コメント提出先：野尻知里（テルモ・医科学研究所）FAX:0465 81 4194
Note: The check (mark) indicates the preferred test method, however alternate test categories
may be acceptable with appropriate rationales.
* Hemolysis only
** Note when used in conjunction with an oxygenator, complement system testing is
recommended.
Other comments (for physician reviewers )
ISO
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ISO/TC 194
Jean A. Goggins, Ph.D.
Convenor, ISO/TC 194/WG 9
attn. Hillary Woehrle
AAMI
3330 Washington Blvd., Suite 400
Arlington, VA 22201-4598
Fax. +703-276-0793
E-mail: hillary_woehrle@aami.com
Doctor xxxxxxx
xxxxxxxxxxx
xxxxxxxxxx, xxx
Date: day/month/year
Dear Doctor,
I am contacting you on behalf of the International Organization for Standardization (ISO)
Technical Committee 194, Working Group 9. We are charged with developing test methods that
can be used to evaluate the safety of medical devices that contact blood. To do this, we need
information that physicians using these devices can provide.
The enclosed table is an attempt by our committee to select test categories that predict significant
complications of device use, such as thrombosis, thromboembolism, hemolysis and complement
activation. We would appreciate your opinion of our selections. Please take a few minutes to
review the form and indicate if the tests selected are adequate and appropriate. If you think that
certain test categories should be added or deleted, please indicate on the table or in the comments
section. If you do indicate that additional testing should be considered, please include appropriate
references that justify the clinical significance of the testing. Please fax or mail the form to one
of the individuals listed below by September 1, 1997.
Please accept the committee's sincere thanks for providing the committee with this information.
Sincerely,
Jean A. Goggins
Jean A. Goggins, Ph.D.
enclosures
Please fax to one of the following:
Jean A. Goggins, Ph.D.
attn. Hillary Woehrle
AAMI
3330 Washington Blvd., Suite 400
Arlington, VA 22201-4598
Fax. +703 276-0793
E-mail: hillary_woehrle@aami.com
Gun Rydhoeg, Ph.D.
Gambro AB
Box 10101
S-22020 LUND
Sweden
Fax.+46 46 16 95 75
Chisato Nojiri, M.D., Ph.D.
Terumo Corp.
1500 Inokuchi, Nakai-machi, Ashigarakami-gun
Kanagawa, 259-01
Japan
Fax. + 81 465 81 4194