ISO/TC 194/SC 1

N 018

Date: 2005-03-11

ISO/TC 194/SC 1Tissue product safety

BRIEF MINUTES AND PROGRESS ACHIEVED AT THE MEETING IN
ROCKVILLE, MD, USA; 08th/11th March 2005
The meeting was attended by 17 delegates from 7 countries.
The meeting was chaired by Mr Donald Marlowe

Resolutions taken at the meeting of ISO/TC 194/SC 1
in Rockville, MD, USA 8th/11th March 2005
Resolution 1: Adoption of the agenda(1 Rockville 2005)
ISO/TC 194/SC 1 unanimously accepted the agenda as presented in doc. N 007.
Resolution 2: Appointment of the drafting committee(2 Rockville 2005)
It was agreed that Donald Marlowe and Gabriele Troescher would draft the resolutions.
Resolution 3: Report of the Secretariat(3 Rockville 2005)
ISO/TC 194/SC 1 accepted the report of the secretariat as given in Document N 17.
Resolution 4: Parallel voting under the Vienna Agreement with CEN/TC 316(4 Rockville 2005)
ISO/TC 194/SC 1 agreed to parallel voting of ISO 22442 Parts 1-3 under the Vienna Agreement(ISO lead) together with CEN/TC 316. Subsequently preparing Annex ZA. Identifying forEN ISO 22442 in Introduction of all three parts the major changes from EN 12442.

Brief Minutes ISO/TC 194/SC 1; Rockville, MD, USA 2005-03-08/11

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Resolution 5: Inclusion of European Directive 2003/32/EC(5 Rockville 2005)
In consultation with CEN/TC 316, seek clarification on the issue of inclusion of EuropeanDirective 2003/32/EC.
Resolution 6: ISO 2nd CD 22442-1 "Animal tissues and their derivatives utilized in themanufacture of medical devices – Part 1: Application of risk management"(6 Rockville 2005)
According to the recommendation of Working Group 1, ISO/TC 194/SC 1 confirms theacceptance of ISO 2nd CD 22442-1 for circulation as Draft International Standard and asks thesecretariat to submit the manuscript to the ISO Central Secretariat before the end of April 2005.
Furthermore, it was decided to change the title of the Standard to read: "Medical devices
utilizing animal tissues and their derivatives - Part 1: Application of risk management".
Resolution 7: ISO 2nd CD 22442-2 "Animal tissues and their derivatives utilized in themanufacture of medical devices – Part 2: Controls on sourcing, collection and handling"(7 Rockville 2005)
According to the recommendation of Working Group 2, ISO/TC 194/SC 1 confirms theacceptance of ISO 2nd CD 22442-2 for circulation as Draft International Standard and asks thesecretariat to submit the manuscript to the ISO Central Secretariat before the end of April 2005.
Furthermore, it was decided to change the title of the Standard to read: "Medical devices
utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection andhandling"
Resolution 8: ISO 2nd CD 22442-3 "Animal tissues and their derivatives utilized in themanufacture of medical devices – Part 3: Validation of the elimination and/or inactivationof viruses and TSE agents"(8 Rockville 2005)
According to the recommendation of Working Group 3, ISO/TC 194/SC 1 confirms theacceptance of ISO 2nd CD 22442-3 for circulation as Draft International Standard and asks thesecretariat to submit the manuscript to the ISO Central Secretariat before the end of April 2005.
Furthermore, it was decided to change the title of the Standard to read: "Medical devices
utilizing animal tissues and their derivatives Part - 3: Validation of the elimination and/or
inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents"
Resolution 9: Establishing of liaison with ISO/TC 198(9 Rockville 2005)
ISO/TC 194/SC 1 resolved to establish a liaison with ISO/TC 198 "Sterilization". Dr. Brian
Matthews serves as a liaison.
Resolution 10: Requirements concerning a subsequent meeting(10 Rockville 2005)
ISO/TC 194/SC 1 resolved that the committee should meet on the conclusion of the DIS voting
to review comments received. ISO/TC 194/SC 1 seeks an invitation for the week of March, 20th
until 24th 2006.

Brief Minutes ISO/TC 194/SC 1; Rockville, MD, USA 2005-03-08/11