Cytotoxicity assessment

Cytotoxicity assessment, Total:143 items.

The international standard classification for "Cytotoxicity assessment" includes: Medical Sciences and health care facilities in general , Biology. Botany. Zoology , Protection against crime , Dental materials , Surgical instruments and materials , Laboratory medicine , Medical materials .

The Chinese standard classification for "Cytotoxicity assessment" includes: Marking, packaing, transport and storage , Basic Subject in general , Basic standards and general methods , Medical apparatus and devices in general , Crime judging technology , Stomatologic device, equipment and material , Medical laboratory equipment , Biological agent and blood products .

Professional Standard - Pharmaceutical Packaging

YBB 0001-2003 Xibao Duxing Jianchafa Tests for cytotoxicity
YBB 0001(03)-2003 Cytotoxicity Test (Trial)

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 14393-5-2004 Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity

Professional Standard - Commodity Inspection

SN/T 2328-2009 Cosmetics acute toxicity of keratinocyte cytotoxicity test
SN/T 3824-2014 Phototoxicity test for cosmetics - Determination of recombinant red blood cell
SN/T 2330-2009 Cosmetics embryotoxicity and developmental toxicity of mice embryonic stem cell test

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

GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 41895-2022 Determination for DNA viruses of cell—MNP marker method
GB/T 41915-2022 Nanotechnologies―In vitro MTS assay for measuring the cytotoxic effect of nanoparticles

Professional Standard - Agriculture

315药典四部-2020 4000 Testing method for pharmaceutical packaging materials 4014 Cytotoxicity testing method for pharmaceutical packaging materials
327药典三部-2020 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
279药典四部-2015 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
259药典三部-2010 Appendix Ⅹ XR Anti-human T cell immunoglobulin titer assay (lymphocytotoxicity test)
274药典四部-2020 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
298药典三部-2015 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test) General 129

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

GB/T 35520-2017 Chemicals—Embryotoxicity—Embryonic stem cell test

Jilin Provincial Standard of the People's Republic of China

DB22/T 2565-2016 Influenza virus MDCK cell virus isolation and detection method

Professional Standard - Public Safety Standards

GA/T 2056-2023 Forensic sciences-Experimental methods for evaluation of neurotoxicity of phenethylamines and cathinone-like substances-In vitro neurocytotoxic testing method

Professional Standard - Medicine

YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry Part 18:Dentine barrier cytotoxicity test
YY/T 1236-2014 Cytomegalovirus(CMV)IgG/IgM antibody detection kit
YY/T 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)

Group Standards of the People's Republic of China

T/SDHCST 007-2023 Procedures for Repeated Dose Toxicity Testing of the Cell Therapy Medical Products
T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
T/SDHCST 006-2023 Procedures for Single Dose Toxicity Testing of the Cell Therapy Medical Products

国家药监局

YY/T 1825-2021 Guideline for measurement uncertainty evaluation of the certified values using the erythrocytes and leucocytes reference measurement procedures
YY/T 1465.6-2019 Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry

国家市场监督管理总局、中国国家标准化管理委员会

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

American Society for Testing and Materials (ASTM)

ASTM E2526-22 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM E2526-08 Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM E2526-08(2013) Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
ASTM F895-84(2001) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F895-11(2016) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
ASTM F1027-86(2007) Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices
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 F3354-19 Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

British Standards Institution (BSI)

BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
BS EN 16418:2014 Paper and board. Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS EN ISO 21427-2:2006 Water quality. Evaluation of genotoxicity by measurement of the induction of micronuclei. Mixed population method using the cell line V79
BS ISO 21115:2019 Water quality. Determination of acute toxicity of water samples and chemicals to a fish gill cell line (RTgill-W1)
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
BS ISO 21427-2:2006 Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Mixed population method using the cell line V79
BS ISO 19007:2018 Nanotechnologies. In vitro MTS assay for measuring the cytotoxic effect of nanoparticles

Standard Association of Australia （SAA）

AS 2567:1982 Cytotoxic drug safety cabinets
AS 2567:1994 Laminar flow cytotoxic drug safety cabinets
AS 2567:2002 Laminar flow cytotoxic drug safety cabinets
AS 2639:1983 Cytotoxic drug safety cabinets - Installation and use

SCC

AWWA ACE68896 Comparative Cytotoxicity and Genotoxicity of Priority DBPs
DANSK DS/EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
NS-EN 15845:2010 Paper and board — Determination of the cytotoxicity of aqueous extracts
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
DIN EN 15845 E:2008 Draft Document - Paper and board - Determination of the cytotoxicity of aqueous extracts; German version prEN 15845:2008
AWWA WQTC65810 Host Cell Capture Quantitative PCR Detection of Viruses
AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
CSA Z316.6-1995(R2000) Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
DANSK DS/EN ISO 10993-5:2009 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
08/30183128 DC BS EN 15845. Paper and board. Determination of the cytotoxicity of aqueous extracts
DANSK DS/EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
NS-EN 16418:2014 Paper and board — Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
CSA Z316.6-2002 Evaluation of Single-Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste
CAN/CSA-ISO 10993.5-97:1997 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods
NS-ISO 10993-5:1992 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
DIN EN 16418 E:2012 Draft Document - Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2); German version prEN 16418:2012
AWWA ACE63225 Mammalian Cell Toxicity of Emerging Drinking Water Disinfection Byproducts
12/30259424 DC BS EN 16418. Paper and board. Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
DANSK DS/ISO 21115:2019 Water quality – Determination of acute toxicity of water samples and chemicals to a fish gill cell line (RTgill-W1)
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)
AENOR UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
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
AWWA WQTC56953 Detection of Infectious Adenovirus by mRNA RT-PCR in Cell Culture
DANSK DS/ISO 19007:2018 Nanotechnologies -In vitro MTS assay for measuring the cytotoxic effect of nanoparticles
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
AWWA WQTC50408 Identification of Viruses Present in Ground Water Cell Culture Harvest by PCR

Lithuanian Standards Office

LST EN 15845-2010 Paper and board - Determination of the cytotoxicity of aqueous extracts

German Institute for Standardization

DIN EN 15845:2010-05 Paper and board - Determination of the cytotoxicity of aqueous extracts; German version EN 15845:2010
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 EN 16418 E:2012-04 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
DIN EN 16418:2014-07 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2); German version EN 16418:2014
DIN EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2); German version EN 16418:2014
DIN 12980:2005 Laboratory furniture - Safety cabinets for handling cytotoxic substances
DIN EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts; German version EN 15845:2010

Association Francaise de Normalisation

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 15845:2010 Paper and cardboard - Determination of the cytotoxicity of aqueous extracts
NF Q03-098*NF EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
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)
NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity
NF S91-144:1988 Dental implants. Cytocompatibility. Evaluation of 51CR extracellular release.
NF S11-820:2012 Contact lens solutions - Evaluation of ocular cytotoxic potentiel of lens solution products.
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF U47-220:2010 Cell culture isolation and immunofluorescence identification of fish viral hemorrhagic septicemia virus.
NF ISO 21115:2019 Water quality - Determination of acute toxicity of water samples and chemicals to fish gill cell line (RTgill-W1)
NF S99-505:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5 : TESTS FOR CYTOTOXICITY : IN VITRO METHODS. (EUROPEAN STANDARD EN 30993-5).
NF T90-723*NF ISO 21115:2019 Water quality - Determination of acute toxicity of water samples and chemicals to a fish gill cell line (RTgill-W1)

Danish Standards Foundation

DS/EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods

Spanish Association for Standardization (UNE)

UNE-EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
UNE-EN 16418:2014 Paper and board - Determination of the cytotoxicity of aqueous extracts using a metabolically competent hepatoma cell line (HepG2)
UNE-EN ISO 10993-5:2000 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5: TESTS FOR IN VITRO CYTOTOXICITY (ISO 10993-5:1999)
UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

European Committee for Standardization (CEN)

EN 15845:2010 Paper and board - Determination of the cytotoxicity of aqueous extracts
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)

RU-GOST R

GOST R 54496-2011 Water. The determination of toxicity with use of green freshwater unicellular algae
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

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 M ISO 4590:2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells

TH-TISI

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

KR-KS

KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS M ISO 4590-2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells
KS P ISO 10993-5-2018 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

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

GSO

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
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

South African Bureau of Standard

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

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 21115:2019 Water quality — Determination of acute toxicity of water samples and chemicals to a fish gill cell line (RTgill-W1)
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

PH-BPS

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

BE-NBN

NBN-EN 30993-5-1994 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992)

DIN

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

Canadian Standards Association (CSA)

CSA Z316.6-02-2002 Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste Second Edition

API - American Petroleum Institute

API PUBL 31-30265-1983 STIMULATION AND INHIBITION OF CHEMOTAXIS IN ABELSON VIRUS TRANSFORMED MACROPHAGES

Indonesia Standards

SNI 7822.1-2013 Identification of carp rhabdoviruses Part 1: Cell culture methods

RO-ASRO

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

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