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MEDICAL DEVICES Guidance document Classification of medical ...

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MEDICAL DEVICES Guidance document Classification of medical ...

THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES . ... These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC.

http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

Date added: January 29, 2012 - Views: 50

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Annex 9 directive 93 / 42 / EEC amended, concerning ...

B ANNEX IX CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less ...

http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf

Date added: November 29, 2011 - Views: 14

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Basic Information about the European Directive 93/42/EEC on ...

... THE MEDICAL DEVICES DIRECTIVE 93/42/EEC INCLUDING DIRECTIVE ... and 93/42/EC (MDD) have been changed by Directive ... Directive 93/42/EEC (MDD) Annex II ...

http://www.mdc-ce.de/fileadmin/user_upload/Downloads/mdc-Dokumente/Broschueren/040100_basic_info_93-42-EEC_06_e.pdf

Date added: December 4, 2013 - Views: 3

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INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES (DEHP ...

April 2012 1/2 INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES (DEHP, DBP, BBP) Phthalates of Concerns and the Medical Device Directive 93/42/EEC

http://www.terumo-europe.com/terumo/_pdf/medical-devices-containing-phthalates.pdf

Date added: September 9, 2012 - Views: 4

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DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ...

carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices

http://ec.europa.eu/health/medical-devices/files/revision_docs/entr-2005-01983-01-00-en_en.pdf

Date added: November 30, 2012 - Views: 2

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KiranMedicalSystemsLimited Directive 93/42/EEC

Directive 93/42/EEC on medical devices, Annex V For the following products Sterile Radiation Protection Gloves, Sterile Radiation shield.

http://www.kiranxray.com/certificate/CE_0120_RPG-1.pdf

Date added: July 3, 2013 - Views: 3

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GUIDELINES ON MEDICAL DEVICES - MedDev

investigations laid out in annex 7 of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC. ... (MEDDEV 2.12/2: ...

http://www.meddev.info/_documents/2_7_4_en.pdf

Date added: March 6, 2013 - Views: 1

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Directive 93/42/EEC - Purple Surgical

Directive 93/42/EEC on medical devices, Annex" (excluding Section 4) For the following products The scope of registration appears on page 2 of this certificate.

http://www.purplesurgical.com/images/stories/documents/ce_directive_9342_eec.pdf

Date added: July 3, 2013 - Views: 4

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EC Certificate TUVRheimaS-ij | - Terumo Medical ...

EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products:

http://www.terumomedical.com/aboutus/93-42-EEC-color(nocover).pdf

Date added: January 8, 2013 - Views: 3

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www.p3-medical.com

Directive 93/42/EEC on medical devices, ... Directive 93/42/EEC on medical devices, Annex V Restricted to the aspects of manufacture concerned with securing and

http://www.p3-medical.com/pdf/Directive%2093%2042%20EEC%20Annex%20V.pdf

Date added: March 16, 2014 - Views: 1

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Medical device directive 93/42/EEC and the revision 2007/47/EC

current EC Medical Device Directive 93/42/EEC become mandatory on March 21, ... Directive include: Clinical data (Annex X) is required for all products ...

http://www.quality-service.ch/pdf/Medical%20Device%20Directive%2093.pdf

Date added: July 17, 2013 - Views: 2

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G & H Wire Directive 93/42/EEC Silicone Rubber: Non-latex ...

Directive 93/42/EEC Silicone Rubber: Non-latex Intraoral Elastic Bands, Orthodontic Wires, Orthodontic Springs, Temporary Orthodontic Implant Screws, Orthodontic ...

https://www.ghwire.com/PDF/QA/MDD-93_42-EEC.pdf

Date added: November 3, 2013 - Views: 2

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Medical Devices Directive (93/42/EEC) Active Implantable ...

Medical Devices Directive (93/42/EEC) • Annex II Full Quality Assurance ... Under the terms of the Medical Device Directive a competent authority is nominated by

http://www.iregqms.com/files/EU%20Medical%20Device%20CE%20mark%20process.pdf

Date added: November 26, 2013 - Views: 1

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EC -Directive 93/ 42/EEC Annex II, Article 3 Certificate for ...

EC -Directive 93/ 42/EEC Annex II, Article 3 Certificate for EN ISO 13485: 2003 [Full Quality Assurance System Medical Devices] Certificate for a Quality Management ...

http://unimed-m.ru/upload/file/R-RUI%20E-Catalogue.pdf

Date added: January 4, 2014 - Views: 1

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www.p3-medical.com

EC Certificate Full Quality Assurance System: GB96/7424, continued P3 Medical Limited Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

http://www.p3-medical.com/pdf/Directive%2093%2042%20EEC%20Annex%20II.pdf

Date added: February 17, 2014 - Views: 3

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COUNCIL DIRECTIVE 93/6/EEC - Esma |

COUNCIL DIRECTIVE 93/6/EEC of 15 March 1993 ... Annex to Directive 93/22/EEC until the warrant's expiry date; 17. Repurchase agreement and reverse

http://www.esma.europa.eu/system/files/Dir_93_6.PDF

Date added: August 26, 2013 - Views: 1

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Content of mandatory certificates - MedDev

(Annex VI of the Directive 93/42/EEC on Medical Devices) We hereby declare that an examination of the under mentioned product quality system has been carried out

http://www.meddev.info/_documents/R2_5_1-4_rev4.pdf

Date added: December 6, 2011 - Views: 20

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Labelling of medical devices containing phthalates

Labelling of medical devices containing phthalates . The revised Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC has included new

http://www.eucomed.org/uploads/Press%20Releases/Eucomed%20Recommendation%20on%20labelling%20of%20medical%20devices%20containing%20phthalates.pdf

Date added: January 30, 2012 - Views: 12

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OneFit Medical Directive 93 / 42 / EEC

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) Directive 93/42/EEC on medical devices, Annexe Il (section 4 exclue)

http://www.onefit-medical.com/assets/files/Certificat_CE.pdf

Date added: January 4, 2014 - Views: 1

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COMMISSION DIRECTIVE 2003/12/EC on the reclassification of ...

on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices ... point 4 of Annex II to Directive 93/42/EEC.

http://www.lne-gmed.com/pdf/en/directive_2003_12.pdf

Date added: October 4, 2012 - Views: 2

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93.42.EEC & 90.385.EEC New Regulation - Xavier Health

Directive 93/42/EEC . Copyright © 2012 BSI. All rights reserved. 4 New Regulation ... requirements of Annex I of Directive 2001/83/EC of the European Parliament

http://xavierhealth.org/wp-content/uploads/Halliday_How-to-Get-a-Product-into-the-European-Market.pdf

Date added: November 26, 2013 - Views: 1

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www.medicontur.com

EC Certificate Full Quality Assurance System: HU14/7098, continued MEDICONTUR MEDICAL Engineering Ltd. Directive 93/42/EEC on medical devices, Annex Il (excluding ...

http://www.medicontur.com/files/Quality_assurance/2014/2014_augusztus/Directive%2093_42_EEC_Annex%20II.pdf

Date added: September 24, 2014 - Views: 1

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EC Certificate - DENTSPLY Implants

Illiò SUD Product Service EC Certificate EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices (MDI)), Annex Il (4) (Devices in Class Ill)

http://www.dentsplyimplants.com/~/media/M3%20Media/DENTSPLY%20IMPLANTS/1214423%20Certificate%20DENTSPLY%20IM%20EC%20Design%20Examination.ashx?filetype=.pdf

Date added: June 25, 2013 - Views: 3

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.COUNCIL DIRECTIVE 93/22/EEC - Esma |

.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 ... 42, 22. 2. 1990, p. 7. ... Annex to this Directive. (9) OJ No L 193, 18. 7.

http://www.esma.europa.eu/system/files/Dir_93_22.PDF

Date added: January 16, 2013 - Views: 3

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COUNCIL DIRECTIVE - Omnex

Council Directive 93/42/EEC 14 June 1993 Council Directive 93/68/EEC 22 July 1993 * Article 1(2), subparagraphs (h) and (I) are added ... * Annex II, section 2, second

http://www.omnex.com/training/iso13485/europe/Active-Implantable-Directive-90-385-EEC.pdf

Date added: November 26, 2013 - Views: 3

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GUIDANCE ON THE COMMISSION DIRECTIVE ON THE RECLASSIFICATION ...

framework of Council Directive 93/42/EEC concerning medical devices (the ... contained in Annex IX of Directive 93/42/EEC, as class III medical devices. 3.

http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con2031594.pdf

Date added: April 2, 2013 - Views: 4

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QS Certificate_Directive 93-42-EEC_CE 1275_E - ...

Directive 93/42/EEC, Annex Il excluding (4). In a certification audit carried out by I-GA InterCert GmbH, evidence was furnished proving that the quality

http://www.medartis.com/uploads/QS-Certificate_Directive_93-42-EEC_CE_1275_EN.pdf

Date added: March 20, 2014 - Views: 1

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Med-Info Council Directive International expert information ...

Council Directive 93/42/EEC on Medical Devices Diagnosis, prevention, monitoring, ... Annex IX of the Directive stipulates the classification

http://www.tuv-sud.co.uk/uploads/images/1384776341055526320183/council-directive-93-42-eec.pdf

Date added: November 27, 2014 - Views: 1

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Directiva - Medicontur

EC Certificate Full Quality Assurance System: HU14/7098, continued MEDICONTUR Medical Engineering Ltda Directive 93/42/EEC on medical devices, Annex Il (excluding ...

http://www.medicontur.com/files/Quality_assurance/2014_new_certies/Directive%2093_42_EEC_Annex%20II.pdf

Date added: October 25, 2014 - Views: 1

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ISO Med s.a.r.1. Directive 93/42/EEC - FBMedical

Directive 93/42/EEC on medical devices, Annex Il (excluding section 4) Directive 93/42/EEC on medical devices, Annexe Il (section 4 exclue) Issue / Version 13

http://www.fbmedical.fr/qualite/pdf/2_CE_ISO%20Med.pdf

Date added: April 18, 2014 - Views: 2

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APPROVAL EC Directive 93/42/EEC Annex Il, Article 3 Full ...

APPROVAL EC Directive 93/42/EEC Annex Il, Article 3 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Scope: Date of Expiry:

http://eng.astar.pl/wp-content/uploads/sites/2/2012/12/Certyfikat_EC_MDD_Annex_II_EN1.pdf

Date added: April 10, 2014 - Views: 1

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NIST GCR 01-815 A Guide to the EU Medical Device Directive

1 The Medical Device Directive1 2 3 Directive 93/42/EEC Applicable since June 1993 and mandatory since June 1998 To Be Considered: The Medical Device Directive (MDD ...

http://gsi.nist.gov/global/docs/EUGuide_MedicalDvceDirective.pdf

Date added: February 28, 2012 - Views: 16

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e ii dir 93 42 eec - ATMOS Med

EC CERTIFICATE for the Quality Assurance System according the directive 93/42/ËEC, Annex Il excluding section (4) As a notified body of the European Union.

http://cdn.atmosmed.com/docs/14974/e_ii_dir_93_42_eec_2.pdf

Date added: September 24, 2014 - Views: 1

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mipm.com

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) Richtlinie 93/42/EEC Für Medizinprodukte, ... Cerüficate according to Annex Il ...

http://mipm.com/dokument/QS_Certificate_Quality_Assurance_System_Directive_93-42-EEC%2C_Annex_II_excluding_%284%29_1392197743_1110.pdf

Date added: March 19, 2014 - Views: 1

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Application for performance/change/extension of a conformity ...

Application for performance/change/extension of a conformity assessment procedure in accordance with Council Directive 93/42/EEC ... Annex II without (4) ...

http://www.tuv-sud.com/uploads/images/1396968529474615381356/mdd-application-for-performance-change-extension-of-a-conformity-assessment-procedure-in-accordance-with-council-directive-93-42-eec-mdd.pdf

Date added: May 1, 2014 - Views: 1

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AT SERTiFiKASI According to Annex II of the Directive 93/42 ...

According to Annex II of the Directive 93/42/EEC on Medical Devices CE . EC CERTIFICATE , 2195 . AT SERTiFiKASI . 93/42/A T Yonetmeligi(T/bbi Cihaz), EK li'ye gore

http://www.agorakimya.com.tr/images2/sistem_belgelerimiz/ce_2195_med_07010004_rev_01.pdf

Date added: July 3, 2013 - Views: 1

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TO COUNCIL DIRECTIVE 93/42/EEC OF JUNE CONCERNING MEDICAL ...

declaration of conformity to council directive 93/42/eec of 14 june 1993· concerning medical devices iii manufacturer: medical device: classification -annex ix:

http://www.viscot.com/download/Declaration%20of%20Conformity%2093.42.EEC%20June%201993.pdf

Date added: May 5, 2013 - Views: 4

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NBOG’s Best Practice Guide AIMDD, 2010-3

NBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2010-3 ... Directive 93/42/EEC on Medical devices, Annex II excluding (4)

http://www.nbog.eu/resources/NBOG_BPG_2010_3.pdf

Date added: December 6, 2011 - Views: 16

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Guidance to Changes to the Medical Devices Directive 93/42/EC ...

The device conforms to the essential requirements of Annex 1 of Medical Device Directive 93/42/EEC ... requirements of Annex 1 of Medical Device Directive 93/42 ...

http://www.mhra.gov.uk/home/groups/dts-bi/documents/websiteresources/con065699.pdf

Date added: April 6, 2012 - Views: 4

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Spellman High Voltage Electronics GmbH - EC Certificate ...

Title: Spellman High Voltage Electronics GmbH - EC Certificate Directive 93/42/EEC, Annex II Excluding (4) Subject: Spellman High Voltage Electronics GmbH has a full ...

http://www.spellmanhv.com/~/media/Files/Downloads/Germany%2093_42_EEC.ashx

Date added: October 22, 2014 - Views: 1

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COUNCIL DIRECTIVE 93

COUNCIL DIRECTIVE 93/68/EEC of 22 July ... Having regard to the Treaty establishing the European Economic Community, ... Council Directive 92/42/EEC of 21 May 1992 ...

http://www.obelis.net/docs/COUNCIL_DIRECTIVE_93.pdf

Date added: November 26, 2014 - Views: 1

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according the directive 93/4 Annex II excluding

according the directive 93/4 Annex II excluding secti ... directive 93/42/EEC annex IL The approval is_ based on_ th_e result of. the r~-certification audit ...

http://www.pulsion.com/fileadmin/pulsion_share/Company/QualityAssurance/2014__EN_Anhang_CECertificate_EN_rev01.pdf

Date added: November 27, 2014 - Views: 1

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Directive 93/42/EEC - Ultra-Controlo

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts MEDICAI VACUUM SYSTEM, MEDICAL COMPRESSED AIR SYSTEM,

http://www.ultracontrolo.com/certificados/93_42_EEC.pdf

Date added: July 3, 2013 - Views: 2

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www.hagerwerken.de

EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products:

http://www.hagerwerken.de/_uploads/media/23131_CE%20Approval%20Annex%20II%2093_42_EEC_GB%2005-2014.pdf

Date added: November 27, 2014 - Views: 1

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QS Certificate Quality Assurance System Directive 93/42/ECC ...

Title: QS Certificate Quality Assurance System Directive 93/42/ECC, Annex II Author: Memmert GmbH +Co. KG Created Date: 7/17/2008 4:10:20 PM

http://eco-analytika.com/d/169064/d/directive_93_94_eec_ii_english.pdf

Date added: March 16, 2014 - Views: 1

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EC Declaration of Conformity to Medical Devices Directive 93 ...

... Visbion EC Declaration of Conformity Issue 8 ... EC Declaration of Conformity to Medical Devices Directive 93/42/EEC ... Annex VII elements are in ...

http://www.visbion.com/wp-content/uploads/2013/08/043_97128-EC-Declaration-of-Conformity-Iss8.pdf

Date added: September 26, 2013 - Views: 1

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mipm.com

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) For the following products ... Ceffcate according to Annex Il (Section 4) is required.

http://mipm.com/dokument/Directive_93-42-EEC_1398240197_1148.pdf

Date added: November 27, 2014 - Views: 1

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1540 01e Checklist MDD Annex I

1540.01 Checklist for the approval of the essential requirements according to the medical device directive 93/42/EEC Annex II Ref: Device: Date:

http://www.dqs-med.de/fileadmin/documents_en/1540_01e_Checklist_MDD_Annex_I.pdf

Date added: November 27, 2014 - Views: 1

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Experience with Directive 93/42/EEC (MDD)

Experience with Directive 93/42/EEC (MDD) ... MDD Annex I, Clause 9.1: If the device is intended for use in combination with other devices or equipment, the

http://www.ihk-schleswig-holstein.de/linkableblob/swhihk24/standortpolitik/downloads/sonstiges/2072620/.7./data/2012_09_05_03_Experience_with_Directive_93_42_EEC_Gebhardt-data.pdf

Date added: August 17, 2014 - Views: 1