Reference Materials for the Biological Tests of Medical Devices
To Our customers:
We are providing you notice of the reference material price revisions that will be executed effective 1 April 2023, 06:00 UTC.
We have been forced to adjust our prices as shown on the attached "price revision table" because of the recent rise in the costs of raw materials.
Of course, any order placed through the EC site before 1 April 2023, 06:00 UTC will be booked at the current pricing, so please consider placing order(s) by then.
Thank you for your understanding.
What are Reference Materials?
Hatano Research Institute (HRI), Food and Drug Safety Center (FDSC) distributes the reference materials (RMs) used in the following tests. These RMs are listed in the revision (draft) of Japanese guidelines for basic biological tests of medical devices (MHLW Japan) and ISO 10993 Series.
♦ RMs for the cytotoxicity test (as Positive and Negative Control Materials)
♦ RMs for the muscle implantation test (as Positive and Negative Control Materials)
♦ RM for the bone implantation test (as Negative Control Material)
♦ RM for the Hemolysis test (as Positive Control Material)
♦ RM for the in vitro skin irritation test (as Positive Control Material)
RMs (not sterilized) 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 the delivery periods are more than one week, we inform the expected delivery periods to you by e-mail, immediately. Shipping is by Japan Post’s Express Mail Service (EMS). Other delivery services, e.g. FedEx etc, can be used depending on your request, if you have the account and permit receiver payment.
If you use sterilized RMs in your test, please sterilize them with an autoclave (121℃, 15 min) or ethylene oxide gas (EOG) .
How to order
Please click "Order" below
If you have any questions concerning ordering, shipping or technical problems, please contact by e-mail below.
Inquiry -Reference Materials-
Please feel free to send any questions, comments, or requests by e-mail.
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