Novel Cell Therapy

Novel Cell Therapy, Total:64 items.

The international standard classification for "Novel Cell Therapy" includes: Biology. Botany. Zoology , Medical materials , Medical Sciences and health care facilities in general .

The Chinese standard classification for "Novel Cell Therapy" includes: Biological agent and blood products , Extracorporeal circulation, artificial organ and prosthesis device , Medical apparatus and devices in general , Marking, packaing, transport and storage .

Group Standards of the People's Republic of China

T/SHSYCXH 7-2022 Test method of human monocyte populations from peripheral blood-Flow cytometry
T/SBX 055-2022 Test methods for tumorigenicity of stem cell therapy products
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
T/CSBT 009-2021 Technical guideline for genotyping of erythrocyte blood group
T/CEAC 039-2024 Stem cell identification methods
T/CACM 1369-2021 Guidelines for clinical diagnosis and treatment of high altitude polycythemia in Chinese medicine
T/CITS 379-2025 Cellular immunophenotyping method based on flow cytometry
T/GXDSL 005-2025 Quality Control Standards for Cold Chain Transportation of Cell Therapy Products
T/CEAC 069-2024 Cell therapy Leukopak raw material collection and immune cell separation technical requirements
T/CEAC 105-2025 TIL Cell Therapy Clinical Application Guidelines
T/SHSYCXH 8-2022 Test method of human Natural Killer cells and Natural Killer T cells from peripheral blood-Flow cytometry

Professional Standard - Agriculture

142药典三部-2015 Monograph II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
149药典三部-2020 Monograph II Therapeutic Human Granulocyte Macrophage Stimulating Factor for Injection
150药典三部-2020 Monograph Ⅱ Therapeutic topical human granulocyte macrophage stimulating factor gel
118药典三部-2010 Chapter II Therapeutic Recombinant Human Granulocyte Macrophage Stimulating Factor for Injection
农业部1719号公告-1-2012 Live swine fever vaccine (passage cell source) (new veterinary drug registration) (three types)
农业部公告第1793号 New veterinary drug: Recombinant avian influenza virus (H5N1 subtype) inactivated vaccine (cell source, Re-5 strain)

Professional Standard - Education

JY 295-1987 Organelle Structure Model Specifications
JY/T 0190-2011 plant cell model
JY 190-1985 Plant Cell Model Technical Conditions

Professional Standard - Hygiene

WS/T 245-2005 Reference method for the enumeration of erythrocytes and leucocytes

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

GB/T 39730-2020 General requirements for cell counting—Flow cytometry
GB/T 39729-2020 General requirements for measurement of cell purity—Flow cytometry

未注明发布机构

NCCLS H7-A3-2000 Procedure for determination of hematocrit by microhematocrit method

Professional Standard - Medicine

YY/T 1465.4-2017 Immunogenic evaluation method of medical devices-Part4:Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes- Ex-vivo method
YY/T 1500-2016 Pyrogen test for medical devices―Monocyte-activation test―Human whole blood ELISA method
YY/T 1465.6-2019 Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
YY/T 0606.13-2008 Tissue Engineered Medical Product - Part 13: Standard Test Method for Automated Enumeration of Cell Suspensions

Shanghai Provincial Standard of the People's Republic of China

DB31/T 687-2013 Basic requirements for clinical cell therapy platform settings

Hebei Provincial Standard of the People's Republic of China

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

Professional Standard - Pharmaceutical Packaging

YBB 0001-2003 Xibao Duxing Jianchafa Tests for cytotoxicity

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F3206:2023 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

GCC Standardization Organization

GSO ASTM F3206:2022 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

American Society for Testing and Materials (ASTM)

ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
ASTM D3576-20 Standard Test Method for Cell Size of Rigid Cellular Plastics
ASTM F895-25 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM D3576-25 Standard Test Method for Cell Size of Rigid Cellular Plastics
ASTM E2526-22 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM F895-84(2001)e1 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F895-84(2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM D6226-21 Standard Test Method for Open Cell Content of Rigid Cellular Plastics
ASTM E2526-08 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells

British Standards Institution (BSI)

BS PAS 84:2012 Cell therapy and regenerative medicine. Glossary
BS PAS 83:2006 Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
BS ISO 20391-1:2018 Biotechnology. Cell counting. General guidance on cell counting methods
BS 5736-10:1988 Evaluation of medical devices for biological hazards-Method of test for toxicity to cells in culture of extracts from medical devices

American Water Works Association (AWWA)

AWWA WQTC55045 New Rapid Methods to Track Diluted Enterobacteriaceae Cells in Drinking Waters
AWWA WQTC56962 Concentration and Detection of Microsporidia Using a Newly-Modified Continuous Flow Centrifuge and Flow Cytometry

Korean Agency for Technology and Standards (KATS)

KS C 7006-1971(2000) TYPE DESIGNATION SYSTEM FOR PHOTOCONDUCTIVE CELLS
KS C 7006-1985 TYPE DESIGNATION SYSTEM FOR PHOTOCONDUCTIVE CELLS
KS P 1600-2018(2023) General guideline of safety test for the cell based therapeutic substances
KS P 1600-2023 General guideline of safety test for the cell based therapeutic substances
KS J ISO 21973-2023 Biotechnology — General requirements for transportation of cells for therapeutic use

American National Standards Institute （ANSI)

ANSI/NCCLS H7-A 2-1996 Procedure for Determining Packed Cell Volume by the Microhematocrit Method

Bureau of Indian Standards

IS 17711-2021 Biotechnology General requirements for transportation of cells for therapeutic use

International Organization for Standardization (ISO)

ISO 21973:2020 Biotechnology — General requirements for transportation of cells for therapeutic use

Canadian Standards Association (CSA)

CAN/CSA Z900.2.5-2012 Lymphohematopoietic Cells for Transplantation, Includes Update No. 1 (2013), Update No. 2 (2016)

IT-UNI

UNI ISO 21973:2021 Biotechnology - General requirements for transportation of cells for therapeutic use

IPC - Association Connecting Electronics Industries

IPC TM-650 2.3.21-1976 Plating Quality Hull Cell Method

Ente Nazionale Italiano di Unificazione

UNI EN ISO 13366-1:1998 Milk - Enumeration of somatic cells - Microscopic method

Gosstandart of Russia

GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods