kSIST FprEN ISO 14644-18:2023

SLOVENSKI STANDARD
oSIST prEN ISO 14644-18:2022
01-december-2022
Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih
materialov (ISO/DIS 14644-18:2022)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability
of consumables (ISO/DIS 14644-18:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der
Reinraumtauglichkeit von Verbrauchsmaterialien (ISO/DIS 14644-18:2022)
Salles propres et environnements maîtrisés apparentés - Partie 18: Titre manque
(ISO/DIS 14644-18:2022)
Ta slovenski standard je istoveten z: prEN ISO 14644-18
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-18:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14644-18:2022

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oSIST prEN ISO 14644-18:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-18
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-30 2022-12-23
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
ICS: 13.040.35
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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BEING ACCEPTABLE FOR INDUSTRIAL,
IMPORTANT — Please use this updated version dated 2022-08-11, and
TECHNOLOGICAL, COMMERCIAL AND
discard any previous version of this DIS because Figure 1 was missing.
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STANDARDS MAY ON OCCASION HAVE TO
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NATIONAL REGULATIONS.
ISO/DIS 14644-18:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-18
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-30 2022-12-23
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
ICS: 13.040.35
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14644-18:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Description and Suitability Properties of Consumables . 5
4.1 Types of Consumables . 5
4.2 Properties of Consumables . . 5
4.2.1 General . 5
4.2.2 Functional Performance Properties . 6
4.2.3 Cleanliness Attributes . 6
4.2.4 Special Properties . 7
4.3 Intended use . 7
4.4 Type of use . 7
4.4.1 Single use consumable . 7
4.4.2 Multiple use consumable . . 7
5 Contaminant of concern . 8
5.1 General . 8
5.2 Emission of contaminants into the air . 8
5.3 Surface contamination by contact transfer . 8
5.4 Surface contamination via liquids. 8
6 Suitability Assessment Prerequisites .8
6.1 General . 8
6.2 Suitability considerations . 8
6.3 Associated risks . . 9
6.4 Requirements, properties and cleanliness attributes . 9
6.5 Sustainability . 9
7 Customer requirements .10
7.1 General . 10
7.2 Description and intended use . 10
7.3 Requirements for consumable assessment . 10
7.3.1 Functional performance properties. 10
7.3.2 Cleanliness attributes . 10
7.3.3 Special properties . 11
8 Consumable properties as designed by the supplier .11
8.1 General . 11
8.2 Description and designed use . 11
8.3 Candidate consumable properties and attributes . 11
8.3.1 Functional performance properties. 11
8.3.2 Cleanliness attributes .12
8.3.3 Special properties .12
8.4 Supplier quality documentation . 13
9 Assessment . .13
9.1 General .13
9.2 Initial comparison . 13
9.3 Detailed comparison .13
9.4 Suitability assessment . 14
9.5 Implementation . . 14
10 Documentation .14
10.1 General . 14
iii
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
10.2 Initial customer’s documentation . 14
10.3 Supplier documentation .15
10.4 Assessment documentation .15
Annex A (informative) Personal and Non-personal consumables .17
Annex B (informative) Impact of consumables on cleanroom cleanliness levels .19
Annex C (informative) Test Methods .23
Annex D (informative) Worked examples .28
Bibliography .36
iv
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(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 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 209, Cleanrooms and associated controlled
environments, and by Technical Committee CEN/TC 243, Cleanroom technology in collaboration.
For biocontamination control, see EN 17141.
A list of all parts in the ISO 14644 and ISO 14698 series can be found on the ISO website.
v
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
Introduction
Cleanrooms and associated controlled environments are used for the control of contamination to levels
appropriate for performing contamination-sensitive activities.
Products and processes that benefit from the control of contamination include those in industries
such as aerospace, microelectronics, optics, displays, nuclear, micro mechanical devices, consumer
goods, cosmetics and life sciences (pharmaceuticals, medical devices, food). Contamination control
in healthcare-related industries (pharmaceutical, medical devices …) benefit the patients by enabling
access to products free of potentially harmful particles.
Consumables are widely used during preparation and operations in cleanrooms, clean zones or
controlled zones to maintain the air or surface cleanliness level in the cleanroom by shielding a
contamination source or a vulnerable object or by removing contamination from a surface. For
monitoring and testing purposes, consumables may be used for sampling contamination. Consumables
need to be carefully selected and appropriately used in order to maintain cleanliness levels and mitigate
risk for processes and products.
Consumables are used for a limited time only. They do not constitute a part of the final product.
This document addresses the assessment of suitability of consumables for being used in cleanrooms,
clean zones or controlled zones in respect to contamination in air and on surfaces by:
— particles,
— chemicals or;
— microorganisms.
Customers or users need to have the possibility to assess a given consumable by matching their intended
use requirements with the designed use data of the supplier. This might be supplemented by additional
tests. This match of intended use and designed use is addressed as appropriate use.
Depending on the use case, an impact assessment to determine the kind and acceptable quantity of
contamination from consumables can be derived by benchmarking the requirements with respect to
emission of contaminants.
This document is written for suppliers (manufacturers of consumables or distributors) and customers
(as users of consumables) to assess the suitability of consumables for their use in cleanrooms.
The cleanroom suitability assessment always has to be accompanied with description of use, technical
data as required by the nature of the consumable and test results. A sole statement such as “suitable
for cleanroom of classification ISO 5” is not foreseen, due to the variety and complexity of use cases and
the likelihood that a consumable suitability assessment would not rely on test data relating solely to
airborne particle emissions.
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oSIST prEN ISO 14644-18:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-18:2022(E)
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
1 Scope
This document gives guidance for assessing personal and non-personal consumables for their
appropriate use in cleanrooms, clean zones or controlled zones, based on product and process
requirements, cleanliness attributes and functional performance properties. The cleanliness attributes
addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles/
microorganisms) is considered as a special property of consumables. Identification of associated risks
are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
— determination of cleanroom suitability of consumables in general;
— specification of requirements for an intended use of a candidate consumable by the customer with
respect to functional performance, cleanliness attributes and special properties;
— specification of properties for a designed use of a candidate consumable by supplier;
— assessment of a candidate consumable for an appropriate use;
— documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification
methods for cleanliness attributes testing as well as the potential impact of consumables on a
cleanroom.
Cleaning agents, disinfectants and lubricants are considered as cleanroom consumables with respect
to their packaging, as their packaging is likely to have cleanliness requirements in common with all
cleanroom consumables.
This document does not apply to:
— design details of consumables,
— testing of functional performance of materials, e.g., barrier properties of gloves, wear and slip
resistance of flooring;
— health and safety requirements; legal documents of a specific country shall be considered;
— cleanability;
— (raw) materials which are added within the production process as ingredient;
— performance or function testing;
— transport containers;
— process media such as gases or liquids;
— the functional performance of cleaning agents, disinfectants and lubricants.
1
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(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 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
ISO 14644-8, Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness
by chemical concentration (ACC)
ISO 14644-9, Cleanrooms and associated controlled environments — Part 9: Assessment of surface
cleanliness for particle concentration
ISO 14644-10, Cleanrooms and associated controlled environments — Part 10: Assessment of surface
cleanliness for chemical contamination
ISO 14644-15, Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for
use of equipment and materials by airborne chemical concentration
ISO 14644-17, Cleanrooms and associated controlled environments — Part 17: Particle deposition rate
applications
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 https:// www .electropedia .org/
3.1
air cleanliness by chemical concentration
ACC
quantity of chemical detected in the air, expressed in terms of an ISO-ACC level N, which represents the
maximum allowable concentration of a given chemical species or a group of chemical species
3
Note 1 to entry: Unit: g/m .
Note 2 to entry: This definition does not include macromolecules of biological origin, which are judged to be
particles.
[SOURCE: ISO 14644-8:2022, 3.1.2, modified: Moved unit to Note to entry]
3.2
appropriate use
application matching designed use and intended use within acceptable limits
Note 1 to entry: This use typically is stated by the customer of the consumable.
3.3
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2013, 3.1.1]
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
3.4
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: ISO 14644-14:2016, 3.1]
Note 1 to entry: In this document, contamination refers to particles, chemicals or viables.
3.6
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation, and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g., temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.7
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone when used as intended
[SOURCE: ISO 14644-14:2016, 3.3, modified: deleted Note 1 to entry]
3.8
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation, and
retention of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g., temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.9
compatibility
state of which at least two things are able to exist without adverse effect
Note 1 to entry: All types of contamination, being emitted from the consumables under consideration that might
have an impact on the quality of the product or process shall be taken into account.
3.10
consumable
item selected for a prescribed use and disposal, if applicable, within cleanrooms and controlled
environments
3
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oSIST prEN ISO 14644-18:2022
ISO/DIS 14644-18:2022(E)
3.11
contamination
unwanted matter in an undesirable location
[SOURCE: ISO 14644-13:2017, 3.4]
3.12
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical,
biocontamination) in air and on surfaces is controlled and specified and which is constructed and used
in a manner to minimize the introduction and impact of contamination
Note 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or
cleanliness in terms of particle, chemical and viable concentrations on surfaces should be specified by class(es).
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e.g., temperature, humidity and
pressure, vibration and electrostatic.
Note 3 to entry: A controlled zone can be a defined space within a cleanroom or may be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
[SOURCE: ISO 14644-15:2016, 3.9]
3.13
designed use
application as foreseen for a specified purpose and shelf-life
Note 1 to entry: This is typically stated by the manufacturer or supplier of the consumable.
3.14
intended use
application in accordance with a specified purpose
Note 1 to entry: This is typically stated by a user, customer or third party of the consumable.
3.15
limited use
application within a defined period of time
Note 1 to entry: In this document, this is applicable for intended use, designed use or appropriate use.
Note 2 to entry: In this document, the period of time has to be justified and verified by test results.
3.16
material
single substance or composite
Note 1 to entry: It may be necessary to provide material in a representative form to enable testing.
[SOURCE: ISO 14644-15, 3.13]
3.17
multiple use
sequence of several t
...