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Update on ISO Cleanroom Standards – 14644 & 14698

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Update on ISO Cleanroom Standards – 14644 & 14698

15 ISO 14644 & 14698-Overview ISO 14644 & 14698 Standards ISO Document Title ISO-14644-1 Classification of Air Cleanliness - 1999 ISO-14644-2 Testing for Continued Compliance to -1 -1999

http://www.oerrg.at/ueber-uns/aktuelles/ISO%20Cleanroom%20Standards%20ORRG%20July%202012%20-%20Conor%20Murray.pdf

Date added: October 15, 2012 - Views: 253

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INTERNATIONAL STANDARD 14698-2 - Esileht - Eesti Standardikeskus

International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled

http://www.evs.ee/eelvaade/iso-14698-2-2003-en.pdf

Date added: May 21, 2013 - Views: 101

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FS209E and ISO Cleanroom Standards - Terra Universal

ISO 14644-2 describes the type and frequency of testing required to conform to certain standards. ... ISO 14644-8 Molecular Contamination ISO 14698-1 Biocontamination: Control General Principles ISO 14698-2 Biocontamination: Evaluation and Interpretation of Data

http://www.terrauniversal.com/file_library/federalcleanroomstandards_010412164241.pdf

Date added: September 20, 2012 - Views: 373

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INTERNATIONAL STANDARD 14698-1 - Esileht - Eesti Standardikeskus

ISO 14698-1:2003(E) © ISO 2003 INTERNATIONAL STANDARD ISO 14698-1 First edition 2003-09-01 Cleanrooms and associated controlled ... ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: ...

http://www.evs.ee/eelvaade/iso-14698-1-2003-en.pdf

Date added: April 29, 2012 - Views: 747

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INTERNATIONAL STANDARD 14698-2

International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=266569

Date added: January 10, 2014 - Views: 3

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iso 14698 - SAI Global

EN ISO 14698-1:2003 (E) 2 Foreword This document (EN ISO 14698-1:2003) has been prepared by Technical Committee ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with Technical Committee

http://www.saiglobal.com/PDFTemp/Previews/OSH/IS/EN/2003/I.S.ENISO14698-1-2003.pdf

Date added: April 29, 2012 - Views: 118

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iso 14698 filetype - Bing - Free PDF Downloads Blog ...

ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. Title: iso 14698 filetype - Bing Created Date:

http://pdfsdir.com/download/iso-14698-filetype.pdf

Date added: April 16, 2014 - Views: 6

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Cleanrooms and associated controlled environments ...

Technical Corrigendum 1 to ISO 14698-2:2003 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. Page 1 3.1. Delete the word “microbiological” from the definition “microbiological level ...

http://www.kssn.net/include/fileDown.asp?category=ISOCORR&fileName=ISO_14698-2_2003_Cor_1_2004(E)-Character_PDF_document.pdf

Date added: October 22, 2014 - Views: 1

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ČSN EN ISO 14698 - 2 OPRAVA 1

ICS 13.040.35 ČSN EN ISO 14698-2 OPRAVA 1 12 5370 Listopad 2006 ČESKÁ TECHNICKÁ NORMA Čisté prostory a příslušné řízené prostředí –

http://seznamcsn.unmz.cz/soubory/opravy/12/69438/Zmeny/76212.pdf

Date added: July 27, 2013 - Views: 12

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New Support for ISO14644-1 - Particle Counters

The International Standards Organization Technical Committee ISO TC 209 has decided that, ... revising ISO 14644-1 and -2. ... revision of ISO 14698-1 and -2 for the classification of the cleanroom environment by microbiological

http://www.particle.com/wp-content/uploads/downloads/2012/05/Particle-Counting-ISO-21501-Application-Note-New-Support-for-ISO-14644-1.pdf

Date added: January 13, 2013 - Views: 139

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ISO TC209 Standards Overview - PharmOut

ISO 14698-2 First edition 2004-11-01, Cleanrooms and ... Chair BSI LBI/030; Chair CEN TC243; Convenor ISO TC209 WG1. c/o Critical Systems Ltd www.critical-systems.co.uk 4, Greencroft, Guildford, Surrey, GU1 2SY, UK. tel +44 (0)1483 579926

http://www.pharmout.net/downloads/pres-01-ISO-TC209-overview-13jun12.pdf

Date added: November 17, 2012 - Views: 16

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Cleanroom Design Basics - ASHRAE chapters

ASHRAE ―Clean Spaces‖ Technical Committee (TC9.11) Chairman (07-10) ―Healthcare Facilities‖ Technical Committee (TC9.6) Member ... ISO-14698-1 Biocontamination: Control General Principles ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data

http://pakistan.ashraechapters.org/web2/pdf/Seminar%201%20-%20Cleanroom%20&%20HVAC%20Design%20-%20Karachi.pdf

Date added: June 3, 2012 - Views: 123

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EN ISO 14644-7:2004 INTERNATIONAL ISO STANDARD 14644-7

2 ISO 14698-1, Cleanrooms and associated controlled environments Part 1: Biocontamination control General principles and methods ISO 14698-2, Cleanrooms and associated controlled environments Part 2: Biocontamination control

http://www.phmach.cn/tech/download/200911494845.pdf

Date added: April 11, 2012 - Views: 617

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Biological Air Sampling Product Line Overview

PMS Proprietary and Confidential Information Objectives of ISO 14698 – 1 Establishes definition of a Formal System for what is to be included in ‘any’ biological

http://www.pmeasuring.com/wrap/files/BiologicalSamplers/ver_1271038094/microbial.pdf

Date added: March 2, 2012 - Views: 25

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SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 NORTH AMERICAN ...

USP <71>, ISO 11737-2, ISO 11135, ... ISO 14698-1 Incubation and Enumeration of Fallout Plates, RODAC® Plates, or Air Sampler Media American Journal of Clinical Pathologists, Volume 95 Kirby-Bauer Standard Antimicrobial Susceptibility Test

http://www.namsa.com/Portals/0/Documents/Accreditation%20to%20ISO_IEC%2017025_2005%20Biological.pdf

Date added: June 26, 2014 - Views: 1

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ISO/FDIS 14644 – 9 CLEANROOMS AND ASSOCIATED CONTROLLED ...

1 ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination. ISO/FDIS 14644-9 provides a classification for the determination and designation of surface

http://www.swissccs.org/d/docs_db/srrt_20120419_105926_02%20Abstract_ISO%20FDIS%2014644-9_e_Straub.pdf

Date added: September 27, 2012 - Views: 228

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ISO c M (ILO) , 45001 ISO 45001 (ISO/ PC283) ORCharIes ...

ISO 14698-2 : Corl http://www.iso.org/iso/home/news_index/news_ archive/news. 843 ISO 9001 , ISO (DIS) , 9001 9001 : , (IAF) nso 9001 2018 http://www.iso.org/iso/home/standards/manag ement—standards/iso_9000.htm . ISO ' (Conformity assessment)

http://www.cpttm.org.mo/cpttm/department/quality/pdf/Issue_03_2014.pdf

Date added: September 20, 2014 - Views: 1

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ISO Std. 14644 Clean Rooms - EMITS Invitation To Tender System

ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces . Title ISO Std. 14644_Clean Rooms Author: Raimondo.Moroni Created Date: 12/11/2013 2:33:00 PM

http://emits.sso.esa.int/emits-doc/ALENIA/Exomars/ExoMars_Mission_2018/ALD_MGSE/ISO_Std.14644_CleanRooms.pdf

Date added: May 19, 2014 - Views: 5

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SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 NORTH AMERICAN ...

USP <71>, ISO 11737-2, ISO 11135, ISO 11137 Sterility ISO 14698-1 Gram Stain & Colony Morphology ISO 10993:5, USP <87> Cytotoxicity Assay – Elution Method (48-hour Exposure): L929 Cells

http://www.namsa.com/Portals/0/Documents/ISO17025_Biological_CA_2419-02.pdf

Date added: September 26, 2012 - Views: 27

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Cyclonic Coriolis®technology qualification according to ISO ...

Context Cyclonic Coriolis®technology qualification according to ISO 14698-1 Protocol Physical efficiency theoretical determination depending on the equipment design characteristics

http://bioamerica-inc.com/files/pdf/Coriolis%20Brochure%202.pdf

Date added: October 18, 2013 - Views: 4

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ISO 14698 & MICROBIOLOGICAL AIR SAMPLERS - Kenelec

ISO 14698 & MICROBIOLOGICAL AIR SAMPLERS Jason Kelly Kenelec Scientific This Article has been previously published in Cleanroom Technology Environments magazine USA (Nov 2005).

http://www.kenelec.com.au/sitebuilder/products/files/833/14698airsampler.pdf

Date added: July 9, 2012 - Views: 168

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FEDERAL STANDARD 209E FOR CLEANROOM - AN OBSOLETE DOCUMENT!

ISO 14644-1 FED STD 209E ISO Class English Metric 1 2 3 1 M1.5 4 10 M2.5 5 100 M3.5 6 1,000 M4.5 7 10,000 M5.5 8 100,000 M6.5 ... particles and ISO 14698-1 and ISO 14698-2 for monitoring microorganisms. ISO-14644-6 Terms and definitions ISO-14644-7 Separative

http://www.iaqtechnology.com.my/site%20document/FEDERAL%20STANDARD%20209E%20FOR%20CLEANROOM%20-%20AN%20OBSOLETE%20DOCUMENT!.pdf

Date added: November 27, 2011 - Views: 97

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Clean Room Particulate Count - Portland State University

Clean Room Particulate Count . Date - 2/28/2012 . Device - Met One Particulate Counter . Mdl. A2408-1 ... ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces By EJS . Title: Clean Room Particulate Count

http://www.pdx.edu/pnna/sites/www.pdx.edu.pnna/files/Clean_Room_Particulate_Count.pdf

Date added: October 21, 2012 - Views: 31

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Physical Efficiency Testing of the bioMérieux air IDEAL 3P ...

Physical Efficiency Testing of the bioMérieux air IDEAL 3P ® air sampler following the ISO 14698-1 standard bioMérieux Industry Culture Media Group, Chemin de l’Orme, 69280 Marcy L’etoile, France

http://www.biomerieux-usa.com/upload/airIDEAL-Physical-Efficiency-Testing-1.pdf

Date added: April 29, 2012 - Views: 21

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Cleanroom Air Systems Design

ISO 14698-3 Technical Report. Cleanliness classes ISO 14644-1 cleanliness classes. ISO 14644-1 formula for maximum allowable particles. Which class do I choose?

http://hightech.lbl.gov/documents/cleanroom_air_design.pdf

Date added: October 16, 2014 - Views: 1

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ISO 14698-1:2003-09 (E)

-1 - ISO 14698-1:2003-09 (E) Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

http://www.nhrs.din.de/cmd%3Bjsessionid=974F03E87A6BF3F96A072D332C927034.1?workflowname=infoInstantdownload&docname=9528317&contextid=nhrs&servicerefname=dino&ixos=toc

Date added: July 27, 2013 - Views: 24

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Voorbeeld - NEN

Nederlandse norm NEN-EN-ISO 14698-2 (en) Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of

http://www.nen.nl/pdfpreview/preview_87938.pdf

Date added: August 6, 2013 - Views: 1

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Biological Efficiency Testing of the bioMérieux air IDEAL 3P ...

Biological Efficiency Testing of the bioMérieux air IDEAL 3P ® air sampler following the ISO 14698-1 standard versus the main commercially-available air samplers

http://www.biomerieux-usa.com/upload/airIDEAL-Biological-Efficiency-Poster-2.pdf

Date added: June 29, 2012 - Views: 1

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Cleanrooms and associated controlled environments ...

BS EN ISO 14698-2:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 24 October 2003

http://files.instrument.com.cn/bbs/upfile/files/20100416/2010416114011.pdf

Date added: June 26, 2013 - Views: 7

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POPRAWKA do POLSKIEJ NORMY

Technical Corrigendum 1 to ISO 14698-2:2003 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. Page 1 3.1. Delete the word “microbiological” from the definition “microbiological level ...

https://sklep.pkn.pl/fileuploader/download/download/?d=0&fileId=5758

Date added: April 16, 2014 - Views: 3

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Irish Cleanroom Society Open Day, Workshop & Podcast 25 June 2014

Background Technical Committee TC 209 is responsible for ISO 14644 & 14698 standards dealing with airborne and surface contamination in cleanrooms and controlled environments.

http://www.wfhss.com/html/conf/assets/ie_ics_conf20140625_en.pdf

Date added: June 26, 2014 - Views: 1

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Environmental Monitoring methods for Decontamination Units

ISO 14698: Part 1:2003 and EN ISO 14698 Part 2:2003) Joy Markey HSE 2012 Environmental control

http://www.wfhss.com/html/conf/wfhss-conference-2012/lectures/wfhss_conf20121121_lecture_sp_s301_en.pdf

Date added: January 30, 2013 - Views: 2

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ISO 14644-4 E - Instrument

ISO 14698-2 and ISO 14698-3; for testing-related issues and for operational-related issues, refer to other relevant parts of this International Standard. C.3 Reports The reports of the tests should be presented in a documented manual.

http://files.instrument.com.cn/FilesCenter/20070205/SH101191-39067.pdf

Date added: May 2, 2013 - Views: 394

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CVG Aseptic Processing [Read-Only]

ISO 14698-1: Bio-contamination: Control General Principles ISO 14698-2: Bio-contamination: Evaluation & Interpretation of Data ISO 14698-3 Bio-contamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces. 20 Cleanroom Classification

http://cvg.ca/Presentations/2007/CVG%20Aseptic%20Processing%20.pdf

Date added: January 12, 2014 - Views: 1

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Deutsche Akkreditierungsstelle GmbH Annex to the ...

DIN EN ISO 14698-1 DIN EN ISO 14698-2 Supplement guidance on sterile products . Annex to the accreditation certificate D-PL-18488-03-00 Period of validity: 09.12.2013 to 05.06.2018 - Translation 11/19 Date of issue: 09.12.2013 Corpus of legislation4

http://www.ul-mdt.com/fileadmin/user/Resource_Center/Certificates/Accreditation_Scope.pdf

Date added: February 23, 2014 - Views: 2

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INTERNATIONAL STANDARD 14644-7 - SAI Global

In applications with biological contamination requirements, ISO 14698-1 and 14698-2 will apply. However, some applications can have special requirements for monitoring because of extreme conditions that may be encountered.

http://www.saiglobal.com/PDFTemp/Previews/OSH/iso/updates2004/wk41/ISO_14644-7_2004%28E%29-Character.pdf

Date added: June 3, 2013 - Views: 4

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AS/NZS ISO 14644.5:2006 Australian/New Zealand Standard

ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data 1) To be published. This is a free 7 page sample. Access the full version online.

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=495632

Date added: May 10, 2012 - Views: 71

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ISO Update - April 2014 - ISO - International Organization ...

2 ISO Update, Supplement to ISO Focus -- April 2014 TC 146 Air quality ISO/CD 18466 Determination of the biogenic fraction in CO2 ... ISO/CD 14698 Cleanrooms and associated controlled environ-ments — Biocontamination control — Microbial

http://www.iso.org/iso/isoupdate_april2014.pdf

Date added: April 17, 2014 - Views: 15

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CLEANROOM ENVIRONMENTAL MONITORING - Kenelec

4 Microbiological Air Sampling & ISO 14698 Selecting the right Air Sampler According to ISO 14698-1 2003 Annex A.3.2 there are many factors to consider when choosing an Air Sampler.

http://www.kenelec.com.au/sb/modules/news/attachments/21/CEM052010.pdf

Date added: October 29, 2012 - Views: 5

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ISO cleanroom classifications - Gelaire

shown below are complemented by ISO-14698, dealing with bio-contamination control and monitoring. ... ISO Class 1 10 2 ISO Class 2 100 24 10 4 ISO Class 3 1000 237 102 35 8 ISO Class 4 10000 2370 1020 352 83 ISO Class 5 ...

http://www.gelaire.com.au/files/documents/BulletinISOcleanroomclassifications.pdf

Date added: November 29, 2011 - Views: 267

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Contamination Control for Pharmaceutical Industry

ISO-14698-3 Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces Status Active Active Draft Active Draft Draft Draft Draft Active Active Active. 14 The World Leader In Particle Counting www.particle.com Verification: ISO 14644-1 ISO 14644-1 FED STD 209E 1 2

http://drug.fda.moph.go.th/zone_gmp/files/GMP2549/May1006/P1/Charn.pdf

Date added: May 16, 2014 - Views: 1

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FAQ – Microbial - Particle Measuring Systems - Particle ...

Guidelines, 2004, or ISO 14698-1 or -2. The ISO 14698-1 document specifically requires all air samplers to be validated for both physical and biological collection efficiency because both recovery percentages are air flow rate and inlet geometry-dependent.

http://www.pmeasuring.com/wrap/files/microbialFAQ/FAQmicrobial.pdf

Date added: April 29, 2012 - Views: 4

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Pairing ISO standard series with new IEST Recommended Practices

ISO/DTR 14698-3 Biocontamination CC013.2: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Control–Methodology for Measuring the Cleanrooms and Other Controlled Environments (2006)

http://www.researchgate.net/profile/Tengfang_Xu/publication/241959939_Keeping_up_with_New_Challenges_in_Contamination_Control_AcrossIndustries_Pairing_ISO_Standard_Series_with_New_Set_of_IEST_RecommendedPractices/links/00463526073e6e7629000000

Date added: August 24, 2014 - Views: 1

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Rebecca is an Irish Subject Matter Expert (SME) Irish ...

Background Technical Committee TC 209 is responsible for ISO 14644 & 14698 standards dealing with airborne and surface contamination in cleanrooms and controlled environments.

http://www.cleanrooms-ireland.ie/index.cfm/fuseaction/common.files/id/AE2D7328198E47E88F019AE6833F31AB

Date added: May 27, 2013 - Views: 7

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Irish Biocontamination Mirror Group

Meet Your Speakers Tony Harrison, Life Sciences Manager Pharmagraph, Convenor WG02 Tony is the Convenor of Working Group, WG02 of ISO TC 209 revising ISO 14698 -1 & -2:2003.

http://www.nsai.ie/NSAI/files/29/29f01306-76d7-4016-ba09-2e9e91fc375e.pdf

Date added: May 13, 2013 - Views: 9

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W. Straub Cofely AG, Zürich, CH

ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle and chemical contamination [1]. ISO/FDIS 14644-9 “Cleanrooms and Associated Controlled Environments”, Part 9

http://www.ecmjournal.org/journal/supplements/vol023supp01/pdf/Vol23supp01a22.pdf

Date added: October 22, 2014 - Views: 1

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Control your microbiological environment - Inici | servei

Collection efficiency as per the ISO 14698 standard: High collection level (100% recovery of particles greater than or equal to 5 μm in size: physical ... • The reliability of the ISO/TS 11133-2 evaluation issued by an independent official

http://jornades.uab.cat/workshopmrama/sites/jornades.uab.cat.workshopmrama/files/Environmental_control.pdf

Date added: June 7, 2012 - Views: 5

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• SAS SUPER ISO - Adelab Scientific | Suppliers of quality ...

of the new “SAS SUPER ISO 100” and “SAS SUPER ISO 180”. SAS (Surface Air System) IN SPACE YOUR PARTNER IN ENVIRONMENTAL MICROBIOLOGY SAS SUPER ISO ... • Performance in compliance with ISO 14698-1 • Large LCD with illuminated touch panel • All operator commands via touch keypad for

http://adelab.com.au/wp-content/uploads/PBI-SAS-Super-ISO-Sampler.pdf

Date added: December 18, 2013 - Views: 1

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Deutsche Akkreditierungsstelle GmbH Annex to the ...

DIN EN ISO 14698-2 : 2004-02 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data DIN 58953-6 : 2010-05 Sterilization - Sterile supply - Part 6: Microbial barrier testing of

http://www.dakks.de/as/ast/d/D-PL-13422-01-02e.pdf

Date added: March 26, 2013 - Views: 6

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Reference Document Title Subject Matter Source

ISO 14698-1,2 Biocontamination Control General Principles AS 2252.1 Biological Safety Cabinets (Class1) Australian Std AS 2252.2 Biological Safety Cabinets (Class 2) “ AS 2647 Biological safety cabinets – Installation and use “ ASTM F ...

http://www.cleanroommanagement.com/image/data/ReferenceSource.pdf

Date added: August 2, 2014 - Views: 1