Trend report on international and Japanese standardization activities for bioceramics and tissue engineered medical products

Abstract

Since porous and injectable bioceramics have recently been utilized often as scaffolds for bone regenerative medicine, the need for their standardization has increased. One of the standard proposals in ISO/TC150 and JIS has been a draft for characterization of the porous bioceramic scaffolds in both micro- and macro-scopic aspects. ISO/TC150/SC7 (Tissue engineered medical products) has been co-chaired by Professor J E Lemons, Department of Surgery, University of Alabama at Birmingham and Dr R Nakaoka, Division of Medical Devices, National Institute of Health Sciences, Japan. The scope of SC7 has been specified as ‘Standardization for the general requirements and performance of tissue engineered medical products with the exclusion of gene therapy, transplantation and transfusion’.

• bioceramics
• tissue engineered medical products
• standardization
• ISO/TC150
• JIS

Notes

1 Objects or devices which are surgically implanted in the body, either temporarily or permanently, for diagnostic or therapeutic purposes.