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ISO14644-1英文版
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洁净室及相关受控环境 第1部分:空气洁净度等级 / 国际标准 / 等效于GB-T 25915.1-2010
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A
Reference number
ISO 14644-1:1999(E)
INTERNATIONAL
STANDARD
ISO
14644-1
First edition
1999-05-01
Cleanrooms and associated controlled
environments —
Part 1:
Classification of air cleanliness
Salles propres et environnements maîtrisés apparentés —
Partie 1: Classification de la propreté de l'air
ISO 14644-1:1999(E) © ISO
ii
Contents
Page
Foreword ......................................................................................................... iii
Introduction ..................................................................................................... iv
1 Scope ........................................................................................................ 1
2 Definitions .................................................................................................. 1
3 Classification ............................................................................................. 3
4 Demonstration of compliance .................................................................... 4
Annexes
Annex A (informative) Graphical illustration of the classes of Table 1 ............ 5
Annex B (normative) Determination of particulate cleanliness classification
using a discrete-particle-counting, light-scattering instrument...... 6
Annex C (normative) Statistical treatment of particle concentration data ..... 9
Annex D (informative) Worked examples of classification calculations ........ 10
Annex E (informative) Considerations for the counting and sizing of particles
outside the size range applicable for classification..................... 13
Annex F (informative) Sequential sampling procedure ................................ 15
Bibliography ................................................................................................... 18
Figures
Figure A.1 Graphical representation of ISO-class concentration limits
for selected ISO classes ............................................................... 5
Figure F.1 Boundaries for pass or fail by the sequential sampling
procedure .................................................................................. 15
Tables
Table 1 Selected airborne particulate cleanliness classes for
cleanrooms and clean zones ........................................................ 3
Table C.1 Student’s
t
distribution for the 95% upper confidence limit ........... 9
Table F.1 Upper and lower limits for time at which
C
observed counts
should arrive ............................................................................... 16
© ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
© ISO
ISO 14644-1:1999(E)
iii
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
nongovernmental, 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.
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.
International Standard ISO 14644-1 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: Metrology and test methods
—
Part 4: Design, construction and start-up
—
Part 5: Operations
—
Part 6: Terms and definitions
—
Part 7: Enhanced clean devices
Users should note that the titles listed for parts 2 to 7 are working titles at the time of the
release of part 1. In the event that one or more of these parts are deleted from the work
programme, the remaining parts may be renumbered.
Annexes B and C form an integral part of this part of ISO 14644. Annexes A, D, E, and F
are for information only.
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 such industries as aerospace, microelectronics, pharmaceuticals, medical
devices, food, and healthcare.
This part of ISO 14644 assigns ISO classification levels to be used for the specification of
air cleanliness in cleanrooms and associated controlled environments. It also prescribes the
standard method of testing as well as the procedure for determining the concentration of
airborne particles.
For classification purposes, this part of ISO 14644 is limited to a designated range of
considered particle sizes for determination of particle concentration limits. This part of ISO
14644 also provides standard protocols for the determination and designation of cleanli-
ness levels that are based on airborne concentrations of particles smaller or larger than the
size range designated for classification.
This part of ISO 14644 is one of a series of standards concerned with cleanrooms and
contamination control. Many factors besides airborne particulate cleanliness must be
considered in the design, specification, operation, and control of cleanrooms and other
controlled environments. These are covered in some detail in other parts of the International
Standards prepared by ISO/TC 209.
In some circumstances, relevant regulatory agencies may impose supplementary policies
or restrictions. In such situations, appropriate adaptations of the standard testing proce-
dures may be required.
ISO 14644-1:1999(E)
© ISO
iv
1
INTERNATIONAL STANDARD © ISO ISO 14644-1:1999(E)
1 Scope
This part of ISO 14644 covers the classification of air cleanli-
ness in cleanrooms and associated controlled environments
exclusively in terms of concentration of airborne particles.
Only particle populations having cumulative distributions based
on threshold (lower limit) sizes ranging from 0,1 µm to 5 µm are
considered for classification purposes.
This part of ISO 14644 does not provide for classification of
particle populations that are outside of the specified particle
size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles
(particles smaller than 0,1 µm) and macroparticles (particles
larger than 5 µm) may be used to quantify these populations in
terms of U descriptors and M descriptors, respectively.
This part of ISO 14644 cannot be used to characterize the
physical, chemical, radiological, or viable nature of airborne
particles.
NOTE The actual distribution of particle concentrations within incre-
mental size ranges normally is not predictable and typically is variable
over time.
2 Definitions
For the purposes of this part of ISO 14644, the following
definitions apply.
2.1 General
2.1.1
cleanroom
room in which the concentration of airborne particles is con-
trolled, and which is constructed and used in a manner to
minimize the introduction, generation, and retention of parti-
cles inside the room, and in which other relevant parameters,
e.g. temperature, humidity, and pressure, are controlled as
necessary
2.1.2
clean zone
dedicated space in which the concentration of airborne parti-
cles 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.
2.1.3
installation
cleanroom or one or more clean zones, together with all
associated structures, air-treatment systems, services, and
utilities
2.1.4
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 3.2.
NOTE 2 Classification in accordance with this International Stan-
dard 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
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness
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