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

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

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 — Symbols to be ...

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: 181

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

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) released ISO 15223-2:2010 - Medical

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

Date added: May 25, 2012 - Views: 411

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The international language of ISO graphical symbols

About ISO ISO is the International Organization for Standardization. It has a membership of 164 national standards bodies from countries large and small,

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

Date added: November 26, 2011 - Views: 2418

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Use of Symbols on Medical Device Labels - FDA Requirements

Quote: In Reply to Parent Post by adv_webdev (Post 439506) ISO 15223 does not declare any symbol as a known symbol (unlike EN 980) and exempt them

http://qs9000.com/quality_assurance_pdf/Use%20of%20Symbols%20on%20Medical%20Device%20Labels%20-%20FDA%20Requirements.pdf

Date added: August 2, 2013 - Views: 21

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

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

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

Date added: September 27, 2012 - Views: 319

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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: 7

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European Guidance Manufacturers Document “IVD Symbols ...

⇒ Click on ISO CATALOGUE ⇒ Choose International Standards ⇒ Select ISO number ⇒Type in Search criteria: 15223ISO 3864 Standard The first two parts of this standard (ISO 3864-

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

Date added: July 25, 2012 - Views: 115

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International standard EN 15223-1 to replace EN 980 as Europe ...

EN ISO 15223-1 is the first part of a two-part series. EN 15223-2 is the second part in the series and covers symbol development, selection and validation. But part 2 is to remain an international standard since it relates to standards being developed for the global market, Rob

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

Date added: December 29, 2012 - Views: 264

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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 shall not

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

Date added: January 11, 2014 - Views: 1

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This document is a preview generated by EVS

15223-1. Second edition. 2012-07-01. Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1:

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

Date added: September 28, 2012 - Views: 98

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This document is a preview generated by EVS

EN ISO 15223-1:2012 (E) 3 Foreword This document (EN ISO 15223-1:2012) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical

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

Date added: November 26, 2012 - Views: 92

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PM5200EN, PM5200MEN, PM5200NIST, PM5200NISTAP, PM5300EN ...

EN ISO 14971 :20 12 EN ISO 15001 :2011 ISO 15223 -1:2012 Notified Body: AMTAC Certification Services Limited 0473 Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK Certification Registration No’s: 1126 CE Date of Expiry: 03/August/2017 ...

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

Date added: March 29, 2014 - Views: 3

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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 device labels, labeling and information to be supplied . Part 1– Lists MDD + IVD Symbols Part 2 – Symbol development, selection and validation . Other Medical Device Standards .

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

Date added: June 26, 2012 - Views: 169

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INTERNATIONAL ISO STANDARD 15223-2 - Esileht - Eesti ...

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

Date added: May 13, 2014 - Views: 1

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INTERNATIONAL ISO STANDARD 15223-2

ISO 15223 consists of the following parts, under the general title Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied:

http://www.resenv.cn/Knowledge/ShowPDF?fileName=IX-ISO&docName=ISO%2015223-2-2010_3125.pdf

Date added: March 1, 2014 - Views: 1

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Symbols Commonly Used in Medical Device Packaging and ...

Note: Symbols were derived from "ISO 15223 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied," "Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices,"

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

Date added: June 26, 2013 - Views: 5

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Medical Device Labeling Overview - Home - Institute of ...

En980 and ISO 15223 are guides but nothing stops manufacturers from creating symbols and submitting them for approval as long as they can be explained in the IFU. Development of new symbols that can be used by the industry

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

Date added: November 30, 2011 - Views: 49

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INTERNATIONAL ISO STANDARD 15223-1

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://www.resenv.cn/Knowledge/ShowPDF?fileName=IX-ISO&docName=ISO%2015223-1-2007.pdf

Date added: September 23, 2013 - Views: 9

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ISO 15223-1:2012-07 (E)

-1 - ISO 15223-1:2012-07 (E) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Pa rt 1: General requirements

http://www.beuth.de/cmd%3Bjsessionid=7CE3BE698C301A35CE5051009B42BBDF.1?workflowname=infoInstantdownload&docname=1910189&contextid=beuth&servicerefname=beuth&ixos=toc

Date added: May 2, 2013 - Views: 111

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11th OO0ctober 2012 - Richard JJS Saunders

(ISO 15223-1:2012) www.companyXXX.com (EN 60601-1:2006) EDMA 25 If alternative labelling is approve d, manufacturers should consider the following: 1. The information provided is intended to ensure safe use of the device. 2.

http://www.medtecireland.com/uploads/Richard%20Saunders.pdf

Date added: February 4, 2013 - Views: 37

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ANSI Standards at the Carnegie Library of Pittsburgh

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 aatcc 105 ansi/aatcc 105-1972 1972 aatcc 106 ansi/aatcc 106-1972 1972

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

Date added: March 14, 2012 - Views: 35

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Glossary of equivalent standards - AAMI - Association for the ...

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 15674:2009 ANSI/AAMI/ISO 15674:2009 Identical ISO 15675 ...

http://www.aami.org/standards/glossary.pdf

Date added: May 9, 2013 - Views: 79

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

-ISO 780 and ISO 15223 shall apply. www.intertek.com Packaging (clause 7.2) Symbols acc. to ISO 780 Fragile Keep away from rain Temperature limits This way up Keep away from sunlight Centre of gravity Use no forks Do not stack Symbols acc. to ISO 15223

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: 161

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OUT FOR COMMENT APPROVED OUT FOR VOTE - BDIA - British Dental ...

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 - Part 1: General requirements – this standard was developed to replace

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

Date added: February 3, 2014 - Views: 5

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Standards Publications Available from AAMI

ANSI/AAMI/ISO 15223-1: 2012 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements, 2ed

http://www.aami.org/subscriptions/cdchart.pdf

Date added: September 25, 2012 - Views: 38

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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, selection and validation

http://www.beuth.de/cmd%3Bjsessionid=95YQTR2L2SHHKV0AH2UI8KSJ.1?workflowname=infoInstantdownload&docname=1617703&contextid=beuth&servicerefname=beuth&ixos=toc

Date added: July 11, 2014 - Views: 1

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Looking ahead to new human factors Ed Israelski standards and ...

ISO 15223-1:2007 Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied ISO 15223-2:2010 Medical devices -Symbols to be used with medical device

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

Date added: May 19, 2013 - Views: 18

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2998 Federal Register /Vol. 78, No. 10/Tuesday, January 15 ...

ISO 15223–2 First edition 2010–01–15 Medical devices—Symbols to be used with medical devices labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation. Withdrawn.

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

Date added: February 18, 2013 - Views: 18

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Symbole ISO 15223-1(2007) - Entrée.

Symbole Définition selon la norme ISO 15223-1 (2007) Ne pas réutiliser Attention Note 1 : Ce symbole invite le lecteur à consulter les documents d’accompagnement pour toutes informations importantes liées à la sécurité, comme les avertissements et précautions

http://www.3sortho.com/_FILES_/Fichiers/Symbole_ISO_15223-1-2007-.pdf

Date added: May 2, 2013 - Views: 31

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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 development,

http://www.nen.nl/pdfpreview/preview_143157.pdf

Date added: August 27, 2013 - Views: 5

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“IVD YMBOLS FOR EAGENTS AND NSTRUMENTS - Home | EDMA

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: 25

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1 2 Sign, Sign Everywhere a Sign Learning Objectives

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 supplied –

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

Date added: March 8, 2014 - Views: 6

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Assessment of the knowledge of graphical symbols labelled on ...

ISO 15223-1:2007: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (International level). This part of ISO 15223 identifies requirements for the development and use of symbols that may be

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

Date added: May 25, 2012 - Views: 20

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Voorbeeld Preview - NEN

Nederlandse norm NEN-ISO 15223-1/A1 (en) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

http://www.nen.nl/pdfpreview/preview_126012.pdf

Date added: October 1, 2013 - Views: 1

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for Comments only Doc No.: MHD 14(310) ISO 15223-1:2012 ...

Draft for Comments only Doc No.: MHD 14(310) ISO 15223-1:2012 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard)

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

Date added: August 20, 2013 - Views: 21

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Re: Docket No. FDA-2013-N-0125, and RIN 0910-AG74; Proposed ...

The ISO 15223 does not require the use of a “symbols glossary” – as the ISO standard explains - these symbols, before being accepted into the list, are put through a validation process to ensure that the symbol is understood before it can be

http://advamed.org/res.download/330

Date added: July 12, 2013 - Views: 1

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INTERNATIONAL ISO/IEC STANDARD 17050-1 - IEC Webstore | Welcome

ISO/IEC 17050 consists of the following parts, under the general title Conformity assessment — Supplier's declaration of conformity:

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

Date added: March 17, 2012 - Views: 729

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510(k) t IMPLANTEO . Inipiantology and Dental surgery motor ...

/ISO 15223-1 (2007) 'Medical devices -Symbols to be used with medical device labels, labeling and information to be supplied' ... V ISO 14971 (2007) -Medical devices -Application of risk management to medical devices" (Recognition number : 5-40)

http://www.accessdata.fda.gov/cdrh_docs/pdf10/K102241.pdf

Date added: March 28, 2012 - Views: 8

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NPi IFU Rev H 3-24-2014 - Neuroptics

Symbol #5.1.7 ISO 15223-1 Serial Number Symbol #5.1.6 ISO 15223-1 Model Number Symbol #5.1.5 ISO 15223-1 Lot Number . 3 NPi-IFU-01 Revision H March 18, 2014

http://www.neuroptics.com/uploads/NPi-100_Instructions%20For%20Use.pdf

Date added: April 17, 2014 - Views: 2

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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 15223—2002 MeaMUMHcKue ngaeÄHA.

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_№1_k_gost_r_iso_15223-2002.pdf

Date added: September 25, 2013 - Views: 3

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Изменение №2 к ГОСТ Р ИСО 15223-2002

Изменение №2 к ГОСТ Р ИСО 15223-2002 Author: www.complexdoc.ru Created Date: 6/26/2014 1:23:05 AM ...

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��2_k_gost_r_iso_15223-2002.pdf

Date added: June 22, 2013 - Views: 1

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

Docket No. FDA-2011-N-0090 November 7, 2012 Page 3 of 22 AdvaMed recommends that the final rule should allow for multiple date formats, with priority given to international standards ISO 8601 and 15223.

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

Date added: May 2, 2013 - Views: 3

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2513 BH, The Hague 0473 - Precision Medical Inc.

ISO 15223 -1:2012 EN 1041 :2008 E N 14971 :20 12 ISO 15001:2011 ISO 15002:2008 EN ISO 13485:2003 Notified Body: AMTAC Certification Services Limited 0473 Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK Certification ...

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

Date added: March 26, 2014 - Views: 2

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MANUFACTURER’S DECLARATION OF CONFORMITY Australian ...

ISO 11135: 2002 ISO 11737 (2004) ISO 15223: 2000 ISO 10993-7 (1995) Authorised Signatory: _____ _____ Name Date Quality Assurance Manager Manufacturer's Declaration of Conformity V10.doc Page 3 of 3. Title: FULL QUALITY ASSURANCE PRODCEDURE Author: Derek Created Date: 4 ...

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

Date added: June 13, 2012 - Views: 16

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ISO 4074, the WHO Specification, and Related Standards

Package labeling (ISO 4074, 780, 15223. EN980) Specifications and ... ISO has specific labeling requirements to show the identity of the manufacturer, the lot number and the expiry date. WHO also requires the manufacturing date and the labeling

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

Date added: May 16, 2012 - Views: 41

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IEC 60601-1:1988- Medical electrical equipment - Part 1 ...

ISO 15223-2:2010 - Medical devices -- Symbols to be used with medical device labels, labeling, and information to be supplied -- Part 2: Symbol development, selection and validation EN 980:2008 - Symbols for use in the labeling of medical devices

http://www.surgical.lumenis.com/pdf/AcuPulseTM%20DUO%20Compliance%20with%20International%20Standards%20-%20EB.pdf

Date added: October 18, 2013 - Views: 30

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Serrano Why ISO - 15189 is Change Lab Operations

Why ISO-15189 is Soon to Change Lab Operations and Public Perceptions of Quality Leo Serrano, FACHE ... • ISO 15223:2007 Labeling for Medical Devices • ISO 15225 – Nomenclature system for medical devices for regulatory data exchange. 4 7

http://www.executivewarcollege.com/wp-content/uploads/2012/04/Serrano-Why-ISO-15189-Change-Laboratory-Operations.pdf

Date added: May 3, 2013 - Views: 13

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DECLARATION OF CONFORMITY

PN-EN ISO 15223-1:2012 President of the board Sławomir Wroński and with the Act of Law of 20 May 2010 on Medical Devices (Dz.U. 2010 nr 107 poz. 679) - Information Supplied By The Manufacturer Of Medical Devices - Assistive Products For Persons With Disability - General

http://www.reh4mat.com/uploads/2014/03/AM-PP_Declaration_EN.pdf

Date added: June 24, 2014 - Views: 1

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MAR 1 6201? - Food and Drug Administration

-ISO 15223:2007, Medical devices -Symbols to be used with medical device labels, labeling and information to be supplied-ISO 14155-1:2003, Clinical investigation of medical devices for human subjects -Part 1: General requirements -ISO 1041 ...

http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110337.pdf

Date added: May 5, 2013 - Views: 15