prEN ISO 14644-7

• Abstract:

  ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.; The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.; ISO 14644-7:2004 is not applicable to full-suits.

• Status: Not Published
• Publication Date: 19-Mar-2028
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 01-Oct-2026
• Completion Date: 01-Oct-2026
• Ref Project: oSIST prEN ISO 14644-7:2026 - Cleanrooms and associated controlled environments - Part 7: Separative devices (ISO/DIS 14644-7:2026)

• Revises: EN ISO 14644-7:2004 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
• Effective Date: 07-Aug-2024

prEN ISO 14644-7 is a draft CEN and ISO standard for cleanrooms and associated controlled environments, focused on separative devices. It specifies minimum requirements for the design, construction, installation, testing and setting to work of devices that use physical or aerodynamic separation to protect a work zone or contain contamination. The document is aimed at the customer-supplier agreement needed to define performance, verification and documentation for equipment such as UDAF units, RABS, isolators, gloveboxes and transfer devices.

What does prEN ISO 14644-7 specify?

prEN ISO 14644-7 specifies the minimum requirements for separative devices in the parts of their lifecycle where they differ from cleanrooms described in ISO 14644-4. It covers design, construction, installation, test and setting to work, and it is intended to support devices that create separation by physical barriers, airflow or both.

The standard applies to devices used to reduce ingress of contaminants, reduce egress of contaminants, or both. It covers UDAF devices, Material Handling Booths, RABS, isolators, Transfer Containers, Biological Safety Cabinets Class II and III, Gloveboxes, Pass-Through Boxes or Transfer Hatches, and Minienvironments.

The scope also sets clear boundaries. It excludes devices designed solely for containment and not associated with cleanrooms or clean zones, application-specific requirements, specific processes to be accommodated, and fire, safety and other regulatory matters.

Annex	What it covers
Annex A	Concepts and types of separative devices
Annex B	Separation Index testing
Annex C	Air-handling systems and gas systems
Annex D	Access devices
Annex E	Transfer device examples
Annex F	Verification testing

What are the key requirements of prEN ISO 14644-7?

prEN ISO 14644-7 is built around agreed requirements, staged design, controlled construction and verification by test. In practice, the standard asks the customer and supplier to define what the device must do, how it will be built, how it will be checked, and how it will be handed over and maintained.

Agree the intended use and operating conditions first

prEN ISO 14644-7 requires an initial risk assessment to establish requirements for product quality, and for personnel and environmental safety. The customer and supplier are expected to agree the intended use, the operations inside the device, how materials and waste enter and leave, the lifecycle, maintenance space, cleaning and decontamination needs, utilities, hazards, accessibility and environmental influences.

This matters because separative devices are not generic enclosures. The document expects the user to define real operating conditions such as occupancy state, cleanliness class, contamination sources, performance limits, monitoring needs and energy targets before design starts.

Define the separation concept and acceptance criteria

prEN ISO 14644-7 requires the method of separation and the associated Separation Index, where applicable, to be specified and agreed. It also requires an appropriate test method, test conditions and environment, and any access or transfer devices needed for routine operation.

This matters because the standard treats separation as a measurable performance characteristic, not just a structural feature. The agreed test method becomes the basis for acceptance and later monitoring.

Develop the design in three reviewed stages

prEN ISO 14644-7 structures design as conceptual design, basic design and detailed design. The conceptual design must establish how the required separation will be achieved, identify airflow, access and transfer concepts, and include a risk assessment. The basic design adds layout, utilities, flow and pressure schematics, calculations, control strategy, maintenance strategy and verification approach. The detailed design must be detailed enough for construction and verification, and must include quality control requirements for construction verification and commissioning.

This matters because the document pushes traceability through the whole project. Each stage is reviewed by customer and supplier, so design decisions, changes and their effects on cost, schedule and quality are documented and agreed.

Control access, transfer and supporting systems

prEN ISO 14644-7 requires access devices and transfer devices to be selected so they do not compromise separation. Glove systems must allow glove change without breaching the device, and their durability, service life and material suitability must be considered. The document also requires air-handling systems to maintain the specified cleanliness level, support operation and transient conditions, and avoid damaging surrounding room airflow.

This matters in practice because the weak points of separative devices are often interfaces rather than walls. Access ports, transfer hatches, filters, pressure control and surrounding room effects all affect whether the device performs as intended.

Build, install and verify under controlled conditions

prEN ISO 14644-7 requires construction to follow approved drawings and specifications, with a clean build protocol where appropriate. It then requires Factory Acceptance Testing (FAT) after construction, Site Acceptance Testing (SAT) after installation, and commissioning activities that set the device to work and verify key parameters in situ.

This matters because a separative device can meet the design on paper but fail after assembly, transport or site integration. The standard therefore links construction verification, installation verification and start-up verification in one sequence.

Use the separation index and supplementary tests

prEN ISO 14644-7 identifies the Separation Index test as the fundamental performance test for separative devices. It also provides for quantitative leak testing where physical barriers are used, and for a glove breach test where gloves are installed.

This matters because the standard does not rely only on visual inspection or general cleanroom tests. It gives specific performance checks for the part of the device that actually separates the work zone from the surrounding environment.

Maintain, retest and decommission with records

prEN ISO 14644-7 requires training for operators and maintainers, defined handover documentation, routine periodic tests, and use of previous test and monitoring data when planning retesting. It also includes decommissioning requirements for safe removal and disposal.

This matters because performance can change over time, especially where gloves, filters, seals and access devices wear or are replaced.

What terms does prEN ISO 14644-7 define?

• Separative device - equipment that uses a physical barrier or aerodynamic means to create assured levels of separation, to reduce ingress, egress, or both.
• Separation index (SI) - a numerical expression of separation effectiveness under specified test conditions, used for ingress or egress performance.
• Access device - a component that lets an operator manipulate materials or equipment inside the separative device without breaking separation.
• Transfer device - a mechanism for moving materials into or out of a separative device while minimizing contamination transfer.
• Isolator - an enclosure that provides separation by physical and aerodynamic means and is operated through access devices.
• Restricted Access Barrier System (RABS) - a separative device with a physical barrier above working height and integral access and transfer devices.
• Biological Safety Cabinet (BSC) - a cabinet used in the document’s device descriptions, including Class II and Class III configurations.
• Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) - verification tests performed at the supplier’s premises and at the customer’s site.

Who uses prEN ISO 14644-7?

prEN ISO 14644-7 is used by cleanroom designers, equipment suppliers, validation teams, quality managers, operations staff and buyers who need separative devices specified, verified and handed over in a controlled way. It is relevant in industries named in the introduction, including aerospace, microelectronics, pharmaceuticals, medical devices, healthcare, nuclear, fine finishing and food.

It is especially useful where a separative device is part of a contamination control strategy and where the user needs evidence of separation performance, not just airflow or particle cleanliness in the room.

What changed in prEN ISO 14644-7 from the previous edition?

prEN ISO 14644-7 replaces ISO 14644-7:2004. This edition was updated in response to user and expert feedback and is intended to integrate better with the other parts of ISO 14644, especially parts 1, 2, 3 and 4.

Which standards are used with prEN ISO 14644-7?

prEN ISO 14644-7 names several companion parts of ISO 14644 and uses them to fill in the broader contamination-control framework.

• ISO 14644-1 - classifies air cleanliness by particle concentration, which is used when the separative device provides clean air.
• ISO 14644-2 - covers monitoring to provide evidence of cleanroom performance related to particle concentration.
• ISO 14644-3 - provides test methods used for verification, airflow, recovery, filter leakage and related checks.
• ISO 14644-4 - provides the design, construction and start-up framework that this part adapts for separative devices.
• ISO 14644-14 - supports assessment of suitability for airborne particle concentration, including some equipment selection decisions.
• ISO 14644-15 - supports suitability for airborne chemical concentration and is used for materials, gloves and manipulators.
• ISO 14644-16 - provides energy efficiency guidance for cleanrooms and separative devices.
• ISO 14644-18 - supports assessment of consumables, including items with a service life such as gloves.

What does the prEN ISO 14644-7 document contain?

prEN ISO 14644-7 contains a performance-based structure: scope, normative references, terms and abbreviations, requirements, design, construction, installation, start-up and specific tests. It also contains Annex A to Annex F, which give device concepts, worked testing guidance, system descriptions, access-device detail, transfer-device examples and verification test options.

Clause 10 is centered on the Separation Index test, including formulas for ingress and egress performance. Annex B expands that with test setup, sampling guidance, documentation needs and worked examples. Annex C describes air-handling and gas-system arrangements, Annex D shows glove systems and half-suits, Annex E illustrates transfer-device configurations, and Annex F gives a practical verification test matrix for design review, FAT, SAT and ongoing checking.

SLOVENSKI STANDARD
01-december-2026
Čiste sobe in podobna nadzorovana okolja - 7. del: Zaprte enote (ISO/DIS 14644-
7:2026)
Cleanrooms and associated controlled environments - Part 7: Separative devices
(ISO/DIS 14644-7:2026)
Reinräume und zugehörige Reinraumbereiche - Teil 7: SD-Module (Reinlufthauben,
Handschuhboxen, Isolatoren und Minienvironments) (ISO/DIS 14644-7:2026)
Salles propres et environnements maîtrisés apparentés - Partie 7: Dispositifs séparatifs
(ISO/DIS 14644-7:2026)
Ta slovenski standard je istoveten z: prEN ISO 14644-7
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 14644-7
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 7: 2026-09-29
Separative devices
Voting terminates on:
2026-12-22
Salles propres et environnements maîtrisés apparentés —
Partie 7: Dispositifs séparatifs
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
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Reference number
ISO/DIS 14644-7:2026(en)
DRAFT
ISO/DIS 14644-7:2026(en)
International
Standard
ISO/DIS 14644-7
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 7:
Separative devices
Voting terminates on:
Salles propres et environnements maîtrisés apparentés —
Partie 7: Dispositifs séparatifs
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
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This document has not been edited by the ISO Central Secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
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Published in Switzerland Reference number
ISO/DIS 14644-7:2026(en)
ii
ISO/DIS 14644-7:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviations . 5
5 Requirements . 6
5.1 General Requirements .6
5.1.1 Usage .6
5.1.2 References .7
5.1.3 Conditions.7
5.1.4 Control / Monitoring . .7
5.2 Specific Requirements .8
5.3 Documentation .8
6 Design . 8
6.1 General .8
6.2 Conceptual design . . .8
6.3 Basic design .9
6.4 Detailed Design .10
6.5 Change management .10
6.6 Typical Design Aspects .10
6.6.1 Separation Concept .10
6.6.2 Critical Attributes and Parameters .10
6.6.3 Fail-Safe Design .11
6.7 Access Devices .11
6.7.1 General .11
6.7.2 Devices for manual operation .11
6.7.3 Glove systems and other manual access devices .11
6.7.4 Remote Manual and Automated (Robotic) Manipulation . 12
6.8 Transfer Devices. 12
6.8.1 General . 12
6.8.2 Selection . 12
6.8.3 Suggested Functional and Design Element Criteria for Transfer Devices . 12
6.9 Air handling systems . 12
7 Construction .13
7.1 General . 13
7.2 Clean build protocol . 13
7.3 Construction Verification. 13
8 Installation . 14
8.1 General .14
8.2 Installation Verification .14
9 Start-up and verification . 14
9.1 General .14
9.2 Commissioning .14
9.2.1 General .14
9.2.2 Setting to Work .14
9.2.3 In-situ Verification .14
9.3 Training . 15
9.4 Handover . 15
9.5 Periodic testing . 15
9.6 Decommissioning . 15

iii
ISO/DIS 14644-7:2026(en)
10 Specific Separative Device Tests .15
10.1 General . 15
10.2 Separation Index Test .16
10.3 Quantitative leak testing .16
10.4 Glove breach test . .16
Annex A (informative) Separative Device – Concepts and Types . 17
Annex B (Informative) Separation Index Testing .30
Annex C (informative) Air-handling systems and gas systems .37
Annex D (informative) Access devices .40
Annex E (informative) Transfer Device Examples .43
Annex F (informative) Verification Testing .48
Bibliography .52

iv
ISO/DIS 14644-7:2026(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14644-7 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
v
ISO/DIS 14644-7:2026(en)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne and surface
contamination to levels appropriate for contamination-sensitive activities. Contamination control can
be beneficial for protection of product or process in industries such as aerospace, microelectronics,
pharmaceuticals, medical devices, healthcare, nuclear, fine finishing and food.
This part of ISO 14644 sets out considerations for the design and testing of separative devices and this
edition of this part is in response to user and expert feedback validated by international enquiry. This
edition has been updated to better integrate with the other parts of ISO 14644 and in particular the latest
editions of parts 1, 2, 3 and 4.
The term ‘separative device’ was originally developed by Technical Committee ISO/TC 209 to encompass
the wide continuum of configurations from open unrestricted air overspill to wholly physically contained
systems. Separative devices provide protection in varying levels by utilising physical or aerodynamic
means, or a combination of both, to create separation between an internal environment and the background
environment. The original continuum of separative devices did not properly distinguish between prevention
of ingress of contaminants (air cleanliness) within the device and prevention of egress of contaminants from
the device (containment). The new continuum recognises that separative devices can provide a variety of
combinations of air cleanliness and containment with varying degrees of effectiveness.
Part 1 of ISO 14644 defines cleanrooms and clean zones. Clean zones ‘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.’ This part of ISO 14644 is intended to apply to a broad range of devices, examples of which are
given in the scope portion of this document. They may be integrated into the cleanroom structure or free-
standing within it. Some separative devices can be independent of a cleanroom and some can be mobile.
Where a separative device provides air cleanliness, it can be classified, monitored, and tested in accordance
with parts 1, 2, 3 and 4 of ISO 14644. Where it provides containment, the containment may be tested and
monitored by part 3 or other methods. In all cases the effectiveness of separation can be expressed by a
characterizing separation index, the basis for calculation and testing of this index is described herein.
ISO 14644 is intended to be broadly applicable; but, as isolators have special requirements, there is an
emphasis in this Part 7 on physical separation – this should be considered when using this standard.

vi
DRAFT International Standard ISO/DIS 14644-7:2026(en)
Cleanrooms and associated controlled environments —
Part 7:
Separative devices
1 Scope
This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test
and setting to work of separative devices, in those respects where they differ from cleanrooms as described
in ISO 14644-4.
It is intended to be complimentary to the requirements of other national and international standards and
guidelines for separative devices as listed below.
This part includes devices providing segregation using either physical or aerodynamic separation for the
purposes of preventing the ingress of contaminants to the device or preventing the egress of contaminants
from the device. It provides design, testing and operational parameters to distinguish between devices with
different purposes and performance characteristics.
Separative devices covered by this section addresses:
— Unidirectional Airflow Devices
— Material Handling Booths
— Restricted Access Barrier Systems (with or without access devices)
— Isolators (open or closed isolators, with or without transfer devices)
— Transfer Containers
— Biological Safety Cabinets Class II and III
— Gloveboxes
— Pass-Through Boxes or Transfer Hatches
— Minienvironments
Refer to Annex A for further information on the above devices.
This part of ISO 14644 excludes:
— Devices designed solely for containment, not associated with cleanrooms or clean zones.
— Environmental health or safety requirements which might drive the need for containment.
— Application-specific requirements
— Specific processes to be accommodated in the separative-device installation.
— Fire, safety and other regulatory matters, specifically where appropriate national and local regulations
apply.
ISO/DIS 14644-7:2026(en)
2 Normative references
The following referenced documents are indispensable for the application 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 14644-2, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of
cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-4, Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 14644-14, Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use
of equipment by airborne particle concentration
ISO 14644-15, Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use
of equipment and materials by airborne chemical concentration
ISO 14644-16, Cleanrooms and associated controlled environments — Part 16: Energy efficiency in cleanrooms
and separative devices
ISO 14644-18, Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of
consumables
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10648-2, 14644-1, 14644-2 14644-
4, and 14644-14 and the following apply
3.1
access device
component of a separative device which allows an operator outside the barrier to manipulate materials,
equipment or products within the separative device without compromising the separation.
3.2
barrier
means employed to provide separation
3.3
breach velocity
speed of air through an aperture in a barrier
Note 1 to entry: Sufficient airflow through a breach will prevent movement of airborne contamination in the opposite
direction (aerodynamic separation)
3.4
containment
resistance to egress of airborne contaminant
Note 1 to entry: The contaminant can be airborne particles, microorganisms or chemicals
3.5
decontamination
reduction of unwanted matter to a defined level

ISO/DIS 14644-7:2026(en)
3.6
glove (of separative devices)
component of an access device that maintains an effective barrier while enabling the hands of an operator to
enter the enclosed volume of a separative device.
Note 1 to entry: Gloves can be two-piece glove and sleeve systems or one-piece glove and sleeve (gauntlet).
3.7
glove port
attachment site for glove sleeve system
3.8
glove sleeve system
multi-component access device that maintains an effective barrier while enabling the replacement of sleeve
piece, connecting cuff piece and the glove
3.9
Isolator
enclosure providing separation by physical and aerodynamic means which is operated via access devices.
Note 1 to entry: isolators for aseptic processing are capable of being subject to reproducible interior bio-
decontamination.
[SOURCE: ISO 11139:2018, modified]
3.10
leak (of a separative device)
defect allowing egress from or ingress to the working zone
3.11
pressure integrity
capability to provide a quantifiable leakage rate repeatable under quantitative leak test conditions
3.12
Separation
Reduction of ingress or egress of contaminants between a working zone and the surrounding environment.
3.13
Separation index SI ,
i
numerical abbreviation expressing the prevention of ingress into a working zone from the surrounding
environment of the separative device under specified test conditions
Note 1 to entry: for formula see section 9.3.2, Formula A.1
Note 2 to entry: the index can be applied for contaminants such as particles, chemicals or microorganisms
3.14
Separation index SI ,
e
numerical abbreviation expressing the prevention of egress of a contaminant from the internal volume of a
separative device into the surrounding environment under specified test conditions
Note 1 to entry: for formula see 9.3.2 , Formula A.2
Note 2 to entry: the index can be applied for contaminants such as particles, chemicals or microorganisms
3.15
separative device
equipment utilizing a physical barrier or aerodynamic means to create assured levels of separation described
by separation indices
Note 1 to entry: The device has the purpose of preventing egress from or ingress into a specified area or volume (e.g.
work zone) or both
ISO/DIS 14644-7:2026(en)
Note 2 to entry: Some industry specific examples of separative devices are unidirectional airflow devices, containment
enclosures, glove boxes, isolators and minienvironments.
3.16
transfer device
mechanism to effect movement of materials into or out of a separative devices while minimizing ingress or
egress of contamination
3.17
work zone
designated part of a separative device in which specified activities are carried out
3.18
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.
3.19
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]
3.20
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]
3.21
contamination
unwanted matter in an undesirable location
[SOURCE: ISO 14644-13:2017, 3.4]

ISO/DIS 14644-7:2026(en)
3.22
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 level(s) as described in the ISO
standard series.
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]
3.23
service life
length of time or number of cycles an item is suitable for use
Note 1 to entry: In this document, items are considered as consumable.
Note 2 to entry: Service life is depending on appropriate use.
[SOURCE: ISO 14644-18:2023, 3.19]
3.24
verification
confirmation, through the provision of objective evidence that specified requirements have been fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an Inspection or of other forms of
determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification are sometimes called a qualification Process.
Note 3 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12, modified: Cross-references to other terms deleted]
3.25
contaminant
particle, chemical or microorganism that adversely affects the product or process
[SOURCE: ISO 14644-4:2022, 3.1.7]
Note 1 to entry: For this standard, contaminant can also adversely affect the environment, personnel or other materials
4 Symbols and abbreviations
The following symbols and abbreviations are used in this part of ISO 14644
Table 1 — Common symbols used in cleanrooms and associated controlled environments
Symbol Meaning
BD Basic Design
BSC Biological Safety Cabinet
BMS Building Management System
CD Concept Design
DD Detailed Design
ISO/DIS 14644-7:2026(en)
TTabablele 1 1 ((ccoonnttiinnueuedd))
Symbol Meaning
EMS Environmental Monitoring System
FAT Factory Acceptance Testing
HEPA filter High Efficiency Particulate Air filter
LSAPC Light-scattering airborne particle counter
RABS Restricted Access Barrier System
SAT Site Acceptance Testing
SI Separation index
SMIF Standard Mechanical Interfaces
UDAF Unidirectional Airflow
ULPA Ultra Low Penetration Air filter
5 Requirements
5.1 General Requirements
Taking into consideration the contamination control concepts and overall strategy for contamination
control, an initial risk assessment shall be conducted to establish the requirements with respect to product
quality and safety aspects for personnel and environment.
The following items listed shall be considered and specified as appropriate, by customer and supplier before,
or in the early stages of, the design process.
5.1.1 Usage
a) The intended use of the separative device and the operations to be carried out therein;
Note 1 Intended use can include purpose of containment
Note 2 Considerations include material compatibility, residues and effluents.
b) Entry and exit of equipment, materials and waste, in terms of quantity, movement and controls applied
such as decontamination;
Note 1 Access devices and transfer devices can be part of these considerations
Note 2 Ergonomics are an integral part of entry and exit of materials
c) Intended life cycle of the separative device
d) Changes of the separative device anticipated over time to be provided for in the design
e) Intended operational cycles and turn-down periods;
Note When systems are planned to be turned off, a detailed process impact assessment should be documented
and an appropriate shutdown and return to service procedure outlined. Shutting systems off generally result in loss of
separation and loss of cleanliness.
f) The intended location of the separative device and any constraints of the installation
g) The identification of surrounding environmental influences;
h) Critical dimensions and weight restrictions, including those related to available space.
Note This includes circulation space and access for personnel and material movements.

ISO/DIS 14644-7:2026(en)
i) Process and product requirements that affect the separative device such as air velocity, light sensitivity
or radioactivity.
j) Cleaning and decontamination requirements.
k) Utility requirements
l) Process hazards;
m) Internal surfaces and finish requirements (including request for smooth, impervious finishes which are
cleanable and resistant to cleaning and decontamination agents and free of gaps to uncontrolled areas);
n) Required availability, reliability level and back-up strategy;
o) Strategy of maintenance operations, space and time needed to maintain the installations during the
process cycle;
p) Access of personnel over all phases of operation, including PPE, access devices and the like.
5.1.2 References
a) Regulatory requirements;
b) The number, edition and year of publication of the relevant parts of ISO 14644 that will be used;
c) Methods of testing, measurement and monitoring, to meet the acceptance criteria and related
documentation.
Note It might be necessary to have special provisions (access or connections) for testing and monitoring of
separative devices.
5.1.3 Conditions
a) The air cleanliness class at the designated particle size(s) and the defined occupancy states in accordance
with ISO 14644-1;
b) Any other requirements with respect to particles or other contaminants in air or on surfaces (e.g.
particle number concentration and particle deposition rate);
c) Considerations of any other influences e.g., electrostatic discharge (ESD), vibration;
d) Sources of contamination and their source strength data;
5.1.4 Control / Monitoring
a) Performance parameters and their acceptance criteria with any specific requirements for alert
(warning) and action (alarm) limits and their management;
Note Management includes initial acceptance testing as well as ongoing monitoring
b) Cleanroom environmental control by stand-alone systems or integrated into building management
system (BMS);
c) Requirements for monitoring of environmental and other parameters, both inside and outside of the
separative device.;
Note Guidance for monitoring to provide evidence of cleanroom and separative performance related to air
cleanliness by particle concentration can be found in ISO 14644-2.
It is recommended for critical parameters to be continuously monitored and alarmed.
d) The preferred contamination control concepts and overall strategy for contamination control, including
physical or chemical decontamination processes;

ISO/DIS 14644-7:2026(en)
e) Environmental and energy efficiency targets;
Note Guidance for these targets can be found in ISO 14644-16 - Energy efficiency in cleanrooms and separative
devices
Any other factors or constraints, not listed above, imposed by operating requirements over the lifecycle
of the separative devices.
5.2 Specific Requirements
The items listed below shall be specified and agreed by customer and supplier:
a) Description of the method of separation and associated separation index (where applicable).
b) An appropriate test method to verify that the specified separation has been achieved.
Note For verification, please refer to clause 10, an example of the separation index test can be found in Annex B,
other tests are provided in Annex F
c) Procedures, conditions and environment(s) for testing
d) If applicable, access and transfer devices, appropriate to process and routine operation.
5.3 Documentation
The requirements shall be agreed and documented to form a basis for subsequent design and allow changes
to be managed in a traceable manner.
Note In some industries this documentation is called User Requirement Specification (URS).
6 Design
6.1 General
The output of the requirements (Clause 5) is the input for the design. The design process shall progress in an
agreed manner, taking into account the agreed requirements, and be documented.
There are typically three stages in the overall design process: Conceptual design, basic design and detailed
design. Depending on the nature and scale of the separative device, these stages can be executed in one or
more steps with appropriate design iterations and reviews. This is particularly relevant for designs based
upon existing standardized modules, such as “off-the-shelf” equipment.
6.2 Conceptual design
During conceptual design (CD) the principle to achieve any required separation index (see formula A.1 and
A.2) shall be determined, considering the internal and external cleanliness levels and specific process to be
separated. Conceptual design will also include assessment of the type of air handling systems, type of access
devices and transfer devices and overall dimensions. Functional interfaces with connected systems need
to be identified. A risk assessment shall be performed to challenge the design concepts with respect to the
product, personnel and environment.
The following documentation shall be considered as a minimum:
a) Intended use or purpose;
b) Description of functionalities,
c) Description of the air handling and utilities,
d) General arrangement drawings, including where applicable for transfer devices and access devices,

ISO/DIS 14644-7:2026(en)
e) Compatibility of materials.
The conceptual design shall be reviewed by the customer and supplier to verify whether it meets the
established requirements (concept design verification) and documented.
6.3 Basic design
A basic design (BD) is developed based on an agreed conceptual design.
The following information shall be considered for the basic design as a minimum:
a) Layout and section drawings, including locations and sizes of transfer and access devices; work areas
and surfaces shall be considered with respect to the ergonomics of the process undertaken. 3D modelling
and mock-up studies can be considered for this purpose.
b) Transport of the separative device for the purpose of installation and removal
c) Utility descriptions with flow, pressure and other relevant parameters;
d) Schematics, such as airflow diagrams and separation and pressurization plan;
e) Supporting calculations to support the concept and level of separation, the supply and extract air volume
flow rates necessary to achieve required levels of air cleanliness, flow pressure cascade and recovery
rate where required (see Annex B);
f) Supporting calculations associated with controlling contaminants of interest (microorganisms,
chemicals, particles in the air and on critical surfaces), such as described in ISO 14644-4 Annex B;
g) Prefiltration and final air filtration (as per ISO 14644-4)
h) Exhaust air treatment and filtration
i) Functional description to describe the sequence of operations for critical performance parameters to
aid control systems and software development;
j) Any alternative designs considered, if applicable, and reasons for rejection;
k) Energy-saving methods (as per ISO 14644-16);
l) Automatic or manual system control to achieve the required separation, airflow rate, airflow direction
and pressure cascade between the surrounding environment and the separative device;
m) Material and component specifications;
n) Finishes and construction details for the surfaces of the separative device;
o) Verification approach, e.g. factory acceptance and site acceptance tests (see section 7 and 9);
p) Reliability and redundancy strategy;
q) Maintenance strategy;
r) Automation and control systems, and associated connection to building management systems (BMS)
where applicable.
s) Environmental monitoring system (EMS)
t) Access provision and process conditions for cleaning or decontamination, including possible safe
disposal of the agents used.
Risk assessments and hazard analysis should be considered for maintaining safety and separation
during all functional states as well as malfunctioning.

ISO/DIS 14644-7:2026(en)
Provisions shall be made to enable the specific testing and monitoring to be carried out according to an
approved method.
The basic design shall be reviewed by the customer and supplier to verify whether it meets the established
requirements and the concept design (basic design verification) and documented.
NOTE Consequent to review it can be necessary to update the requirements. This is subject to agreement.
6.4 Detailed Design
The Detailed Design (DD) develops the agreed basic design. Upon completion of the detailed design stage a
detailed design document(s) shall be produced in sufficient depth to enable construction and verification to
be carried out.
During this stage a digital or physical mock up is useful
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