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  1. HOME
  2. Standards for immune cells in tissues

immune cells in tissues

immune cells in tissues, Total:54 items.

The international standard classification for "immune cells in tissues" includes: Laboratory medicine , Surgical instruments and materials , Implants for surgery, prosthetics and orthotics , Medical materials , Animal husbandry and breeding .

The Chinese standard classification for "immune cells in tissues" includes: Medical laboratory equipment , Medical optical instrument and endoscope , Extracorporeal circulation, artificial organ and prosthesis device , Medical apparatus and devices in general , Domesticate animal .

Professional Standard - Agriculture

Group Standards of the People's Republic of China

  • T/FDSA 0055-2024 Guidelines for the development of Cell immunotherapy products based on mRNA-LNP technology
  • T/CI 390-2024 The technical regulation for preparation and clinical application of immuno-cell CIK from healthy person
  • T/ZSA 150-2023 Management requirements for donor materials of immune cell product
  • T/CEAC 044-2024 Safety management specifications for the separation, preparation and storage of immune cells
  • T/CGCPU 028-2023 Requirements for quality control on non gene modified immune cells clinical research
  • T/XSMIA 0004-2022 Quality Accreditation of Immunocyte Preparation Center
  • T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
  • T/CGCPU 009-2020 Control requirements for the preparation process of immune cell products
  • T/ZSA 146-2023 Technical requirements for Flow Cytometry validation of CD3、CD4、CD8 of immune cell product
  • T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products
  • T/CRHA 088-2024 Quality control specimen set-up and usage specification for pathology immunohistochemical detection
  • T/CGCPU 019-2022 Material management requirements for immune cell product donors
  • T/GDMDMA 0001-2022 Interleukin 6 Detection kit (Chemiluminescent Immunoassay)
  • T/CGCPU 011-2020 Quality Control Requirements for Immune Cell Products
  • T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
  • T/CGCPU 018-2022 Technical requirements for CD3, CD4, CD8 flow cytometric detection and verification of immune cell products
  • T/CGCPU 010-2020 Environmental requirements for the preparation of immune cell products

Hebei Provincial Standard of the People's Republic of China

  • DB13/T 5332-2021 Technical specification for clinical operation of cellular immunotherapy

Professional Standard - Medicine

  • YY/T 0606.15-2014 Tissue engineered medical products―Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests
  • YY/T 0606.15-2023 Tissue engineered medical productsStandard practice for evaluation of immune responses ofsubstrate and scaffolds products: Lymphocyte proliferation tests
  • YY/T 1181-2010 Immunohistochemistry kit
  • YY/T 0606.20-2014 Tissue engineered medical products―Part 20:Standard practice for evaluation of immune responses of substrate and scaffold products:Cell migration tests

国家药监局

  • YY/T 1465.6-2019 Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
  • YY/T 1181-2021 Immunohistochemistry kit

国家食品药品监督管理局

  • YY/T 1465.4-2017 Immunogenic evaluation method of medical devices-Part4:Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes- Ex-vivo method

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

US-FCR

American Society for Testing and Materials (ASTM)

  • ASTM F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
  • ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
  • ASTM F1906-98 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration

American National Standards Institute （ANSI)

  • ADA TR 1089-2019 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  • ADA TR 1089-2016 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

SCC

  • ADA 1089-2016 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Technical Report

Association Francaise de Normalisation

  • CWA 15849:2008 Coding of Information and Traceability of Human Tissues and Cells

immune cells in tissues,immune cells in tissue

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