T/CIRA 2-2020 Active Group standards

T/CIRA 2-2020 Guidelines for radiation sterilization of biological products and tissue products based on organizations

Publish Date: 2020-08-04 Implement Date: 2020-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CIRA 2-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Isotopes and radioactive sources

ICS Name: Other standards related to nuclear energy

Publish Date: 2020-08-04

Implement Date: 2020-11-01

Scope

Scope: This document provides guidance on the development, validation, and routine control of radiation sterilization processing for tissue-based biological products and tissue products. This document applies to tissue-based biological products and tissue products, and does not address the requirements for the elimination and/or inactivation of viruses and prions, the validation of sterilization for cell (tissue) by-products, or the handling or safety issues of cell (tissue) by-products. Main technical content: The structure of this standard includes a preface, an introduction, six chapters, and two informative appendices. The first two chapters of the six chapters are "Scope" and "Normative Reference Documents". Chapters three to six are the specific content of this standard. The specific content of the standard includes terms and definitions; dose setting, dose verification, and the definition and maintenance of product families in sterilization dose audits; the selection and testing of products in establishing and validating sterilization doses; and the method of dose establishment. Appendix A is an informative appendix: Selection of dose setting methods. Appendix B is an informative appendix: Example of MPN test.