Biological Evaluation of Medical Devices Part 10: Systemic Toxicity Test

Biological Evaluation of Medical Devices Part 10: Systemic Toxicity Test, Total:211 items.

The international standard classification for "Biological Evaluation of Medical Devices Part 10: Systemic Toxicity Test" includes: Medical equipment in general , Laboratory medicine , Dental materials .

The Chinese standard classification for "Biological Evaluation of Medical Devices Part 10: Systemic Toxicity Test" 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 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
SPC GB/T 16886.3-2019 Biological evaluation of medical devices -- Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity (TEXT OF DOCUMENT IS IN CHINESE)

Professional Standard - Medicine

YY/T 0127.15-2009 Biological evaluation of medical devices used in dentistry Part 2:Test method Subacute and subchronic systemic toxicity test:oral route
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute oral toxicity test
YY/T 0127.15-2018 Biological evaluation of medical devices used in dentistry―Part 15:Subacute and subchronic systemic toxicity test:oral route
YY/T 0127.19-2023 Biological evaluation of medical devices used in dentistry-Part 19:Subacute and subchronic systemic toxicity test : implant route
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity test
YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute systemic toxicity: intravenous path

British Standards Institution (BSI)

BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
25/30473199 DC BS EN ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
BS 5736-3:1981 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
BS EN ISO 10993-5:2009+A11:2025 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS EN ISO 10993-3:2003 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN ISO 10993-3:2009 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO 10993-5:2017 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
BH GSO ISO/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
BH GSO ISO 10993-10:2017 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Ente Nazionale Italiano di Unificazione

UNI EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
UNI EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
UNI EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
UNI EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
UNI EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
UNI EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
UNI EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
UNI EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
UNI EN ISO 10993-5:2025 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
UNI EN ISO 10993-17:2024 Biological evaluation of medical devices - Part 17:Toxicological risk assessment of medical device constituents
UNI EN ISO 10993-1:1999 Biological evaluation of medical devices - Evaluation and testing

Canadian Standards Association (CSA)

CAN/CSA-ISO 10993.11-1998(R2002) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
CAN/CSA-ISO 10993.11-1998(C2002) Biological evaluation of medical devices - Part 11: Systemic toxicity testing
CAN/CSA-ISO 10993.11-1998(R2003) Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (Adopted ISO 10993-11:1993)
CAN/CSA-ISO 10993-5-01:2001 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
CAN/CSA-ISO 10993.3-1997(C2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
CAN/CSA-ISO 10993.10-1998(R2003) Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
CAN/CSA-ISO 10993.3-1997(R2006) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
CAN/CSA-ISO 10993.5-97:1997 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 10993-11:2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
ANSI/AAMI/ISO 10993-11:2017(R2023) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
ANSI/AAMI/ISO 10993-3:2014(R2023) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO 10993-10:2010(2014) Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

Bureau of Indian Standards

IS/ISO 10993-11-2017 Biological Evaluation of Medical Devices Part 11 Tests for Systemic Toxicity
IS/ISO 10993-5-2009 Biological Evaluation of Medical Devices Part 5 Tests for in vitro Cytotoxicity
IS 12572-13-1995 Biological Evaluation of Medical Devices - Part 13 : Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
IS/ISO/TS 10993-20-2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
IS 12572-6-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 6 Method of Test for Systemic Toxicity; Assessment of Pyrogenicity In Rabits of Extracts from Medical Devices
IS/ISO 10993-10-2010 Biological Evaluation of Medical Devices Part 10 Tests for Irritation and Skin Sensitization

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
OS GSO ISO 10993-10:2016 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Association for the Advancement of Medical Instrumentation

AAMI/ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
AAMI/ISO 10993-11:2006(R2014) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI/ISO 10993-3:2003(R2013) Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

GCC Standardization Organization

BH GSO ISO 10993-11:2024 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
GSO ISO 10993-5:2015 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
OS GSO ISO 10993-11:2024 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
GSO ISO 10993-10:2016 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
GSO ISO 10993-23:2024 Biological evaluation of medical devices — Part 23: Tests for irritation
GSO ISO 10993-3:2015 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
OS GSO ISO 10993-10:2024 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

Association Francaise de Normalisation

NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing
NF S99-501-11:2009 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
NF S99-501-11*NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
NF S99-501-10*NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10 : tests for skin sensitization
NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: tests concerning genotoxicity, carcinogenicity and reproductive toxicity
NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: skin sensitization testing
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF EN ISO 10993-17:2023 Biological evaluation of medical devices - Part 17 : toxicological risk assessment of medical device constituents
NF S99-501-5/A11*NF EN ISO 10993-5/A11:2025 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity
NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity

Thai Industrial Standards Institute (TISI)

TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing

German Institute for Standardization

DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
DIN EN ISO 10993-11:2006-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
DIN EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
DIN EN ISO 10993-11:2009-08 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
DIN EN ISO 10993-11/A1 E:2009-02 Draft Document - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version prEN ISO 10993-11:2008, Amendment 1
DIN EN ISO 10993-11/A1 E:2009 Draft Document - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); English version prEN ISO 10993-11:2008, Amendment 1
DIN EN ISO 10993-11 E:2015 Draft Document - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2015); German and English version prEN ISO 10993-11:2015
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 10993-3:2015-02 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
DIN ISO 10993-1:2003-12 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
DIN EN ISO 10993-3 E:2011-08 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
DIN EN ISO 10993-3 E:2013-03 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)
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 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Danish Standards Foundation

DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
DANSK DS/EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
DANSK DS/EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
DANSK DS/ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DANSK DS/EN ISO 10993-10:2013 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices － Part 11: Tests for systemic toxicity
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-11:2007 Biological evaluation of medical devices － Part 11: Tests for systemic toxicity
KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-5-2023 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-3-2018(2023) Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
KS P ISO 10993-3-2023 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
KS P ISO 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-20-2009(2024) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

International Organization for Standardization (ISO)

ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
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 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation

Standard Association of Australia （SAA）

AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing

Bureau of Philippine Standards

PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

European Committee for Standardization (CEN)

EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
prEN ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

Spanish Association for Standardization (UNE)

UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-11:1996 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 11: TESTS FOR SYSTEMIC TOXICITY. (ISO 10993-11:1993)
UNE-EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
UNE-EN ISO 10993-11:2007 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
AENOR UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN ISO 10993-3:2004 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicty and reproductive toxicity (ISO10993-3:2003)
UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
AENOR UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
UNE-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

Standards Norway

NS-EN ISO 10993-11:1995 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)
NS-EN ISO 10993-11:2018 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
NS-EN ISO 10993-11:2006 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
NS-EN ISO 10993-11:2009 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
NS-ISO 10993-3:1992 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
NS-ISO 10993-5:1992 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
NS-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
NS-EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
NS-EN ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
NS-EN ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
NS-EN ISO 10993-5:1999 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Swedish Institute for Standards

SS-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
SS-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
SS-EN ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)
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 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Gosstandart of Russia

GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

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

TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing

National Standardisation Body (ASRO)

STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity

Indonesia Standards

SNI ISO 10993-11:2016 Evaluasi biologis alat kesehatan - Bagian 11: Uji toksisitas sistemik (ISO 10993-11:2006, IDT)

Japanese Industrial Standards Committee (JISC)

JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing

Others: