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ISO 15223-2:2010 Details Medical Device Symbols,...

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ISO 15223-2:2010 Details Medical Device Symbols,...

ISO 15223-2:2010 Details Medical Device Symbols, Labeling March 30, 2010 // Published as a news service by IHS The International Organization for Standardization (ISO ...

http://www.pacelabs.com/assets/documents/Twitter2/ISO-15223.pdf

Date added: May 25, 2012 - Views: 411

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IS/ ISO 15223-1 (2007): Medical Devices - Symbols...

is/iso 15223-1 : 2007 indian standard medical devices — symbols to be used with medical device labels, labelling and information to be supplied

https://law.resource.org/pub/in/bis/S09/is.iso.15223.1.2007.pdf

Date added: April 4, 2015 - Views: 2

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ANSI/AAMI/ ISO 15223-1:2007, Medical devices -...

Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 15223-1:2007 and ANSI/AAMI/ISO 15223-1:2007/A1:2008 Medical devices — Symbols to be used with

http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files%5C15223010807_preview.pdf

Date added: February 4, 2012 - Views: 590

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ANSI/AAMI/ ISO 15223-2:2010, Medical devices —...

Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 15223-2:2010 Medical devices — Symbols to be used with medical device

http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/15223021004_preview.pdf

Date added: December 4, 2011 - Views: 185

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The international language of ISO graphical...

The international language of ISO graphical symbols Graphical symbols are vital for giving information when written words are not adequate.

http://www.iso.org/iso/graphical-symbols_booklet.pdf

Date added: November 26, 2011 - Views: 2462

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INTERNATIONAL ISO STANDARD 15223-2

ISO 15223-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.

http://www.evs.ee/preview/iso-15223-2-2010-en.pdf

Date added: May 13, 2014 - Views: 1

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Client information note - LRQA

Client information note EN 980 superseded by ISO 15223 Labelling Symbols to be used with medical device labels, labelling and information to be supplied

http://www.lrqa.co.uk/images/8564-.pdf

Date added: October 18, 2013 - Views: 12

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ISO 15223 E - SAI Global

ISO 15223:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but ...

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=273085

Date added: January 11, 2014 - Views: 1

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Human Factors in Medical Device Design

ISO 15223-1:2007 ; ISO 15223-2:2010 . Medical devices – Symbols . to be used with medical ... Human Factors Standards have been expanded, revised, replaced

http://www.hfes.org/web/HFESmeetings/HCSpresentations/israelskistandardsppt.pdf

Date added: June 26, 2012 - Views: 183

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INTERNATIONAL ISO STANDARD 15223-1 - SAI Global

ISO 15223-1:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but

http://infostore.saiglobal.com/store/PreviewDoc.aspx?saleItemID=273052

Date added: January 10, 2014 - Views: 17

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This document is a preview generated by EVS

This part of ISO 15223 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined descriptions.

http://www.evs.ee/preview/evs-en-iso-15223-1-2012-en.pdf

Date added: November 26, 2012 - Views: 92

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OUT FOR COMMENT APPROVED OUT FOR VOTE

STANDARDS UPDATE – NOVEMBER 2013 BS EN ISO 15223-1:2012 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied ...

http://bdia.org.uk/uploads/PDFs/BDTA%20News/November%202013%20Standards%20Update%20For%20Web.pdf

Date added: May 1, 2015 - Views: 2

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IVD YMBOLS FOR EAGENTS AND NSTRUMENTS

Page 6 of 23 SYMBOLS FOR ISO CEN IEC Others ISO 7000 ISO 15223-1: 07 EN 980: 08 IEC 60417 Biological risks (ISO7000: Biological hazards)

http://www.edma-ivd.eu/uploads/use%20of%20symbols/2012_04_12_LAB_GUI_IVD%20symbols%20for%20reagents%20and%20instruments_PUB.pdf

Date added: August 2, 2013 - Views: 42

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1 2 Sign, Sign Everywhere a Sign Learning...

1/8/2014 3 What’s That Sign? 9 ANSI/AAMI/ISO 15223-1:20 12 Medical devices –Symbols to be used with medical device labels, labeling, and information to be ...

http://www.njcl.us/images/Signs_and_Symbols_.pdf

Date added: March 8, 2014 - Views: 12

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EN 980:2008: Graphical Symbols for use in the...

ISO 15223-1:2007: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements ...

http://www.malariajournal.com/content/download/figures/1475-2875-10-331-1.pdf

Date added: September 27, 2012 - Views: 322

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International standard EN 15223-1 to replace EN...

EN ISO 15223-1 – Medical devices - Symbols to be used with medical device labels, ... It will be harmonized under all three EU medical device directives.

http://www.informa-ls.com/appdata/downloads/labelling12/SRA_Europe%27s_symbols.pdf

Date added: November 27, 2014 - Views: 1

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This document is a preview generated by EVS

ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels and ...

http://www.tecnologias-sanitarias.com/normativa/iso-15223-1-2012-en.pdf

Date added: September 28, 2012 - Views: 98

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European Guidance Manufacturers Document “IVD...

SYMBOLS FOR ISO CEN IEC Others ISO 7000 ISO 15223 EN 980 IEC 60417 Upper limit of temperature 9 0533 3.10 4.16.1 9 9 Temperature limitation

http://www.labquality.be/documents/LAB%20MANAGEMENT/QA/IVD_SYMBOLS_final.pdf

Date added: July 25, 2012 - Views: 128

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Symbols Commonly Used in Medical Device Packaging...

Note: Symbols were derived from "ISO 15223 Medical Devices - Symbols to be Used with Medical Device Labels,

http://www.smith-nephew.com/global/assets/pdf/temp/sn_symbols_09_(copy-1).pdf

Date added: June 26, 2013 - Views: 11

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PM5200EN, PM5200MEN, PM5200NIST, PM5200NISTAP,...

ISO 11195 :1995 EN ISO 13485:20 12 EN ISO 14971 :20 12 EN ISO 15001 :2011 ISO 15223 -1:2012 Notified Body: AMTAC Certification Services Limited 0473

http://www.precisionmedical.com/sites/www.precisionmedical.com/files/literature/blenders-declaration-conformity.pdf

Date added: March 29, 2014 - Views: 5

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Medical Device Labeling Overview - IoPP

IOPP Medical Device Packaging Committee October 22, 2003 ... En980 and ISO 15223 are guides but nothing stops manufacturers from creating symbols and

http://www.iopp.org/files/public/Labeling_TG_ReportOct_2003.pdf

Date added: November 30, 2011 - Views: 49

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Use of Symbols on Labels and in Labeling of In...

other symbols identified by FDA in its recognition of ISO 15223 and EN 980, whether or not used in labeling for the particular device.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085679.pdf

Date added: May 25, 2012 - Views: 34

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Use of Symbols on Medical Device Labels - FDA...

Use of Symbols on Medical Device Labels - FDA Requirements ... ISO 15223 does not declare any symbol as a known symbol (unlike EN 980) and exempt them

http://elsmar.com/pdf_files/quality_assurance_pdf/Use%20of%20Symbols%20on%20Medical%20Device%20Labels%20-%20FDA%20Requirements.pdf

Date added: June 28, 2013 - Views: 1

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FINAL - Ministerio de Sanidad, Servicios Sociales...

medical device standards (ISO 15223-1, ISO 3826-2 and EN 980) • The maximum volume of the blood/component that is to be collected into the container

http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransfusional/congresos/docs/eurobloodpack.pdf

Date added: December 24, 2012 - Views: 7

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for Comments only Doc No.: MHD 14(310) ISO 15223...

ISO 15223-1:2012 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard

http://www.bis.org.in/sf/mhd/MHD14(310).pdf

Date added: August 20, 2013 - Views: 21

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Looking ahead to new human factors Ed Israelski...

ISO/IEC 62366:2007 Ed 1, ... ISO 15223-1:2007 Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied

http://www.hfes.org/web/HFESMeetings/HCSPresentations/HCS2013Israelski.pdf

Date added: May 19, 2013 - Views: 22

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Major IEC 60601-1 3rd Ed changes 9-14-10 -...

ISO 14971. • IEC 60601-1 is intended to serve as a tool in the risk management process. ... -ISO 780 and ISO 15223 shall apply. www.intertek.com Packaging (clause 7.2)

http://www.intertek.com/uploadedFiles/Intertek/Divisions/Commercial_and_Electrical/Media/PDF/Medical_Equipment/Major-IEC-60601-1-3rd-Ed%20-changes-9-14-10.pdf

Date added: December 16, 2011 - Views: 174

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0473 - Precision Medical Inc.

iso 15223 -1:2012 en 1041 :2008 iso 10524 -1 :2006 iso 10524 -3 :200 6 en iso 14971 :20 12 en iso 15001 :2010 iso 18779 :2005 ss 367615 :2001 notified ...

http://www.precisionmedical.com/sites/www.precisionmedical.com/files/literature/oxygen-conserving-device-declaration-conformity.pdf

Date added: March 31, 2014 - Views: 13

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ISO 15223-2:2010-01 (E)

-1 - ISO 15223-2:2010-01 (E) Medical devices - Symbols to be used with medical device labels, labelling, and informa tion to be supplied - Part 2: Symbol development ...

http://www.beuth.de/cmd%3Bjsessionid=ESKMGTR1WQXRQWOSS1XMJGSD.3?workflowname=infoInstantdownload&docname=1617703&contextid=beuth&servicerefname=beuth&ixos=toc

Date added: June 19, 2015 - Views: 1

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biofiredx.com

ISO 15223-1:2012 Medical Devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements

http://biofiredx.com/pdfs/CE%20Declarations/FLM1-PRT-0139_FilmArray_BCID2.0_EC_Kit.pdf

Date added: March 17, 2014 - Views: 4

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DIN EN ISO 15223-1:2013-02 (E)

-1-DIN EN ISO 15223-1:2013-02 (E) Medical devices - Symbols to be used with medical device labels, labelling and infor mation to be supplied - Part 1: General ...

http://www.named.din.de/cmd%3Bjsessionid=SWOVGJ7MGW9OFU5C1VYD1EWO.4?workflowname=infoInstantdownload&docname=1950737&servicerefname=dino&ixos=toc

Date added: June 1, 2015 - Views: 1

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EDMA SYMBOLS FOR REAGENTS AND COMPONENTS

“EDMA SYMBOLS FOR IVD REAGENTS AND COMPONENTS ... and ISO 15223-1 into a single symbol standard to be used internationally by the medical devices industry.

http://intranet.edma-ivd.eu/index.php/component/docman/doc_download/110-20091007labedmasymbolsguipub?Itemid=

Date added: January 6, 2014 - Views: 2

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Comments on Docket No. FDA-2011-N-0090, Proposed...

ISO 15223, recognized by FDA as a consensus standard (Recognition Number 5-68), specifies internationally accepted symbols for expiration date and manufactured date.

http://advamed.org/res.download/163

Date added: May 2, 2013 - Views: 5

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ISO 4074:2014 Standard Update - Health Sciences...

ISO (the International Organization for Standardization) is a worldwide federation ... • Symbol shall meet the requirements in ISO 15223.

http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Regulatory_Updates/TUV%20SUD%20Slides.pdf

Date added: December 3, 2014 - Views: 1

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INTERNATIONAL ISO/IEC STANDARD 17050-1

ISO/IEC 17050-1:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but

http://webstore.iec.ch/preview/info_isoiec17050-1{ed1.0}en.pdf

Date added: March 17, 2012 - Views: 741

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Voorbeeld Preview - NEN

Nederlandse norm NEN-ISO 15223-2 (en) Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol ...

https://www.nen.nl/web/preview.pdf?recordNumber=143157

Date added: May 1, 2015 - Views: 1

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Assessment of the knowledge of graphical symbols...

ISO 15223-1:2007: Medical devices - Symbols to be used with medical device labels, ... graphical symbols labelled on malaria rapid diagnostic tests in four

http://www.malariajournal.com/content/pdf/1475-2875-10-331.pdf

Date added: May 25, 2012 - Views: 25

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FROM: BYRON ou=Department of Agriculture, RIPPKE...

ANSI/AAMI/ISO 15223-1:2012, Symbols to be used with medical device labels, labeling and information to be supplied ASTM D5445-11a (ISO 780), ...

http://www.aphis.usda.gov/animal_health/vet_biologics/publications/notice_15_02.pdf

Date added: March 28, 2015 - Views: 1

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17 March 2015 Standards Monitor Online (2) -...

AAMI Standards Monitor Online 17 March 2015 1 | Page ... AAMI/ISO 15223-2/Ed.1, Medical devices - Symbols to be used with medical device labels, labeling

http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/Standards/SM150317.pdf

Date added: May 12, 2015 - Views: 1

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2998 Federal Register /Vol. 78, No. 10/Tuesday,...

Jan 14, 2013 · 2998 Federal Register/Vol. 78, No. 10/Tuesday, January 15, 2013/Notices ... ISO 15223–2 First edition 2010–01–15 Medical devices—Symbols to

http://www.gpo.gov/fdsys/pkg/FR-2013-01-15/pdf/2013-00605.pdf

Date added: February 18, 2013 - Views: 22

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Voorbeeld Preview - NEN

ISO 15223:2000/Amd.1:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or ...

https://www.nen.nl/pdfpreview/preview_66482.pdf

Date added: June 19, 2015 - Views: 1

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ISO 4074, the WHO Specification, and Related...

Understand why ISO standards and the WHO specification are requirements for ... Package labeling (ISO 4074, 780, 15223. EN980) Specifications and Prequalification.

http://www.path.org/publications/files/RH_condom_wrkshp_session5_en.pdf

Date added: May 16, 2012 - Views: 45

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AAMI Glossary of Equivalent Standards

ISO 15223-2:2010 ANSI/AAMI/ISO 15223-2:2010 Identical ISO 15225:2010 ANSI/AAMI/ISO 15225:2010 Identical ISO/TR 15499:2012 ANSI/AAMI/ISO TIR15499:2012 Identical ISO ...

http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/Standards/glossary.pdf

Date added: May 1, 2015 - Views: 2

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ANSI Standards at the Carnegie Library of...

aami/iso 15223 ansi/aami/iso 15223-2000 2000 aami/iso 15225 ansi/aami/iso 15225-2000 2000 aami/iso 5840 ansi/aami/iso 5840-1991 1991 aatcc 101 ansi/aatcc 101-1972 1972

http://www.carnegielibrary.org/research/scitech/standards/ansi.pdf

Date added: March 14, 2012 - Views: 36

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Изменение №2 к ГОСТ Р ИСО 15223-2002

2 1-OCT P 1-1CO 15223—2002 ugaenHq. ROJIN, Mapxgponannu na MenunnneKHX 'Tuxer- Kax H B conPOB011Te1bnoii YTBepxaeno n arenTcTBa no or 27.06.2005 Ne 165-œr

http://www.complexdoc.ru/pdf/%D0%98%D0%B7%D0%BC%D0%B5%D0%BD%D0%B5%D0%BD%D0%B8%D0%B5%20%E2%84%962%20%D0%BA%20%D0%93%D0%9E%D0%A1%D0%A2%20%D0%A0%20%D0%98%D0%A1%D0%9E%2015223-2002/izmenenie_%E2%c3%83%c6%92%c3%82%c2%af%c3%83%e2%80%9a%c3%82%c2%bf%c3%83%e2%80%9a%c3%82%c2%bd%c3%83%c6%92%c3%82%c2%af%c3%83%e2%80%9a%c3%82%c2%bf%c3%83%e2%80%9a%c3%82%c2%bd2_k_gost_r_iso_15223-2002.pdf

Date added: November 27, 2014 - Views: 1

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1 Sign, Sign Everywhere a Sign Learning Objectives

4/13/2014 2 What’s That Sign? 7 ANSI/AAMI/ISO 15223-1:2012 Medical devices –Symbols to be used with medical device labels, labeling, and information to be ...

http://www.mhcsma.org/documents/uppermidwest/2014/Rose%20Seavey%20Signs%20and%20Symbols%20HANDOUTS.pdf

Date added: November 19, 2014 - Views: 3

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special newsletter final after 2011

ISO 15223-2:2010, Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2 : Symbol develop-Title:

http://www.seychelles.net/sbsorg/Documents/wsdmessage.pdf

Date added: June 16, 2013 - Views: 3

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Изменение №1 к ГОСТ Р ИСО 15223-2002

I K rOCT P "CO 15223—2002) Orpaww1eHHe B11a*HOCTM Orva1rw-1eHHe arMoctþepHoro naBne- H0Mep rrauuewra HOMep 3.29 3.30 3.31 CHMB-ona 113MeHeHue No 1 1-OCT P IICO ...

http://www.complexdoc.ru/pdf/%D0%98%D0%B7%D0%BC%D0%B5%D0%BD%D0%B5%D0%BD%D0%B8%D0%B5%20%E2%84%961%20%D0%BA%20%D0%93%D0%9E%D0%A1%D0%A2%20%D0%A0%20%D0%98%D0%A1%D0%9E%2015223-2002/izmenenie_%E2%c3%83%c2%af%c3%82%c2%bf%c3%82%c2%bd%c3%83%c2%af%c3%82%c2%bf%c3%82%c2%bd1_k_gost_r_iso_15223-2002.pdf

Date added: November 27, 2014 - Views: 1

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MANUFACTURER’S DECLARATION OF CONFORMITY...

This is a declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods ... ISO 15223: 2000 ISO 10993-7 (1995)

http://www.cockatooblue.com/protected/Manufacturer%20Declaration%20of%20Conformity%20V10.pdf

Date added: June 13, 2012 - Views: 16