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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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The ISO contamination control standards - ICCCS

The ISO contamination control standards Hans H. Schicht, Dr. sc. techn. Dr. Hans Schicht Ltd. Contamination Control Consulting ... ISO 14698-2 Biocontamination control: Evaluation and interpretation of biocontamination data FDIS 04.03

http://www.icccs.net/news/ContamCtrlStdsSchicht.pdf

Date added: February 13, 2012 - Views: 371

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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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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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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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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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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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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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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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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: 121

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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: 138

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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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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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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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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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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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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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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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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: 26

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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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Clean Room Particulate Count - Portland State University

Clean Room Particulate Count . Date - 2/28/2012 . Device - Met One Particulate Counter . Mdl. A2408-1-115-1 . Cal. Date: 4/12/11 by Hach Ultra (Cal#000200172) Location ... ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data

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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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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Air Sampler Qualification According to ISO 14698 NORM

In its last version (2004), the ISO 14698 norm presents two different types of collection methods: 1) passive sampling (settle plates), and 2) active sampling equipment. Passive sampling is a good way to get a representative result concerning the

http://www.cemag.us/printpdf/articles/2009/07/air-sampler-qualification-according-iso-14698-norm

Date added: July 18, 2013 - Views: 4

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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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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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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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Cleanroom Air Systems Design - High-Performance Buildings for ...

ISO 14698-2 Evaluation and interpretation of ... ISO class 5 LBNL Cleanroom Benchmark Data ISO Class 5 (Class 100) Cleanrooms 0 100 200 300 400 500 600 Facility A Facility B Facility C Facility D Facility E Facility F Facility G Facility H M e a s ur e d A i r C h a n g e R a te (A C /

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

Date added: March 15, 2012 - Views: 51

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Standards for classification and testing of cleanrooms - ICCCS

2 ISO Standards A range of cleanroom standards is being produced by the International Organization for Standardization (ISO). ... 2.2 ISO 14698 This consists of the following parts under the general title ‘Cleanrooms and Associated

http://www.icccs.net/news/ClassificationOfCleanrooms2005.pdf

Date added: February 9, 2012 - Views: 165

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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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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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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://socks-us.blogspot.w.ecmjournal.org/journal/supplements/vol023supp01/pdf/Vol23supp01a22.pdf

Date added: September 11, 2014 - Views: 1

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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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Detection of Micro-organisms in Compressed Gases

The International Standard ISO 14698-1/2 1 demands the monitoring of bio-contamination in compressed gas systems which are used in pharmaceutical production processes. The norm describes the detection of bio-

http://www.swissccs.org/d/docs_db/swissccs_20131031_000319_SwissCCS_Microorganismen_Druckgase_Paper_01e.pdf

Date added: December 4, 2013 - Views: 3

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Microbiological Monitoring in Aseptic Environments - IESMAT

ISO 14698-1 and -2 • Provides detailed definition of the functional aspects of a microbial monitoring system ... PMS ‘Airtrace’ Slit-to Agar Collection Efficiencies Very high physical collection efficiency especially for small particles.

http://www.iesmat.com/iesmat/upload/5.%20Microbial%20Monitoring%20Technology.pdf

Date added: April 6, 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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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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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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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

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Focus on ISO Standards & Research

ISO Standards 14698 –1 & 2 – An Introduction Enrico Bompadre, Asco Tec CTCB, (Cleanroom Testing & Certification Board) Peter Fernie & Conor Murray, Irish Cleanroom Society Automatic Microbiolgical Air Sampling to ISO 14698 Enrico Bompadre, Asco Tec

http://www.cleanrooms-ireland.ie/index.cfm/fuseaction/common.files/id/FF0EADE9D2C740BF8B386351D2C5B957

Date added: May 27, 2013 - Views: 3

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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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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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Contamination Control for Pharmaceutical Industry

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data 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

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

Date added: November 24, 2012 - Views: 19

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ISO 14698 & MICROBIOLOGICAL AIR SAMPLERS - Kenelec Scientific

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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ISO Technical Committee 209 Status Report

ISO-14698-2 Biocontamination: Evaluation & Interpretation of Data 2004 2007 - SG6 2004 2007 2003-WG2 2003-WG2. ISO TC 209 ... ISO-14644-2 Specification of Testing for Continued Compliance to -1 ISO-14644-3 Test Methods & Metrology ISO -14644 -4 Design, ...

http://www.racc.com.ro/standarde%20europene%20camere%20curate.pdf

Date added: January 8, 2014 - Views: 7

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Environmental Monitoring, risk assessment and responsibilities

Environmental Monitoring, risk assessment and responsibilities . Medical Devices Directive -93/42/EEC ANNEX I ESSENTIAL REQUIREMENTS ... (Reference EN ISO 14698: Part 1:2003 and EN ISO 14698 Part 2:2003). Routes of microbial contamination

http://www.wfhss.com/html/conf/assets/ie_idi_conf20130907_lecture_1_en.pdf

Date added: October 11, 2013 - Views: 9

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British European and ISO Decontaminated Related Standards 27 ...

BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices

http://www.idsc-uk.co.uk/documents/British-European-and-ISO-Decontaminated-Related-Standards.pdf

Date added: August 27, 2013 - Views: 47

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Test: Test Method(s) - Mytex Polymers

ASTM D785; ISO 2039-2 Density / Specific Gravity ASTM D792 (Method A); ISO 1183-1 (Method A) Mold Shrinkage ASTM D955; ISO 294-4 FTIR Spectroscopy ... GMW 14698-B; LP-463DD-1801 Non-instrumented Impact - Dupont HES 2500, Section 3.2 Gray Scale - Using Spectrophotometer ISO 105-AO2

http://mytexpolymers.com/pdf/ISO-IEC_17025_2016.pdf

Date added: April 24, 2014 - Views: 9