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)
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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