Medical Device Evaluation
Medical Device Evaluation, Total:82 items.
The international standard classification for "Medical Device Evaluation" includes: Medical equipment in general , Laboratory medicine , Medical equipment , Dental materials , Surgical instruments and materials .
The Chinese standard classification for "Medical Device Evaluation" 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 16886.14-2003 Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics
- 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 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
- GB/T 16886.12-2023 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 16886.15-2003 Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys
- GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
- GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
- GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
- GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
- GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6:Tests for local effects after implantation
- GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substances
- GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation
- GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
- GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
- GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys
- GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
- GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
- GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
- GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
- GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
- GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
- GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices
- GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials
- GB/T 16886.10-2000 Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization
- GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
- GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
- GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
Professional Standard - Medicine
- YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry―Part 11:Pulp capping test
- YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity 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 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
- YY/T 0268-2008 Dentistry - Biological evaluation of medical devices used in dentistry Part1: Evaluation and test
- YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry―Part 3:Endodontic usage test
- YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute oral toxicity test
- YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
- YY/T 1930-2024 Medical Device Clinical Evaluation Terms and Definitions
- YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute systemic toxicity: intravenous path
- YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry―Part 17:Mouse lymphoma cells(TK)gene mutation 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 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
- GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
- GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
- GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
- GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
- GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
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
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 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
- GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products
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
- T/CSBM 0029-2022 Standard guide for in vivo assessment of implantable devices intended to repair or regenerate articular cartilage
Jiangsu Provincial Standard of the People's Republic of China
- DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
German Institute for Standardization
- DIN EN ISO 10993-18:2009 Biological assessment of medical devices
- DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
- DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
International Organization for Standardization (ISO)
- ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
SCC
- DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
- BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
- AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
- AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
- CAN/CSA-ISO 10993-1-01:2001 Biological evaluation of medical devices - Part 1: Evaluation and Testing
- AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- 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 10993-18:2005 Biological evaluation of medical devices-Chemical characterization of materials
- BS EN ISO 10993-18:2009 Biological evaluation of medical devices-Chemical characterization of materials
- BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
- BS EN ISO 10993-2:1998 Biological evaluation of medical devices-Animal welfare requirements
GOSTR
- GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
Association Francaise de Normalisation
- NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
Spanish Association for Standardization (UNE)
- UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
- UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
British Standards Institution (BSI)
- BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
- BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
VN-TCVN
- TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
TH-TISI
- TIS 2395.1-2008 Biological evaluation of medical devices.part 1: evaluation and testing
GSO
- GSO ISO 10993-2:2015 Biological evaluation of medical devices -- Part 2: Animal welfare requirements
Evaluation index,fuel evaluation,Aging Evaluation,test evaluation,Metallographic evaluation,sbr evaluation,Non-clinical evaluation of medical devices,,Chemical Evaluation of Medical Devices,Non-clinical evaluation of medical devices,Clinical Evaluation of Medical Devices,Biological Evaluation of Medical Devices,Biological Evaluation of Medical Devices,Medical Device Evaluation,Clinical Evaluation of Medical Devices,Medical Device Evaluation,Clinical Evaluation of Medical Devices,Double evaluation evaluation factor,Double evaluation water resource evaluation,Medical Device Biological Evaluation,Ethylene Oxide Residues in Biological Evaluation of Medical Devices
