ST-019 IS NOW OPEN FOR PUBLIC COMMENT


The Assisted Reproductive Technology Technical Advisory Group (ARTTAG) cordially invites you to review and comment on the proposed “ISBT 128 Standard for Labeling of Reproductive Tissue and Cell Products.”


Representatives from the American Society for Reproductive Medicine (ASRM), the European Society of Human Reproduction and Embryology (ESHRE), and ICCBBA have developed this Standard:

  • taking into account World Health Assembly Resolution WHA63.22 which calls for the implementation of globally consistent coding systems for human cells, tissues, and organs;

  • recognizing the significant benefits of international standardization of nomenclature, coding and labeling in clinical practice;

  • recognizing the need for globally unique identification of grafts to support international traceability and biovigilance; and,

  • acknowledging the widespread use of the international information standard ISBT 128 in the fields of transfusion and transplantation.

The intent of the draft Standard, designed to be used in conjunction with the ISBT 128 Standard Technical Specification and ISBT 128 Standard Terminology for Medical Products of Human Origin, is to improve the traceability of reproductive tissue and cell products in ART by providing an international reference table for product descriptions based on standard terminology, a mechanism for globally unique identification, a means for standardized bar coding of essential information, and label design templates to facilitate consistency worldwide.


Please email your comments to ST-019comments@isbt128.org. Comments will be accepted through December 20, 2021.

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