Cellular and Regenerative Medicine

Cellular and Regenerative Medicine, Total:131 items.

The international standard classification for "Cellular and Regenerative Medicine" includes: Food microbiology , Protection against dangerous goods , Medical equipment in general , Dental materials , Surgical instruments and materials , Animal feeding stuffs , General methods of tests and analysis for food products , Biology. Botany. Zoology , Raw materials for rubber and plastics in general .

The Chinese standard classification for "Cellular and Regenerative Medicine" includes: Medical apparatus and devices in general , Food sanitation , Marking, packaging, transport and storage in general , Stomatologic device, equipment and material , Medical optical instrument and endoscope , Livestock and poultry feed and additive , Basic standards and general methods , Reclaimed rubber .

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

GB/T 4789.30-2003 Microbiological examination of food hygiene―Examination of Listeria monocytogenes
GB 30000.22-2013 Rules for classification and labelling of chemicals—Part 22:Germ cell mutagenicity
GB/T 42076.1-2022 Biotechnology—Cell counting—Part 1: General guidance on cell counting methods
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 4789.30-2008 Microbiological examination of food hygiene - Examination of listeria monocytogenes
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity

未注明发布机构

ANSI/AAMI/ISO 10993-5:2009(2014) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Professional Standard - Medicine

YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)
YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test
YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry―Part 17:Mouse lymphoma cells(TK)gene mutation test
YY/T 0930-2014 Medical endoscopes―Endotherapy device―Cytology brush11.040.90
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry Part 18:Dentine barrier cytotoxicity test

海关总署

SN/T 5159-2019 Chemicals-Transgenic rodent somatic and germ cell gene mutation assays

Professional Standard - Agriculture

1317药典化学药和生物制品卷-2010 Chapter 18 Biological Products 4. Cytokine Recombinant Human Granulocyte Stimulating Factor
1320药典化学药和生物制品卷-2010 Chapter 18 Biological Products 4. Cytokine Recombinant Bovine Basic Fibroblast Growth Factor
GB 4789.30-1994 Food Hygiene Microbiological Testing Listeria Monocytogenes Testing
289药典四部-2015 3500 Biological Activity-Potency Assay 3526 Recombinant Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
337药典三部-2020 Biological Activity-Potency Assay 3526 Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
NY/T 1902-2010 Microbiological examination of Listeria monocytogenes in feeds
1318药典化学药和生物制品卷-2010 Chapter 18 Biological Products 4. Cytokine Recombinant Human Granulocyte Macrophage Stimulating Factor
NY/T 800-2004 Enumeration of somatic cells in raw milk
NY/T 2186.4-2012 Microbial Pesticide Toxicological Test Guidelines - Part 4: Cell Culture Study
246药典三部-2010 Appendix Ⅹ XE Recombinant human granulocyte-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
1324药典化学药和生物制品卷-2010 Chapter 18 Biological Products 4. Cytokine Recombinant Human Interleukin-11
284药典四部-2020 3500 Biological Activity-Potency Assay 3526 Recombinant Human Granulocyte Macrophage Stimulating Factor Biological Activity Assay
247药典三部-2010 Appendix Ⅹ XF Determination of Biological Activity of Recombinant Human Granulocyte Macrophage Stimulating Factor

Group Standards of the People's Republic of China

T/SZAS 39-2021 Dataset of single-cell transcriptomics
T/QMHIPA 001-2022 Specifications For Establishment and Manngement of Cell Preparation Center
T/CECCEDA 002-2023 Manufacture practice of single-use materials in CAR-T production
T/ZHYX 001-2024 General requirements for the preparation of endometrial regenerative cells derived from human menstrual blood for clinical use
T/CECCEDA 003.2-2023 Technical requirement of single-use materials in CAR-T production Part 2: Cell sap culture tank
T/ZJBMQA 005-2019 High quality recycled fine aggregate
T/CECCEDA 003.1-2023 Technical requirement of single-use materials in CAR-T production Part 1: Cell frozen bag、Cell storage bag

Hebei Provincial Standard of the People's Republic of China

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 5863-2023 Standards for hospital infection prevention and control in hematopoietic stem cell transplantation ward

Taiwan Provincial Standard of the People's Republic of China

CNS 14393.5-2004 Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity
CNS 3820-1975 Classification of Nuclear Science and Technology (Biology and Medical Science)
CNS 15030-21-2006 Classification and labelling of chemicals - Germ cell mutagenicity
CNS 14393-5-2004 Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity

Henan Provincial Standard of the People's Republic of China

DB41/T 2708-2024 Technical regulations for biosafety assessment of bovine semen, ova and embryos

Professional Standard - Commodity Inspection

SN/T 2552.12-2010 Microbiological Examination Method for Milk and Milk Products Hygiene - Part 12: Detection and Enumeration of Listeria Monocytogenes

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 - Chemical Industry

HG/T 4609-2014 Non blackness refined reclaimed rubber

Sichuan Provincial Standard of the People's Republic of China

DB5101/T 184-2024 Cell preparation center setup and management specifications

国家食品药品监督管理局

YY/T 1562-2017 Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation

国家药监局

YY/T 1688-2021 Medical devices for human assisted reproductive technology—A method for blastocyst cell staining and counting

Yunnan Provincial Standard of the People's Republic of China

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

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 123-2020 Construction and management of tumor cell bank

British Standards Institution (BSI)

BS PAS 84:2012 Cell therapy and regenerative medicine. Glossary
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
PAS 157:2015 Evaluation of materials of biological origin used in the production of cell-based medicinal products. Guide
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS ISO 20391-1:2018 Biotechnology. Cell counting. General guidance on cell counting methods
PAS 84-2008 Regenerative medicine-- Glossary PUBLICLY AVAILABLE SPECIFICATION
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 EN ISO 10712:1996(2008)*BS 6068-5.19:1996 Water quality — Pseudomonas putida growth inhibition test (Pseudomonas cell multiplication inhibition test)

GSO

GSO ASTM F3206:2022 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
BH GSO ASTM F3206:2023 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
BH GSO ISO 10993-5:2017 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
GSO ISO 10993-5:2015 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

SCC

BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
BS PAS 84:2008 Regenerative medicine. Glossary
AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
CAN/CSA-ISO 10993-5-01:2001 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
DANSK DS/EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
NS-ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
CAN/CSA-ISO 10993.5-97:1997 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods
DANSK DS/ISO/TR 10993-55:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
NS-EN ISO 10993-5:1999 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
07/30160957 DC EN ISO 10993-5. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
NS-EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN ISO 10993-5:2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:1999)
AENOR UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
AWWA WQTC65976 Application of a Flow Cytometry Method to Quantify Bacterial Regrowth and Assimilable Organic Carbon in Distribution Systems
DIN EN ISO 10993-5/A1 E:2009 Draft Document - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999); English version prEN ISO 10993-5:2008, Amendment 1
DIN EN ISO 10993-5 E:2007 Draft Document - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO/DIS 10993-5:2007); German version prEN ISO 10993-5:2007
AWWA WQTC58824 Catalytic GAC for Water Treatment: DBP-Removal vs. Bacterial Regrowth
DANSK DS/ISO 20391-1:2018 Biotechnology – Cell counting – Part 1: 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
CSA Z316.6-1995(R2000) Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
CSA Z316.6-2002 Evaluation of Single-Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
DANSK DS/EN ISO 10712:1996 Water quality - Pseudomonas putida growth inhibition test (Psedomonas cell multiplication inhibition test)

American Society for Testing and Materials (ASTM)

ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 10993-5:2009(R2022) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

VN-TCVN

TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-5-2023 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS J ISO 20391-1:2019 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
KS I ISO 10712-2023 Water quality－Pseudomonas putida growth inhibition test (Pseudomonas cell multiplication inhibition test)

KR-KS

KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS J ISO 20391-1-2019 Biotechnology — Cell counting — Part 1: General guidance on cell counting methods

ZA-SANS

SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

TH-TISI

TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity

Association Francaise de Normalisation

NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF S91-145:1988 Dentistry. Dental implants. Cytocompatibility. Study of cells attachment and spreading on the biomaterial.
NF S99-505:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5 : TESTS FOR CYTOTOXICITY : IN VITRO METHODS. (EUROPEAN STANDARD EN 30993-5).
CWA 15849:2008 Coding of Information and Traceability of Human Tissues and Cells

German Institute for Standardization

DIN EN ISO 10993-5:2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
DIN 58932-2:1998 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
DIN 58932-2:1998-06 Haematology - Determination of the concentration of blood corpuscles in blood - Part 2: Characteristic quantities for erythrocytes (erythrocyte indices)
DIN EN ISO 10712:1996 Water quality - Pseudomonas putida growth inhibition test (Pseudomonas cell multiplication inhibition test) (ISO 10712:1995); German version EN ISO 10712:1995

RU-GOST R

GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods

International Organization for Standardization (ISO)

ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 20391-1:2018 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
ISO/DIS 24479:2023 Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features

PH-BPS

PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Danish Standards Foundation

DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods

DIN

DIN EN ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

AENOR

UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

RO-ASRO

STAS SR EN 30993-5-1996 Biological evaluation of medical devices -Part 5: Tests for cytotoxicity: in vitro methods

GOST

GOST R ISO 20391-1-2023 Biotechnology. Cell counting. Part 1. General guidance on cell counting methods
GOST R ISO 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

IT-UNI

UNI ISO 20391-1:2021 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods

Military Standards (MIL-STD)

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

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)

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