7/24/2019 ISO 14644 Cuartos Limpios

http://slidepdf.com/reader/full/iso-14644-cuartos-limpios 1/4

ISO 14644

ISO 14644 Standards   were first formed from the   US

Federal Standard 209E Airborne Particulate Cleanliness

Classes in  Cleanrooms and Clean Zones. The need for

a single standard for cleanroom classification and testing

was long felt. After ANSI and  IEST petitioned to ISO

for new standards, the first document of ISO 14644 was

published in 1999, ISO 14644-1.[1]

In 2000, ISO 14644-2 was published, which began the

process of FED-STD-209E being canceled. On Novem-

ber 29, 2001, the document was canceled and superseded

by ISO 14644-1 and ISO 14644-2.[2]

ISO 14644 is now composed of

•  ISO 14644-1: Classification of air cleanliness[3]

•   ISO/DIS 14644-1.2(2014): Classification of air

cleanliness by particle concentration[4]

•   ISO 14644-2: Specifications for testing and mon-

itoring to prove continued compliance with ISO

14644-1[3]

•   ISO/DIS 14644-2.2(2014):Monitoring to provide

evidence of cleanroom performance related to air

cleanliness by particle concentration[5]

•  ISO 14644-3: Test Methods[3]

•  ISO 14644-4: Design, Construction, and Start-up[3]

•   ISO 14644-5: Operations[3]

•  ISO 14644-6: Vocabulary[3]

•   ISO 14644-7: Separative devices (clean air hoods,

gloveboxes, isolators and minienvironments[3]

•   ISO 14644-8: Classification of airborne molecular

contamination[3]

•   ISO 14644-9: Classification of surface particle

cleanliness[3]

•   ISO 14644-10: Classification of Surface Cleanliness

by Chemical Concentration

•  ISO 14644-12: Classification of Air Cleanliness by

Nanoscale Particle Concentration

1 Part 1: Classification of air

cleanliness

ISO 14644-1 covers the classification of air cleanliness

in cleanrooms and associated controlled environments.

Classification in accordance with this standard is speci-

fied and accomplished exclusively in terms of concentra-

tion of airborne  particulates.[6] The document was sub-

mitted as an American National Standard and has been

adopted as ANSI/IEST/ISO 14644-1:1999 in the UnitedStates, following the cancellation of FED-STD-209E.[6]

2 Part 2: Specifications for testing

and monitoring to prove contin-

ued compliance with ISO 14644-

1

Part 2 specifies requirements for periodic testing of acleanroom or clean zone to prove its continued compli-

ance with  ISO 14644-1 for the designated classification

of airborne particulate cleanliness. It also specifies re-

quirements for the monitoring of a cleanroom or clean

zone (installation) to provide evidence of its continued

compliance with ISO 14644-1 for the designated classifi-

cation of airborne particulate cleanliness.[7] It became an

International Standard following the cancellation of FED-

STD-209E. In the United States in 2000 it was adopted

as ANSI/IEST/ISO 14644-2:2000.[7]

3 Part 3: Test Methods

This part specifies  test methods for designated classifi-

cation of airborne particulate cleanliness and for charac-

terizing the performance of cleanrooms and clean zones.

These test methods are specified in the document for two

different types of cleanrooms and clean zones; unidirec-

tional flow and nonunidirectional flow.[8]

The most important objectives of this highly referenced

document are to provide an internationally common ba-

sis of measurement and evaluation of cleanrooms and,at the same time, not to prevent the introduction of new

technologies.[8]

1

7/24/2019 ISO 14644 Cuartos Limpios

http://slidepdf.com/reader/full/iso-14644-cuartos-limpios 2/4

2   9 PART 9: CLASSIFICATION OF SURFACE PARTICLE CLEANLINESS 

4 Part 4: Design, construction and

start-up

This part specifies requirements for the design and con-

struction of cleanroom and clean air devices, as well as

requirements for start-up and qualification, but does notprescribe specific technological nor contractual means

to meet the requirements. This document is intended

for  purchasers,   suppliers, and   designers   of cleanroom

installations.[9] It was submitted as an American National

Standard in 2001.[9]

5 Part 5: Operations

ISO 14644-5 provides the basic requirements for oper-

ating and maintaining cleanrooms and associated con-

trolled environments. This standard addresses require-ments that are basic to the operation of all cleanrooms,

regardless of the application. Topics include:[10]

•  Operational systems that must be in place[10]

•   Selection and use of appropriate cleanroom

garments[10]

•   Training   and monitoring of   personnel   and

activities[10]

•  Installation and use of equipment[10]

•   Requirements for materials used in the

cleanroom[10]

•  Maintaining the cleanroom environment in a clean,

usable condition conforming to design standards.[10]

This part was published as an International Standard in

2004. The document was submitted as an American Na-

tional Standard and has been adopted as ANSI/IEST/ISO

14644-5:2004 in the United States.[10]

6 Part 6: Vocabulary

This part is an important document for any contamina-

tion control professional. This document describes all the

terms and definitions in ISO 14644 and ISO 14698. In

March 2008 this ISO Standard recently became an Amer-

ican National Standard.[11]

7 Part 7: Separative devices (clean

air hoods, gloveboxes,   isolators

and minienvironments)

This part of ISO 14644 specifies the minimum require-

ments for the design, construction, installation, testing

and approval of separative devices in those respects where

they differ from cleanrooms as described in Parts 4 and 5.

Separative devices range from open to closed systems.[12]

The limitations are:

•   Application-specific requirements are notaddressed.[12]

•  User requirements are as agreed by customer and

supplier.[12]

•  Specific processes to be accommodated in the sep-

arative device installation are not specified.[12]

•   Fire, safety and other regulatory matters are not con-

sidered specifically; the appropriate national and lo-

cal requirements shall be respected.[12]

•   Full-suits are not within the scope of this

standard.[12]

This part was published as an International Standard in

2004. The document was submitted as an American Na-

tional Standard and has been adopted as ANSI/IEST/ISO

14644-7:2004.[12]

8 Part 8: Classification of airborne

molecular contamination

This part of ISO 14644 covers the classification of air-

borne molecular contamination (AMC) in  cleanrooms

and associated controlled environments, in terms of air-

borne concentrations of specific chemical substances (in-

dividual, group or category) and provides a protocol to

include test methods, analysis and time-weighted factors

within the specification for classification.[13]

This document became a Standard in 2006. It was de-

veloped by the Secretariat of ISO Technical Committee

209, IEST.[13]

9 Part 9: Classification of surface

particle cleanliness

This ISO document describes the classification of the

particle contamination levels on solid surfaces in clean-

rooms and associated controlled environments applica-

tions. Recommendations on testing and measuring meth-

ods as well as information about surface characteristics

are given in informative annexes.

[14]

It is currently a Committee Draft and is not yet available

as a Standard.[14]

7/24/2019 ISO 14644 Cuartos Limpios

http://slidepdf.com/reader/full/iso-14644-cuartos-limpios 3/4

3

10 See also

•   ISO 14000   —   environmental management   stan-

dards exist to help organizations minimize how their

operations negatively affect the environment (cause

adverse changes to air, water, or land) and comply

with applicable laws and regulations

•  Application to cleanrooms

11 References

[1]   “ISO 14644 History”. TSS, Inc. 2007-12-03. Archived

from the original on 2007-12-30. Retrieved 2008-01-17.

[2]  “FED-STD-209E Cancellation”. IEST. 2007-12-03. Re-

trieved 2008-01-17.

[3]   “ISO 14644 Standards”. IEST. 2007-12-03. Retrieved2008-01-17.

[4]   “ISO 14644-1”. IEST. 2014-09-23. Retrieved 2014-09-

23.

[5]   “ISO 14644-2”. IEST. 2014-09-23. Retrieved 2014-09-

23.

[6]   “ISO 14644-1 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[7]   “ISO 14644-2 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[8]   “ISO 14644-3 Scope”. IEST. 2007-12-03. Retrieved2008-01-17.

[9]   “ISO 14644-4 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[10]   “ISO 14644-5 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[11]   “ISO 14644-6 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[12]   “ISO 14644-7 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

[13]   “ISO 14644-8 Scope”. IEST. 2007-12-03. Retrieved2008-01-17.

[14]   “ISO 14644-9 Scope”. IEST. 2007-12-03. Retrieved

2008-01-17.

12 External links

•   http://www.iest.org

•   http://www.ansi.org

•   http://www.iso.org

•  http://www.cleanrooms.com

7/24/2019 ISO 14644 Cuartos Limpios

http://slidepdf.com/reader/full/iso-14644-cuartos-limpios 4/4

4   13 TEXT AND IMAGE SOURCES, CONTRIBUTORS, AND LICENSES 

13 Text and image sources, contributors, and licenses

13.1 Text

•   ISO 14644  Source:   https://en.wikipedia.org/wiki/ISO_14644?oldid=676786487 Contributors:  SebastianHelm, Robbot, Giraffedata, Josh

Parris, Hydrargyrum, Leolaursen, Swpb, CliffC, Mfisherkirshner, Environ1561, Addbot, AnomieBOT, Nasa-verve, Commander-pirx, Full-

date unlinking bot, H3llBot, Twillisjr, BG19bot, Probity incarnate, Safehaven86, BattyBot and Anonymous: 2

13.2 Images

•   File:Folder_Hexagonal_Icon.svg Source:  https://upload.wikimedia.org/wikipedia/en/4/48/Folder_Hexagonal_Icon.svg License:   Cc-by-

sa-3.0 Contributors:  ?  Original artist:  ?

13.3 Content license

•   Creative Commons Attribution-Share Alike 3.0