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Cells and Cell Engineering

Cells and Cell Engineering, Total:252 items.

In the international standard classification, Cells and Cell Engineering involves: Laboratory medicine, Astronomy. Geodesy. Geography, Biology. Botany. Zoology, Farming and forestry, Paper and board, Pharmaceutics, Medical sciences and health care facilities in general, Veterinary medicine, Milk and milk products, Medical equipment, Audio, video and audiovisual engineering, Sterilization and disinfection, Occupational safety. Industrial hygiene, Cellular materials, Thermodynamics and temperature measurements, Protection against dangerous goods, Structure and structure elements, Microbiology, Analytical chemistry, Dentistry, Products of the chemical industry, Company organization and management, Organic chemicals, Ceramics, Radiation protection, Radiation measurements, Pesticides and other agrochemicals, Water quality, Construction industry, General methods of tests and analysis for food products, Telecommunication systems, Materials and articles in contact with foodstuffs.


American National Standards Institute (ANSI), Cells and Cell Engineering

American Society for Testing and Materials (ASTM), Cells and Cell Engineering

  • ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
  • ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
  • ASTM F1906-98 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
  • ASTM F2151-01 Standard Practice for Assessment of White Blood Cell Morphology After Contact with Materials (Withdrawn 2007)
  • ASTM F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
  • ASTM E1397-91(2003) Standard Practice for the in vitro Rat Hepatocyte DNA Repair Assay
  • ASTM E1397-91(1998) Standard Practice for the in vitro Rat Hepatocyte DNA Repair Assay
  • ASTM E1397-91(2008) Standard Practice for In Vitro Rat Hepatocyte DNA Repair Assay
  • ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro
  • ASTM F2210-02(2010) Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
  • ASTM F2210-02 Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
  • ASTM E2603-08 Standard Practice for Calibration of Fixed-Cell Differential Scanning Calorimeters
  • ASTM F320-94(1999) Standard Test Method for Hail Impact Resistance of Aerospace Transparent Enclosures
  • ASTM F3209-16 Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
  • ASTM F3504-21 Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
  • ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
  • ASTM F813-07(2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
  • ASTM E1482-23 Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
  • ASTM E1482-12(2017) Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
  • ASTM E1482-12 Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
  • ASTM F1027-86(2002) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
  • ASTM F1027-86(1995)e1 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
  • ASTM F1027-86(2017) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
  • ASTM F2997-13 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
  • ASTM F2997-21 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
  • ASTM F1027-86(2012) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
  • ASTM E1532-00 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of the Bisbenzamide DNA-Binding Fluorochrome
  • ASTM E1532-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome
  • ASTM C1674-16 Standard Test Method for Flexural Strength of Advanced Ceramics with Engineered Porosity (Honeycomb Cellular Channels) at Ambient Temperatures
  • ASTM E1531-00 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium
  • ASTM E1531-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium
  • ASTM E1533-93 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining
  • ASTM E1533-00(2006) Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining
  • ASTM E3286-21 Standard Practice for Preparation Of Cell Monolayers on Glass Surfaces for Evaluation of Microbicidal Properties of Non-Chemical Based Antimicrobial Treatment Technologies
  • ASTM F2888-19 Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
  • ASTM E1533-00 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4'-6-Diamidino-2-2 Phenylindole (DAPI) Staining

Group Standards of the People's Republic of China, Cells and Cell Engineering

  • T/SDHCST 001-2022 Technical Specification for Artificially Induced Pluripotent Stem Cells to Differentiate into Neural Cells
  • T/QMHIPA 001-2022 Specifications For Establishment and Manngement of Cell Preparation Center
  • T/CACM 1481-2023 Technical regulation of medicinal plant cell culture
  • T/CRHA 007-2022 Specification for mononuclear cell resource storage in healthy blood donors Part 4:Isolation, processing and cryopreservation of mononuclear cells
  • T/SPEMF 0050-2023 Technical standards for selection of ligand-free on living cells
  • T/SZLSBA 02-2023 Technical standards for selection of ligand-free on living cells
  • T/CGCPU 009-2020 Control requirements for the preparation process of immune cell products
  • T/CAME 49-2022 Construction and equipment standard of hematopoietic stem cell transplantation ward
  • T/CRHA 009-2022 Specification for mononuclear cell resource storage in healthy blood donors Part 6:Design and construction of cell resource storage facility
  • T/CRHA 013-2022 Specification for menstrual blood-derived mesenchymal stem cells resource storage - Part 2:Isolation, processing and cryopreservation of menstrual blood-derived mesenchymal stem cells
  • T/CRHA 008-2022 Specification for mononuclear cell resource storage in healthy blood donors Part 5:Quality evaluation and release of mononuclear cell products
  • T/SDHCST 005-2022 Technical Specification of identification for Artificially Induced Pluripotent Stem Cells
  • T/SDHCST 004-2022 Technical Specification for Artificially Induced Pluripotent Stem Cells
  • T/CRHA 014-2022 Specification for menstrual blood-derived mesenchymal stem cells resource storage - Part 3:Quality evaluation and release of menstrual blood-derived mesenchymal stem cells products
  • T/SDHCST 003-2021 Standard Practice for Preparation of Human Umbilical Cord/Placental Mesenchymal Stem Cells
  • T/CRHA 017-2023 Operational Guidelines for Construction, Quality Control and Preservation of Human Liver Progenitor Cell Organoids
  • T/CRHA 018-2023 Operational Guidelines for Construction, Quality Control and Preservation of Human Hepatobiliary Tumor Cell Organoids
  • T/CRHA 012-2022 Specification for menstrual blood-derived mesenchymal stem cells resource storage - Part 1:Collection and transportation
  • T/CRHA 005-2022 Specification for mononuclear cell resource storage in healthy blood donors Part 2:Collection and transportation
  • T/TPPA 0002-2022 RBL-2H3 mast cell RTCA method for evaluating allergic reactions of traditional Chinese medicine injections
  • T/TPPA 0001-2022 RBL-2H3 mast cell degranulation method for evaluation of allergic reactions of traditional Chinese medicine injections
  • T/CRHA 004-2022 Specification for mononuclear cell resource storage in healthy blood donors Part 1:Informed consent and donor screening
  • T/CSBME 050-2022 Artificial intelligence medical devices for cervical liquid-based cytology— Quality requirements and evaluation— Part 1: requirements for datasets

National Metrological Verification Regulations of the People's Republic of China, Cells and Cell Engineering

  • JJG 714-1990 Verification Regulation of Blood Cell Analyzer
  • JJG 714-2012 Verification Regulation of Blood Cell Analyzers
  • JJG 552-1988 Verification Regulation of the Chambers for Counting Blood Cells

Hebei Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB13/T 5163-2020 Comprehensive cell bank construction and management specifications
  • DB13/T 5162-2020 Construction and management specifications of cell preparation center
  • DB13/T 705-2005 Technical regulations for the prevention and treatment of porcine eperythrozoonosis
  • DB13/T 1385-2011 Technical regulations for the prevention and treatment of sheep eperythrozoonosis
  • DB13/T 804-2006 Technical regulations for the prevention and treatment of leukocytozoonosis in chickens

Ningxia Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB64/T 1783-2021 Milk somatic cell control technical regulations
  • DB64/T 1683-2019 Rapid detection method for Listeria monocytogenes and Escherichia coli 0157:H7 in meat and meat products

European Committee for Standardization (CEN), Cells and Cell Engineering

  • EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
  • EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)
  • FprCEN/TS 17688-1-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
  • CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA
  • prCEN ISO/TS 7552-2 Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 2: Isolated DNA
  • prCEN ISO/TS 7552-1 Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood -- Part 1: Isolated RNA
  • EN ISO 19238:2017 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • CEN/TS 17811:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
  • prEN ISO 18704 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
  • FprCEN/TS 17742-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • prEN ISO 18703 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma
  • PD CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
  • DD ENV 1186-4-1994 Materials and Articles in Contact with Foodstuffs - Plastics - Part 4: Test Methods for Overall Migration into Olive Oil by Cell
  • CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA
  • CEN/TS 17390-1:2020 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

Association Francaise de Normalisation, Cells and Cell Engineering

  • CWA 15849:2008 Coding of Information and Traceability of Human Tissues and Cells
  • NF EN 15702:2009 Plastiques alvéolaires - Mode opératoire de dénombrement des alvéoles des polyuréthanes souples et rigides
  • NF X42-070:1989 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICES FOR RESEARCH AND DEVELOPMENT IN THE FIELD OF USE OF MICROORGANISMS AND OF SUPERIOR ORGANISM CELLS.
  • NF X42-052:1989 BIOTECHNOLOGY. GUIDE OF GOOD PRACTICE IN INDUSTRIAL MAKING OF MONOCLONE ANTIBODIES OBTAINED FROM CELLULAR CULTURES.
  • NF V04-040-2*NF EN ISO 13366-2:2007 Milk - Enumeration of somatic cells - Part 2 : guidance on the operation of fluoro-opto-electronic counters
  • NF T20-813:1987 Light olefins for industrial use. Determination of molecular oxygen in gaseous phase. Electrochemical method with a membrane-covered cell.
  • NF M60-220:2005 Radiation protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics.
  • NF S92-075-1*NF EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
  • XP S92-075-1*XP CEN/TS 16835-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA
  • NF EN ISO 20186-1:2019 Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux - Partie 1 : ARN cellulaire extrait
  • NF M60-220:2014 Radiation protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • NF V45-009:2023 Poissons transformés - Méthode pour le dénombrement de Listeria monocytogenes aux faibles niveaux de contamination dans le poisson fumé (Méthode de dénombrement par inclusion)

Guangdong Provincial Standard of the People's Republic of China, Cells and Cell Engineering

Yunnan Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB53/T 939-2019 Livestock somatic cell line establishment and cryopreservation

German Institute for Standardization, Cells and Cell Engineering

  • DIN 58932-4:2003 Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes
  • 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 58933-1:1995-01 Haematology - Procedure for determining the volume fraction of erythrocytes (packed cell volume) in blood - Part 1: Reference method based on centrifugation
  • 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 15702:2009-04 Cellular Plastics - Cell count procedure for flexible and rigid polyurethane; German version EN 15702:2008
  • DIN CEN/TS 17688-1:2022-06 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA; German version CEN/TS 17688-1:2021
  • 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 ISO 13022:2014-06 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
  • DIN EN ISO 20186-1:2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
  • DIN EN ISO 13366-2:2007 Milk - Enumeration of somatic cells - Part 2: Guidance on the operation of fluoro-opto-electronic counters (ISO 13366-2:2006); English version of DIN EN ISO 13366-2:2007-01
  • DIN CEN/TS 17811:2022-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA; German version CEN/TS 17811:2022
  • DIN CEN/TS 17742:2022-07 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma; German version CEN/TS 17742:2022
  • DIN EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
  • DIN CEN/TS 17390-3:2020-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining; German version CEN/TS 17390-3:2020
  • DIN CEN/TS 17390-2:2020-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNA; German version CEN/TS 17390-2:2020
  • DIN CEN/TS 17390-1:2020-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA; German version CEN/TS 17390-1:2020

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Cells and Cell Engineering

  • GB/T 24863-2010 Technical regulation of farm animals cell culture and cryopreservation
  • GB/T 24862-2010 Technical regulation of farm animals somatic cell bank detection
  • GB/T 38506-2020(英文版) Determination of biochemical parameters in animal cell culture process
  • GB/T 38506-2020 Determination of biochemical parameters in animal cell culture process
  • GB/T 21768-2008 Chemical.Test method of DNA damage and repair/unscheduled DNA synthesis with mammalian cells in vitro
  • GB/T 21767-2008 Chemical.Test method of unscheduled DNA synthesis (UDS)test with mammalian liver cells In Vivo
  • GB 15193.10-2014 National Food Safety Standard In Vitro Mammalian Cell DNA Damage Repair (Non-programmed DNA Synthesis) Test

Jilin Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB22/T 2853-2017 Peripheral Blood High Fluorescence Intensity Lymphocyte Percentage (HFLC%) Screening Technical Regulations for Atypical Lymphocytes
  • DB22/T 396.9-2017 Toxicological evaluation procedures and test methods for health care products Part 9: Chromosomal aberration test of cultured mammalian cells

Hunan Provincial Standard of the People's Republic of China, Cells and Cell Engineering

国家药监局, Cells and Cell Engineering

  • YY/T 1825-2021 Guidelines for the evaluation of measurement uncertainty of reference measurement procedures for red and white blood cell counts.
  • YY/T 1744-2020 Method for measuring cell migration in bioactive ceramic porous materials for tissue engineering medical device products
  • YY/T 0606.15-2023 Test methods for evaluating the immune response of matrices and scaffolds in tissue-engineered medical products: Lymphocyte proliferation test

Professional Standard - Agriculture, Cells and Cell Engineering

  • NY/T 1900-2010 Procedures for cell and embryo cryopreservation of domestic animals
  • 96兽药产品说明书范本第三册-2013 Diagnostic product FMD cell neutralization test antigen, positive serum and negative serum instructions
  • 112兽药典 三部-2015 Text Table of Contents Diagnostic Products Foot-and-Mouth Disease Cell Neutralization Test Antigen, Positive Serum and Negative Serum
  • 9药典 三部-2010 General headings Preparation and verification procedures of animal cell matrix for production and verification of biological products
  • 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
  • 1680药典 化学药和生物制品卷-2010 Chapter 26 Ophthalmic Drugs Section 10 Biological Products and Biochemical Drugs Recombinant Bovine Basic Fibroblast Growth Factor

Zhejiang Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB33/T 2030-2017 Standards for construction and management of human mesenchymal stem cell bank

Shaanxi Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB61/T 1497-2021 Standards for construction and management of human mesenchymal stem cell bank

Professional Standard - Commodity Inspection, Cells and Cell Engineering

  • SN/T 1919-2007 Protocol of hemagglutination inhibition test for porcine parvovirus
  • SN/T 1109-2002 Newcastle disease micro erythrocyte agglutination inhibition test operating procedures
  • SN/T 2022-2007 Protocol of polymerase chain reaction (PCR) for Eperythrozoon wenyoni
  • SN/T 2552.12-2010 Microbiological examination for milk and milk products hygiene-Part 12:Detection and enumeration of listeria monocytogenes

AENOR, Cells and Cell Engineering

  • UNE 103405:1994 GEOTECHNICS. ONE-DIMENSIONAL CONSOLIDATION TEST IN AN EDOMETRIC CELL.
  • UNE-EN 15702:2009 Cellular Plastics - Cell count procedure for flexible and rigid polyurethane

Guangxi Provincial Standard of the People's Republic of China, Cells and Cell Engineering

Anhui Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB34/T 3994-2021 Technical regulations for the control of somatic cell number in fresh milk
  • DB34/T 3987-2021 Technical regulations for cell culture isolation and detection of avian leukosis virus

Professional Standard - Medicine, Cells and Cell Engineering

  • YY/T 0606.13-2008 Tissue engineered medical product.Part 13: Standard test method for automated enumeration of cell suspensions
  • YY/T 0606.12-2007 Tissue engineered medical products.Part 12:Guide for processing cells,tissues,and organs
  • 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
  • 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

Professional Standard - Aquaculture, Cells and Cell Engineering

  • SC/T 7209.1-2007 Diagnostic Protocols for Mikrocytosis of Oyster- Part 1: Cytological Method with Tissue Imprints
  • SC/T 7201.3-2006 Fish Bacterial Disease Quarantine Technical Regulations Part 3: Diagnosis of Aeromonas hydrophila and Aeromonas caviae enteritis
  • SC/T 7206.1-2007 Diagnostic Protocols for Haplosporidiosis of Oyster-Part 1: Cytological Method with Tissue Imprints
  • SC/T 7205.1-2007 Diagnostic Protocols for Bonamiosisof Oyster-Part 1: Cytological Method with Tissue Imprints
  • SC/T 7207.1-2007 Diagnostic protocols for Marteiliosis of Oyster-Part 1: Cytological Method with Tissue Imprints
  • SC/T 7201.4-2006 Fish Bacterial Diseases Quarantine Technical Regulations Part 4: Diagnosis of Pseudomonas fluorescens Erythroderma
  • SC/T 7201.5-2006 Fish Bacterial Diseases Quarantine Technical Regulations Part 5: Diagnostic Methods for Pseudomonas Albidermis Leukoderma

International Organization for Standardization (ISO), Cells and Cell Engineering

  • ISO 20186-3:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
  • ISO 18362:2016 Manufacture of cell-based health care products - Control of microbial risks during processing
  • ISO 19090:2018 Tissue-engineered medical products - Bioactive ceramics - Method to measure cell migration in porous materials
  • ISO 13079:2011 Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
  • ISO 18362:2016/Amd 1:2022 Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
  • ISO 13366-2:2006 Milk - Enumeration of somatic cells - Part 2: Guidance on the operation of fluoro-opto-electronic counters
  • ISO 13366-2:2008 Milk - Enumeration of somatic cells - Part 2: Guidance on the operation of fluoro-opto-electronic counters
  • ISO 20404:2023 Biotechnology — Bioprocessing — General requirements for the design of packaging to contain cells for therapeutic use
  • ISO 13366-2:2006|IDF 148-2:2006 Colony Counting of Bovine Milk Somatic Cells Part 2: Working Guide for Fluorescent Photoelectric Counters
  • ISO 19238:2004 Radiation protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • ISO 19238:2014 Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • ISO 20186-1:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
  • ISO/TS 20399-1:2018 Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
  • ISO 21709:2020 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • ISO 20399:2022 Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
  • ISO 21709:2020/Amd 1:2021 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines; Amendment 1

Xinjiang Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB65/T 3501-2013 In vitro fertilization technology operation rules for sheep oocytes
  • DB65/T 3502-2013 Technical regulations for in vitro culture of sheep ear skin tissue fibroblasts

Taiwan Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • CNS 14172-1998 ATM cell mapping into plesiochronous digital hierarchy (PDH)
  • CNS 14763-2003 Extensions to the B-ISDN user part-Modification procedures for sustainable cell rate parameters

Chongqing Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB50/T 1460-2023 Technical specifications for preparation and cryopreservation of local pig ear margin fibroblasts

British Standards Institution (BSI), Cells and Cell Engineering

  • BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing
  • PD CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs). Isolated cellular RNA
  • BS ISO 20404:2023 Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use
  • BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
  • 21/30427340 DC BS EN ISO 18362 AMD1. Manufacture of cell-based health care products. Control of microbial risks during processing
  • BS ISO 19090:2018 Tissue-engineered medical products. Bioactive ceramics. Method to measure cell migration in porous materials
  • BS EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
  • 22/30428167 DC BS ISO 20404. Biotechnology. Bioprocessing. General requirements for the design of packaging to contain cells for therapeutic use
  • BS ISO 19238:2004 Radiation protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • BS ISO 20399:2022 Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
  • BS ISO 19238:2014 Radiological protection. Performance criteria for service laboratories performing biological dosimetry by cytogenetics
  • PD CEN/TS 17390-2:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated DNA
  • PD CEN/TS 17811:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA
  • BS EN ISO 20186-3:2019 Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free DNA from plasma
  • BS ISO 21709:2020 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • BS ISO 21709:2020+A1:2021 Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • PD CEN/TS 17390-1:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Isolated RNA
  • PD ISO/TS 23565:2021 Biotechnology. Bioprocessing. General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
  • PD CEN/TS 17742:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
  • 22/30424231 DC BS ISO 20399. Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products
  • 19/30366132 DC BS ISO 21709. Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • 21/30432828 DC BS ISO 21709 AMD1. Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • PD CEN/TS 17390-3:2020 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood. Preparations for analytical CTC staining

Inner Mongolia Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB15/T 2801-2022 Technical regulations for rapid identification of F Owen type sugar beet cytoplasmic types
  • DB15/T 3151-2023 Preparation of cow mammary epithelial cells by enzymatic digestion and technical procedures for RNA extraction
  • DB15/T 1900-2020 Technical regulations for the construction of hydrogen peroxide-induced oxidative damage model of dairy cow mammary gland epithelial cells
  • DB15/T 2555-2022 Technical regulations for isolation, culture and identification of primary dairy cow mammary gland epithelial cells - milk separation method

农业农村部, Cells and Cell Engineering

  • NY/T 3426-2019 Technical regulations for the production of maize cytoplasmic male sterile hybrids

Occupational Health Standard of the People's Republic of China, Cells and Cell Engineering

  • GBZ/T(卫生) 240.13-2011 Procedures and tests for toxicological evaluations of chemicals—Part 13:Mammalian spermatogonium/primary spermatocyte chromosome aberration test
  • GBZ/T 240.13-2011 Procedures and tests for toxicological evaluations of chemicals. Part 13: Mammalian spermatogonium/primary spermatocyte chromosome aberration test
  • GBZ/T 248-2014 Test and assessment of chromosomal aberrations on occupational health examinations for radiation workers
  • GBZ/T(卫生) 248-2014 Test and assessment of chromosomal aberrations on occupational health examinations for radiation workers
  • GBZ/T(卫生) 240.10-2011 Procedures and tests for toxicological evaluations of chemicals—Part 10:In vitro mammalian cell forward gene mutation test
  • GBZ/T 240.10-2011 Procedures and tests for toxicological evaluations of chemicals. Part 10:In vitro mammalian cell forward gene mutation test
  • GBZ/T(卫生) 240.9-2011 Procedures and tests for toxicological evaluations of chemicals—Part 9:In vitro mammalian chromosome aberration test
  • GBZ/T 240.9-2011 Procedures and tests for toxicological evaluations of chemicals. Part 9:In vitro mammalian chromosome aberration test

Danish Standards Foundation, Cells and Cell Engineering

  • DS/EN 15702:2009 Cellular Plastics - Cell count procedure for flexible and rigid polyurethane
  • DS/ISO 21709:2020 Biotechnology – Biobanking – Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • DS/ISO/TS 23565:2021 Biotechnology – Bioprocessing – General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use
  • DS/EN 1186-4:2002 Materials and articles in contact with foodstuffs - Plastics - Part 4: Test methods for overall migration into olive oil by cell
  • DS/ISO 21709:2021 Biotechnology – Biobanking – Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines – Amendment 1

Lithuanian Standards Office , Cells and Cell Engineering

  • LST EN 15702-2009 Cellular Plastics - Cell count procedure for flexible and rigid polyurethane
  • LST EN 1186-4-2002 Materials and articles in contact with foodstuffs - Plastics - Part 4: Test methods for overall migration into olive oil by cell

国家食品药品监督管理局, Cells and Cell Engineering

  • YY/T 1562-2017 Guidelines for Cell Activity Testing of Biomaterial Scaffolds for Tissue Engineering Medical Device Products

Shandong Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB37/T 2037-2012 Technical regulations for molecular detection of bovine leukocyte adhesion deficiency (BLAD) gene

AT-ON, Cells and Cell Engineering

  • ONR CEN/TS 17688-1-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA

ES-UNE, Cells and Cell Engineering

  • UNE-CEN/TS 17688-1:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA (Endorsed by Asociación Española de Normalización in February of 2022.)
  • UNE-EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019)
  • UNE-CEN/TS 17742:2022 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma (Endorsed by Asociación Española de Normalización in May of 2022.)
  • UNE-EN ISO 20186-3:2020 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

Japanese Industrial Standards Committee (JISC), Cells and Cell Engineering

  • JIS T 0301:2000 Testing method for biocompatibility of implantable metals using cultured cells

Korean Agency for Technology and Standards (KATS), Cells and Cell Engineering

  • KS H ISO 13366-2:2006 Milk-Enumeration of somatic cells-Part 2:Guidance on the operation of fluoro-opto-electronic counters
  • KS P ISO 13022:2018 Medical products containing viable human cells — Application of risk management and requirements for processing practices

VN-TCVN, Cells and Cell Engineering

  • TCVN 6686-2-2007 Milk.Enumeration of somatic cells.Part 2: Guidance on the operation of fluoro-opto-electronic counters

Sichuan Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB5107/T 137.3-2023 National Food Safety Demonstration City “Cell Engineering” Construction Specifications Part 3: Food Supermarket Industry Model Store
  • DB5107/T 137.4-2023 National Food Safety Demonstration City “Cell Engineering” Construction Specifications Part 4: Food Business Store Industry Model Store
  • DB5107/T 137.1-2023 National Food Safety Demonstration City “Cell Engineering” Construction Specifications Part 1: Model Enterprises in the Food Production Industry
  • DB5107/T 137.2-2023 National Food Safety Demonstration City "Cell Engineering" Construction Specifications Part 2: Model Store of Small Food Workshop Industry

KR-KS, Cells and Cell Engineering

  • KS P ISO 13022-2018 Medical products containing viable human cells — Application of risk management and requirements for processing practices
  • KS P ISO 20186-1-2022 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
  • KS J ISO 21709-2023 Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

National Health Commission of the People's Republic of China, Cells and Cell Engineering

  • GBZ/T 328-2023 Micronucleus detection method and exposure dose estimation standard of peripheral blood lymphocytes in occupational health examination of radiation workers

US-CFR-file, Cells and Cell Engineering

  • CFR 9-113.304-2014 Animals and animal products. Part113:Standard requirements. Section113.304:Feline Panleukopenia Vaccine.

US-AAMI, Cells and Cell Engineering

  • ANSI/AAMI/ISO 13022:2012 Medical products containing viable human cells.Application of risk management and requirements for processing practices

(U.S.) Ford Automotive Standards, Cells and Cell Engineering

  • FORD WSS-M2D515-A-2012 POLYURETHANE (PUR) FOAM, MICROCELLULAR, SHOCK AND VIBRATION ISOLATING, MEDIUM DENSITY ***TO BE USED WITH FORD WSS-M99P1111-A***

CEN - European Committee for Standardization, Cells and Cell Engineering

  • EN ISO 20186-1:2019 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Cells and Cell Engineering

  • GB/T 15670.22-2017 Toxicological test methods for pesticides registration—Part 22:DNA damage and repair/unscheduled DNA synthesis in mammalian cells in vitro
  • GB/T 15670.21-2017 Toxicological test methods for pesticides registration—Part 21: Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo

RU-GOST R, Cells and Cell Engineering

  • GOST R 53910-2010 Water. Methods of toxicity determination by growth inhibition of marine unicellular algae Phaeodactylum tricornutum Bohlin and Sceletonema costatum (Greville) Cleve

IT-UNI, Cells and Cell Engineering

  • UNI ISO 21709:2021 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
  • UNI CEN/TS 17390-1-2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNA

Beijing Provincial Standard of the People's Republic of China, Cells and Cell Engineering

  • DB11/T 1841-2021 Fineness standard of construction process model for ventilation and air-conditioning engineering

Standard Association of Australia (SAA), Cells and Cell Engineering

  • AS 1807:2021 Separative devices — Biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators — Methods of test




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