EN ISO 14644-2:2015

SLOVENSKI STANDARD
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Cleanrooms and associated controlled environments - Part 2: Monitoring to provide
evidence of cleanroom performance related to air cleanliness by particle concentration
(ISO 14644-2:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der
Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-
2:2015)
Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du
maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO
14644-2:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-2:2015
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.

EN ISO 14644-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-2:2000
English Version
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration (ISO 14644-2:2015)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 2:
- Partie 2: Surveillance du maintien des performances Überwachung zum Nachweis der Reinraumleistung
de la salle propre pour la propreté particulaire de l'air bezüglich Luftreinheit anhand der
(ISO 14644-2:2015) Partikelkonzentration (ISO 14644-2:2015)
This European Standard was approved by CEN on 27 November 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-2:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-2:2015) 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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.
This document supersedes EN ISO 14644-2:2000.
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 14644-2:2015 has been approved by CEN as EN ISO 14644-2:2015 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-2
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 2:
Monitoring to provide evidence of
cleanroom performance related to air
cleanliness by particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 2: Surveillance du maintien des performances de la salle propre
pour la propreté particulaire de l’air
Reference number
ISO 14644-2:2015(E)
©
ISO 2015
ISO 14644-2:2015(E)
© ISO 2015, 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
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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 2015 – All rights reserved

ISO 14644-2:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Creating, implementing and maintaining a monitoring plan . 2
4.1 Principle . 2
4.2 Risk assessment . 2
4.3 Monitoring plan . 3
4.4 Calibration . 3
4.5 Review and approval. 4
4.6 Response to a deviation during monitoring . 4
5 Periodic classification of air cleanliness by particle concentration .4
Annex A (informative) Matters to consider when developing a monitoring plan .5
Annex B (informative) Considerations for setting alert and action levels .9
Bibliography .14
ISO 14644-2:2015(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 WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces the first edition (ISO 14644-2:2000), which has been
technically revised throughout.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
— Part 1: Classification of air cleanliness by particle concentration
— Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle
concentration
— Part 3: Test methods
— Part 4: Design, construction and start-up
— Part 5: Operations
— Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
— Part 8: Classification of air cleanliness by chemical concentration (ACC)
— Part 9: Classification of surface cleanliness by particle concentration
— Part 10: Classification of surface cleanliness by chemical concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-
contamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of bio-contamination data
iv © ISO 2015 – All rights reserved

ISO 14644-2:2015(E)
Introduction
This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to
the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with
ISO 14644-1:2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby
providing a more detailed view of the performance of the installation.
Potential benefits gained from monitoring are
— faster response to adverse events and conditions,
— ability to develop trends from data over time,
— integration of data from multiple instruments,
— enhanced knowledge of installation and process, which allows for more effective risk assessment, and
— improved control of operational costs and product losses.
ISO 14644-2 specifies the requirements of a monitoring plan, based on risk assessment of the intended
use. The data obtained provide evidence of cleanroom or clean zone performance related to air
cleanliness by particle concentration.
In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements
or restrictions. In such situations, appropriate adaptations of the monitoring procedures may be
required. After a monitoring plan is initially established and implemented, it may be necessary to
revise the plan when significant changes are made to the installation or process requirements. It is also
prudent to conduct periodic reviews of a monitoring plan based on data obtained and experience in use.
INTERNATIONAL STANDARD ISO 14644-2:2015(E)
Cleanrooms and associated controlled environments —
Part 2:
Monitoring to provide evidence of cleanroom performance
related to air cleanliness by particle concentration
1 Scope
This part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean
zone performance related to air cleanliness by particle concentration, based upon parameters that
measure or affect airborne particle concentration.
This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general
maintenance of the engineering systems. It does not provide for monitoring of particle populations
that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of
ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.
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 terms and definitions given in ISO 14644-1 and the following apply:
3.1
test
procedure undertaken in accordance with a defined method to determine the performance of an
installation or an element thereof
3.2
monitoring
observations made by measurement in accordance with a defined method and plan to provide evidence
of the performance of an installation
Note 1 to entry: Monitoring may be continuous, sequential or periodic; and if periodic, the frequency shall be
specified.
Note 2 to entry: This information may be used to detect trends in operational state and to provide process support.
3.3
action level
level of a parameter set by the user which, when exceeded, requires immediate intervention, including
investigation of cause, and corrective action
ISO 14644-2:2015(E)
3.4
alert level
level of a parameter set by the user giving early warning of a drift from normal conditions, which, when
exceeded, should result in increased attention or corrective action
4 Creating, implementing and maintaining a monitoring plan
4.1 Principle
In order to gain assurance that a cleanroom or clean zone is performing adequately by delivering
the required control of air cleanliness by particle concentration, a monitoring plan shall be created,
implemented and maintained.
A monitoring plan shall take into account the level of air cleanliness required, critical locations and
performance attributes of the cleanroom or clean zone that affect the performance of the installation. The
following steps shall be included in the creation, implementation and maintenance of the monitoring plan:
— use appropriate risk assessment tools to understand, evaluate and document the risk of adverse
contamination events;
— develop a written monitoring plan;
— review and approve the plan;
— implement the plan by performing the monitoring;
— analyse the data derived from the monitoring activity, undertake trend analysis where appropriate
and report performance;
— implement and document actions or corrective actions required;
— undertake periodic review of the monitoring plan.
The concentration of airborne particles measured under a monitoring plan may be higher than the
concentration observed during at-rest classification. The observed values may fluctuate considerably
due to factors such as, but not limited to, the number of personnel present, the airflow rate, ventilation
effectiveness, the operation of instruments or machinery, and activities in adjacent spaces.
For processes that inherently produce particles as part of the process and where these particles are
not a threat to the process or product, it may be appropriate to rely on periodic at-rest classification,
or operational classification of simulated operations, rather than monitoring of airborne particles in
operation. Other performance and cleanliness attributes may still be required to be monitored.
4.2 Risk assessment
Risk assessment is a systematic process of identification of hazards and the analysis and evaluation of
risks associated with exposure to those hazards.
A risk assessment shall be undertaken in order to
— develop a monitoring plan by determining factors that may affect the ability to maintain the agreed
air cleanliness by particle concentration of the cleanroom or clean zone, and
— determine the monitoring requirements to provide evidence of performance.
For guidance on what to consider when undertaking a risk assessment, see informative Annex A.
2 © ISO 2015 – All rights reserved

ISO 14644-2:2015(E)
4.3 Monitoring plan
4.3.1 The monitoring plan shall take into account the output from the risk assessment.
When developing the monitoring plan, the factors described in 4.3.2 to 4.3.13 shall be included as a
minimum.
4.3.2 Listing and justification of all the parameters to be monitored, including those that may affect the
airborne particle concentration.
4.3.3 Description and justification of measurement methods. For further guidance on considerations
when developing a monitoring plan, see informative Annex A.
4.3.4 Accuracy, maintenance and calibration of monitoring instrumentation.
4.3.5 Identification and justification of selected monitoring locations. Monitoring locations shall be
defined in three dimensions.
4.3.6 Identification and justification of monitoring acceptance criteria or limits, including
establishment of a single alarm level, or a dual alarm approach of alert and action levels. The minimum
requirement is that a single alarm action level is established. Additionally, an alarm alert level can be
established to provide early warning of performance deviation. For further guidance on setting alert and
action levels, see informative Annex B.
4.3.7 Specification of the response required should the data fall outside the specified limits.
4.3.8 The need for and frequency of periodic cleanroom or clean zone air cleanliness classification by
particle concentration in accordance with ISO 14644-1:2015, 5.1.
4.3.9 The format for recording data.
4.3.10 The methods, including statistical methods to be used for data trending or other appropriate
analysis.
4.3.11 The reporting requirements.
4.3.12 The policy and media to be used for record retention.
4.3.13 The frequency of review of the monitoring plan.
NOTE Monitoring plans are reviewed periodically; and based on the knowledge gained about the cleanroom
or clean zone, the monitoring programme is revised.
4.4 Calibration
Instrumentation used for monitoring shall be adequate to perform the monitoring operations required,
shall have a valid calibration certificate, and shall meet current accepted practices for the frequency
and method of calibration.
In particular for airborne particle counters, the frequency and method of calibration should be based
upon current accepted practice as specified in ISO 21501-4.
NOTE Some particle counters cannot be calibrated to all of the required tests in ISO 21501-4. If this is the
case, record the decision to use the counter in the monitoring plan.
ISO 14644-2:2015(E)
4.5 Review and approval
The completed plan shall be reviewed and approved.
4.6 Response to a deviation during monitoring
If monitoring results exceed the specified limit(s), an investigation shall be conducted to determine
cause, and remedial action taken as required.
If the remedial action requires significant changes to the installation and/or its operation, then the
classification test according to ISO 14644-1 shall be undertaken. The monitoring plan shall also be
reviewed as a result of the changes to the installation and/or its operation.
When the desired classification has been achieved, monitoring may be resumed.
5 Periodic classification of air cleanliness by particle concentration
Periodic classification testing shall be undertaken annually in accordance with ISO 14644-1. This
frequency can be extended based on risk assessment, the extent of the monitoring system, and data
that are consistently in compliance with acceptance limits or levels defined in the monitoring plan.
NOTE ISO 14644-3 specifies ancillary tests related to other aspects of cleanroom performance such as
pressure difference, airflow, etc.
4 © ISO 2015 – All rights reserved

ISO 14644-2:2015(E)
Annex A
(informative)
Matters to consider when developing a monitoring plan
A.1 Risk assessment considerations
A.1.1 Selection of an appr
...