Directive 93 42 Eec Annex I PDF
B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Amended by: ... Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions
Having regard to the Treaty establishing the European Economic Community,andinparticularArticle100athereof, ... by Directive 65/65/EEC; whereas if, however, ... meaning ofDirective 93/42/EEC(*) ...
B ANNEX IX CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less than 60 minutes.
EC Certificate Full Quality Assurance System: US98/12072, continued . G & HWire Company . Directive 93/42/EEC . on medical devices, Annex II (excluding section 4)
guidelines relating to the application of . the council directive 93/42/eec on medical devices
EC Certificate Production Quality Assurance System: Certificate GB11/83845, continued Purple Surgical International Limited Directive 93/42/EEC on medical devices, Annex V
Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) For the followmg products Anaesthetic Gás Scavenging Systems ULTRASEG Medicai Vacuum Systems ULTRAVAC ... Certificate according to Annex II (Section 4) is required.
Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts MEDICAI VACUUM SYSTEM, MEDICAL COMPRESSED AIR SYSTEM, MEDICAI OXYGEN SUPPLY SYSTEM ... Certificate according to Annex II (Section 4} is required.
Phthalates of Concerns and the Medical Device Directive 93/42/EEC last amended by Directive 2007/47/EC Annex I, section 7.5 ... Annex I of Directive 67/548/EEC (*), and parts of the medical device (or the medical device itself) are
classification rules (Annex IX of Directive 93/42/EEC), new certification in accordance with the conformity assessment procedure applicable to the reclassified device is necessary for devices placed on the market or put into service as of 21 March 2010. 4.
" 0 EC Certificate EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices (MDD), Annex II (4) (Devices in Class 111) No. G7 13 06 81854 007
declaration of conformity to council directive 93/42/eec of 14 june 1993· concerning medical devices iii manufacturer: medical device: classification -annex ix:
according to Annex I of the EC-Directive 93/42/EEC 224000_03_e_ Essential_Requirements_MDD_NEW page 1 of 10 © mdc 2009-10-22 224000/3 Customer Number Company Products/Product groups Conformity assessment procedure Classification, Rule ER
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices Page 1 Name and address of the notified bodies Identification ... Annex II Annex IV Annex V Annex VI Class Ilb active devices for administering gas and/or extracting medicines/substances
Council Directive 93/42/EEC on Medical Devices Diagnosis, prevention, monitoring, treatment or alleviation of disease ... to the essential requirements of Annex I of the Directive and issues a type examination certificate. Annex IV: EC verification
EC Certificate Full Quality Assurance System: FR12/00999, continued/suite OneFit Medical Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)
AIM OF THE DIRECTIVE 6. The purpose of the Directive is to provide by way of derogation from the general classification rules of Annex IX of the Medical Devices Directive 93/42/EEC, for
Medical device directive 93/42/EEC and the revision 2007/47/EC The changes (Amendment 2007/47/EC) to the ... Directive include: Clinical data (Annex X) is required for all products (independent of classification, including Class I devices) and from every
The revised Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC has included new ... category 1 or 2, in accordance with Annex I of Directive 67/548/EEC, and the device is intended to administer and/or remove medicines, ...
EC Certificate Full Quality Assurance System: GB96/7424, continued P3 Medical Limited Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)
217 Rev 01 Council Directive 93/42/EEC Index Page 20 of 69 Indent Parag Annex Article Term Line L 2 (h) 1 1device intended for clinical investigation, other than 9762 D1
Directive93/42/EEC onmedical devices, Annex V For the following products Sterile Radiation Protection Gloves, ... Directive 93/42/EEC on medical devices, Annex V For the following products Sterile Radiation Protection Gloves, Sterile Radiation shield.
ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE 93/42/EEC COMPANY: ... reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions
vi Text of Directive 93/42/EEC -----27 Annex I Essential Requirements -----47 Annex II EC Declaration of Conformity -----
EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products:
93.42.EEC & 90.385.EEC New Regulation Copyright © 2012 BSI. All rights reserved. Suzanne Halliday May 2013. ... (Article 3, Annex I) Directive 93/42/EEC Copyright © 2012 BSI. All rights reserved. 3 5. Assemble “Technical Documentation” (Annex II, III, VII) 6.
Medical Devices Directive 93/42/EEC The National Standards Authority of Ireland as a duly designated Notified Body, (identification number 0050), ... on the basis of examination under the requirements of Annex 11, Section 3.2 of Directive 93/42/EEC.
Motor vehicles and their trailers covered by Directive 70/156/EEC of 6 February ... but the latter are already covered by the Medical Devices Directive 93/42/EEC. 3) ... process ensures compliance with the Technical File and the Directive . The requirements for Annex IV Machinery using ...
COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple ... Annex III section 4 is replaced by the following text: '4.1. ... Directive 92/42/EEC is hereby amended as follows:
the European Directive 93/42/EEC on Medical Devices . Basic Information MDD 93/42/EEC ... labeling as outlined in Annex I of the MDD. Safety requirements are not restricted to patients but include users and, where applicable, other persons.
Directive 93/42/EEC VTT, NOTIFIED BODY NO 0537 VTT has a long experience as a Notified Body under the Medical Devices Directive. ... (Annex II) EC design examination (Annex II, 4) Manufacturer's option Manufacturer's option EC verification (Annex IV) Production quality
Council Directive 93/42/EEC of 14 June 1993 (OJ L 169 of 12 July 1993) and Council Directive 93/68/EEC of 22 July 1993 ... Annex 1, which shall apply to them account being taken of the intended purpose of the devices concerned. Article 4 1.
Manufacturer: Products: Expiry Date: EC Certificate Directive 93/42/EEC Annex V Production Quality Assurance Medical Devices TÜVRheinland Registration No.:
Directive 93/42/EEC for Medical Devices, Annex V . ... AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473. This Certificate is for the e.
EC CERTIFICATE OF CONFORMITY Production quality assurance system, Annex V of the Directive 93/42/EEC concerning medical devices No. MD - 220/1/2009
DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with the Identification Number 0297. 1 / 2 2 01208 0 3 / 2 / EN 3803 08 EC-CERTIFICATE ... Annex II – excluding Section 4 of Council Directive 93/42/EEC
¾Directive 93/42/EEC ... essential requirements laid down in Annex I to 93/42/EEC
Directive 93/42/EEC Annex V For the following products Sterile and Non sterile Cardiopulmonary bypass sets, CardiotomyNenous reservoirs and cannulae for Cardiopulmonary bypass. Non-sterile components for extracorporeal bypass procedure.
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
EC Certification. FULL QUALITY ASSURANCE SYSTEM Directive 93/42/EEC for Medical Devices, Annex II excluding (4) We hereby declare that an examination of the under mentioned full quality assurance system has been carried out
,0 ~ EC Certificate Product Service Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MOD), Annex 11 excluding (4) (Devices in Class lIa, IIb cr 111)
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 certificate:
Phone : +33 (0) 466 515 080 Fax : +33 (0) 466 515 047 mail : [email protected] www.nausicaa-medical.com EC DECLARATION OF CONFORMITY In accordance with Annex of Decree No. 95-292 of the Code of Public Health
Directive 93/42/EEC on Medical devices, Annex II excluding (4) (Devices in Class I with measuring function) Each certificate shall be identified through a title and a subtitle as specified above. The certificate according to MDD, Annex II excluding (4) must at least contain the following ...
93/42/EEC &xed email: December 15,2009 The undersigned declares that the product named in the document, Council Directive Sincerely, ... Council Directive 93/42/EEC dated 14 June 1993 Annex VII paragraphs 3. 4 and 5, amended by 2007/47/EC,
DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC concerning medical devices with the Notified Body Number 0297. 1 / 2 2 0101105 / 1 / EN 3 8 0309 ... Annex V of Council Directive 93/42/EEC concerning medical devices with respect to the following medical devices:
risks are termed “broadly acceptable” (see Annex E of EN/ISO 14971) ... Guidelines on the implications of the Medical Devices Directive (93/42/EEC) in relation to medical devices containing natural rubber latex Guide for manufacturer and notified bodies Keywords:
.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 ... 42, 22. 2. 1990, p. 7.((2) OJ No C 304, 4. 12. 1989, p. 39; and OJ No C 115, 26. 4. ... 93/22/EEC 10/05/93 ANNEX SECTION A Services 1. (a) Reception and transmission, on behalf of investors, ...
History of Directive 93/6/EEC ... Provisions of recast 93/6/EEC Article 39-disclosure Articles 42 and 43 - comitology Articles 45 to 45d - transitional provisions Articles 46 to 50 ... Provisions of recast 93/6/EEC Annex IV - commodities risk Annex V
M1 Council Directive 93/42/EEC of 14 June 1993 L 169 1 12.7.1993 ... specified in Annex I to Directive 2001/83/EC. For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the