Medical Device Biology

Medical Device Biology, Total:135 items.

The international standard classification for "Medical Device Biology" includes: Medical equipment in general , Laboratory medicine , Medical equipment , Dental materials , Surgical instruments and materials .

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

Professional Standard - Medicine

YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute systemic toxicity: intravenous path
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry-Part 4: Bone implant test
YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute oral toxicity test
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity 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 0127.10-2009 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 0127.3-2014 Biological evaluation of medical devices used in dentistry―Part 3:Endodontic usage test

国家市场监督管理总局、中国国家标准化管理委员会

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 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

国家食品药品监督管理局

YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

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 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

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

Professional Standard - Agriculture

GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization

German Institute for Standardization

DIN EN ISO 10993-18:2009 Biological assessment of medical devices
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 10993-17:2021-12 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 10993-10:2023-04 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

SCC

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 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
BS EN ISO 10993-2:1998 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 PD ISO/TR 10993-22:2017 Biological evaluation of medical devices-Guidance on nanomaterials
BS EN ISO 10993-12:1997 Biological evaluation of medical devices-Sample preparation and reference materials
BS EN ISO 10993-12:2009 Biological evaluation of medical devices-Sample preparation and reference materials
CAN/CSA-ISO 10993-1-01:2001 Biological evaluation of medical devices - Part 1: Evaluation and Testing
BS EN ISO 10993-10:1996 Biological evaluation of medical devices-Tests for irritation and sensitization
BS EN 30993-6:1995 Biological evaluation of medical devices-Tests for local effects after implantation
AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
BS EN ISO 10993-7:1996 Biological evaluation of medical devices-Ethylene oxide sterilization residuals
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
DANSK DS/ISO 10993-2:2022 Biological evaluation of medical devices – Part 2: Animal welfare requirements
BS EN ISO 10993-6:2007 Biological evaluation of medical devices-Tests for local effects after implantation
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
CAN/CSA-ISO 10993.11-1998(C2002) Biological evaluation of medical devices - Part 11: Systemic toxicity testing
CAN/CSA-ISO 10993.11-1998(R2002) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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
DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
CAN/CSA-ISO 10993-1-98:1998 Biological evaluation of medical devices - Part 1: Guidelines for the selection of tests
DANSK DS/ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents

British Standards Institution (BSI)

BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices Ethylene oxide sterilization residuals
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity

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
ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

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(2021) 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(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
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 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: skin sensitization testing
NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing

VN-TCVN

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 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity

TH-TISI

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

Danish Standards Foundation

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements

GSO

GSO ISO 10993-23:2024 Biological evaluation of medical devices — Part 23: Tests for irritation
BH GSO ISO 10993-2:2017 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
OS GSO ISO 10993-18:2016 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO/TR 10993-22:2022 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
OS GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO 10993-18:2017 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO/TR 10993-22:2021 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
BH GSO ISO/TS 37137-1:2023 Biological evaluation of absorbable medical devices — Part 1: General requirements

Canadian Standards Association (CSA)

CSA ISO-10993.2-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 2: Animal Protection Requirements

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

Others: biology,biological biology,biological research,biology guide,molecular biology,chemical biology,frontiers of biology,Medical Device Biology,Medical Device Biology,biological evaluation,biological evaluation,Biological Evaluation of Medical Devices,Biological Evaluation of Medical Devices,Biological Evaluation of Medical Devices Part 4,Biology,Biological Evaluation of Medical Devices Part 8,Ethylene Oxide Residues in Biological Evaluation of Medical Devices