Iso Dis 14644 6

DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-6
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:

2005-11-10 2006-04-10
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Cleanrooms and associated controlled environments —

Part 6:
Vocabulary
Salles propres et environnements maîtrisés apparentés —
Partie 6: Vocabulaire
ICS 13.040.35
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ISO/DIS 14644-6
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ii © ISO 2005 – All rights reserved
ISO/DIS 14644-6
Contents Page
1 Scope ..................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 1
3 Terms and definitions........................................................................................................................... 2

© ISO 2005 – All rights reserved iii

ISO/DIS 14644-6
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14644-6 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
⎯ Part 1: Classification of air cleanliness
⎯ Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
⎯ Part 3: Test methods
⎯ Part 4: Design, construction and start-up
⎯ Part 5: Operations
⎯ Part 6: Terms and definitions
⎯ Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
⎯ Part 8: Classification of airborne molecular contamination
Also included in this part of ISO 14644 are the terms and definitions used in ISO 14698 which consists of the
following parts, under the general title Cleanrooms and associated controlled environments ⎯
Biocontamination control:
⎯ Part 1: General principles and methods
⎯ Part 2: Evaluation and interpretation of biocontamination data

iv © ISO 2005 – All rights reserved

ISO/DIS 14644-6
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and
processes that benefit from the control of airborne contamination include those in the aerospace,
microelectronic, pharmaceutical, medical device, food, and healthcare industries.
This part of ISO 14644 compiles the terms and the definitions used in the other parts of ISO 14644 and ISO
14698 prepared by ISO/TC 209, i.e. 14644-1, 14644-2, 14644-3, 14644-4, 14644-5, 14644-7, 14644-8,
14698-1 and 14698-2.
The terms and definitions listed in this part of ISO 14644 have been taken verbatim from all the other parts.
Therefore, in some cases two different definitions appear for the same term.

© ISO 2005 – All rights reserved v

DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-6
Cleanrooms and associated controlled environments —

Part 6:
Vocabulary
1 Scope
This part of ISO 14644 is a verbatim compendium of terms and definitions used in ISO 14644-1, 14644-2,
14644-3, 14644-4, 14644-5, 14644-7, 14644-8, 14698-1 and 14698-2.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing
and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-3:1), Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14644-5:2004, Cleanrooms and associated controlled environments — Part 5: Operations
ISO 14644-7:2004, Cleanrooms and associated controlled environments — Part 7: Separative devices (clean
air hoods, gloveboxes, isolators and mini-environments)
ISO 14644-8:1), Cleanrooms and associated controlled environments — Part 8: Classification of airborne
molecular contamination
ISO 14698-1:2003, Cleanrooms and associated controlled environments ⎯ Biocontamination control: Part 1:
General principles and methods
ISO 14698-2:2003, Cleanrooms and associated controlled environments ⎯ Biocontamination control:

Part 2: Evaluation and interpretation of biocontamination data
1) To be published.
© ISO 2005 – All rights reserved 1

ISO/DIS 14644-6
3 Terms and definitions

For the purposes of this part of ISO 14644, the following terms and definitions apply. Italics are used within the
definition of each term to indicate a term that has its own definition in this clause.
3.1 6 months
updating that occurs at an average interval not exceeding 183 days throughout periods of operational use,
subject to no interval exceeding 190 days
[ISO 14644-2:2000, 3.2.3]
3.2 12 months
[ISO 14644-2:2000, 3.2.4]
3.3 24 months
[ISO 14644-2:2000, 3.2.5]
3.4 access device
device for manipulation of processes, tools or products within the separative device
[ISO 14644-7:2004, 3.1]
3.5 acid
species whose chemical reaction characteristic is to establish new bonds by the acceptance of electron pairs
[ISO/DIS 14644-8:2004, 3.2.1]
3.6 action level
level set by the user in the context of controlled environments, which, when exceeded, requires immediate
intervention, including the investigation of cause, and corrective action
[ISO 14644-7:2004, 3.2] [ISO 14698-1:2003, 3.1.1] [ISO 14698-2:2003, 3.1]
3.7 aerosol challenge
challenging of a filter or an installed filter system by test aerosol
[ISO/FDIS 14644-3:2004, 3.3.1]

2 © ISO 2005 – All rights reserved

ISO/DIS 14644-6
3.8 aerosol generator
instrument capable of generating particulate matter having appropriate size range (e.g. 0.05µm to 2µm) at a
constant concentration, which may be produced by thermal, hydraulic, pneumatic, acoustic, or electrostatic
means
[ISO/FDIS 14644-3:2004, 3.2.1]
3.9 aerosol photometer
light-scattering airborne particle mass concentration measuring apparatus, which uses a forward-scattered-
light optical chamber to make measurements
[ISO/FDIS 14644-3:2004, 3.6.1]
3.10 air exchange rate
rate of air exchange expressed as number of air changes per unit of time and calculated by dividing the
volume of air delivered in the unit of time by the volume of the space
[ISO/FDIS 14644-3:2004, 3.4.1]
3.11 airborne molecular contamination

AMC
presence in the atmosphere of a cleanroom or controlled environment of molecular (chemical, non-particulate)
species in the gaseous or vapour state that may have a deleterious effect on the product, process or
equipment in the cleanroom or controlled environment
NOTE This definition does not include biomolecules, which are judged to be particulates.
[ISO/DIS 14644-8:2004, 3.1.2]
3.12 airborne particle
solid or liquid object suspended in air, viable or non-viable, sized (for the purpose of this part of ISO 146442))
between 1 nm and 100 µm
NOTE For classification purposes refers to ISO 14644-1:1999, 2.2.13).
[ISO/FDIS 14644-3:2004, 3.2.2]
3.13 alert level
level set by the user in the context of controlled environments, giving early warning of a drift from normal
conditions, which, when exceeded, should result in increased attention to the process
[ISO 14644-7:2004, 3.3] [ISO 14698-1:2003, 3.1.2] [ISO 14698-2:2003, 3.2]
2) ISO 14644-3
3) See 3.103 of this part of ISO 14644


ISO/DIS 14644-6
3.14 anisokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inlet is significantly different
from the mean velocity of the unidirectional airflow at that location
[ISO/FDIS 14644-3:2004, 3.6.2]
3.15 as-built
condition where the installation is complete with all services connected and functioning, but with no production
equipment, materials or personnel present
[ISO 14644-1:1999, 2.4.1] [ISO/FDIS 14644-3:2004, 3.7.1] [ISO 14644-5:2004, 3.2.1] [ISO 14698-1:2003,
3.2.1]
3.16 at-rest
condition where the installation is complete with equipment installed and operating in a manner agreed upon
by the customer and supplier, but with no personnel present
3.2.2]
3.17 audit trail
chain of related documents, or entries within records, that allows related information to be traced
[ISO 14698-2:2003, 3.3]
3.18 average air flow rate
averaged volume of air per unit of time, to determine the air exchange rate in a cleanroom or clean zone
3
NOTE Air flow rate is expressed in cubic metres per hour (m /h).
[ISO/FDIS 14644-3:2004, 3.4.2]
3.19 barrier
means employed to provide separation
[ISO 14644-7:2004, 3.4]
3.20 base
species whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs
[ISO/DIS 14644-8:2004, 3.2.2]
3.21 bioaerosol
dispersed biological agents in a gaseous environment
[ISO 14698-1:2003, 3.1.3]


ISO/DIS 14644-6
3.22 biocleanroom
cleanroom used for products and processes that are sensitive to microbiological contamination
[ISO 14644-5:2004, 3.1.1]
3.23 biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
[ISO 14698-1:2003, 3.1.4] [ISO 14698-2:2003, 3.4]
3.24 biotoxic
contaminant species that is obnoxious to the development and preservation of the life of organisms,
microorganisms, tissues or individual cells
[ISO/DIS 14644-8:2004, 3.2.3]
3.25 breach velocity
velocity through an aperture sufficient to prevent movement of matter in the direction opposite to the flow
[ISO 14644-7:2004, 3.5]
3.26 cascade impactor
sampling device, which collects particles from an aerosol using the principle of impaction upon a series of
collector surfaces
NOTE Each successive collector surface is exposed to an aerosol stream flowing at a higher velocity than was the
previous one, thus allowing collection of smaller particles than the previous one.
[ISO/FDIS 14644-3:2004, 3.6.3]
3.27 changing room
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
[ISO 14644-4:2001, 3.1] [ISO 14644-5:2004, 3.1.2]
3.28 classification
level (or the process of specifying or determining the level) of airborne particulate cleanliness applicable to a
cleanroom or clean zone, expressed in terms of an ISO Class N, which represents maximum allowable
concentrations (in particles per cubic metre of air) for considered sizes of particles
NOTE 1 The concentrations are determined by using equation (1) in 3.24).
NOTE 2 Classification in accordance with this International Standard is limited to the range extending from ISO Class 1
through ISO Class 9.
NOTE 3 The considered particle sizes (lower threshold values) applicable for classification in accordance with this
International Standard are limited to the range from 0,1 µm through 5 µm. Air cleanliness may be described and specified
4) Equation (1) in ISO 14644-1, 3.2


ISO/DIS 14644-6
(but not classified) in terms of U descriptors or M descriptors (see 2.3.1 or 2.3.2)5) for considered threshold particle sizes
that are outside of the range covered by classification.
NOTE 4 Intermediate ISO classification numbers may be specified, with 0,1 the smallest permitted increment; i.e., the
range of intermediate ISO classes extends from ISO Class 1,1 through ISO Class 8,9.
NOTE 5 Classification may be specified or accomplished in any of three occupancy states (see 2.4)6).
[ISO 14644-1:1999, 2.1.4]
3.29 clean air device
stand-alone equipment for treating and distributing clean air to achieve defined environmental conditions
[ISO 14644-4:2001, 3.2]
3.30 cleanliness
condition of a product, surface, device, gas, fluid, etc. with a defined level of contamination
NOTE Contamination can be particulate, non-particulate, biological, molecular or of other consistency.
[ISO 14644-4:2001, 3.3]
3.31 cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a
manner to minimize the introduction, generation, and retention of particles inside the room, and in which other
relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary
[ISO 14644-1:1999, 2.1.1] [ISO/FDIS 14644-3:2004, 3.1.1] [ISO 14698-1:2003, 3.1.5] [ISO 14698-2:2003, 3.5]
3.32 clean zone
dedicated space in which the concentration of airborne particles is controlled, and which is constructed and
used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in
which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary
NOTE This zone may be open or enclosed and may or may not be located within a cleanroom.
[ISO 14644-1:1999, 2.1.2] [ISO/FDIS 14644-3:2004, 3.1.2]
3.33 commissioning
planned and documented series of inspections, adjustments, and tests carried out systematically to set the
installation into correct technical operation as specified
[ISO 14644-4:2001, 3.4]
3.34 condensable
species capable of depositing on a surface by condensation, under cleanroom operating conditions
5) See 3.89 or 3.136 of this part of ISO 14644
6) See 3.17, 3.18 and 3.97 of this part of ISO 14644


ISO/DIS 14644-6
[ISO/DIS 14644-8:2004, 3.2.4]
3.35 condensation nucleus counter

CNC
instrument that is capable of enlarging ultrafine particles by means of condensation for subsequent counting
using optical particle counting techniques
[ISO/FDIS 14644-3:2004, 3.6.4]
3.36 contact device
specially designed appliance holding an appropriate, sterile, culture medium with an accessible surface used
for surface sampling
[ISO 14698-1:2003, 3.1.6]
3.37 contact plate
contact device where the container is a rigid dish
[ISO 14698-1:2003, 3.1.7]
3.38 containment
state achieved by separative devices with high degree of separation between operator and operation
[ISO 14644-7:2004, 3.6]
3.39 contaminant
any particulate, molecular, non-particulate and biological entity that can adversely affect the product or
process
[ISO 14644-4:2001, 3.5]
3.40 contaminant category
common name for a group of compounds with a specific an similar deleterious effect when deposited on the
surface of interest
[ISO/DIS 14644-8:2004, 3.1.4]
3.41 continuous
updating that occurs constantly
[ISO 14644-2:2000, 3.2.1]
3.42 control point
point in a controlled environment at which control is applied and a hazard can be prevented, eliminated or
reduced to acceptable levels
[ISO 14698-1:2003, 3.1.8]


ISO/DIS 14644-6
3.43 controlled environment
defined zone in which sources of contamination are controlled by specified means
[ISO 14698-1:2003, 3.1.9]
3.44 corrective action
action to be taken when the results of monitoring indicate that alert or action levels are exceeded
[ISO 14698-1:2003, 3.1.10]
3.45 corrosive
species that causes destructive chemical change of a surface
[ISO/DIS 14644-8:2004, 3.2.5]
3.46 count median particle diameter

CMD
median particle diameter based on the number of particles
NOTE For the count median, one half of the particle number is contributed by particles with a size smaller that the
count median size, and one half by particles larger that the count median size
[ISO/FDIS 14644-3:2004, 3.2.3]
3.47 counting efficiency
ratio of the reported concentration of particles in a given size range to the actual concentration of such
particles
[ISO/FDIS 14644-3:2004, 3.6.5]
3.48 cross-over bench
bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of
floor contamination
[ISO 14644-5:2004, 3.1.3]
3.49 customer
organization, or the agent thereof, responsible for specifying the requirements of a cleanroom or clean zone
[ISO 14644-1:1999, 2.5.1]
3.50 data stratification
regrouping of data so that important trends and deviations can be more easily seen and understood
[ISO 14698-2:2003, 3.6]


ISO/DIS 14644-6
3.51 decontamination
reduction of unwanted matter to a defined level
[ISO 14644-7:2004, 3.7]
3.52 designated leak
maximum allowable penetration, which is determined by agreement between customer and supplier, through
a leak, detectable during scanning of an installation with discrete-particle counters or aerosol photometers
[ISO/FDIS 14644-3:2004, 3.3.2]
3.53 differential mobility analyzer

DMA
instrument for measuring the particle size distribution, based on the electrical mobility of particles
[ISO/FDIS 14644-3:2004, 3.6.6]
3.54 diffusion battery element
individual component from a multi-stage particle size cutoff device, operating on the principle of diffusion to
remove smaller particles from an aerosol stream
[ISO/FDIS 14644-3:2004, 3.6.7]
3.55 dilution system
system wherein aerosol is mixed with particle-free dilution air in a known volumetric ratio to reduce
concentration
[ISO/FDIS 14644-3:2004, 3.3.3]
3.56 discharge time
time required to reduce the voltage to the level, positive or negative, to which an isolated conductive
monitoring plate was originally charged
[ISO/FDIS 14644-3:2004, 3.5.1]
3.57 discrete-particle counter

DPC
instrument having a means of displaying and recording the count and size of discrete particles (with a size
discrimination) for specific air volume
[ISO/FDIS 14644-3:2004, 3.6.8]
3.58 disinfection
removal, destruction, or de-activation of micro-organisms on objects or surfaces
[ISO 14644-5:2004, 3.1.4]


ISO/DIS 14644-6
3.59 dopant
species that, after sorption and/or diffusion, is incorporated in the bulk of a product and is capable of changing
the properties of materials, even in trace amounts
[ISO/DIS 14644-8:2004, 3.2.6]
3.60 estimate
value of an estimator obtained as a result of an estimation
[ISO 14698-2:2003, 3.7]
3.61 estimation
operation of assigning, from the observations in a sample, numerical values to the parameters of a distribution
chosen as the statistical model for the population from which this sample is taken
[ISO 14698-2:2003, 3.8]
3.62 estimator
statistic to estimate a population parameter
[ISO 14698-2:2003, 3.9]
3.63 false count

background noise count
zero count
count produced by a discrete-particle counter due to internal or external unwanted electronic signal when no
particles exist
[ISO/FDIS 14644-3:2004, 3.6.9]
3.64 fibre
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7] [ISO 14644-5:2004, 3.1.5]
3.65 filter system
system composed of filter, frame and other support system or other housing
[ISO/FDIS 14644-3:2004, 3.3.4]
3.66 final filter
filters in a final position before the air enters the cleanroom
[ISO/FDIS 14644-3:2004, 3.3.5]


ISO/DIS 14644-6
3.67 flowhood with flowmeter
device with apparatus to directly measure the airflow volume at each final filter or air diffuser in an installation,
set up to completely cover the filter or diffuser
[ISO/FDIS 14644-3:2004, 3.6.10]
3.68 Formal System
system of biocontamination control with established and documented procedures
[ISO 14698-1:2003, 3.1.11]
3.69 frequent
updating that occurs at specified intervals not exceeding 60 minutes during operation
[ISO 14644-2:2000, 3.2.2]
3.70 gauntlet
one-piece glove covering the full arm-length
[ISO 14644-7:2004, 3.8]
3.71 glove
(of separative devices) component of an access device that maintains an effective barrier while enabling the
hands of the operator to enter the enclosed volume of an separative device
[ISO 14644-7:2004, 3.9]
3.72 glove port
attachment site for gloves, sleeves and gauntlets
[ISO 14644-7:2004, 3.10]
3.73 glove sleeve system
multi-component access device that maintains an effective barrier while enabling replacement of the sleeve
piece, connecting cuff piece and the glove
[ISO 14644-7:2004, 3.11]
3.74 half-suit
access device that maintains an effective barrier while enabling the head, trunk and arms of the operator to
enter the working space of the separative device
[ISO 14644-7:2004, 3.12]
3.75 hazard
potential source of harm


ISO/DIS 14644-6
[ISO 14698-1:2003, 3.1.12]
3.76 hazard
biological, chemical or physical element or factor that adversely affects individuals, the environment, process
or product
[ISO 14698-2:2003, 3.10]
3.77 hourly leak rate
Rh
ratio of the hourly leakage q of the containment enclosure under normal working conditions (pressure and
temperature) to the volume V of the said containment enclosure
NOTE It is expressed in reciprocal hours (h –1 ).
[ISO 14644-7:2004, 3.13]
3.78 impact sampler
device designed to sample particles in the air, or other gas, through a collision with a solid surface
[ISO 14698-1:2003, 3.1.13]
3.79 impingement sampler
device designed to sample particles in the air, or other gas, through a collision with a liquid surface and the
subsequent entering into the liquid
[ISO 14698-1:2003, 3.1.14]
3.80 installation
cleanroom or one or more clean zones, together with all associated structures, air-treatment systems,
services, and utilities
[ISO 14644-1:1999, 2.1.3] [ISO/FDIS 14644-3:2004, 3.1.3]
3.81 installed filter system
filter system mounted in the ceiling, wall, apparatus or duct
[ISO/FDIS 14644-3:2004, 3.3.6]
3.82 installed filter system leakage test
test performed to confirm that the filters are properly installed by verifying that there is absence of bypass
leakage in the installation, and that the filters and the grid system are free of defects and leaks
[ISO/FDIS 14644-3:2004, 3.3.7]
3.83 iso-axial sampling
sampling condition in which the direction of the airflow into the sample probe inlet is the same as that of the
unidirectional airflow being sampled

ISO/DIS 14644-6
[ISO/FDIS 14644-3:2004, 3.6.11]
3.84 isokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inlet is the same as the
mean velocity of the unidirectional airflow at that location
[ISO/FDIS 14644-3:2004, 3.6.12]
3.85 leak
(of air filter system) penetration of contaminants that exceed an expected value of downstream concentration
through lack of integrity or defects
[ISO/FDIS 14644-3:2004, 3.3.8]
3.86 leak
(of separative devices) defect revealed by testing under a pressure differential after corrections for
atmospheric conditions
[ISO 14644-7:2004, 3.14]
3.87 M descriptor
measured or specified concentration of macroparticles per cubic metre of air, expressed in terms of the
equivalent diameter that is characteristic of the measurement method used
NOTE The M descriptor may be regarded as an upper limit for the averages at sampling locations (or as an upper
confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone). M
descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or in
conjunction with airborne particulate cleanliness classes.
[ISO 14644-1:1999, 2.3.2] [ISO/FDIS 14644-3:2004, 3.2.5]
3.88 macroparticle
particle with an equivalent diameter greater than 5 µm
[ISO 14644-1:1999, 2.2.6] [ISO/FDIS 14644-3:2004, 3.2.4]
3.89 mass median particle diameter

MMD
median particle diameter based on the particle mass
NOTE For the mass median, one half of mass of all particles is contributed by particles with a size smaller that the
mass median size, and one half by particles larger that the mass median size
[ISO/FDIS 14644-3:2004, 3.2.6]
3.90 measuring plane
cross-sectional area for testing or measuring a performance parameter such as the airflow velocity
[ISO/FDIS 14644-3:2004, 3.4.3]


ISO/DIS 14644-6
3.91 molecular contamination
molecular (non-particulate) species that may have a deleterious effect on the product, process or equipment
[ISO/DIS 14644-8:2004, 3.1.1]
3.92 monitoring
observations made by measurement in accordance with a defined method and plan to provide evidence of the
performance of an installation
NOTE This information may be used to detect trends in operational state and to provide process support.
[ISO 14644-2:2000, 3.1.3]
3.93 non-unidirectional airflow
air distribution where the supply air entering the clean zone mixes with the internal air by means of induction
[ISO 14644-4:2001, 3.6] [ISO/FDIS 14644-3:2004, 3.4.4]
3.94 offset voltage
voltage that will accumulate upon an initially uncharged isolated conductive plate when that plate is exposed
to an ionized air environment
[ISO/FDIS 14644-3:2004, 3.5.2]
3.95 operational
condition where the installation is functioning in the specified manner, with the specified number of personnel
present and working in the manner agreed upon
3.2.3]
3.96 operator
person working in the cleanroom performing production work or carrying out process procedures
[ISO 14644-5:2004, 3.1.6]
3.97 organic
species based on carbon and also containing hydrogen, with or without oxygen, nitrogen or other elements
[ISO/DIS 14644-8:2004, 3.2.7]
3.98 outgassing
release of molecular species in the gaseous or vapour state from a material
[ISO/DIS 14644-8:2004, 3.1.5]


ISO/DIS 14644-6
3.99 oxidant
species that, upon deposition to a product or surface of interest, results in the formation of an oxide or
participates in a redox reaction
[ISO/DIS 14644-8:2004, 3.2.8]
3.100 particle
solid or liquid object which, for purposes of classification of air cleanliness, falls within a cumulative distribution
that is based upon a threshold (lower limit) size in the range from 0,1µm to 5 µm
[ISO 14644-1:1999, 2.2.1]
3.101 particle
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1:1999.
[ISO 14644-4:2001, 3.7] [ISO 14644-5:2004, 3.1.7]
3.102 particle concentration
number of individual particles per unit volume of air
[ISO 14644-1:1999, 2.2.3] [ISO/FDIS 14644-3:2004, 3.2.7]
3.103 particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the
response produced by the particle being measured
NOTE For discrete-particle-counting, light-scattering instruments, the equivalent optical diameter is used.
[ISO 14644-1:1999, 2.2.2] [ISO/FDIS 14644-3:2004, 3.2.8]
3.104 particle size cutoff device
device capable of removing particles smaller than those of interest that is attached to the inlet of a DPC or
CNC
[ISO/FDIS 14644-3:2004, 3.6.13]
3.105 particle size distribution
cumulative distribution of particle concentration as a function of particle size
[ISO 14644-1:1999, 2.2.4] [ISO/FDIS 14644-3:2004, 3.2.9]
3.106 personnel
persons entering the cleanroom for any purpose
[ISO 14644-5:2004, 3.1.8]


ISO/DIS 14644-6
3.107 pre-filter
air filter fitted upstream of another filter to reduce the challenge on that filter
[ISO 14644-4:2001, 3.8]
3.108 pressure integrity
capability to provide a quantifiable pressure leakage rate repeatable under test conditions
[ISO 14644-7:2004, 3.15]
3.109 process core
location at which the process and the interaction between the environment and the process occurs
[ISO 14644-4:2001, 3.9]
3.110 qualification
process of demonstrating whether an entity - activity or process, product, organization, or any combination
thereof - is capable of fulfilling specified requirements
[ISO 14698-1:2003, 3.1.15]
3.111 requalification
execution of the test sequence specified for the installation to demonstrate compliance with ISO 14644-1
according to the classification of the installation, including the verification of the selected pre-test conditions
[ISO 14644-2:2000, 3.1.1]
3.112 risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO 14698-1:2003, 3.1.16] [ISO 14698-2:2003, 3.11]
3.113 risk zone
defined and delimited space where individuals, products or materials (or any combination of these) are
particularly vulnerable to contamination
[ISO 14698-1:2003, 3.1.17] [ISO 14698-2:2003, 3.12]
3.114 scanning
method for disclosing leaks in filters and parts of units, whereby the probe inlet of an aerosol photometer or
discrete-particle counter (DPC) is moved in overlapping strokes across the defined test area
[ISO/FDIS 14644-3:2004, 3.3.9]


ISO/DIS 14644-6
3.115 separation descriptor
[Aa:Bb]
numerical abbreviation summarizing the difference in cleanliness classification between two areas as ensured
by a separative device under specified test conditions, where:
A is the ISO class inside the device;
a is particle size at which A is measured;
B is the ISO class outside the device;
b is the particle size at which B is measured
[ISO 14644-7:2004, 3.16]
3.116 separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between the
inside and outside of a defined volume
NOTE Some industry-specific examples of separative devices are clean air hoods, containment enclosures,
gloveboxes, isolators and mini-environments.
[ISO/FDIS 14644-3:2004, 3.1.4] [ISO 14644-5:2004, 3.1.9] [ISO 14644-7:2004, 3.17]
3.117 settle plate
suitable container (e.g. a Petri dish) of appropriate size, containing an appropriate, sterile, culture medium,
which is left open for a defined period to collect viable particles depositing from the air
[ISO 14698-1:2003, 3.1.18]
3.118 standard leak penetration
leak penetration detected by a discrete-particle counter or aerosol photometer with a standard sample flow-
rate when the sampling probe is stationary in front of the leak
NOTE Penetration is the ratio of the particle concentration downstream of the filter to the concentration upstream.
[ISO/FDIS 14644-3:2004, 3.3.10]
3.119 start up
act of preparing and bringing an installation into active service, including all systems
EXAMPLE Systems may include procedures, training requirements, infrastructure, support services, statutory
undertakings requirements.
[ISO 14644-4:2001, 3.10]
3.120 static-dissipative property
capability for reducing electrostatic charge on work or product surface, as a result of conduction or other
mechanism to a specific value or nominal zero charge level
[ISO/FDIS 14644-3:2004, 3.5.3]


ISO/DIS 14644-6
3.121 supplier
organization engaged to satisfy the specified requirements of a cleanroom or clean zone
[ISO 14644-1:1999, 2.5.2]
3.122 supply air flow rate
air volume supplied into an installation from final filters or air ducts in unit of time
[ISO/FDIS 14644-3:2004, 3.4.5]
3.123 surface molecular contamination (SMC)
presence of molecular (chemical, non-particulate) species in the sorbed state that may have a deleterious
effect on the product or surface of interest, in the cleanroom or controlled environment
[ISO/DIS 14644-8:2004, 3.1.3]
3.124 surface voltage level
positive or negative voltage level of electrostatic charging on work or product surface, as indicated by use of
suitable apparatus
[ISO/FDIS 14644-3:2004, 3.5.4]
3.125 swab
sterile collection device, non-toxic and non-inhibitory to the growth of the micro-organisms being sampled,
consisting of a specific matrix of suitable size, mounted on an applicator
[ISO 14698-1:2003, 3.1.19]
3.126 target level
defined level set by the user as a goal for routine operations, for the user’s own purpose
[ISO 14698-1:2003, 3.1.20]
3.127 target level
defined microbiological level set by the user, for its own purpose
[ISO 14698-2:2003, 3.13]
3.128 test
procedure undertaken in accordance with a defined method to determine the performance of an installation or
an element thereof
[ISO 14644-2:2000, 3.1.2]
3.129 test aerosol
gaseous suspension of solid and/or liquid particles with known and controlled size distribution and
concentration

ISO/DIS 14644-6
[ISO/FDIS 14644-3:2004, 3.2.10]
3.130 threshold size
selected minimum particle size chosen for measuring a concentration of particles larger than or equal to that
size
[ISO/FDIS 14644-3:2004, 3.6.14]
3.131 time-of-flight particle size measurement
measurement of aerodynamic particle diameter determined by the time required for travelling the distance of
two fixed planes
NOTE This measurement utilizes the particle velocity shift caused when a particle is introduced into the flow field with
different velocity
[ISO/FDIS 14644-3:2004, 3.6.15]
3.132 total air flow rate
air volume that passes through a section of an installation in unit of time
[ISO/FDIS 14644-3:2004, 3.4.6]
3.133 transfer device
mechanism to effect movement of material into or out of separative devices while minimizing ingress or egress
of unwanted matter
[ISO 14644-7:2004, 3.18]
3.134 U descriptor
measured or specified concentration, in particles per cubic metre of air, including the ultrafine particles
NOTE The U descriptor may be regarded as an upper limit for the averages at sampling locations (or as an upper
confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone). U
descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or in
conjunction with airborne particulate cleanliness classes.
[ISO 14644-1:1999, 2.3.1] [ISO/FDIS 14644-3:2004, 3.2.11]
3.135 ultrafine particle
particle with an equivalent diameter less than 0,1 µm
[ISO 14644-1:1999, 2.2.5] [ISO/FDIS 14644-3:2004, 3.2.12]


ISO/DIS 14644-6
3.136 unidirectional airflow7)
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately
parallel streamlines
NOTE This type of airflow results in a directed transport of particles from the clean zone.
[ISO 14644-4:2001, 3.11]
3.137 unidirectional airflow7)
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately
parallel airstreams
NOTE This type of airflow results in a directed transport of particles from the clean zone.
[ISO/FDIS 14644-3:2004, 3.4.7] [ISO 14644-5:2004, 3.1.10]
3.138 uniformity of airflow
unidirectional airflow pattern in which the point-to-point readings of velocities are within a defined percentage
of the average airflow velocity
[ISO/FDIS 14644-3:2004, 3.4.8]
3.139 validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled
[ISO 14698-1:2003, 3.1.21] [ISO 14698-2:2003, 3.14]
3.140 verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
NOTE Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used
in the verification of the Formal System.
[ISO 14698-1:2003, 3.1.22]
3.141 viable particle
particle that consists of, or supports, one or more live microorganisms
[ISO 14698-1:2003, 3.1.23] [ISO 14698-2:2003, 3.15]
3.142 viable unit

VU
one or more viable particles which are enumerated as a single unit
7) This definition only differs from 3.136 in the use of the word 'airstreams' instead of the word 'streamlines'


ISO/DIS 14644-6
NOTE When viable units are enumerated as colonies on agar media, it is common usage to name them colony
forming units (CFU). One CFU might consist of one or more VU.
[ISO 14698-1:2003, 3.1.24]
3.143 viable unit

VU
one or more viable particles that are enumerated as a single unit
NOTE When VU are enumerated as colonies on agar media, it is common usage to name them colony forming units
(CFU).
[ISO 14698-2:2003, 3.16]
3.144 virtual impactor
instrument to separate the particle sizing by inertial force to collide on the hypothetical (virtual) surface
NOTE Large particles pass through the surface into a stagnant volume and small particles deflected with the bulk of
the original airflow
[ISO/FDIS 14644-3:2004, 3.6.16]
3.145 witness plate
contamination-sensitive material of defined surface area used in lieu of direct evaluation of a specific surface
that is either inaccessible or too sensitive to be handled
[ISO/FDIS 14644-3:2004, 3.6.17]


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DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-6

ISO/TC 209 Secretariat: ANSI

Voting begins on: Voting terminates on:

Cleanrooms and associated controlled environments —

ISO/CEN PARALLEL ENQUIRY

Adobe is a trademark of Adobe Systems Incorporated.

ISO copyright office

Reproduction may be subject to royalty payments or a licensing agreement.

Violators may be prosecuted.

Licensed to INFOESTRATEGICA LATINA/XÓCHITL AGUERO

Licensed to INFOESTRATEGICA LATINA/XÓCHITL AGUERO

© ISO 2005 – All rights reserved iii

⎯ Part 1: Classification of air cleanliness

⎯ Part 3: Test methods

⎯ Part 4: Design, construction and start-up

⎯ Part 6: Terms and definitions

⎯ Part 8: Classification of airborne molecular contamination

⎯ Part 1: General principles and methods

⎯ Part 2: Evaluation and interpretation of biocontamination data

Licensed to INFOESTRATEGICA LATINA/XÓCHITL AGUERO

iv © ISO 2005 – All rights reserved

Licensed to INFOESTRATEGICA LATINA/XÓCHITL AGUERO

© ISO 2005 – All rights reserved v

Cleanrooms and associated controlled environments —

ISO 14644-5:2004, Cleanrooms and associated controlled environments — Part 5: Operations

ISO 14698-2:2003, Cleanrooms and associated controlled environments ⎯ Biocontamination control:

© ISO 2005 – All rights reserved 1

3 Terms and definitions

[ISO 14644-2:2000, 3.2.3]

[ISO 14644-2:2000, 3.2.4]

[ISO 14644-2:2000, 3.2.5]

3.4 access device

[ISO 14644-7:2004, 3.1]

[ISO/DIS 14644-8:2004, 3.2.1]

3.6 action level

[ISO 14644-7:2004, 3.2] [ISO 14698-1:2003, 3.1.1] [ISO 14698-2:2003, 3.1]

3.7 aerosol challenge

challenging of a filter or an installed filter system by test aerosol

[ISO/FDIS 14644-3:2004, 3.3.1]

Licensed to INFOESTRATEGICA LATINA/XÓCHITL AGUERO

2 © ISO 2005 – All rights reserved

3.8 aerosol generator

[ISO/FDIS 14644-3:2004, 3.2.1]

3.9 aerosol photometer

[ISO/FDIS 14644-3:2004, 3.6.1]

3.10 air exchange rate

[ISO/FDIS 14644-3:2004, 3.4.1]

3.11 airborne molecular contamination

[ISO/DIS 14644-8:2004, 3.1.2]

3.12 airborne particle

NOTE For classification purposes refers to ISO 14644-1:1999, 2.2.13).

[ISO/FDIS 14644-3:2004, 3.2.2]

3.13 alert level

[ISO 14644-7:2004, 3.3] [ISO 14698-1:2003, 3.1.2] [ISO 14698-2:2003, 3.2]

3) See 3.103 of this part of ISO 14644

© ISO 2005 – All rights reserved 3

3.14 anisokinetic sampling

[ISO/FDIS 14644-3:2004, 3.6.2]

3.17 audit trail