Class II medical device cytotoxicity

Class II medical device cytotoxicity, Total:80 items.

The international standard classification for "Class II medical device cytotoxicity" includes: Medical equipment in general , Dental materials , Surgical instruments and materials .

The Chinese standard classification for "Class II medical device cytotoxicity" includes: Medical apparatus and devices in general , Stomatologic device, equipment and material .

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

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity

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 - Medicine

YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test
YY/T 0993-2015 Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)
YY/T 0870.3-2019 Test for genotoxicity of medical devices―Part 3:TK gene mutation test using mouse lymphoma cells
YY/T 0870.4-2014 Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus test
YY/T 0870.6-2019 Test for genotoxicity of medical devices―Part 6:In vitro mammalian cell micronucleus test
YY/T 0870.3-2013 Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell
YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry Part 18:Dentine barrier cytotoxicity test
YY/T 0870.8-2024 Test for genotoxicity of medical devices—Part 8:Unscheduled DNA synthesis test with mammalian liver cells in vivo

Ente Nazionale Italiano di Unificazione

UNI 9582-2:1990 Biocompatibility of medical materials and devices. Cytotoxicity.
UNI EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
UNI EN ISO 10993-5:2025 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

British Standards Institution (BSI)

BS EN ISO 10993-5:2009+A11:2025 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
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
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
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
07/30160957 DC EN ISO 10993-5. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Gosstandart of Russia

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
GOST R ISO 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-5-2023 Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods

GCC Standardization Organization

GSO ASTM F3206:2022 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
GSO ISO 10993-5:2015 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
BH GSO ISO/TR 10993-55:2024 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
OS GSO ISO/TR 10993-55:2024 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

Kingdom of Bahrain Testing and Metrology Directorate

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

Association for the Advancement of Medical Instrumentation

AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
AAMI/ISO 10993-5:2009(R2022) Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity

Thai Industrial Standards Institute (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 S99-501-5/A11*NF EN ISO 10993-5/A11:2025 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(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 P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Bureau of Indian Standards

IS/ISO 10993-5-2009 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

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

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

Canadian Standards Association (CSA)

CAN/CSA-ISO 10993-5-01:2001 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
CAN/CSA-ISO 10993.5-97:1997 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods

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 EN ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
DIN EN ISO 10993-5:1999-11 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
DIN EN ISO 10993-5/A1 E:2009-02 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:2007-06 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
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

Danish Standards Foundation

DANSK DS/EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
DS/EN 30993-5:1994 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

Bureau of Philippine Standards

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

American Society for Testing and Materials (ASTM)

ASTM F3206-17 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

International Organization for Standardization (ISO)

ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5:2009 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

Standards Norway

NS-ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
NS-EN ISO 10993-5:1999 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
NS-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 ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Swedish Institute for Standards

SS-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
SS-EN ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Spanish Association for Standardization (UNE)

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

Belgian Standards Institute

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

South African Bureau of Standard

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

Indonesia Standards

SNI ISO 10993-5:2015 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity (ISO 10993-5:2009, identical adoption)

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