N 559
Transcription
N 559
NOTICE OF MEETING / DRAFT AGENDA CONVOCATION / PROJET D'ORDRE DU JOUR Date 2006-02-20 Reference ISO/TC 194 N 559 Title of / Titre du TC/SC BIOLOGICAL EVALUATION OF MEDICAL DEVICES Secretariat / Secrétariat: MEETING / RÉUNION 194 - 19 DIN Meeting dates: 2006-07-14 (morning) Dates de la réunion: 2006-07-14 (matin) Host / Invitant: Place / Lieu: AAMI/ANSI Swissotel 323 E. Wacker Drive Chicago, Illinois 60601 Tel: + 1 312 565-0565 Fax: + 1 312 565-0540 Email: [email protected] web: www.swissotel.com P-and O-members are invited to inform the secretariat of the committee concerned, within one month of the receipt of this notice of meeting, of their intention to be represented at the meeting, the approximate number of their delegates and their need for interpretation. Les membres (P) et (O) sont invités, dans un délai d'un mois à partir de la réception de la présente convocation, à faire connaître au secrétariat du comité concerné leur intention d'être représentés à la réunion, le nombre approximatif de leurs délégués et leur besoin en matière d'interprétation. Whenever possible, the names of delegates (or observers) and the name of the head of the delegation should also be sent to the secretariat of the committee concerned at least one month before the opening of the meeting. Dans la mesure du possible, une liste indiquant les noms des délégués (ou observateurs), ainsi que le nom du chef de la délégation, devrait également parvenir au secrétariat concerné un mois au moins avant l'ouverture de la réunion. Parallel meeting(s) / Réunion(s) parallèle(s) ISO/TC 194/WG 1 ISO/TC 194/WG 2 ISO/TC 194/WG 3 ISO/TC 194/WG 4 ISO/TC 194/WG 5 ISO/TC 194/WG 6 ISO/TC 194/WG 7 ISO/TC 194/WG 8 ISO/TC 194/WG 9 ISO/TC 194/WG 10 ISO/TC 194/WG 11 ISO/TC 194/WG 12 ISO/TC 194/WG 13 ISO/TC 194/WG 15 CEN/TC 206 ISO/TC 150/WG 11 3/Version 98.2/98-10-13 2006-07-10 (all day) and 2006-07-11 (all day) 2006-07-12 (all day) and 2006-07-13 (all day) 2006-07-10 (afternoon) 2006-07-10 (all day) and 2006-07-11 (all day) 2006-07-11 (all day) 2006-07-13 (all day) 2006-07-10 (all day) 2006-07-11 (all day) and 2006-07-12 (all day) 2006-07-12 (morning) 2006-07-13 (all day) 2006-07-12 (all day) and 2006-07-13 (all day) 2006-07-11 (all day) 2006-07-13 (morning) 2006-07-10 (morning) and 2006-07-13 (afternoon) 2006-07-14 (afternoon) 2006-07-10 (all day) ISO/TC 194 N 559 DRAFT AGENDA / PROJET D'ORDRE DU JOUR 1 Opening of the meeting (2006-07-14, 09:00 a.m.) 2 Roll call of delegates 3 Adoption of the agenda Doc. ISO/TC 194 N 559 4 Appointment of the drafting committee 5 Information from the Advisory Group meeting 6 Report of the Secretariat Doc. ISO/TC 194 N 560 * 7 Report, deliberation and decision about the activities of the working groups 7.1 WG 1 - Systematic approach to biological evaluation and terminology Doc. ISO/TC 194 N 561 * Convener: Dr. J. Anderson (USA) 7.2 WG 2 - Degradation aspects related to biological testing Doc. ISO/TC 194 N 562 * Convener: Dr. S. McNamee (USA) 7.3 WG 3 - Animal protection aspects Doc. ISO/TC 194 N 563 * Convener: Dr. J. Richmond (United Kingdom) 7.4 WG 4 – Clinical investigations in humans Doc. ISO/TC 194 N 564 * Convenor: Dr. W. Ziegler (Switzerland) 7.5 WG 5 – Cytotoxicity Doc. ISO/TC 194 N 565 * Convener: Dr. M.F. Harmand (France) 7.6 WG 6 - Mutagenicity, cancerogenicity, reproductive toxicity Doc. ISO/TC 194 N 566 * Convener: Dr. A. Poth (Germany) 7.7 WG 7 - Systemic toxicity Doc. ISO/TC 194 N 567 * Convener: Dr. D. McLain (USA) 3/Version 98.2/98-10-13 ISO/TC 194 N 559 DRAFT AGENDA / PROJET D'ORDRE DU JOUR 7.8 WG 8 - Irritation, sensitization Doc. ISO/TC 194 N 568 * Convener: Mr. W. H. de Jong (Netherlands) 7.9 WG 9 - Effects on blood Doc. ISO/TC 194 N 569 * Convener: Dr. R. Kammula (USA) 7.10 WG 10 – Implantation Doc. ISO/TC 194 N 570 * Convener: Dr. A. Hensten (Norway) 7.11 WG 11 – Allowable limits for leachable substances Doc. ISO/TC 194 N 571 * Convener : Dr. H. L. Hecker (USA) 7.12 WG 12 - Sample preparation and reference materials Doc. ISO/TC 194 N 572 * Convener: Mr. D.F. Marlowe (USA) 7.13 WG 13 – Toxicokinetic study Doc. ISO/TC 194 N 573 * Convener: Dr. J. Dahl (Norway) 7.14 WG 15 - Strategic approach to biological assessment Doc. ISO/TC 194 N 574 * Convener: Mr. B. Page (USA) 8 Review of convenorship 9 Information concerning SC 1 and working groups Doc. ISO/TC 194 N * 10 Coordination with CEN technical committees 10.1 CEN/TC 206 10.2 CEN/TC 258 11 Liaison reports, if any 12 Items for future work 13 Requirements concerning a subsequent meeting 14 Any other business 15 Expression of thanks by the Chairman 16 Approval of resolutions 17 Closure of the meeting (2006-07-14, 12:00 a.m.) *) Documents will be distributed later. 3/Version 98.2/98-10-13