Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE          Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
-      assessment of suitability with respect to biocontamination;
-      testing for suitability of decontamination agents and techniques;
-      cleanability of equipment and materials;
-      requirements on design of equipment and selection of materials;
-      physical properties of materials (e.g. electrostatic, thermal properties);
-      optimizing performance of equipment for specific process applications;
-      selection and use of statistical methods for testing;
-      protocols and requirements for local safety regulations.

Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO 14644-14:2016)

Dieser Teil von ISO 14644 legt eine Methodik zur Bewertung der Reinraumtauglichkeit von Geräten (z. B. Maschinen, Messgeräte, Prozessausrüstung, Komponenten und Werkzeuge) für die Anwendung in Reinräumen und zugehörigen kontrollierten Bereichen in Bezug auf die luftgetragene Partikelreinheit nach den Festlegungen in ISO 14644 1 fest. Der Partikelgrößenbereich reicht von 0,1 µm bis gleich oder größer als 5 µm (in ISO 14644 1 angegeben).
ANMERKUNG   Sofern die zuständigen Behörden ergänzende Richtlinien oder Einschränkungen vorgeben, können geeignete Anpassungen der Methodik zur Bewertung erforderlich sein.
Die folgenden Aspekte sind nicht durch diesen Teil von ISO 14644 abgedeckt:
   Bewertung der Tauglichkeit in Bezug auf die Biokontamination;
   Prüfung zur Tauglichkeit von Dekontaminationsmitteln und -techniken;
   Reinigungsfähigkeit der Geräte und Materialien;
   Anforderungen an die konstruktive Auslegung von Geräten und die Auswahl von Materialien;
   physikalische Materialeigenschaften (z. B. elektrostatische, thermische Eigenschaften);
   Optimierung der Geräteleistung für spezifische Prozessanwendungen;
   Auswahl und Anwendung statistischer Verfahren für die Prüfung;
   Protokolle und Anforderungen hinsichtlich regionaler Sicherheitsvorschriften.

Salles propres et environnements maîtrisés apparentés - Partie 14: Évaluation de l'aptitude à l'emploi des équipements par la détermination de la concentration de particules en suspension dans l'air (ISO 14644-14:2016)

ISO 14644-14:2016 définit une méthodologie pour évaluer l'aptitude de l'équipement (par exemple, machines, équipements de mesure, équipements de procédé, composants, outils) à être employé dans les salles propres et les environnements maîtrisés apparentés, pour ce qui concerne la propreté particulaire de l'air telle que spécifiée dans l'ISO 14644‑1. La taille des particules varie de 0,1 µm à 5 µm ou plus (indiquée dans l'ISO 14644‑1).
NOTE          Lorsque les instances réglementaires imposent des lignes directrices ou des restrictions supplémentaires, il peut s'avérer nécessaire d'adapter la méthodologie d'évaluation en conséquence.
Les éléments suivants ne sont pas traités dans l'ISO 14644-14:2016:
-      l'évaluation de l'aptitude à l'emploi par rapport à la biocontamination;
-      les essais d'aptitude à l'emploi des agents et des techniques de décontamination;
-      la nettoyabilité des équipements et matériaux;
-      les exigences relatives à la conception de l'équipement et à la sélection des matériaux;
-      les propriétés physiques des matériaux (par exemple, propriétés électrostatiques, thermiques);
-      l'optimisation des performances de l'équipement pour des applications de procédé particulières;
-      la sélection et l'utilisation de méthodes statistiques pour les essais;
-      les protocoles et exigences relatifs à la réglementation locale sur la sécurité.

Čiste sobe in podobna nadzorovana okolja - 14. del: Ocenjevanje primernosti uporabe opreme na osnovi koncentracije lebdečih delcev (ISO 14644-14:2016)

Ta del standarda ISO 14644 določa metodologijo za ocenjevanje primernosti opreme (npr. strojev, merilne opreme, procesne opreme, komponent in orodij) za uporabo v čistih sobah in podobnih nadzorovanih okoljih glede na čistost zraka na osnovi koncentracije lebdečih delcev, kot je določena v standardu ISO 14644-1.
Velikost delcev je v razponu od 0,1 μm do 5 μm ali več (razpon je podan v standardu ISO 14644-1).
OPOMBA: Če zakonodajni organi predpisujejo dodatne smernice ali omejitve, je metodologijo ocenjevanja morda treba ustrezno prilagoditi.
Naslednji elementi niso vključeni v ta del standarda ISO 14644:
– ocenjevanje primernosti glede na možnost biokontaminacije;
– preskušanje primernosti sredstev in tehnik za dekontaminacijo;
– možnost čiščenja opreme in materialov;
– zahteve za zasnovo opreme in izbiro materialov;
– fizične lastnosti materialov (npr. elektrostatične in toplotne lastnosti);
– optimizacija delovanja opreme za uporabo pri določenem postopku;
– izbira in uporaba statističnih metod za preskušanje;
– protokoli in zahteve za lokalne varnostne predpise.

General Information

Status
Published
Publication Date
04-Oct-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
05-Oct-2016
Completion Date
05-Oct-2016

Buy Standard

Standard
EN ISO 14644-14:2016
English language
29 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-14:2016
01-december-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQMHYDQMHSULPHUQRVWL
XSRUDEHRSUHPHQDRVQRYLNRQFHQWUDFLMHOHEGHþLKGHOFHY ,62

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability

for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der

Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft ((ISO 14644-

14:2016)

Salles propres et environnements maîtrisés apparentés - Partie 14: Evaluation de la

compatibilité des équipments en termes d'émission particulaire pour une utilisation en

salle propre (ISO 14644-14:2016)
Ta slovenski standard je istoveten z: EN ISO 14644-14:2016
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-14:2016 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 14644-14:2016
---------------------- Page: 2 ----------------------
SIST EN ISO 14644-14:2016
EN ISO 14644-14
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
14: Assessment of suitability for use of equipment by
airborne particle concentration (ISO 14644-14:2016)

Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil

- Partie 14: Évaluation de l'aptitude à l'emploi des 14: Bewertung der Reinraumtauglichkeit von Geräten

équipements par la détermination de la concentration durch Partikelkonzentration in der Luft (ISO 14644-

de particules en suspension dans l'air (ISO 14644- 14:2016)
14:2016)
This European Standard was approved by CEN on 13 August 2016.

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

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

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

member.

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

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

Centre has the same status as the official versions.

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

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-14:2016 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
European foreword

This document (EN ISO 14644-14:2016) has been prepared by Technical Committee ISO/TC 209

“Cleanrooms and associated controlled environments” in collaboration with Technical Committee

CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.

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

identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be

withdrawn at the latest by April 2017.

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

patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent

rights.

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

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

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

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

Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 14644-14:2016
---------------------- Page: 6 ----------------------
SIST EN ISO 14644-14:2016
INTERNATIONAL ISO
STANDARD 14644-14
First edition
2016-09-15
Cleanrooms and associated controlled
environments —
Part 14:
Assessment of suitability for use
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l’aptitude à l’emploi des équipements par
la détermination de la concentration de particules en suspension
dans l’air
Reference number
ISO 14644-14:2016(E)
ISO 2016
---------------------- Page: 7 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 General outline of the assessment ..................................................................................................................................................... 3

5 Visual inspection .................................................................................................................................................................................................. 3

6 Assessment of suitability by airborne particle concentration measurements ...................................4

6.1 General ........................................................................................................................................................................................................... 4

6.2 Assessment procedure ..................................................................................................................................................................... 4

6.2.1 Overview ................................................................................................................................................................................. 4

6.2.2 Requirements and considerations .................................................................................................................... 5

6.2.3 Representative mode of operation ................................................................................................................... 6

6.2.4 Considerations for the test environment .................................................................................................... 6

6.2.5 Determination of the test environment ....................................................................................................... 6

6.2.6 Approximate identification of HPC location(s) ..................................................................................... 6

6.2.7 Precise determination of HPC location(s) .................................................................................................. 7

6.2.8 Suitability measurement(s) .................................................................................................................................... 7

6.2.9 Data processing ................................................................................................................................................................. 8

6.2.10 Reference to ISO 14644‑1 classification system ................................................................................10

7 Documentation ....................................................................................................................................................................................................10

7.1 General ........................................................................................................................................................................................................10

7.2 Common documentation requirements .........................................................................................................................10

7.3 Documentation for visual inspection ...............................................................................................................................11

7.4 Documentation for assessment of test environment ..........................................................................................11

7.5 Documentation for classification measurement .....................................................................................................12

8 Statement on cleanroom suitability ..............................................................................................................................................12

Annex A (informative) Example for data processing deriving from measurements .......................................14

Annex B (informative) Additional optional tests ..................................................................................................................................18

Bibliography .............................................................................................................................................................................................................................21

© ISO 2016 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.

The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled

environments.

A list of all part in the ISO 14644 series, published under the general title Cleanrooms and associated

controlled environments, can be found on the ISO website.
iv © ISO 2016 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
Introduction

Cleanrooms and associated controlled environments provide for the control of contamination to levels

appropriate for accomplishing contamination‑sensitive activities. Products and processes that benefit

from the control of contamination include those in such industries as aerospace, microelectronics,

optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).

This part of ISO 14644 links the cleanroom classification of air cleanliness by particle concentration to

the suitability of equipment for use in cleanrooms and associated controlled environments.

© ISO 2016 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 14644-14:2016
---------------------- Page: 12 ----------------------
SIST EN ISO 14644-14:2016
INTERNATIONAL STANDARD ISO 14644-14:2016(E)
Cleanrooms and associated controlled environments —
Part 14:
Assessment of suitability for use of equipment by airborne
particle concentration
1 Scope

This part of ISO 14644 specifies a methodology to assess the suitability of equipment (e.g. machinery,

measuring equipment, process equipment, components and tools) for use in cleanrooms and associated

controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1.

Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644-1).

NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation

of the assessment methodology can be required.
The following items are not covered by this part of ISO 14644:
— assessment of suitability with respect to biocontamination;
— testing for suitability of decontamination agents and techniques;
— cleanability of equipment and materials;
— requirements on design of equipment and selection of materials;
— physical properties of materials (e.g. electrostatic, thermal properties);
— optimizing performance of equipment for specific process applications;
— selection and use of statistical methods for testing;
— protocols and requirements for local safety regulations.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air

cleanliness by particle concentration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleanliness
condition not exceeding a specified level of contamination
© ISO 2016 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
3.2
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]
3.3
cleanroom suitability

ability to maintain the critical control attributes or condition of any clean zone when used as intended

Note 1 to entry: For the purposes of this part of ISO 14644, the assessment is based on airborne particle

concentration.
3.4
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]
3.5
decontamination
reduction of unwanted matter to a defined level
[SOURCE: ISO 14644-7:2004, 3.7]
3.6
equipment

system designed for specific function(s), integrating materials, components and/or controls

EXAMPLE Testing and manufacturing equipment and machinery, equipment for transport and handling,

storage units, tools, furniture, doors, ceilings, Information Technology (IT) hardware and handling robots.

3.7
test environment
space in which the test is carried out, described by a set of parameters
2 © ISO 2016 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
4 General outline of the assessment
Cleanroom suitability assessment has the following outline.

a) Before the assessment can be executed, the customer and supplier shall agree upon the particle

size range(s), with reference to air cleanliness by particle concentration, designated by ISO Class

N as given in ISO 14644-1 and item to be tested including the modes of operation(s). Each selected

mode of operation shall be assessed separately.

b) A short description regarding how the equipment will be used in routine operation (with operating

parameters) shall be given to promote setting the appropriate testing condition and parameters.

c) Visual inspection (see Clause 5).

d) The procedure described in Clause 6 shall be used in order to establish a link to the ISO 14644-1

classification system.
e) Execution of measurements (see 6.2).

f) The data gathered will be processed and the results linked to the ISO classification system (see

6.2.9 and 6.2.10).

g) The results obtained shall conclude the equipment’s cleanroom suitability; the statement shall

follow the defined designation (see Clause 8).

Additional optional tests (not linked to ISO class N), such as total emission of particles or operational

life cycle test, are described in Annex B.

The method described in B.4 may be used to determine the average total emission of equipment and

provides data that may be used to determine the particle load on a cleanroom.
5 Visual inspection

Visual inspection of the equipment shall be carried out before and after any measurement‑based

assessment.

The visual inspection shall ensure that all packaging has been removed and that the equipment is

undamaged and that it is correctly assembled and appropriately connected to its required utilities.

Visual surface cleanliness shall be qualitatively assessed such that any subsequent quantifiable tests

shall not be compromised. This part of the visual inspection can include assessment for particles,

surface films or inappropriately located lubricants.
The objectives of this inspection are the following:

— identify contamination, such as particles and films originated from manufacturing, packaging,

transportation or initial assembly;
— identify contamination that has withstood any prior decontamination process.

It is not intended that this inspection will provide a measurement of surface cleanliness.

Depending on the location of the contamination, the results from visual inspection shall be

— recorded and available for comparison with the post-test visual inspection of surface cleanliness, and

— used as basis to direct a repeat or improved decontamination process.

Detection efficiency of visible contamination on equipment will depend upon the following factors:

— the accessibility and orientation of the surface to be inspected;
© ISO 2016 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)

— the materials used for equipment construction, their surface condition and treatment;

— the viewing parameters (e.g. illumination, field of view, vision magnification, viewing distance).

6 Assessment of suitability by airborne particle concentration measurements
6.1 General

The objective of Clause 6 is to describe a suitability methodology using measurement of airborne

particle emissions at critical locations. By including measurement locations at, or close to, the locations

of high particle concentration (HPC), the intended use of the application is reflected.

This assessment methodology enables a link to the classification system of ISO 14644‑1, in one or more

particle size ranges to be established.

In order to assess the cleanroom suitability of equipment, it is intended that the location(s) with HPC

emitted by the equipment be identified and included in the final suitability measurement. Since the size

distribution of the emitted particles is not known in advance, it is required that more than one particle

size range is measured. Ideally, three widely spread particle size ranges should be selected.

Subsequently, the particle concentrations thus determined from equipment assessment are compared

with the air cleanliness by particle concentration limits for ISO Class N as specified in ISO 14644‑1.

For the equipment to be tested, it shall be ensured that cleanroom compliant design principles have

been incorporated. These principles include, but are not limited to, the following:

— selection of appropriate materials and surface finishes;
— avoidance of static air zones;
— design principles for cleanability;
— considerations for maintenance.

This measurement methodology is not intended to determine overall emission rates for the equipment

under test.
6.2 Assessment procedure
6.2.1 Overview
The flowchart in Figure 1 gives an overview of the necessary assessment steps.
4 © ISO 2016 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
Figure 1 — Overview of the assessment procedure
6.2.2 Requirements and considerations

When defining the scope of the suitability assessment, aspects that could influence the assessment

results shall be considered, for example (but not limited to):
— variability between the same type of equipment;
— pre‑conditioning of the equipment to be tested (accumulated operating hours);
— running-in of equipment.
© ISO 2016 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
The test environment shall be agreed upon before testing (see 6.2.4 and 6.2.5).
6.2.3 Representative mode of operation

A representative mode of operation of equipment shall be defined, which ensures that particle emission

sources are detected. The mode of operation shall reflect the intended use of the equipment. If the

equipment can be operated in different modes of operation (e.g. with or without product), it shall be

decided which of these different modes form part of the assessment. Equipment parameters of operation

shall be defined and agreed upon before testing.

If standardized procedures exist, these procedures shall be taken into consideration. For non-

standardized handling, the manner of handling chosen shall be documented, and reasons for this choice

shall be given.
6.2.4 Considerations for the test environment

The objective of these tests is to characterize and select a test environment prior to installing the

equipment that is to undergo assessment for cleanroom suitability.

Consideration should be given to whether all or some pre-tests are conducted at more than one

measuring plane. An illustration of selected measurement plane(s) may be added.

Information on measurement test methods and equipment can be obtained from ISO 14644-1 and

ISO 14644-3. The following shall be considered.

— Airborne particle concentration measurement: The aim is to confirm that the test environment is

at least one ISO class N (as given in ISO 14644-1) cleaner than the cleanroom or clean zone within

which the equipment is intended to be used.

— Airflow velocity measurement: Guidance range for vertical velocity should be in the range of 0,3 m/s

to 0,5 m/s.
— Temperature: Guidance range should be 18 °C to 25 °C.
— Humidity: Guidance range should be 30 % RH to 70 % RH.
Additional informative pre-tests can include the following:
— airflow direction test and visualization;
— electrostatic and ion generator test;
— particle deposition test.

The results of the considerations shall be used for the determination of the test environment (see 6.2.5).

6.2.5 Determination of the test environment

The test environment shall provide a background level at least one ISO Class N (as given in ISO 14644-1)

cleaner than the cleanroom or clean zone in which the equipment is intended to be used.

NOTE Testing of equipment for ISO Class 1 suitability is accomplished in an ISO Class 1 environment.

The test environment shall not contain any other particle sources than the equipment to be assessed to

avoid influencing the measurement results. This can be achieved using unidirectional airflow.

6.2.6 Approximate identification of HPC location(s)

For equipment with moving elements/components, there is frequently a significant variation in the

concentration of particles generated between different zones of the equipment. The intention of the

6 © ISO 2016 – All rights reserved
---------------------- Page: 18 ----------------------
SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)

cleanroom suitability methodology is to include those zones that contain HPC(s) within the suitability

assessment measurements.

The objective of this stage of the assessment is to determine the measuring locations of HPC(s)

that shall be included in the subsequent final suitability measurement. It is essential that moving

elements/components, utilities, interfaces, etc., are included in this assessment.

NOTE The number of moving elements/components can influence the number of approximate HPC locations.

Although safe sampling can impose sampling position limitations, the objective is to vary the distance

and/or position of the sampling probe in order to identify the HPC location(s).

The approximate identification shall be performed using a systematic scan of the equipment with a

light scattering discrete airborne particle counter (LSAPC). The entire system including product spaces

of the equipment should be scanned by the sampling probe. While the equipment is scanned using a

sampling probe of the LSAPC, a correlation between its position and the HPC is acquired. Depending on

the make/model of the LSAPC used, the feedback required to establish this correlation can use visual

and/or acoustic means. The sample acquisition time shall be chosen to ensure that the lo

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.