In situ test methods for high efficiency filter systems in industrial facilities (ISO 16170:2016, Corrected version 2017-04)

This standard prescribes methods and equipment for periodic in-situ testing the performance of HEPA and ULPA filter installations. This standard applies to systems used for contamination control in the industrial applications including but not limited to nuclear, pharmaceutical and micro electronics industry, for which the efficiency of the systems is a required parameter.

Verfahren zur Prüfung von Luftfiltersystemen mit sehr hohen Wirkungsgraden im eingebauten Zustand (ISO 16170:2016, korrigierte Fassung 2017-04)

Diese Norm ist für Nutzer von HEPA- und ULPA-Filtern anwendbar, die die Leistung dieser in ihren Anwendungen eingebauten Filter vor Ort steuern wollen, insbesondere in einigen technischen Bereichen, in denen die Aerosolfilter verwendet werden, um die Freisetzung in die Umwelt einzuschränken (z. B. nukleare Anlagen oder Anlagen, aus denen toxische Aerosole oder biologische Stoffe freigesetzt werden). Von dieser Norm ist die Anwendung ausgenommen, die bereits in ISO 14644 3 (Reinräume und zugehörige Reinraumbereiche — Teil 3: Prüfverfahren) behandelt wird.
Der Anwendungsbereich dieser Norm umfasst Einzelheiten des Verfahrens bzw. der Verfahren, die für die regelmäßige Prüfung von HEPA- und ULPA-Filtern angewendet werden müssen, welche in anspruchsvollen Anwendungen mit dem Ziel, die Umwelt zu schützen, verwendet werden, wie z. B. in der Atomwirtschaft. Das schließt Beispiele für die anwendbare und nicht anwendbare Verwendung von Filtern ein sowie die Festlegung des Prüfintervalls, des Aerosoltyps, der Aerosolmischung und der Messverfahren.

Méthodes d'essai in situ pour les systèmes filtrants à très haute efficacité dans les installations industrielles (ISO 16170:2016, Version corrigée 2017-04)

L'ISO 16170 :2016 spécifie les méthodes d'essai in situ des filtres à très haute efficacité des particules contenues dans l'air utilisés afin de limiter les rejets dans l'environnement (par exemple, installations nucléaires ou installations rejetant des aérosols toxiques ou biologiques). Ceci s'applique lorsque des installations comprenant ces filtres sont utilisées, dans des installations industrielles (y compris nucléaires) dans lesquelles des matériaux toxiques/radioactifs/biologiques sont manipulés ou préparés, afin de nettoyer les effluents gazeux avant de les rejeter dans l'environnement.
Elle exclut l'application déjà traitée dans l'ISO 14644‑3.
Le domaine d'application de l'ISO 16170 :2016 inclut le détail de deux méthodes, qui s'appliquent toutes deux aux essais périodiques des filtres à très haute efficacité utilisés dans des applications exigeantes dans le but de protéger l'environnement, telles que l'industrie nucléaire.
Dans le cas des applications nucléaires, l'ISO 16170 :2016 est applicable aux installations couvertes par l'ISO 17873 (applications autres que les réacteurs nucléaires) et ISO 26802 (réacteurs nucléaires).
Les deux méthodes de référence spécifiées dans l'ISO 16170 :2016 ne sont pas équivalentes mais liées par les exigences présentées dans les résultats d'essai. Le choix d'utiliser l'une ou l'autre des deux méthodes dans chaque cas spécifique dépend si les résultats requièrent un essai d'intégrité ou un essai de quantification de l'efficacité à visée réglementaire.
Pour les industries manipulant ou préparant des matériaux radioactifs ou toxiques ayant pour conséquence un risque plus élevé de rejet possible, l'objectif principal des essais est de confirmer que l'installation de filtre est apte à l'emploi. Dans le cas d'essais d'intégrité (Annexe B), l'objectif est de confirmer qu'aucune fuite significative d'aérosols toxiques par l'installation de filtre n'est possible.
Dans le cas d'un essai d'efficacité réglementaire (Annexe C), l'essai est conçu pour faire une mesure précise du facteur de décontamination en fonction de la plage granulométrique MPPS.
La méthode de référence décrite à l'Annexe B (essai d'intégrité) requiert un aérosol d'essai de particules d'huile dispersées principalement dans la plage de dimensions submicronique, stable pendant le mode opératoire d'essai et compatible avec les autres composants de l'installation. Les concentrations de particule sont mesurées en temps réel par un détecteur à diffusion de lumière (détecteurs optiques).
La méthode de référence décrite à l'Annexe C (essai d'efficacité réglementaire) requiert un aérosol d'essai de particules ayant une plage de dimensions étroite centrée sur la plage granulométrique MPPS pour les média filtrants HEPA. Leurs concentrations en amont et en aval des filtres est mesurées par analyse fluométrique des solutions aqueuses obtenues en lavant la membrane des échantillons de filtres.
Il convient de noter que les exigences pour un essai d'efficacité réglementaire couvrent également les exigences d'un essai d'intégrité, qui est considéré comme une exigence minimum.
Les méthodes d'essai développées dans l'ISO 16170 :2016 ne couvrent pas les autres exigences de performance in situ telles que la résistance mécanique, résistance à l'éclatement ou résistance à l'humidité. Des systèmes spécifiques opérant à haute température ou produisant des effluents gazeux spécifiques peuvent être couverts par des méthodes d'essai spécifiques.
La conception d'ins

Metode za preskušanje vgrajenih visoko učinkovitih zračnih filtrskih sistemov v industrijskih postrojenjih (ISO 16170:2016, popravljena različica 2017-04)

Ta standard predpisuje metode in opremo za redno preskušanje učinkovitosti filtrirnih inštalacij HEPA in ULPA na mestu uporabe. Ta standard se uporablja za nadzor onesnaženosti v industrijskih aplikacijah, kar med drugim vključuje jedrsko, farmacevtsko in mikroelektronsko industrijo, kjer je učinkovitost sistemov obvezen parameter.

General Information

Status
Published
Publication Date
16-Aug-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-Aug-2016
Due Date
10-Oct-2016
Completion Date
17-Aug-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16170:2016
01-oktober-2016
Metode za preskušanje vgrajenih visoko učinkovitih zračnih filtrskih sistemov v
industrijskih postrojenjih (ISO 16170:2016, popravljena različica 2017-04)
In situ test methods for high efficiency filter systems in industrial facilities (ISO
16170:2016, Corrected version 2017-04)
Verfahren zur Prüfung von Luftfiltersystemen mit sehr hohen Wirkungsgraden im
eingebauten Zustand (ISO 16170:2016, korrigierte Fassung 2017-04)
Méthodes d'essai in situ pour les systèmes filtrants à très haute efficacité dans les
installations industrielles (ISO 16170:2016, Version corrigée 2017-04)
Ta slovenski standard je istoveten z: EN ISO 16170:2016
ICS:
91.140.30 Prezračevalni in klimatski Ventilation and air-
sistemi conditioning systems
SIST EN ISO 16170:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16170:2016

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SIST EN ISO 16170:2016


EN ISO 16170
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2016
EUROPÄISCHE NORM
ICS 91.140.30
English Version

In situ test methods for high efficiency filter systems in
industrial facilities (ISO 16170:2016, Corrected version
2017-04)
Méthodes d'essai in situ pour les systèmes filtrants à Verfahren zur Prüfung von Luftfiltersystemen mit sehr
très haute efficacité dans les installations industrielles hohen Wirkungsgraden im eingebauten Zustand (ISO
(ISO 16170:2016, Version corrigée 2017-04) 16170:2016, korrigierte Fassung 2017-04)
This European Standard was approved by CEN on 5 May 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, Serbia, 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 16170:2016 E
worldwide for CEN national Members.

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SIST EN ISO 16170:2016
EN ISO 16170:2016 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 16170:2016
EN ISO 16170:2016 (E)
European foreword
This document (EN ISO 16170:2016) has been prepared by Technical Committee ISO/TC 142 “Cleaning
equipment for air and other gases” in collaboration with Technical Committee CEN/TC 195 “Air filters
for general air cleaning” the secretariat of which is held by UNI.
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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 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 16170:2016, Corrected version 2017-04 has been approved by CEN as
EN ISO 16170:2016 without any modification.


3

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SIST EN ISO 16170:2016

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SIST EN ISO 16170:2016
INTERNATIONAL ISO
STANDARD 16170
First edition
2016-07-01
Corrected version
2017-04
In situ test methods for high efficiency
filter systems in industrial facilities
Méthodes d’essai in situ pour les systèmes filtrants à très haute
efficacité dans les installations industrielles
Reference number
ISO 16170:2016(E)
©
ISO 2016

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SIST EN ISO 16170:2016
ISO 16170:2016(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

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SIST EN ISO 16170:2016
ISO 16170:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Principle of the method . 4
5 Prerequisites . 6
5.1 Filter initial characterization . 6
5.2 Preparatory conditions . 6
5.2.1 General. 6
5.2.2 Choice of injection and sampling locations. 7
5.2.3 Conditions for the ventilation systems on which the test is performed . 7
5.2.4 Climatic conditions in the rooms where the injection/sampling is performed . 7
5.2.5 Apparatus selection and preparation . 8
5.2.6 Qualification of the test personnel .10
5.2.7 Health and safety .10
5.2.8 Test conditions.11
6 Test sequence .11
6.1 Evaluation of filtration system under test .11
6.2 Preparation of test equipment .12
6.3 Preparation of log sheets .12
6.4 Monitoring of climatic conditions .12
6.5 Aerosol generation setup .12
6.6 Sampling equipment setup .12
6.7 Monitoring of upstream challenge .12
6.8 Monitoring of downstream .13
6.9 Test performance .13
6.10 Calculations .13
7 Evaluation and report .14
Annex A (informative) Aerosol candidates for in situ testing .16
Annex B (normative) Integrity testing — Typical methodology using dispersed oil test aerosols .17
Annex C (normative) Efficiency accountancy testing — Uranine test method .26
Annex D (informative) Leakage test methods .33
Annex E (informative) Guideline for representative sampling .34
Bibliography .36
© ISO 2016 – All rights reserved iii

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SIST EN ISO 16170:2016
ISO 16170:2016(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/d irectives).
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/p atents).
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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO
principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary
information.
This document was prepared by Technical Committee ISO/TC 142, Cleaning equipment for air and other
gases.
This corrected version of ISO 16170:2016 incorporates the following corrections.
All figures have been replaced with higher quality diagrams.
In C.3.2 the key and cross-references within the text to Figure C.3 have been corrected.
iv © ISO 2016 – All rights reserved

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SIST EN ISO 16170:2016
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Introduction
Methods for measuring the performance of high efficiency gas cleaning devices are described in a
number of existing standards. These specify procedures for quality assurance following manufacture
(e.g. ISO 29463 and EN 1822).
Some other standards specify the filter medium used in such devices, how they are constructed and
how they are installed within industrial facilities.
Installations of high efficiency particulate filters are extensively used within nuclear and toxic material
processing plants and laboratories to confine these materials within the facility and prevent their
discharge to the environment.
Radioactive and other toxic materials are confined within processing facilities inside containment zones
bordered by barriers. Air and gases vented from these zones are decontaminated by passage through
a series of highly efficient particulate filters before final discharge to the environment. The membrane
(filter medium) of the filters acts as part of the containment barrier. In view of its perceived fragility,
confirmation of its integrity is required on a periodic basis because operational safety cases depend on
the knowledge that the effectiveness of these filters is maintained at all times. These periodic checks
are made by the procedure(s) known as “in-situ” or “in-place” testing.
The basic principles of in situ tests on installed filters are the same as for laboratory tests, such as those
described in EN 1822 and ISO 29463, insofar as known quantities of a challenge aerosol are dispersed
into the airstream upstream of the filter installation; the particulate contents of the unfiltered
and filtered air are sampled and analysed to determine whether the integrity of the filters has been
compromised.
In the case of testing a single unit (manufacturer’s production test or in the case of a laboratory testing
on a single filter unit), the purpose is to confirm that the unit performance [efficiency/penetration at
Most Penetrating Particle Size (MPPS) and other parameters] lies within specified limits, and further,
that the results are globally reproducible. To achieve this requires the use of a laboratory test rig
setup with full dispersion of a challenge aerosol, prescribed geometry of the test rig, and to obtain
and analyse fully representative particulate samples both upstream and downstream of the test filter.
Some ventilation systems are highly complex and it should be noted that many facilities use ventilation
systems in which a high percentage of the air is recirculated.
The purpose of an in situ test is to detect any adverse change in the filtration performance of the
installation and to compare it with the expected efficiency or decontamination factor. Such a change
might be caused by deterioration of a unit or units or a faulty sealing system and would be manifested
by the appearance of a proportion of unfiltered aerosol in the effluent airstream. Testing methodologies
developed in this International Standard do not cover the other requirements that relate to filters in
terms of mechanical resistance, burst strength or temperature and moisture resistance.
It is neither fully necessary nor useful for the results of an in situ test to replicate the results of
production tests on the individual filters in the installation, nor is it necessary to confine the test
aerosol size distribution to one which replicates that used in production tests.
No International Standard for general in situ testing of high efficiency filters has been produced before,
explaining the needs for such an International Standard.
This International Standard describes the requirements for test equipment, data interpretation and
reporting for the in situ testing of HEPA and ULPA air cleaning installations designed for the removal of
airborne particulate contamination in high-integrity ventilation systems.
This International Standard includes specification of the test interval, aerosol type, aerosol mixing and
measurement methods, i.e. the following:
— aerosol: solid or liquid, monodisperse or polydisperse;
— mixing: degree of mixing, mixing lengths, etc.;
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— method: injection, detection.
This International Standard proposes an outline testing philosophy to highlight the following:
— principle of the method;
— prerequisites;
— preparatory conditions;
— injected aerosol properties;
— qualification and selection of measuring devices;
— qualification of test personnel;
— test setup;
— test sequence;
— evaluation and reporting.
vi © ISO 2016 – All rights reserved

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SIST EN ISO 16170:2016
INTERNATIONAL STANDARD ISO 16170:2016(E)
In situ test methods for high efficiency filter systems in
industrial facilities
1 Scope
This International Standard specifies in situ test methods for high efficiency particulate air filters used
to limit releases towards the environment (e.g. from nuclear facilities or facilities with aerosol toxic or
biological releases). This applies where installations of these filters are used to clean effluent air before
discharge to the environment from industrial (including nuclear) installations where toxic/radioactive/
biological materials are handled or processed.
This International Standard excludes the application already covered by ISO 14644-3.
The scope of this International Standard includes detail of two methods, either of which applies to the
periodic testing of high efficiency filters which are used in demanding applications aiming at protecting
the environment, such as the nuclear industry.
In the case of nuclear applications, this International Standard is applicable to installations covered by
ISO 17873 (applications other than nuclear reactors) and ISO 26802 (nuclear reactors).
The two reference methods specified in this International Standard are not equivalent, but related to,
the requirements to be addressed by the test results. The choice of which of the two methods is adopted
in any specific case depends on whether the outcome requires an integrity test or a statutory efficiency
accountancy test.
For industries handling or processing radioactive or toxic materials giving rise to a risk of possible
release, the main goal of the tests is to confirm that the filter installation is fit for purpose. In the case
of integrity tests (Annex B), this is to confirm that no significant leakage of toxic aerosols through the
filter installation is possible.
In the case of efficiency accountancy tests (Annex C), the test is designed to make an accurate
measurement of decontamination factor with respect to the MPPS size range of particles.
The reference method described in Annex B (integrity test) requires a test aerosol of dispersed oil
particles mainly submicrometre in size range, which is stable during the test procedure and compatible
with other installation components. Particle concentrations are measured in real time by light
scattering instrumentation (optical detectors).
The reference method described in Annex C (efficiency accountancy test) requires a test aerosol
of particles having a narrow size range centred on MPPS size range for HEPA filter media. Their
concentration both upstream and downstream the filters is measured by fluorimetric analysis of
aqueous solution obtained by washing the membrane sampling filters.
It should be noted that the requirements for an efficiency accountancy test also cover the requirements
of an integrity test, which is considered to be a minimum requirement.
Test methods developed in this International Standard do not cover the other in situ performance
requirements, such as mechanical resistance, bursting resistance or humidity resistance. Specific
systems operating at high temperature or with specific gaseous effluents might require specific test
methods.
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SIST EN ISO 16170:2016
ISO 16170:2016(E)

The engineering design of HEPA and ULPA filter installations does not fall within the scope of this
International Standard.
NOTE In the field of filters for general ventilation applications, ISO 29462 is a detailed and comprehensive
description of a method which uses scanning and particle counting methods to evaluate the performance of a filter
in terms of particle grade efficiency, as well as pressure drop. Such a method and procedure would not be applicable
in those nuclear installations where quantification of the decontamination factor at MPPS size is needed.
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 29463-1, High-efficiency filters and filter media for removing particles in air — Part 1: Classification,
performance testing and marking
ISO 14644-3:2005, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 17873, Nuclear facilities — Criteria for the design and operation of ventilation systems for nuclear
installations other than nuclear reactors
ISO 26802, Nuclear facilities — Criteria for the design and the operation of containment and ventilation
systems for nuclear reactors
ISO 2889, Sampling airborne radioactive materials from the stacks and ducts of nuclear facilities
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aerosol
system of solid or liquid particles suspended in gas
Note 1 to entry: In general, one divides the atmospheric aerosol into three size categories: the ultrafine range
x ≤ 0,1 μm, the fine range 0,1 μm < x ≤ 1 μm, and the coarse range x > 1 μm, where x is the particle diameter.
[SOURCE: ISO 29464:2011, 3.1.1]
3.1.1
monodisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , is less than 1,15 μm
g
[SOURCE: ISO 29464:2011, 3.1.2]
3.1.2
polydisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , exceeds 1,5 μm
g
[SOURCE: ISO 29464:2011, 3.1.3]
3.1.3
quasi-monodisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , is between 1,15 μm and 1,5 μm
g
[SOURCE: ISO 29464:2011, 3.1.4]
2 © ISO 2016 – All rights reserved

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ISO 16170:2016(E)

3.1.4
test aerosol
aerosol (3.1) used for determining filter efficiency
3.2
decontamination factor
ratio between the concentration or particles number upstream the filter and the concentration or
particles number contamination downstream the filter
Note 1 to entry: This ratio is also defined by 1/(1- overall efficiency (3.13)).
3.3
effective filter media area
area of the media contained in the filter (without adhesive spaces or ligament) and passed by air during
operation
[SOURCE: ISO 29464:2011, 3.1.11]
3.4
efficiency
E
fraction of contaminant entering the filter which is retained
[SOURCE: ISO 29464:2011, 3.1.55]
3.5
efficiency accountancy test
in-situ test procedure meeting a requirement for an accurate system overall efficiency (3.13)
determination at MPPS (3.11)
3.6
integrity test
in-situ test procedure meeting the requirement for confirming the absence of unfiltered leakage of
the system
3.7
filter element
filtering material in a preformed shape being a part of a complete filter
[SOURCE: ISO 29464:2011, 3.1.67]
3.8
filter face area
frontal face area of the filter including the header frame
[SOURCE: ISO 29464:2011, 3.1.83]
3.9
HEPA filter
filter with performance complying with requirements of filter class ISO 35 – ISO 45 as per ISO 29463-1
[SOURCE: ISO 29464:2011, 3.1.88]
3.10
filter medium
material used for filtering
[SOURCE: ISO 29464:2011, 3.1.90]
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3.11
most penetrating particle size
MPPS
particle size at which the minimum of the particle size efficiency (3.14) curve occurs under test
conditions
Note 1 to entry: This MPPS is media and ventilation conditions dependent. This MPPS is in the 0,1 µm to 0,2 µm
medium aerodynamic size range for fibreglass type filters commonly used in nuclear applications.
[SOURCE: ISO 29464:2011, 3.1.129]
3.12
user nominal air volume flow rate
q
v,nom
air volume flow rate specified by the user, at which the filter element (3.7) is tested in situ
Note 1 to entry: This flow rate may be different from the one specified by the manufacturer.
3.13
overall efficiency
efficiency averaged over the whole superficial face area (3.15) of a filter element (3.7) under given
operating conditions of the filter
Note 1 to entry: It is expressed in percentage (%).
3.14
particle size efficiency
efficiency for a specific particle diameter
Note 1 to entry: The efficiency plotted as a function of the particle diameter gives the fractional efficiency curve.
Note 2 to entry: It is expressed in percentage (%).
3.15
superficial face area
cross-sectional area of the filter element (3.7) through which the air flow passes
3.16
ULPA filter
filters with performance complying with requirements of filter class ISO 55 – ISO 75 as per ISO 29463-1
[SOURCE: ISO 29464:2011, 3.1.100]
3.17
user nominal filter medium face velocity
nominal air volume flow rate divided by the effective filter medium (3.10) area
4 Principle of the method
For industries handling radioactive and/or toxic materials, the main goals of the tests are the following.
a) For efficiency accountancy tests: to confirm that the overall filtration efficiency, in particular the
decontamination factor for the MPPS size range and other performance parameters, remain within
the operating envelope criteria authorized in the site operating licence.
b) For integrity tests: to detect any significant leakages of airborne particles bypassing the filter media.
The test procedure follows the following sequence:
— measure the main ventilation parameters (e.g. flow rates, pressure drops, temperature and
humidity) of the system under test;
4 © ISO 2016 – All rights reserved

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— inject the appropriate quantity/quantities and type of the test aerosol into the airstream(s) upstream
of the filter installation with a size dist
...

SLOVENSKI STANDARD
SIST EN ISO 16170:2016
01-oktober-2016
0HWRGH]DSUHVNXãDQMHYJUDMHQLK]HORXþLQNRYLWLK]UDþQLKILOWUVNLKVLVWHPRYY
LQGXVWULMVNLKSRVWURMHQMLK ,62
In situ test methods for very high efficiency filter systems in industrial facilities (ISO
16170:2016)
Verfahren zur Prüfung von Luftfiltersystemen mit sehr hohen Wirkungsgraden im
eingebauten Zustand (ISO 16170:2016)
Méthodes d'essai in situ pour les systèmes filtrants à haute efficacité dans les
installations industrielles (ISO 16170:2016)
Ta slovenski standard je istoveten z: EN ISO 16170:2016
ICS:
91.140.30 3UH]UDþHYDOQLLQNOLPDWVNL Ventilation and air-
VLVWHPL conditioning systems
SIST EN ISO 16170:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16170:2016

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SIST EN ISO 16170:2016


EN ISO 16170
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2016
EUROPÄISCHE NORM
ICS 91.140.30
English Version

In situ test methods for high efficiency filter systems in
industrial facilities (ISO 16170:2016)
Méthodes d'essai in situ pour les systèmes filtrants à Verfahren zur Prüfung von Luftfiltersystemen mit sehr
très haute efficacité dans les installations industrielles hohen Wirkungsgraden im eingebauten Zustand (ISO
(ISO 16170:2016) 16170:2016)
This European Standard was approved by CEN on 5 May 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 16170:2016 E
worldwide for CEN national Members.

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SIST EN ISO 16170:2016
EN ISO 16170:2016 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 16170:2016
EN ISO 16170:2016 (E)
European foreword
This document (EN ISO 16170:2016) has been prepared by Technical Committee ISO/TC 142 “Cleaning
equipment for air and other gases” in collaboration with Technical Committee CEN/TC 195 “Air filters
for general air cleaning” the secretariat of which is held by UNI.
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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 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 16170:2016 has been approved by CEN as EN ISO 16170:2016 without any modification.
3

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SIST EN ISO 16170:2016

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SIST EN ISO 16170:2016
INTERNATIONAL ISO
STANDARD 16170
First edition
2016-07-01
In situ test methods for high efficiency
filter systems in industrial facilities
Méthodes d’essai in situ pour les systèmes filtrants à très haute
efficacité dans les installations industrielles
Reference number
ISO 16170:2016(E)
©
ISO 2016

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SIST EN ISO 16170:2016
ISO 16170:2016(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

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SIST EN ISO 16170:2016
ISO 16170:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Principle of the method . 4
5 Prerequisites . 6
5.1 Filter initial characterization . 6
5.2 Preparatory conditions . 6
5.2.1 General. 6
5.2.2 Choice of injection and sampling locations. 7
5.2.3 Conditions for the ventilation systems on which the test is performed . 7
5.2.4 Climatic conditions in the rooms where the injection/sampling is performed . 7
5.2.5 Apparatus selection and preparation . 8
5.2.6 Qualification of the test personnel .10
5.2.7 Health and safety .10
5.2.8 Test conditions.11
6 Test sequence .11
6.1 Evaluation of filtration system under test .11
6.2 Preparation of test equipment .12
6.3 Preparation of log sheets .12
6.4 Monitoring of climatic conditions .12
6.5 Aerosol generation setup .12
6.6 Sampling equipment setup .12
6.7 Monitoring of upstream challenge .12
6.8 Monitoring of downstream .13
6.9 Test performance .13
6.10 Calculations .13
7 Evaluation and report .14
Annex A (informative) Aerosol candidates for in situ testing .16
Annex B (normative) Integrity testing — Typical methodology using dispersed oil test aerosols .17
Annex C (normative) Efficiency accountancy testing — Uranine test method .26
Annex D (informative) Leakage test methods .33
Annex E (informative) Guideline for representative sampling .34
Bibliography .36
© ISO 2016 – All rights reserved iii

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SIST EN ISO 16170:2016
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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 142, Cleaning equipment for air and other gases.
iv © ISO 2016 – All rights reserved

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SIST EN ISO 16170:2016
ISO 16170:2016(E)

Introduction
Methods for measuring the performance of high efficiency gas cleaning devices are described in a
number of existing standards. These specify procedures for quality assurance following manufacture
(e.g. ISO 29463 and EN 1822).
Some other standards specify the filter medium used in such devices, how they are constructed and
how they are installed within industrial facilities.
Installations of high efficiency particulate filters are extensively used within nuclear and toxic material
processing plants and laboratories to confine these materials within the facility and prevent their
discharge to the environment.
Radioactive and other toxic materials are confined within processing facilities inside containment zones
bordered by barriers. Air and gases vented from these zones are decontaminated by passage through
a series of highly efficient particulate filters before final discharge to the environment. The membrane
(filter medium) of the filters acts as part of the containment barrier. In view of its perceived fragility,
confirmation of its integrity is required on a periodic basis because operational safety cases depend on
the knowledge that the effectiveness of these filters is maintained at all times. These periodic checks
are made by the procedure(s) known as “in-situ” or “in-place” testing.
The basic principles of in situ tests on installed filters are the same as for laboratory tests, such as those
described in EN 1822 and ISO 29463, insofar as known quantities of a challenge aerosol are dispersed
into the airstream upstream of the filter installation; the particulate contents of the unfiltered
and filtered air are sampled and analysed to determine whether the integrity of the filters has been
compromised.
In the case of testing a single unit (manufacturer’s production test or in the case of a laboratory testing
on a single filter unit), the purpose is to confirm that the unit performance [efficiency/penetration at
Most Penetrating Particle Size (MPPS) and other parameters] lies within specified limits, and further,
that the results are globally reproducible. To achieve this requires the use of a laboratory test rig
setup with full dispersion of a challenge aerosol, prescribed geometry of the test rig, and to obtain
and analyse fully representative particulate samples both upstream and downstream of the test filter.
Some ventilation systems are highly complex and it should be noted that many facilities use ventilation
systems in which a high percentage of the air is recirculated.
The purpose of an in situ test is to detect any adverse change in the filtration performance of the
installation and to compare it with the expected efficiency or decontamination factor. Such a change
might be caused by deterioration of a unit or units or a faulty sealing system and would be manifested
by the appearance of a proportion of unfiltered aerosol in the effluent airstream. Testing methodologies
developed in this International Standard do not cover the other requirements that relate to filters in
terms of mechanical resistance, burst strength or temperature and moisture resistance.
It is neither fully necessary nor useful for the results of an in situ test to replicate the results of
production tests on the individual filters in the installation, nor is it necessary to confine the test
aerosol size distribution to one which replicates that used in production tests.
No International Standard for general in situ testing of high efficiency filters has been produced before,
explaining the needs for such an International Standard.
This International Standard describes the requirements for test equipment, data interpretation and
reporting for the in situ testing of HEPA and ULPA air cleaning installations designed for the removal of
airborne particulate contamination in high-integrity ventilation systems.
This International Standard includes specification of the test interval, aerosol type, aerosol mixing and
measurement methods, i.e. the following:
— aerosol: solid or liquid, monodisperse or polydisperse;
— mixing: degree of mixing, mixing lengths, etc.;
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— method: injection, detection.
This International Standard proposes an outline testing philosophy to highlight the following:
— principle of the method;
— prerequisites;
— preparatory conditions;
— injected aerosol properties;
— qualification and selection of measuring devices;
— qualification of test personnel;
— test setup;
— test sequence;
— evaluation and reporting.
vi © ISO 2016 – All rights reserved

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SIST EN ISO 16170:2016
INTERNATIONAL STANDARD ISO 16170:2016(E)
In situ test methods for high efficiency filter systems in
industrial facilities
1 Scope
This International Standard specifies in situ test methods for high efficiency particulate air filters used
to limit releases towards the environment (e.g. from nuclear facilities or facilities with aerosol toxic or
biological releases). This applies where installations of these filters are used to clean effluent air before
discharge to the environment from industrial (including nuclear) installations where toxic/radioactive/
biological materials are handled or processed.
This International Standard excludes the application already covered by ISO 14644-3.
The scope of this International Standard includes detail of two methods, either of which applies to the
periodic testing of high efficiency filters which are used in demanding applications aiming at protecting
the environment, such as the nuclear industry.
In the case of nuclear applications, this International Standard is applicable to installations covered by
ISO 17873 (applications other than nuclear reactors) and ISO 26802 (nuclear reactors).
The two reference methods specified in this International Standard are not equivalent, but related to,
the requirements to be addressed by the test results. The choice of which of the two methods is adopted
in any specific case depends on whether the outcome requires an integrity test or a statutory efficiency
accountancy test.
For industries handling or processing radioactive or toxic materials giving rise to a risk of possible
release, the main goal of the tests is to confirm that the filter installation is fit for purpose. In the case
of integrity tests (Annex B), this is to confirm that no significant leakage of toxic aerosols through the
filter installation is possible.
In the case of efficiency accountancy tests (Annex C), the test is designed to make an accurate
measurement of decontamination factor with respect to the MPPS size range of particles.
The reference method described in Annex B (integrity test) requires a test aerosol of dispersed oil
particles mainly submicrometre in size range, which is stable during the test procedure and compatible
with other installation components. Particle concentrations are measured in real time by light
scattering instrumentation (optical detectors).
The reference method described in Annex C (efficiency accountancy test) requires a test aerosol
of particles having a narrow size range centred on MPPS size range for HEPA filter media. Their
concentration both upstream and downstream the filters is measured by fluorimetric analysis of
aqueous solution obtained by washing the membrane sampling filters.
It should be noted that the requirements for an efficiency accountancy test also cover the requirements
of an integrity test, which is considered to be a minimum requirement.
Test methods developed in this International Standard do not cover the other in situ performance
requirements, such as mechanical resistance, bursting resistance or humidity resistance. Specific
systems operating at high temperature or with specific gaseous effluents might require specific test
methods.
© ISO 2016 – All rights reserved 1

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SIST EN ISO 16170:2016
ISO 16170:2016(E)

The engineering design of HEPA and ULPA filter installations does not fall within the scope of this
International Standard.
NOTE In the field of filters for general ventilation applications, ISO 29462 is a detailed and comprehensive
description of a method which uses scanning and particle counting methods to evaluate the performance of a filter
in terms of particle grade efficiency, as well as pressure drop. Such a method and procedure would not be applicable
in those nuclear installations where quantification of the decontamination factor at MPPS size is needed.
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 29463-1, High-efficiency filters and filter media for removing particles in air — Part 1: Classification,
performance testing and marking
ISO 14644-3:2005, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 17873, Nuclear facilities — Criteria for the design and operation of ventilation systems for nuclear
installations other than nuclear reactors
ISO 26802, Nuclear facilities — Criteria for the design and the operation of containment and ventilation
systems for nuclear reactors
ISO 2889, Sampling airborne radioactive materials from the stacks and ducts of nuclear facilities
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aerosol
system of solid or liquid particles suspended in gas
Note 1 to entry: In general, one divides the atmospheric aerosol into three size categories: the ultrafine range
x ≤ 0,1 μm, the fine range 0,1 μm < x ≤ 1 μm, and the coarse range x > 1 μm, where x is the particle diameter.
[SOURCE: ISO 29464:2011, 3.1.1]
3.1.1
monodisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , is less than 1,15 μm
g
[SOURCE: ISO 29464:2011, 3.1.2]
3.1.2
polydisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , exceeds 1,5 μm
g
[SOURCE: ISO 29464:2011, 3.1.3]
3.1.3
quasi-monodisperse aerosol
aerosol (3.1), the width of whose distribution function, described by the geometric standard deviation
σ , is between 1,15 μm and 1,5 μm
g
[SOURCE: ISO 29464:2011, 3.1.4]
2 © ISO 2016 – All rights reserved

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ISO 16170:2016(E)

3.1.4
test aerosol
aerosol (3.1) used for determining filter efficiency
3.2
decontamination factor
ratio between the concentration or particles number upstream the filter and the concentration or
particles number contamination downstream the filter
Note 1 to entry: This ratio is also defined by 1/(1- overall efficiency (3.13)).
3.3
effective filter media area
area of the media contained in the filter (without adhesive spaces or ligament) and passed by air during
operation
[SOURCE: ISO 29464:2011, 3.1.11]
3.4
efficiency
E
fraction of contaminant entering the filter which is retained
[SOURCE: ISO 29464:2011, 3.1.55]
3.5
efficiency accountancy test
in-situ test procedure meeting a requirement for an accurate system overall efficiency (3.13)
determination at MPPS (3.11)
3.6
integrity test
in-situ test procedure meeting the requirement for confirming the absence of unfiltered leakage of
the system
3.7
filter element
filtering material in a preformed shape being a part of a complete filter
[SOURCE: ISO 29464:2011, 3.1.67]
3.8
filter face area
frontal face area of the filter including the header frame
[SOURCE: ISO 29464:2011, 3.1.83]
3.9
HEPA filter
filter with performance complying with requirements of filter class ISO 35 – ISO 45 as per ISO 29463-1
[SOURCE: ISO 29464:2011, 3.1.88]
3.10
filter medium
material used for filtering
[SOURCE: ISO 29464:2011, 3.1.90]
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3.11
most penetrating particle size
MPPS
particle size at which the minimum of the particle size efficiency (3.14) curve occurs under test
conditions
Note 1 to entry: This MPPS is media and ventilation conditions dependent. This MPPS is in the 0,1 µm to 0,2 µm
medium aerodynamic size range for fibreglass type filters commonly used in nuclear applications.
[SOURCE: ISO 29464:2011, 3.1.129]
3.12
user nominal air volume flow rate
q
v,nom
air volume flow rate specified by the user, at which the filter element (3.7) is tested in situ
Note 1 to entry: This flow rate may be different from the one specified by the manufacturer.
3.13
overall efficiency
efficiency averaged over the whole superficial face area (3.15) of a filter element (3.7) under given
operating conditions of the filter
Note 1 to entry: It is expressed in percentage (%).
3.14
particle size efficiency
efficiency for a specific particle diameter
Note 1 to entry: The efficiency plotted as a function of the particle diameter gives the fractional efficiency curve.
Note 2 to entry: It is expressed in percentage (%).
3.15
superficial face area
cross-sectional area of the filter element (3.7) through which the air flow passes
3.16
ULPA filter
filters with performance complying with requirements of filter class ISO 55 – ISO 75 as per ISO 29463-1
[SOURCE: ISO 29464:2011, 3.1.100]
3.17
user nominal filter medium face velocity
nominal air volume flow rate divided by the effective filter medium (3.10) area
4 Principle of the method
For industries handling radioactive and/or toxic materials, the main goals of the tests are the following.
a) For efficiency accountancy tests: to confirm that the overall filtration efficiency, in particular the
decontamination factor for the MPPS size range and other performance parameters, remain within
the operating envelope criteria authorized in the site operating licence.
b) For integrity tests: to detect any significant leakages of airborne particles bypassing the filter media.
The test procedure follows the following sequence:
— measure the main ventilation parameters (e.g. flow rates, pressure drops, temperature and
humidity) of the system under test;
4 © ISO 2016 – All rights reserved

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— inject the appropriate quantity/quantities and type of the test aerosol into the airstream(s) upstream
of the filter installation with a size distribution covering the MPPS range;
— measure the concentration of aerosol challenging the filter installation upstream of the filters;
— measure the quantity of aerosol present in the airflow downstream of the filter installation;
— calculate the efficiency or decontamination factor(s) within a size range covering the most
penetrating particle size (MPPS);
— compare the measured value(s) against the required regulatory value(s) or other criteria, such as
MPPS filter classification.
Figure 1 shows one general
...

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