Definition of terminal cell production

Definition of terminal cell production, Total:169 items.

The international standard classification for "Definition of terminal cell production" includes: General methods of tests and analysis for food products , Animal feeding stuffs , Biology. Botany. Zoology , Geology. Meteorology. Hydrology .

The Chinese standard classification for "Definition of terminal cell production" includes: Basic standards and general methods , Livestock and poultry feed and additive , Sanitation in general , Oceanology .

Group Standards of the People's Republic of China

T/CMBA 021-2023 Specification of quality management for ancillary materials present during the production of cellular therapeutic products
T/QGCML 4275-2024 Determination of Listeria monocytogenes in meat floss food
T/CECCEDA 003.2-2023 Technical requirement of single-use materials in CAR-T production Part 2: Cell sap culture tank
T/CECCEDA 003.4-2023 Technical requirement of single-use materials in CAR-T production Part 4: Connect joint
T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
T/SHRH 055-2023 Anti-Wrinkle and Firming Efficacy Test of Cosmetics — Inhibition of carboxymethyl lysine content of advanced glycation end products induced by methylglyoxal in fibroblasts
T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products
T/SHQAP 003-2023 Guidelines for application of space separative closed systems for cell therapies production
T/CECCEDA 003.1-2023 Technical requirement of single-use materials in CAR-T production Part 1: Cell frozen bag、Cell storage bag
T/CSTE 0379-2023 Identification and Cytoactivity Determination of Bioactive Peptides
T/CECCEDA 002-2023 Manufacture practice of single-use materials in CAR-T production

Professional Standard - Agriculture

246药典四部-2020 3400 Bioassay 3417 Acellular Pertussis Vaccine Identification Test
262药典四部-2015 3400 biological assay 3426 human erythrocyte antibody assay
279药典四部-2015 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
336药典三部-2020 Biological Activity-Potency Assay 3525 Human Granulocyte Stimulating Factor Biological Activity Assay
337药典三部-2020 Biological Activity-Potency Assay 3526 Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
149药典四部-2020 1200 Biological activity assay 1206 Cytochrome C activity assay
9药典三部-2010 General headings Preparation and verification procedures of animal cell matrix for production and verification of biological products
327药典三部-2020 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
24药典三部-2015 General rules for biological products Preparation and testing procedures for animal cell substrates used in the production and testing of biological products
274药典四部-2020 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
NY/T 1902-2010 Microbiological examination of Listeria monocytogenes in feeds
19药典三部-2020 General rules for biological products Preparation and quality control of animal cell substrates for production and testing of biological products
水产品质量安全检验手册 3.8.2.0-2005 Chapter 3 Inspection of microorganisms in aquatic products Section 8 Inspection of Listeria monocytogenes 2. Inspection of Listeria monocytogenes (SN 0184-1993)
247药典三部-2010 Appendix Ⅹ XF Determination of Biological Activity of Recombinant Human Granulocyte Macrophage Stimulating Factor
161药典四部-2015 1200 Biological activity assay 1206 Cytochrome C activity assay
306药典三部-2020 Bioassay 3426 Human Erythrocyte Antibody Assay
289药典四部-2015 3500 Biological Activity-Potency Assay 3526 Recombinant Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
308药典三部-2015 Biological Activity - Potency Assay 3526 Recombinant Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay General Rules 135
163兽药典三部-2015 Appendix Table of Contents Specific Biological Raw Materials Animal 3502 Cell Standards for Production
281药典三部-2015 Bioassay 3426 General Principles of Human Erythrocyte Antibody Assay 118
水产品质量安全检验手册 3.8.1.0-2005 Chapter 3 Inspection of microorganisms in aquatic products Section 8 Inspection of Listeria monocytogenes 1. Inspection of Listeria monocytogenes (GBT 4789.30-2003)
297药典三部-2020 Bioassay 3417 Acellular Pertussis Vaccine Identification Test
298药典三部-2015 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test) General 129
284药典四部-2020 3500 Biological Activity-Potency Assay 3526 Recombinant Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
255药典四部-2020 3400 biological assay 3426 human erythrocyte antibody assay
253药典四部-2015 3400 Bioassay 3417 Acellular Pertussis Vaccine Identification Test
NY/T 800-2004 Enumeration of somatic cells in raw milk

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 38484-2020 Determination of the biological activity for plant hormone-related secondary metabolites. Cytological method

Professional Standard - Hygiene

WS/T 123-1999 Determination of hematocrit

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

GB/T 38506-2020(英文版) Determination of biochemical parameters in animal cell culture process
GB/T 30737-2014 Determination of marine photosynthetic picoplankton—Flow cytometry
GB/T 38506-2020 Determination of biochemical parameters in animal cell culture process

农业农村部

NY/T 3426-2019 Technical code of practice for maize cytoplasmic male sterility seed production

未注明发布机构

DIN ISO 13022 E:2013-07 Medical products containing viable human cells - Application of risk management and requirements for processing practices
DIN CEN/TS 17303:2019*DIN SPEC 10703:2019 Foodstuffs - DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
DIN 58932-6 E:2021-02 Haematology - Determination of the concentration of blood corpuscles in blood - Part 6: Reference method for the determination of the concentration of CD4 positive lymphocytes

Jinlin Provincial Food Standard of the People's Republic of China

DBS22/ 026-2014 Quantitative detection of Listeria monocytogenes in food

Professional Standard - Nuclear Industry

EJ/T 553-1991 Determination of Mineral Cell Parameters Powder X-ray Diffraction Method

US-FCR

FCR 21 CFR PART 1271-2014 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
FCR 21 CFR PART 1271-2015 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
FCR 21 CFR PART 1271-2012 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

British Standards Institution (BSI)

BS ISO 20391-1:2018 Biotechnology. Cell counting. General guidance on cell counting methods
PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
BS PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
23/30463781 DC BS ISO 18162. Biotechnology. Biobanking. Requirements for human neural stem cells derived from pluripotent stem cells
23/30466937 DC BS ISO 24479 Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features
BS ISO 20399:2022 Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
22/30424231 DC BS ISO 20399. Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing
BS EN 12885:1999 Biotechnology - Performance criteria for cell disrupters
24/30469263 DC BS ISO 8472-2 Biotechnology. Data interoperability for stem cell data - Part 2: Key characteristics of stem cell data
BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
BS ISO 8472-1:2024 Biotechnology. Data interoperability for stem cell data - Framework
BS EN 16418:2014 Paper and board. Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
21/30427340 DC BS EN ISO 18362 AMD1. Manufacture of cell-based health care products. Control of microbial risks during processing

KR-KS

KS M ISO 4590-2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells
KS J ISO 20391-1-2019 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
KS J ISO 21973-2023 Biotechnology — General requirements for transportation of cells for therapeutic use
KS J ISO 24603-2024 Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells

American Society for Testing and Materials (ASTM)

ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
ASTM E2526-08 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM F2739-08 Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds
ASTM E2643-09 Standard Terminology Relating to Natural Multi-Cellular Biological Control Organisms
ASTM E2643-08 Standard Terminology Relating to Natural Multi-Cellular Biological Control Organisms
ASTM F1027-86(2007) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
ASTM C796/C796M-19 Standard Test Method for Foaming Agents for Use in Producing Cellular Concrete Using Preformed Foam

Korean Agency for Technology and Standards (KATS)

KS M ISO 4590:2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells
KS J ISO 20391-1:2019 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
KS M ISO 1926-2013(2018) Rigid cellular plastics — Determination of tensile properties
KS M ISO 1922-2013(2018) Rigid cellular plastics — Determination of shear strength

International Organization for Standardization (ISO)

ISO/DIS 24479:2023 Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features
ISO 20391-1:2018 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
ISO 20399:2022 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
ISO/TS 20399-1:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
ISO/DTS 23511 Biotechnology — General requirements and considerations for cell line authentication
ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
ISO 19344:2015 | IDF 232:2015 Milk and milk products — Starter cultures, probiotics and fermented products — Quantification of lactic acid bacteria by flow cytometry
ISO 19344:2015 Milk and milk products - Starter cultures, probiotics and fermented products - Quantification of lactic acid bacteria by flow cytometry
ISO/FDIS 17174:2024 Molecular biomarker analysis-DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
ISO 21973:2020 Biotechnology — General requirements for transportation of cells for therapeutic use
ISO 18362:2016 Manufacture of cell-based health care products - Control of microbial risks during processing
ISO 24603:2022 Biotechnology — Biobanking — Requirements for human and mouse pluripotent stem cells
ISO/DIS 17174 Molecular biomarker analysis — DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments

Association Francaise de Normalisation

NF S91-145:1988 Dentistry. Dental implants. Cytocompatibility. Study of cells attachment and spreading on the biomaterial.
NF EN 16418:2014 Paper and cardboard - Determination of the cytotoxic effect of aqueous extracts using a hepatoma cell line possessing metabolic enzymes (HepG2 cells)
NF EN ISO 8692:2012 Water quality – Freshwater algae growth inhibition test with single-celled green algae
NF X42-052:1989 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICE IN INDUSTRIAL MAKING OF MONOCLONE ANTIBODIES OBTAINED FROM CELLULAR CULTURES.
NF EN 12885:1999 Biotechnology - Performance criteria for cell crushers
NF EN ISO 10712:1996 Water quality - {Pseudomonas} {putida} growth inhibition test ({Pseudomonas} cell multiplication inhibition test)
NF EN ISO 17099:2018 Radioprotection - Performance criteria for laboratories carrying out biological dosimetry using the micronucleus test with blockade of cytodieresis (CBMN) in peripheral blood lymphocytes
NF X42-141*NF EN 12885:1999 Biotechnology. Performance criteria for cell disrupters.
NF Q03-111*NF EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)

American National Standards Institute （ANSI)

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

DANSK DS/ISO 20391-1:2018 Biotechnology – Cell counting – Part 1: General guidance on cell counting methods
BS PD ISO/TS 20399-1:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-General requirements
DANSK DS/ISO 20399:2022 Biotechnology – Ancillary materials present during the production of cellular therapeutic products and gene therapy products
DIN EN ISO 17174 E:2024 Draft Document - Molecular biomarker analysis - DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments (ISO/DIS 17174:2023); German and English version prEN ISO 17174:2023
DANSK DS/EN 12885:1999 Biotechnology - Performance criteria for cell disrupters
NS-EN 12885:1999 Biotechnology — Performance criteria for cell disrupters
DANSK DS/ISO/TS 20399-1:2018 Biotechnology – Ancillary materials present during the production of cellular therapeutic products – Part 1: General requirements
ADA 1089-2016 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Technical Report
DANSK DS/CEN/TS 17303:2019 Foodstuffs – DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
BS PD ISO/TS 20399-2:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-Best practice guidance for ancillary material suppliers
DANSK DS/ISO 21973:2020 Biotechnology – General requirements for transportation of cells for therapeutic use
AS 1766.2.15(INT):1991 Food microbiology - Examination for specific organisms, Part 2.15: Listeria monocytogenes in dairy products
DANSK DS/ISO 24603:2022 Biotechnology – Biobanking – Requirements for human and mouse pluripotent stem cells
DIN CEN/TS 17710:2022 Plant biostimulants - Detection of Listeria monocytogenes; German version CEN/TS 17710:2022
DIN 58932-3 E:2016 Draft Document - Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes; Text in German and English
BS PD ISO/TS 20399-3:2018 Biotechnology. Ancillary materials present during the production of cellular therapeutic products-Best practice guidance for ancillary material users
BS PD CEN/TS 17710:2022 Plant biostimulants. Detection of Listeria monocytogenes
NS-EN 16418:2014 Paper and board — Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
BS PD CEN/TS 17303:2019 Foodstuffs. DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
DANSK DS/EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
SN-CEN/TS 17303:2019 Foodstuffs - DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments
DIN EN ISO 18362 E:2018 Draft Document - Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018

HU-MSZT

MSZ 10192/10-1982 Check the definition of plastic, non-public cell number is clearly hard foam
MSZ 12880/1-1981 Basic definition of unwoven fabric production definition

IT-UNI

UNI ISO 20391-1:2021 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
UNI ISO 21973:2021 Biotechnology - General requirements for transportation of cells for therapeutic use

VE-FONDONORMA

NORVEN 22-1-1965 Definition of production and controlled testing of relevant end components in steel bars

German Institute for Standardization

DIN 58932-2:1998-06 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
DIN 58932-2:1998 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
DIN EN ISO 18362:2018-11 Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 / Note: Date of issue 2018-09-28
DIN EN 12885:1999-04 Biotechnology - Performance criteria for cell disrupters; German version EN 12885:1999
DIN 58932-3:2023 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes; Text in German and English
DIN 58932-3:2024 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes; Text in German and English
DIN 58932-3:2023-07 Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrocytes; Text in German and English / Note: Date of issue 2023-06-02*Intended as replacement for...
DIN EN ISO 17174:2023-06 Molecular biomarker analysis - DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments (ISO/DIS 17174:2023); German and English version prEN ISO 17174:2023 / Note: Date of issue 2023-05-...
DIN 58932-4:2003-07 Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes
DIN ISO 13022:2014 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
DIN EN ISO 18362:2018 Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
DIN EN ISO 17174:2024-03 Molecular biomarker analysis - DNA barcoding of fish and fish products using defined mitochondrial cytochrome b and cytochrome c oxidase I gene segments (ISO/DIS 17174:2023); German and English version prEN ISO 17174:2023 / Note: Date of issue 2024-01-...

PT-IPQ

NP 1268-1976 condiment. Ginger powder. Definition and characteristics
NP 1848-1987 Meat and its derivatives and other meat products. Determination of volatile nitrogen content (Conway cell method)

RU-GOST R

GOST 23453-2014 Milk. Methods for determination of somatic cells
GOST 18158-1972 Production of meat products. Terms and definitions
GOST R 57481-2017 Poultry slaughtering products, poultry meat products and environmental production objects. Pathogen microorganisms identification (Salmonella spp., L. monocytogenes) by molecular analysis method
GOST 23453-1990 Milk. Methods for determination of somatic cells quantity

GSO

OS GSO ISO 10560:2002 MILK AND MILK PRODUCTS — DETERMINATION OF LISTERIA MONOCYTOGENES
GSO ISO 19344:2021 Milk and milk products — Starter cultures, probiotics and fermented products — Quantification of lactic acid bacteria by flow cytometry
BH GSO ISO 19344:2022 Milk and milk products — Starter cultures, probiotics and fermented products — Quantification of lactic acid bacteria by flow cytometry

Lithuanian Standards Office

LST EN 12885-2000 Biotechnology - Performance criteria for cell disrupters

Danish Standards Foundation

DS/EN 12885:1999 Biotechnology - Performance criteria for cell disrupters

AENOR

UNE-EN 12885:1999 Biotechnology - Performance criteria for cell disrupters
UNE-EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)

Military Standards (MIL-STD)

DOD A-A-51801-1987 FIXATIVE, CYTOLOGY (AEROSOL SPRAY)

Association of Official Analytical Chemists (AOAC)

AOAC Official Method 993.12 Determination of Listeria monocytogenes in milk and dairy products

European Committee for Standardization (CEN)

EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)

ES-AENOR

UNE 53-201-1992 Plastics materials. Flexible foams of polyurethane. Determination of number of cells

PL-PKN

PN A75052-10-1990 Fruits, vegetables and vegetable meat products Methods of microbiological analyses Enumeration and determination of titre of anaerobic sporeforming bacterias, mesophilic and thermophilic

Japanese Industrial Standards Committee (JISC)

JIS K 3706-2:2008 Test methods for culture media -- Culture medium for Listeria monocytogenes -- Part 2: Enumeration of Listeria monocytogenes
JIS K 3706-1:2008 Test methods for culture media -- Culture medium for Listeria monocytogenes -- Part 1: Detection of Listeria monocytogenes

ES-UNE

UNE-CEN/TS 17710:2022 Plant biostimulants - Detection of Listeria monocytogenes (Endorsed by Asociación Española de Normalización in May of 2022.)

BELST

STB 2388-2014 Sugar production. Terms and definitions

Others: