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Implementation of VAI Products - Food and Drug Administration

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Implementation of VAI Products - Food and Drug Administration

Please refer to ISO 14698 whereby no sampling method is named by name. Rather a validated system is called for. Please refer to the Orange Guide whereby no sampling method is named by name.

http://www.fda.gov/ohrms/dockets/dailys/03/oct03/102703/03D-0382-emc-000004-01.doc

Date added: February 10, 2012 - Views: 32

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Cezar Lucki's Quality and Validation Engineering Resume

OSHA) 10CFR (NRC reg’s) 40CFR (EPA reg’s) ANSI/ASQC Z1.9-1993 MIL-STD-105E ANSI/ASQC Z1.4 Fed. Std. 209E (ISO TC 209-14698) USP / BAM. NIST / ASTM / ACS. MDD (med. dev. directive) DOT. CE Mark / UL. EU GMP (91/356/EEC, 91/412/EEC) Government Regulations: FDA. NRC. OSHA. DEA. DOT. EPA. Tasks ...

http://www.qualityleader.com/QE%20&%20Val%20FULL%20resume%20-%20focus%20on%20API1.doc

Date added: September 30, 2011 - Views: 57

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ISOupdate_april2014-en-text - ISO - International ...

ISO/CD 18466 Determination of the biogenic fraction in ... — Definition of a global concept for Local Dynamic Maps TC 209 Cleanrooms and associated controlled environments ISO/CD 14698 Cleanrooms and associated controlled environments — Biocontamination control — Microbial ...

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

Date added: April 16, 2014 - Views: 15

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ISO/TC 76/SC N - Welcome to the PQG >

ISO 9000:2005, quality management systems – Fundamentals and vocabulary. Terms and definitions. ... Monitoring may be conducted in accordance with ISO 14698-1 and ISO 14698-2. Note: See Annex “D ...

http://www.pqg.org/download-files/PS9000-2010DraftForComment-V6-04-04-2011.doc

Date added: June 26, 2012 - Views: 47

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Quality & Validation Resume / Curriculum Vitae - Cezar Lucki

... ISO TC 209-14698, EN45001/ISO17025. Languages: Native: English / Polish Conversational: French / Spanish . EXPERIENCE: Applied Medical, R. Santa Margarita, CA [medical devices: surgical] Feb 06 – Feb 07, Aug 07- Mar 08. SAP Validation Engineer .

http://www.qualityleader.com/QE_Val_CV_Cezar.doc

Date added: October 6, 2011 - Views: 45

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Hellenic Accreditation System - Αρχική Σελίδα

Detection of Listeria monocytogenes ISO 11290-1:1996/Amd 1:2004 VIDAS Biomerieux- LMO2-Πιστοποιητικό επικύρωσης AFAQ ... Air 1. Microbiological Air quality in Controlled Environment CYS EN ISO 14698-1:2003 12. Potable water, Surface water, See water, Well waters ...

http://www.esyd.gr/eped/1.135406_en.doc

Date added: June 21, 2013 - Views: 4

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Send Final Report To:

iso 14698-1 e ...

http://mycindustrial.com/wp-content/uploads/2013/05/FM-024_B-Sample-Submission-Form-Español.docx

Date added: May 19, 2014 - Views: 1

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Focus on Prevention: Conducting a Mining Hazard Risk Assessment

NEW standards BS EN ISO 14698 Parts 1 & 2 . Guidance on biocontamination control. Hygiene has become increasingly important in modern society. So that manufacturers can create safe and stable products, it is essential that they use hygiene or biocontamination control.

http://archiwum.ciop.pl/zasoby/CISN0404.doc

Date added: June 4, 2014 - Views: 3

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ATCC® Number: - instrument.com.cn

Geneva (Switzerland): International Organization for Standardization/ANSI; ISO ISO 14698-1:2003. 92419: Medical microbiology; methods for the determination of susceptibility of pathogens (except mycobacteria) to antimicrobial agents: carrier of agents for agar diffusion test. Berlin, ...

http://www.instrument.com.cn/Quotation/Manual/71869.doc

Date added: December 6, 2011 - Views: 24

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室內空氣中細菌濃度檢測方法 - Indoor Air Quality

(十一)BS EN ISO 14698-1: Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. 2003. http://www.scribd.com/doc/ 73559124/ISO-14698-1 ...

http://140.116.67.115/upload/news/new1-2012927144240.doc

Date added: July 23, 2013 - Views: 4

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www.istr.org.uk

09.50 Introduction and background to cleanrooms and their applications, international cleanroom standards ISO 14644 and ISO 14698 and the future, cleanrooms v biosafety labs and their conflicting requirements Connor Murphy .

http://www.istr.org.uk/docs/2011%20Nov%20ISTR%20booking%20form.doc

Date added: May 8, 2012 - Views: 4

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SOUTH AFRICAN QUALIFICATIONS AUTHORITY - merSETA

14698 Cut materials using plasma cutting SGB NAME. ABET BAND. PROVIDER NAME. SGB Welding Undefined FIELD DESCRIPTION. SUBFIELD DESCRIPTION. ... ISO 5817 (Visual Inspection). Resource material related to this cutting process.

http://ww2.merseta.org.za/US/Documents/14698.doc

Date added: July 1, 2013 - Views: 8

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ExoMars Pasteur Payload Experiment Interface Requirements ...

RD12 ISO 14698-3 Cleanrooms and Associated Controlled Environments – Biocontamination control: Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms.

http://homepages.nildram.co.uk/~adr/EXOMARS/PLANETARY%20PROTECTION/ExoMars_PanCam_PP_20080624_adr.doc

Date added: October 23, 2011 - Views: 17

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ООО «Technological systems» e-mail: info-ts-company@yandex

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.

http://technoligicalsystems.ru/img/GOST%20R%20%20ISO%2014644-6-2010.docx

Date added: November 30, 2013 - Views: 4

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img11.chem17.com

... (依据iso-14698-1相关条款)。 *浮游菌采样器本身不能直接给出检测结果,列为实验室三级设备,无需国家计量单位认证。 mas-100浮游菌采样器特殊说明: 1、mas-100 nt ex®:严格按照国际防爆标准snch atex 3418 ...

http://img11.chem17.com/5/20110130/634319890307327500.doc

Date added: October 29, 2013 - Views: 1

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ФЕДЕРАЛЬНОЕ АГЕНТСТВО

ISO 14644-8:2006 Clean rooms and associated controlled environments ... Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) [4] ISO 14698 (all parts) Cleanrooms and associated controlled environments ...

http://technoligicalsystems.ru/img/GOST%20R%20ISO%2014644-8-2008.doc

Date added: December 5, 2013 - Views: 3

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CLEAN ROOM 규격 - "+document.title+" ["+srcFileName+"]

ISO 14698-3. Bio-contamination control- Part 3 : Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing bio-contaminated wet soiling or bio-films. DIS [ISO/TC 209 문서] ISO classification number (N)

http://ujenc.co.kr/niabbs/doc/pds/CLEAN%20ROOM.doc

Date added: June 30, 2012 - Views: 39

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Про затвердження національних

(iso 14698-2:2003, idt) – Вперше . ДСТУ iso 15496:2009 Матеріали текстильні. Метод вимірювання проникності водяної пари через тканини для перевіряння ...

http://www.stand.lutsk.ua/downloads/Order09/448_14_12_2009.doc

Date added: January 2, 2014 - Views: 2

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空氣中細菌濃度檢測方法(E301.13C)

(十)BS EN ISO 14698-1: Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. http://www.scribd.com/doc/ 73559124/ISO-14698-1, 2003.

http://www.niea.gov.tw/niea/doc/E30113C.doc

Date added: July 1, 2013 - Views: 5

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NosoVeille Août 2011 - NosoBase

Les normes NF EN ISO 14698-1 et 2 sur la maîtrise de biocontamination dans les salles propres et environnements maîtrisés associés, vont être révisées. On s’oriente vers des classes de propreté microbiologique de l’air et des surfaces.

http://nosobase.chu-lyon.fr/NosoVeille/2013/NosoVeille_Janvier2013.doc

Date added: June 1, 2013 - Views: 5

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室內空氣中真菌濃度檢測方法

(十一)BS EN ISO 14698-1:2003. Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. http://www.scribd.com/doc/ 73559124/ISO-14698-1 (十二)蘇慧貞、李家偉、李俊彰,2011 ...

http://atftp.epa.gov.tw/announce/101/S0/00615/NIEA%20E401.12C%AF%F3%AE%D7.doc

Date added: May 19, 2013 - Views: 3

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空氣中細菌濃度檢測方法(NIEA E301.13C)

(十)BS EN ISO 14698-1: Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. http://www.scribd.com/doc/ 73559124/ISO-14698-1, 2003.

http://www.niea.gov.tw/niea/announce/E30114C草案.doc

Date added: June 4, 2014 - Views: 1

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files.instrument.com.cn

14698-1由洁净室及其相关控制环境技术委员会 . iso/tic 209编写。 iso14698 ... iso 14698-2 。 由于细菌 ...

http://files.instrument.com.cn/FilesCenter/20101008/148975.doc

Date added: May 3, 2013 - Views: 6

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seznam.normy.biz

ČSN EN ISO 14698-2 (12 5370), kat. č. 69438převzata vyhlášením ve věstníkuČisté prostory a příslušné řízené prostředí - Regulace biologického znečištění - Část 2: Vyhodnocení a výklad údajů o biologickém znečištěníVydána: ...

http://seznam.normy.biz/tisteny/dl.php?trida=12&typ=doc

Date added: June 18, 2013 - Views: 10

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Download

(ISO 14698-1:2003, ІDТ) – Вперше . ДСТУ ISO 17995:2008. Якість води. Визначення та підраховування термостійких різновидів Campylobacter (ISO 17995:2005, ІDТ) – Вперше .

http://www.stand.lutsk.ua/downloads/Order09/519_2008_01_12.doc

Date added: November 24, 2013 - Views: 4

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Download - Behin Moshaveran [صفحه اصلي سايت]

... واخواست رشته ای جهانی ایزو 1-14698 مربوط به کنترلر های Bio-contamination ایزو 2-14698 مربوط به سنجش و تفسیر Bio ... سامانه مديريت زيست بر مبناي ISO 14001 به عنوان يك الگوي اجرايي ...

http://behinmoshaveran.com/userfiles/downloads/90-11-01/esteghrar%20iso.doc

Date added: June 15, 2012 - Views: 42

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www.rootlaw.com.tw

(十一) BS EN ISO 14698-1: Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. 2003. http://www.scribd.com/doc/73559124/ISO-14698-1

http://www.rootlaw.com.tw/Attach/L-Doc/A040300081055900-1020516-1000-001.doc

Date added: December 8, 2013 - Views: 3

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Tiªu chuÈn ViÖt nam vÒ nhµ vµ vËt liÖu x©y dùng nhµ

Yªu cÇu thiÕt kÕ 15 TCVN 6227:1996 C¸t tiªu chuÈn ISO ®Ó x¸c ®Þnh c­êng ®é cña xi m¨ng 8 TCVN 5065-90 Kh ... Part 2: Evaluation and interpretation of biocontamination data 11 ISO 14698-1:2003 Cleanrooms and associated controlled environments -- Biocontamination control ...

http://www.xaydung.gov.vn/c/document_library/get_file?p_l_id=10499&folderId=29703&name=1287

Date added: April 29, 2012 - Views: 167

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Mode opératoire - pharmacien hospitalier

Norme ISO/DIS 14698-1 Maîtrise de la biocontamination dans les salles propres et environnements contrôlés apparentés. ASPEC Contrôles de l’environnement dans les zones à haut et très haut risque infectieux.

http://pharmacienhospitalier.hautetfort.com/media/01/00/713185320.doc

Date added: June 30, 2012 - Views: 4

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ALKALMAZÁSI ELŐÍRÁS - Medi-Radiopharma Co., Ltd. | Medi ...

Limiti raccomandati per particelle vitali in aree asettiche classificate in accordo alle guide ISO (ISO-14644-1, ISO-14698-2) Classificazione (Grado o Classe) secondo EU CGMP, ISO e US Federal Standard Dischi a. Contatto. CFU/disco Impronte di guanti.

http://www.mediradiopharma.com/mediradio_media/files/medi-media-fill-kit-instructions-for-use-i.doc

Date added: December 22, 2013 - Views: 3

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TT - Xin chào mừng các bạn đến với website Tổng ...

ISO 14698-1:2003 Viện TTB&CTYT 2011 2011 Bộ Y tế 64. Phòng sạch và môi trường kiểm soát liên quan - Kiểm soát sự nhiễm khuẩn - Phần 2: Đánh giá và giải trình các dữ liệu về sự nhiễm sinh học Chấp nhận .

http://portal.tcvn.vn/media/Ke_hoach_TCVN_2011_trinh_Bo_KHCN_ngay_17-12_Final[1].doc

Date added: February 17, 2012 - Views: 47

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1 - IPSJ

ISO/IEC JTC 1/SC 29/WG 11. CODING OF MOVING PICTURES AND AUDIO. ISO/IEC JTC 1/SC 29/WG 11 N9157. Lausanne, CH – July 2007. Source: Leonardo Chiariglione Title: Report of 81st meeting Status ... 14698 (FhG) CTS Offsets and hierarchical B-Frames. Yes, ...

http://itscj.ipsj.or.jp/sc29/open/29view/29n87271.doc

Date added: January 27, 2014 - Views: 8

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생물학적제제등 제조지원설비 가이드라인

... ISO 14644 series, “Cleanrooms and Associated Controlled Environments” 4) ISO 14698, “Cleanrooms and Associated Controlled Environments – Biocontamination Control” 5) Biosafety in Microbiological and Biomedical Laboratories, ...

http://www.mfds.go.kr/jsp/common/download.jsp?fileinfo=S*1*%BB%FD%B9%B0%C7%D0%C0%FB%C1%A6%C1%A6%B5%EE%20%C1%A6%C1%B6%C1%F6%BF%F8%20%BC%B3%BA%F1%20%B9%EB%B8%AE%B5%A5%C0%CC%BC%C7%20%B9%D7%20%C0%AF%C1%F6%B0%FC%B8%AE%20%B0%A1%C0%CC%B5%E5%B6%F3%C0%CE(%C3%D6%C1%BE%B0%E1%C0%E7%BA%BB).doc*i6WkiLs91qfTZtO9TqftgeNeMijmGGQX*doc*/files/upload/1/TB_N_GUIDE/125/i6WkiLs91qfTZtO9TqftgeNeMijmGGQX*206848*2009-01-22%2010:25:40

Date added: May 3, 2013 - Views: 9

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Compte-rendu partiel et partial sous forme de restitution de ...

Norme ISO 14698-1 de maîtrise des biocontamination. EAU : Legionella, microbactéries multiples qui s’attachent, ... Arrêté du médicament 2011 quasiment = norme ISO ; obligatoire, calendrier, contrôle de déploiement opérationnel. Mais c’est lourd.

http://www.jiqhs.fr/wp-content/uploads/2013/02/AFQUARIS_Congr%C3%A8s_Jan2013_CR_V3.doc

Date added: May 7, 2013 - Views: 8

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Vägledning och grundläggande krav för mikrobiologisk ...

SS-EN ISO 14644-1, Renhetsteknik - Renrum och tillhörande renhetskontrollerade miljöer - Del 1: ... SS-EN ISO 14698-1 Renhetsteknik - Kontroll av mikrobiologiska föroreningar i renrum och tillhörande renhetskontrollerade miljöer ...

http://styrelse.mtf.nu/remisser/Dokumentbibliotek1/1/2011/SIS-Remiss%209252%20Renhet%20i%20operationsrum/SIS%20TR%2039%20Remissutg%C3%A5va.doc

Date added: June 15, 2012 - Views: 4

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TESTO UNICO DELLE LEGGI - Area-c54.it - Blog di informazione ...

2004 – UNI EN ISO 14698-1:2004 – Camere bianche ed ambienti associati controllati. Controllo della biocontaminazione. Parte 1: Principi generali e metodi. 2004 – UNI EN ISO 14698-2:2004 – Camere bianche ed ambienti associati controllati.

http://www.area-c54.it/public/testo%20%20unico%20%20delle%20%20leggi%20-%20testo.doc

Date added: January 27, 2012 - Views: 44

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www.mlsi.gov.cy

... την αρχή του Anderson παγκοσμίως αποδεκτή και σύμφωνα με το πρότυπο ISO 14698-1 (Clean rooms and associated controlled environments – Biocontamination control – Part 1: ...

http://www.mlsi.gov.cy/mlsi/dli/dli.nsf/All/A1CD32D516F2F7BDC2257C770044453B/$file/Kodikas%20Poiot%20Aera%20Esot%20Xorou%202014.docx

Date added: March 12, 2014 - Views: 1

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Laborator mobil pentru detecţia pierderilor de apă în ...

conform ISO 14698-1:2003 Accesorii: set baterii reincarcabile . incarcator baterii AUTOCLAV DE LABORATOR . ... de management al calităţii în conformitate cu cerinţele referenţiarului ,standardul internaţional SR EN ISO 17025/2005 ...

http://www.e-achizitii.com/download_document.php?id_document=923377&id_anunt=432496&id_anunt_atribuit=0

Date added: December 8, 2013 - Views: 3

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ΕΘΝΙΚΟ ΣΥΣΤΗΜΑ ΔΙΑΠΙΣΤΕΥΣΗΣ

cys en iso 660:2000. 2. Προσδιορισμός των ... cys en iso 14698-1:2003. 12. Νερά Πόσιμα, Επιφανειακά, Θαλασσινά νερά, νερά διατρήσεων (υπόγεια νερά) 1.

http://www.esyd.gr/eped/1.135406_el.doc

Date added: May 19, 2013 - Views: 7

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Servicio - CARM.es - Portal CARM

UNE-EN ISO 14698: Partes 1 y 2. Salas limpias y ambientes controlados asociados. Guía práctica para el diseño y mantenimiento de la climatización en quirófanos. Instituto Nacional de la Salud.

http://www.carm.es/web/PDescarga?IDCONTENIDO=1618&PARAM=%3FidDocumento%3Dworkspace%3A%2F%2FSpacesStore%2Fcc6b9f0e-ca03-4e5c-9423-1c39637c44bb%2F1.1%26descargar%3Dtrue

Date added: December 26, 2013 - Views: 4

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PROCEDURE DES PROCEDURES - pharmacien hospitalier

Norme ISO/DIS 14698-1. Guide de l’ultra-propreté Edition 2008-2009. BCMI. ASPEC La Biocontamination Salles propres, environnements maîtrisés et zone de bioconfinement . Contrôles de l’environnement dans les zones à haut et très haut risque infectieux.

http://pharmacienhospitalier.hautetfort.com/media/02/02/731227374.doc

Date added: June 29, 2012 - Views: 18

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室內空氣中真菌濃度檢測方法

(十一)BS EN ISO 14698-1:2003. Cleanrooms and associated controlled environments-Biocontamination control-Part 1: General principles and methods. http://www.scribd.com/doc/ 73559124/ISO-14698-1 ...

http://atftp.epa.gov.tw/announce/101/S0/01203/NIEA%20E401.12C.doc

Date added: May 19, 2013 - Views: 1

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达华工程管理(集团)有限公司关于ABC单位

2 功能及技术要求 2.1 符合ISO 14698-1的要求 2.2 流量:空气样本以50L/分钟的速度快速通过BioCapt反应板 2.3 MiniCapt易于清洁,反应板可以被抽走高压灭菌 2.4 MiniCapt的设计符合cGMP, GAMP®, ...

http://www.chinabidding.com/cms/attachment/29995775

Date added: January 21, 2014 - Views: 4

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Hi Greg, Attached is an updated version of the annual report ...

... ISO 9000 requirements, etc.) will help the military installation meet U.S. Air Force mandates for ISO 9000 certification, having high ... 596 18531 Employment Retention Rate 85.1% 353 78.9% 5509 415 6978 Earnings Replacement Rate $15,923 5588819 $14,698 79984512 351 ...

http://www.okcommerce.gov/Libraries/Documents/Workforce-Investment-Act-Oklah_3512.doc

Date added: May 4, 2013 - Views: 8

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Znak sprawy - ..:: 4 Regionalna Baza Logistyczna ...

Zgodny z standardem ISO 14698-1 i ISO 18593 i NF V 08-037. Podłoże zawierające czynniki neutralizujące, które inaktywują pozostałości środków dezynfekujących. Płytki odpowiednie do aplika torów firmy BioMerieux. Skład:

http://www.4rblog.wp.mil.pl/plik/file/przetargi_siwz/dost%20na%20mater%20diagn%20WOMP%205-6-2011/SIWZ%20WOMP)5)6)2011.doc

Date added: May 6, 2013 - Views: 1

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Dla wykonawców

1/ Certyfikat ISO 9000 dla w/w urządzenia dołączony przez wykonawcę do protokół€ zdawczo-odbiorczego TAK 2/ Szkolenie w siedzibie użytkownika przez 3 dni w trakcie instalacji TAK 3/ Minimum 24 ... (m.in. ISO 14698 i USP 1116 Pharmacopeia) TAK zasilanie akumulatorowe TAK ...

http://www.up.lublin.pl/szp/2014/AZP-PN-p-207-6-2014/zal._1_-27_opis_przedmiotu_zamowienia.doc

Date added: May 27, 2014 - Views: 1

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洁净厂房设计规范条文说明

附录c 洁净室或洁净区性能测试和认证 c1 通则 本附录编写的指导思想是与国际接轨,依据iso-14644、14698等的内容进行编制。

http://file.yizimg.com/369241/2011091610514388.doc

Date added: August 12, 2013 - Views: 1

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Kołobrzeg, dnia 17 lipca 2013r

Praca zgodna ze standardem ISO/DIS 14698-1. Aparat wykonany z materiału: plastik ABS. Instrukcja obsługi w 2 egzemplarzach w języku polskim. Tabele przeliczeniowe. Ładowarka baterii. Certyfikaty dot. urządzenia oraz certyfikat kalibracji otworów.

http://zoz.kolobrzeg.pl/przetargi/przetarg/0436_dzie/zap.doc

Date added: December 11, 2013 - Views: 2

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U

We generally purchase used ISO containers when ... rent $116.81 $127.91 $126.81 $129.78 $127.97 $122.41 Type 7 Number of Units 14,698 4,326 330 44 7 19,405 Average rent $107 .23 $113.07 $124.08 $123.35 $119.48 $108.86 Type 8 Number of Units ...

http://www.mobilemini.com/files/documents/10KDec31-05.doc

Date added: August 1, 2013 - Views: 8

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DRAFT Nr

... maximum 0,1% determined according to ISO ... NS 14685 008001-31-8 Coconut oil 3 14693 008001-30-7 Corn oil 3 14695/1 - Corn oil fatty acids 3 14698 008001-29-4 Cottonseed oil 3 14700/1 - Cottonseed oil fatty acids 3 14710 000108-39-4 m-Cresol 3 14740 000095-48-7 o ...

http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=10210B&DWNLD=CoE%20ResAP%20Coatings%20version%203%20-%202009[1].02.12.doc

Date added: October 30, 2011 - Views: 13