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

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

... VII of the Medical Devices Directive 93/42/EEC (MDD) Annex II ... mdc’s accreditation scope contains medical devices according to MDD 93/42/EWG and in vitro

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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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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MEDICAL DEVICES Guidance document Classification of medical ...

In order to ensure that conformity assessment under the Medical Device Directive functions ... 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: 51

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

Phthalates of Concerns and the Medical Device Directive 93/42/EEC ... in accordance with Annex I of Directive 67/548/EEC and that can be applied in some ...

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

Date added: September 9, 2012 - Views: 4

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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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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 - Ultra-Controlo

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) For the followmg products Anaesthetic Gás Scavenging Systems ULTRASEG

http://www.ultracontrolo.com/certificados/CERTIFICADO_93_42.pdf

Date added: November 26, 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 ... Active implantable devices covered by Directive 90/385/EEC; ...

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

Date added: November 26, 2013 - Views: 3

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Content of mandatory certificates - MedDev INFO - MEDICAL ...

(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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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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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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93.42.EEC & 90.385.EEC New Regulation - Home - Xavier ...

Directive 93/42/EEC . Copyright © 2012 BSI. All rights reserved. 4 ... Article 42 Point 4 Annex VIII Technical Doc . Vigilance System Full Quality Assurance

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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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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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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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.com/uploads/images/1384776341055526320183/council-directive-93-42-eec.pdf

Date added: December 8, 2013 - Views: 6

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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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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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www.p3-medical.com

EC Certificate Production Quality Assurance System: Certificate CBI 2/86101, continued P3 Medical Limited Directive 93/42/EEC on medical devices, Annex V

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

Date added: March 16, 2014 - Views: 1

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Directive 93/42/EEC - Ultra-Controlo,ar medicinal,vácuo ...

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts ... Certificate according to Annex II (Section 4} is required.

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

Date added: July 3, 2013 - Views: 2

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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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Medical Device Directive Certificate - Terumo

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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EC Certificate - DENTSPLY Implants, Dental products, dental ...

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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OneFit Medical Directive 93 / 42 / EEC

EC Certificate Full Quality Assurance System: FR12/00999, continued/suite OneFit Medical Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

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

Date added: January 4, 2014 - Views: 1

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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: 18

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ANNEX II.3 Directive 93/42/EEC - Meridian AG: Home

C e r t i f i e d M a n a g e m e n t S y s t e m s Si t erand b y ANNEX II.3 Directive 93/42/EEC This Appendix is valid only in connection with the following ...

http://www.meridian.ch/fileadmin/media/pdf/zertifikate/105193_en_9001_13485_app_anh_12_03.pdf

Date added: February 17, 2014 - Views: 2

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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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Directive 93/42/EEC

EC Certificate Full Quality AssuranceSystem: GB98/13044, continued Research Instruments Ltd Directive 93/42/EEC on medical devices, Annex II (excluding section 4)

http://www.research-instruments.com/wp-content/uploads/RI-MDD-CE-iss-14.pdf

Date added: January 31, 2015 - Views: 1

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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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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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.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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www.medartis.com

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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Full page fax print - Neovasc Inc. | Home - Neovasc Inc.

on the basis of our examination under the requirements of Council Directive 93/42/EEC, Annex Il, section 4, ... a Notified Body for the above Directive ...

http://www.neovasc.com/tissue-products/documents/BSI-EC-Directive-93-42-EEC-AnnexII-Article-4-Biologic-Patches.pdf

Date added: January 31, 2015 - Views: 1

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cdn.atmosmed.com

according the directive 93/42/EEC Annex Il excluding section (4) As a notified body of the European Union, DEKRA Certification _GrnbH çertifie$,fthat C;

http://cdn.atmosmed.com/docs/14974/e_ii_dir_93_42_eec_4.pdf

Date added: December 28, 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://obeliscemarking.net/wp-content/uploads/2014/12/Doc_Legislation_93.68.EEC_.pdf

Date added: January 31, 2015 - Views: 1

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www.velfina.ro

TÜVRheinland APPROVAL EC Directive 93/42/EEC; Annex Il without Article 4 Registration No.: Report No.: Manufacturer: Scope: Date of expiry: Full Quality Assurance System

http://www.velfina.ro/certificari/Directive%2093_42_EEC,%20Annex%20II.pdf

Date added: September 24, 2014 - Views: 1

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COUNCIL DIRECTIVE - Omnex | Quality and Business Management ...

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

EC Certificate Full Quality Assurance System: FROO/51371.00, continued/suite ISO Med s.a.r.l. Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

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

Date added: January 31, 2015 - Views: 1

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Directive 93/42/EEC - Home - SLE

Directive 93/42/EEC on medical devices, Annex II (excluding Section 4) For the following ... Annex (Section 4) is required. This certificate is valid from 23

http://www.sle.co.uk/files/library/files/products/brochures/CE%20cert.pdf

Date added: September 24, 2014 - Views: 1

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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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Certificate EC Directive 93/42/EEC Annexe II.3 + V.3

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

http://www.heraeus-kulzer.com/media/webmedia_local/deutschland/pdf_2/3_Certificate_Zertifikat_RL_93_42_EWG_ed.pdf

Date added: May 19, 2014 - 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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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/Directive_93_42_EEC_Annex2.pdf

Date added: August 8, 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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Medical Devices Directive Conformity Paths - TÜV SÜD ...

Medical Devices Directive Conformity Paths ... Annex 7 Class I* Sterile or Measurement Medical Devices Directive 93/42/EEC Conformity *Additional requirements

http://www.tuvamerica.com/services/medical/downloads/mdd-chart.pdf

Date added: October 6, 2013 - Views: 5

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EC Certificate Product Service - Medical Devices | Balloon ...

EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class Ma, lib or III)

http://www.creaghmedical.com/wp-content/uploads/2013/01/EC-Full-Quality-Assurance-System-Certificate.pdf

Date added: August 13, 2013 - Views: 1

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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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Definition – 93/42/EEC, Art. 1, para 2, a)

¾Directive 93/42/EEC ... essential requirements laid down in Annex 1 to 90/385/EC. 16 Specific Provisions for MD combined in ATMP

http://www.asiaitc.com/download/article/KTL_Seminar/AdvMD_Jan%20Petrik_16042009_KTL_final_X.pdf

Date added: April 14, 2012 - Views: 2

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Understanding the Machinery Directive ( 2006 / 42 / EC )

93/42/EEC. 3) Partly Completed Machinery . ... Annex IV Annex IV of the Machinery Directive defines categories of machinery to which the

http://www.intertek.com/uploadedFiles/Intertek/Divisions/Commercial_and_Electrical/Media/PDF/Industrial/Guidance-Machinery-Directive.pdf

Date added: April 13, 2013 - Views: 6