Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices, Total:141 items.

The international standard classification for "Biological Evaluation of Medical Devices" includes: Medical equipment in general , Laboratory medicine , Medical equipment , Dental materials , Surgical instruments and materials .

The Chinese standard classification for "Biological Evaluation of Medical Devices" 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 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substances
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
GB/T 16886.11-2021 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 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.16-2003 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6:Tests for local effects after implantation
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity

Professional Standard - Medicine

YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry―Part 3:Endodontic usage test
YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute systemic toxicity: intravenous path
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping 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 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity test
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute oral toxicity test
YY/T 0127.10-2009 Biological Evaluation of Medical Devices Used in Dentistry - Part 2：Test Method - Salmonella Typhimurium Reverse Mutation Assay (Ames Mutaaenicity Test)
YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Oral mucous membrane irritation test
YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process

Group Standards of the People's Republic of China

T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating: Sample preparation

German Institute for Standardization

DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN ISO 10993-1:2003-12 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
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 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

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices

Ente Nazionale Italiano di Unificazione

UNI EN ISO 10993-1:1999 Biological evaluation of medical devices - Evaluation and testing
UNI EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
UNI EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
UNI EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements
UNI EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
UNI EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization

British Standards Institution (BSI)

BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
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 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
BS EN ISO 10993-5:2009+A11:2025 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS EN ISO 10993-12:2009 Biological evaluation of medical devices-Sample preparation and reference materials
BS EN ISO 10993-12:1997 Biological evaluation of medical devices-Sample preparation and reference materials
BS EN 30993-6:1995 Biological evaluation of medical devices-Tests for local effects after implantation
BS EN ISO 10993-10:1996 Biological evaluation of medical devices-Tests for irritation and sensitization
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices Ethylene oxide sterilization residuals
BS EN ISO 10993-7:1996 Biological evaluation of medical devices-Ethylene oxide sterilization residuals
BS EN ISO 10993-6:2007 Biological evaluation of medical devices-Tests for local effects after implantation
BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods

Standard Association of Australia （SAA）

AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
AS ISO 10993.12:2002 Biological evaluation of medical devices - Sample preparation and reference materials

SCC

AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
AAMI/ISO 10993-2:1993 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
AAMI/ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Canadian Standards Association (CSA)

CAN/CSA-ISO 10993-1-01:2001 Biological evaluation of medical devices - Part 1: Evaluation and Testing
CAN/CSA-ISO 10993.2-1997(R2006) Biological evaluation of medical devices - Part 2: Animal welfare requirements
CAN/CSA-ISO 10993.2-1997(C2006) Biological evaluation of medical devices - Part 2: Animal protection requirements
CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements
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

VN-TCVN

TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity

TH-TISI

TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing
TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity

Korean Agency for Technology and Standards (KATS)

KS P ISO TS 20993-2020 Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2021 Biological evaluation of medical devices － Part 2: Animal welfare requirements
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2024 Biological evaluation of medical devices — Part 2: Animal welfare requirements
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices － Part 11: Tests for systemic toxicity

Association Francaise de Normalisation

NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Irritation tests
NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing
NF S99-501-10*NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10 : tests for skin sensitization
NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: skin sensitization testing

Danish Standards Foundation

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DANSK DS/ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials

GCC Standardization Organization

GSO ISO 10993-23:2024 Biological evaluation of medical devices — Part 23: Tests for irritation
GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
BH GSO ISO 10993-11:2024 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 10993-2:2006(2010) Biological evaluation of medical devices— Part 2: Animal welfare requirements
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

Bureau of Indian Standards

IS 12572-2-1995 Biological Evaluation of Devices Medical - Part 2 : Animal Welfare Requirements
IS 17932-6-2023 Biological Evaluation of Medical Devices Part 6 Tests for skin sensitization
IS/ISO/TR 10993-22-2017 Biological Evaluation of Medical Devices Part 22 Guidance on Nanomaterials
IS 12572-1-1994 Biological Evaluation of Medical Devices - Part 1 : Guidance on Selection of Tests

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 10993-2:2017 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
BH GSO ISO/TR 10993-22:2022 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

Swedish Institute for Standards

SS-EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

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 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials