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Japan-Oriented New International Standards for Methods to Measure Characteristics Applied to Regenerative Medical Care Involving Bioceramics Issued To gain international markets in the field of regenerative medical care

As the worldwide need for regenerative medical care is increasing, the importance of bioceramics* applied to regenerative medical care is increasing.

In light of this trend, Japan submitted a proposal to the International Organization for Standardization(ISO)for the establishment of new standards for methods to measure cell migration in porous materials. In response, the ISO finally issued the new international standards. This establishment will encourage related industries to appropriately measure bioceramics materials with high biological compatibility, a field in which Japan has a strong point in terms of related technologies. It is also expected to enhance the competitiveness of Japanese industries in international markets in the field of regenerative medical care.

1. Background

As the recent arrival of the super-aging population has been driving the worldwide need for regenerative medical care to grow, the importance of bioceramics applied to such care, e.g. artificial bones, is increasing. Japan is a global leader in the field of bioceramic technologies, and to gain international markets, Japanese industries need to secure global trust in such technologies.

Nevertheless, no authorized standard methods have been stipulated for measuring such bioceramics applied to biological compatibility tests, and this causes challenges in the reproduction of bioceramics. Moreover, since these tests require complicated experiments on animals, overseas manufacturers in countries stipulating rigid regulations over such experiments have also been requiring the establishment of international standards for measuring the biological compatibility of bioceramics as an alternative measuring method.

*Note:The term "bioceramics" refers to ceramic materials applied to medical care. Industries in the related fields have been advancing the development and commercialization of those made of materials with high compatibility with biological objects, e.g., hydroxyapatite.

2. Outline of new ISO standard and background to the issuance

Key points of the issued new standards(ISO 19090: Tissue-engineered medical products -- Bioactive ceramics -- Method to measure cell migration in porous materials)are as follows.

  • The standards stipulate method for measuring the biological compatibility of porous bodies made of bioceramics applied to medical care for bone regeneration.
  • Specifically, they stipulate testing methods for measuring how well such cells assimilate with the inside of bioceramics so that test operators are able to appropriately measure the biological compatibility of such bioceramics.

Regarding the background to the establishment of the new standards, in April 2013, Japan submitted a proposal to a working group called "ISO/TC150(implants for surgery)/SC7(tissue-engineered medical products)/WG3(tissue-engineered medical products for skeletal tissues)." The ISO/TC150/SC7 is a technical committee engaging in Japan-led activities, the Secretariat of which has been served by Japan. For approximately five years, the technical committee continuously and repeatedly held discussions to coordinate the development of new standards, mainly among expert members from the National Institute for Materials Science(NIMS), the National Institute of Advanced Industrial Science and Technology(AIST), the National Institute of Health Sciences(NIHS), universities and bioceramics manufacturers. As a result, on January 17, 2018, the ISO officially issued new international standards based on Japan’s proposal as the first achievement made by the committee.

In addition to these new standards, Japan will lead international standardization activities in a strategic manner, as seen in its ongoing efforts for the establishment of new standards for quantitative measuring methods of regenerated cartilage, which the ISO is now examining based on Japan's proposal.

3. Expected effects

This new standards will contribute to measurement of ceramics products for regenerative medical care with high biological compatibility in an easy and appropriate method. This achievement is expected to fortify Japan’s competitiveness in international markets in the field of regenerative medical care through exhibiting to such markets the strong points of Japanese products with outstanding technological functions in the field. Moreover, providing simple approaches with medical practitioners and patients in choosing bioceramics with high biological compatibility is expected to decrease the ratios causing physical disorders in patients after their surgery operations and improve the QOL of such patients.

Note:This successful standardization is partly due to the achievements under the Strategic Development of International Standards project(standardization for methods for measuring characteristics applied to regenerative medical care involving bioceramics), which METI commissioned to the private entity.

Release date

January 29, 2018

Division in Charge

International Standardization Division, Industrial Science and Technology Policy and Environment Bureau

Related website

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