T/CIRA 2-2020 in English

本文件提供了基于组织的生物制品和组织产品辐射灭菌加工的开发、确认和常规控制的指南。本文件适用于基于组织的生物制品和组织产品，不涉及针对病毒和朊病毒的消除和（或）灭活、细胞（组织）副产物灭菌的确认要求，也不涉及细胞（组织）副产物的处理或安全问题。

Scope

The structure of this standard includes a preface, introduction, six chapters and two informative appendices. The first two of the six chapters are "Scope" and "Normative References". Chapters 3 to 6 are the specific contents of this standard. The specific content of the standard includes terms and definitions; definition and maintenance of product families in dose setting, dose verification and sterilization dose review; selection and testing of products in establishing and verifying sterilization doses; methods for dose establishment. Appendix A is an informative appendix: Selection of dose setting methods. Appendix B is an informative appendix: Examples of MPN tests.