Reference Materials for the Biological Tests of Medical Devices

Good and Scientific Safety Evaluation For Health and Life

What are Reference Materials?

Japanese guidelines for basic biological tests of medical devices (MHLW Japan, 2003) and ISO10993/TC194 recommend the use of Reference Materials (RM) for confirming sensitivity and accuracy of cytotoxicity and implantation tests.
Each RM batch is certified for biological activity and stability by bioassay in Hatano Research Institute (HRI), Food and Drug Safety Center (FDSC).
The RMs can be applied in any type of cytotoxicity assay or short-term implantation test listed in ISO10993.The following types of RMs are supplied by HRI:

● RMs for Positive and Negative Controls for the cytotoxicity tests

● RMs for Positive and Negative Controls for the short-term muscle implantation test

● RMs for Negative Controls for bone implantation test

RMs are distributed not only in Japan but also all around the world. The delivery period is 2 days to 1week, depending on the delivery conditions in the receiving country. If an RM is temporarily out of stock, you will be immediately informed of the expected delivery date by e-mail. Shipping is by Japan Post’s Express Mail Service (EMS). Other modes of transport can be used upon request, at an additional cost. Before you use RMs in your test, please sterilize them with an autoclave or EO gas.

How to order

Please click "Order" below

 If you have any questions concerning ordering, shipping or technical problems, please contact the RM office at HRI/FDSC as follows:


TEL: +81-463-82-4751
FAX: +81-463-82-9627

Inquiry -Reference Materials-

Please feel free to send any questions, comments, or requests by e-mail