Document: ISO/TC 194

N 409
Date: 2002-03-15

ISO/TC 194/WG 15 Strategic approach to biological testingof medical devices

BRIEF MINUTES AND PROGRESS ACHIEVED AT THE MEETING IN BERLIN;GERMANY; 14 MARCH 2002
The meeting was attended by 21 delegates from 9 countries.
The meeting was chaired by Mr. Barry Page.
1. Opening
The meeting was opened by the Chairman, Mr. Barry Page, who welcomed all attendants. He introduced
the new secretary for WG 15, Mrs. Ellen Wissink (NEN, The Netherlands), who has taken over thesecretariat from Mrs. Jeannette van Loon, now a member of the Dutch delegation. Since this has also
consequences for CEN/TC 206, which Mrs. Van Loon was unable to attend, the new chairman ofCEN/TC 206, Mr. Wim de Jong, was allowed to express his gratitude for her excellent work done in
CEN/TC 206 on behalf of the committee. After that Mrs. Van Loon was also thanked for her work as
secretary of ISO/TC 194/WG 15 by Barry Page, on behalf of the WG.
2. Approval of the agenda
The agenda, as in N 35 was approved.
3. Brief minutes of last meeting in Hayama-Machi 26 May 2000
There were no comments to the minutes (N 32).
4. Report of Core Group meeting on Monday, 10 March 2002
Mr. Barry Page reported from the Core Group meeting which took place on Monday; the report was tabledat the meeting.

Page 2A) Guidance on the use of 10993-series
The NWI prepared by Mr. Jeremy Tinkler (Technical Specification to provide guidance on the use of the10993-series) was approved by ISO/TC 194 in September 2001 and assigned to WG 1. In the WG 1
meeting on Wednesday it was decided that the members of the WG 15/TF would draft the TS. They
should take into account the outline of the presentation by Mr. Tinkler on Risk Management, the result ofthe work to be circulated in WG 1. The TF, which comprised of several experts, drafted an outline, which
was tabled at the WG 15 meeting for information. A more comprehensive document will be drafted nextmonth.
B) TF 2 Format for guidance
Mr. Mel Stratmeyer reported on the basis of N 30. The NWI (Guidelines for the preparation of standards
on biological evaluation) was approved by TC 194. He agreed to act as project leader; some of theexperts present on Monday already volunteered to give input. After the WG 15 meeting a meeting isscheduled for the TF to start the work. It was suggested and agreed that all ISO/TC 194 convenors would
be informed as the user group of this TS.
Mr. Barry Page thanked both Mr. Tinkler and Mr. Stratmeyer for moving the work forward.
C) TF 3 Topological and physiochemical characteristics of materials
Report on TF 3 was given by the TF-leader, Mr. Donald Gibbons.
-The work on Part 18 (Chemical characterization of materials) is awaiting DIS-phase;
The work on part 19 (Topological and physiochemical characteristics of materials) will start;
There were some investigations done on the effects of surface morphology and particulate material,
which led to recommendations to several WG’s.

Mr. Gibbons offered his help to endorse the relevant recommendations during the WG 14-meeting thisweek, which was gladly accepted.
A written report will be circulated to WG 15 members after the meeting.
D) Contacts with Global Harmonization Task Force (GHTF)
Mr. Barry Page reported that there had been contacts with GHTF on the lack of uniformity in theinterpretation of the ISO 10993-series by different regulatory authorities. This was the result of a survey on
the use of the series in several countries. It was proposed and agreed to first draft the TS (guidance onthe use) before having a new contact with GHTF. It was suggested to conduct a new survey after theguidance document would be finished in order investigate whether the situation is improved.
Mr. Akitada Nakamura asked whether action should be taken towards GHTF on the issue of Medicaldevice GCP in relation to the work of WG 4 (clinical investigation standard). It is decided, that it is up toWG 4 to bring this on the ISO/TC 194 Plenary.
E) Tissue engineering
Mr. Barry Page reported that a recommendation was given by the Core Group to install a new TF on thesubject. The hand-outs of the presentation by Mr. Robert Geertsma (The Netherlands) were tabled at themeeting. Mr. Geertsma would be TF leader with the following task:-to collect information (on regulatory and standardization developments);
to report back to WG 15, andto recommend any actions to be taken by ISO 194 on the subject.

This was agreed by WG 15.

Page 3
The following suggestions were made for activities to be taken onto account:-International conference on the subject;
ISO/TC 150 activities;
CEN/TC 316 (animal tissue);
CHeF FTG on Tissue engineering;
UK Code of Practice;
ASTM-standardization activities;
Regulations, f.i. in USA, JapanF) Biological evaluation of Polymeric Devices
Mr. Barry Page reported on the presentation given by Mr. Akitada Nakamura during the Core Group
meeting, of which the hand-out and scientific back ground document were tabled during the meeting.
Mr. Akitada Nakamura pointed out, that some of the parameters were already included in Part 18.
Mr. John Lang, convenor of WG 14 , proposed to discuss the item in his WG. This probably could lead tochanges in Part 18, although a significant delay would not be acceptable, since the document isscheduled for publication as DIS.
G) Question on implantable drug devices
Mr. Barry Page reported that a question was raised by ISO/TC 150/SC 6 on implantable drug devices.
Due to interactions between drug and device material, the drug may change and even lead to toxic
reactions. It was asked whether ISO/TC 194 could play a role in setting requirements for drug device
biocompatibility.
The Core Group recognized the problem, but was of the opinion that this belongs to the responsibility ofthe pharmaceutical companies. Mr. Jeremy Tinkler was asked to report this back to ISO/TC 150/SC 6.
5. Other subjects
On a plenary session on Tuesday Mr. Ron Brown gave a presentation on compromised animal models,
which are under development, but need more investigation. It was decided to keep WG 15 and WG 11
informed about the progress on the subject.
Mr. Wim de Jong asked whether a TF on pyrogenicity would come under WG 7 or WG 15. Based on thepresentation by Mr. Hartung on Monday on the subject a discussion took place in WG 7. There it wasdecided that a TF should be installed to gather information and provide a state of the art report.
It was decided that the subject should be brought up by WG 7 during the ISO/TC 194 Plenary, but that
WG 15 would gladly provide the coordination for such a TF, if needed (under the condition that experts
are available for this TF).
6. Closure
Mr. Barry Page thanked all participants for attending and closed the meeting.