
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
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/

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;

— 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 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1 to
entry has been added.]
3.10
processing
activity to prepare a new or used medical device (3.8) for its intended use
[SOURCE: ISO 11139:2018, 3.214, modified — The term “medical device” has replaced “health care product”.]
3.11
product family
group or subgroup of product characterized by similar attributes determined to be equivalent for evaluation
and processing (3.10) purposes
[SOURCE: ISO 11139:2018, 3.218]
3.12
reusable medical device
medical device (3.8) designated or intended by the manufacturer as suitable for processing (3.10) and reuse
Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.
[SOURCE: ISO 11139:2018, 3.236]

3.13
soil
natural or artificial contamination on a medical device (3.8) or surface following its use or simulated use
[SOURCE: ISO 11139:2018, 3.257]
3.14
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The word “validated” is used to designate the corresponding status.
[SOURCE: ISO 11139:2018, 3.313, modified — Notes 1 and 3 to entry have been deleted and Note 2 was
renumbered as Note 1.]
3.15
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
Note 1 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 11139:2018, 3.314, modified — Note 1 to entry has been deleted and Note 2 renumbered as
Note 1.]
4 Risk analysis
The medical device manufacturer should undertake risk analysis in accordance with ISO 17664-1 or
ISO 17664-2, as applicable to the medical device. The processing facility should undertake risk analysis if
using an alternative processing method not specified by the medical device manufacturer.
5 Product families
5.1 General
The designation of medical devices into product families is based on four primary attributes:
— geometric design feature (including surface characteristics);
— material of construction;
— clinical use;
— type of cleaning process.
If a collection of medical devices has similar attributes for cleaning, the medical devices may be grouped into
the same product family. These attributes can affect the cleaning process and are considered as elements
of the cleaning product families. Multiple product families may be designated to a cleaning classification
category. Requirements for information to be provided by the manufacturer for the processing of reusable
medical devices are given in the ISO 17664 series.
For the purpose of identifying appropriate cleaning steps included within a medical device manufacturer’s
instruction for use (IFU) and designating a cleaning classification category, a medical device should be
broadly identified by its design attributes to include surface area, surface characterization, and med
...