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regenerative medicine therapy

regenerative medicine therapy, Total:499 items.

In the international standard classification, regenerative medicine therapy involves: Vocabularies, Medical sciences and health care facilities in general, Medical equipment, Laboratory medicine, Sterilization and disinfection, Applications of information technology, Microbiology, Dentistry, Bottles. Pots. Jars, Information sciences. Publishing, Services, Company organization and management, Pharmaceutics, Animal feeding stuffs, Veterinary medicine, Software development and system documentation, Non-destructive testing, Water quality, Electromagnetic compatibility (EMC), Corrosion of metals, Iron and steel products, Protection against crime, HEALTH CARE TECHNOLOGY, Analytical chemistry, Wastes.

British Standards Institution (BSI), regenerative medicine therapy

BS PAS 84:2012 Cell therapy and regenerative medicine. Glossary
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
PAS 84-2008 Regenerative medicine-- Glossary PUBLICLY AVAILABLE SPECIFICATION
PD 6610:1997 Medical informatics. Methodology for the development of healthcare messages
BS 5213:1975 Specification for medical specimen containers for microbiology
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS DD CEN/TS 14463:2003 Health informatics - A syntax to represent the content of medical classification systems (CIaML)
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BS EN 16872:2016 Services of Medical Doctors with additional qualification in Homeopathy (MDQH). Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy
BS PD ISO/TS 22077-5:2021 Health informatics. Medical waveform format. Neurophysiological signals
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
PD 6610-1997 Medical informatics. Methodology for the development of healthcare messages
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS EN ISO 7405:2009 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
BS EN ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TS 22077-5:2021 Health informatics. Medical waveform format. Neurophysiological signals
BS EN 62563-1:2010+A2:2021 Medical electrical equipment. Medical image display systems - Evaluation methods
BS EN ISO 7405:2008+A1:2013 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
18/30358832 DC BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process
21/30439273 DC BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices - Part 18. Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-10:2002 Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
BS EN ISO 10993-12:2007 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-7:2008 Biological evaluation of medical devices - Ethylene oxide sterilization residuals
BS EN ISO 10993-12:2004 Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-12:2012 Biological evaluation of medical devices. Sample preparation and reference materials
19/30363066 DC BS EN IEC 63120. Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
BS EN ISO 10993-10:2023 Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-1:2009 Biological evaluation of medical devices - Evaluation and testing within a risk management process
BS EN ISO 10993-23:2021 Biological evaluation of medical devices. Evaluation and testing within a risk management process
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
DD ENV 13730-2:2002 Healthcare informatics. Blood transfusion related messages. Production related messages (BTR-PROD)
BS PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
BS EN ISO 10993-14:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
PD ISO/TR 15499:2016 Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
BS EN ISO 10993-7:2008+A1:2022 Tracked Changes. Biological evaluation of medical devices. Ethylene oxide sterilization residuals
BS EN ISO 10993-6:2016 Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-12:2021 Tracked Changes. Biological evaluation of medical devices. Sample preparation and reference materials

Professional Standard - Medicine, regenerative medicine therapy

YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1815-2022
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry.Part 11:Pulp capping test
YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin 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 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 0606.10-2008 Tissue engineered medical product.Part 10: In vivo assessment of implantable devices intended torepair or regenerate articular cartilage

未注明发布机构, regenerative medicine therapy

DIN EN ISO 10993-18:2009 Biological assessment of medical devices
BS EN ISO 10993-18:2020 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
DIN EN ISO 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
DIN EN ISO 10993-7:2022 Biological assessment of medical devices – Part 7: Ethylene oxide sterilization residues
DIN EN ISO 10993-1 Berichtigung 1:1999 Biological assessment of medical devices – Part 1: Assessment and testing (ISO 10993-1: 1997)

American Society for Testing and Materials (ASTM), regenerative medicine therapy

ASTM F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E2314-03(2008) Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E1766-95(2007) Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM E1766-95 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM E1766-95(2002) Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM F1329-00 Standard Guide for Training the Emergency Medical Technician (Basic) in Basic Anatomy and Physiology (Withdrawn 2006)

GOSTR, regenerative medicine therapy

GOST 34310-2017 Biological medicine remedies for veterinary use. Methods for determination of mertiolyt, phenol, formaldehyde
GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety
GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST 33871-2016 Biological medicine remedies for veterinary use. Vaccines against viral diseases of animals. Method of determination of activity
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements
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
GOST R EN 12322-2010 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media

RU-GOST R, regenerative medicine therapy

GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 55291-2012 Probiotic medicine remedies for veterinary use. Methods of microbiological analysis
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST 33275-2015 Biological medicine remedies for veterinary use. Vaccines fowl pox. Specifications
GOST ISO 11138-3-2012 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R ISO 10993.4-1999 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 11138-1-2012 Sterilization of health care products. Biological indicators. Part 1. Technical requirements
GOST R ISO 11138-1-2000 Sterilization of health care products. Biological indicators. Part 1. General requirements
GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 11138-2-2012 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST R ISO 11138-2-2000 Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
GOST ISO 10993-9-2011 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R ISO 10993.13-1999 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices / Note: To be replaced by GOST R ISO 10993-13 (2009).
GOST R ISO 18472-2009 Sterilization of health care products. Biological and chemical indicators. Test equipment
GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
GOST R ISO 10993.1-1999 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing / Note: To be replaced by GOST R ISO 10993-1 (2009).
GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R ISO 10993-15-2001 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST R 55765-2013 Biological medicine remedies for vteterinary use. Vaccines against a virus hemorrhagic disease of rabbits tissue inactivated. Specifications
GOST ISO 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

Korean Agency for Technology and Standards (KATS), regenerative medicine therapy

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 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-18:2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 7405:2010 Dentistry-Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 7405:2014 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
KS P ISO 10993-18:2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-1:2007 Biological evaluation of medical devices－Part 1：Evaluation and testing
KS P ISO 10993-1:2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
KS P ISO 10993-5:2007 Biological evaluation of medical devices－Part 5：Tests for in vitro cytotoxicity
KS P ISO TR 10993-22:2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS C IEC 62563-1:2019 Medical electrical equipment — Medical image display systems — Part 1: Evaluation methods
KS P ISO 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-8:2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-8:2007 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-11:2007 Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO TR 37137:2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS P ISO 10993-7:2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-19-2009(2019) Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-7:2010 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO 10993-12:2007 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
KS P ISO 10993-6:2007 Biological evaluation of medical devices－Part 6：Tests for local effects after implantation
KS P ISO 10993-10:2018 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
KS P ISO 10993-12-2014(2019) Biological evaluation of medical devices —Part 12: Sample preparation and reference materials
KS P ISO 10993-12:2014 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
KS P ISO TS 10993-19:2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, regenerative medicine therapy

GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 19973.1-2023 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products
GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
GB/T 24628-2009 Sterilization of health care products.Biological and chemical indicators.Test equipment
GB/T 18732-2002 Determination of limits for industrial,scientific and medical equipment
GB/Z 18732-2002/GISPR 23-1987 Determination of limits for industrial,scientific and medical equipment(CISPR 23:1987,IDT)
GB/Z 18732-2002 Determination of limits for industrial,scientific and medical equipment (CISPR 23:1987,IDT)
GB/Z 18732-2002/GISPR 23:1987 Determination of limits for industrial,scientific and medical equipment(CISPR 23:1987,IDT)
GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
GB/T 16886.19-2011 Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.12-2000 Biological evaluation of medical devices--Part 12: Sample preparation and reference materials
GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 22597-2014 Determination of chemical oxygen demand of reclaimed wastewater.Potassium dichromate method
GB/T 22597-2008 Recalimed wastewater-Determination of chemical oxygen demand.Postassium dichromate method

Canadian Standards Association (CSA), regenerative medicine therapy

CSA SPE 1112-2014 Medical Device Reprocessing in Community Health Care Settings
CSA ISO-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux
CSA ISO 10993.2-97-CAN/CSA:1997 Evaluation biologique des dispositifs medicaux - Partie 2: Exigences concernant la protection des an imaux La Premiere Edition; ISO 10993-2: 1992
CSA ISO 10993-13-00-CAN/CSA:2000 Biological Evaluation of Medical Devices - Part 13: Identification and Quantification of Degradation Products from Polymeric Medical Devices First Edition; ISO 10993-13: 1998

Shanghai Provincial Standard of the People's Republic of China, regenerative medicine therapy

DB31/T 60.1-1991 Basic Requirements for Medical Inspection Report Form
DB31/T 60.3-1991 Format and printing quality of medical and health medical examination report
DB31/T 60.2-1991 Naming rules and classification of inspection items in medical and health medical inspection reports

Danish Standards Foundation, regenerative medicine therapy

DS/CEN/CR 12587:1997 Medical Informatics - Methodology for the development of healthcare messages
DS/EN ISO 11737-1/AC:2009 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
DS/EN ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods
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
DS/ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
DS/EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
DS/EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN 30993-4:1994 Biological evaluation of medical devices. Part 4: Selection of tests for interactions with blood
DS/EN 30993-6:1995 Biological evaluation of medical devices - Part 6:Tests for local effects after implantation
DS/EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
DS 2451-13:2011 Infection control in the health care sector - Part 13: Requirements for reprocessing of reusable medical equipment
DS 2451-13 E:2011 Infection control in the health care sector - Part 13: Requirements for reprocessing of reusable medical equipment

German Institute for Standardization, regenerative medicine therapy

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 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
DIN EN 16872:2017-02 Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy; German version EN 16872:2016
DIN 58959 Bb.1:1997 Quality management in medical microbiology - Overview and index
DIN EN 16872:2017 Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy
DIN EN ISO 10993-18:2021-03 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020 / Note: To be amended by DIN EN ISO 10993-18/A1 (2021-10).
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 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
DIN 58959-4:1997 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes
DIN 6870-1:2009 Quality management system in medical radiology - Part 1: Radiotherapy
DIN EN ISO 10993-18:2023-11 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
DIN 58959-6:1997 Quality management in medical microbiology - Part 6: Requirements for control strains
DIN EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005
DIN EN ISO 10993-13:2010-11 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010
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-Fachbericht 73:1998 Medical informatics - Methodology for the development of healthcare messages - CEN-Report 12587
DIN 58943-8:2009 Medical microbiology - Diagnosis of tuberculosis - Part 8: Methods for the determination of susceptibility of tubercle bacilli to chemotherapeutic agents; Text in German and English
DIN 58962-2:1994 Medical microbiology - Diagnosis of infections of the lower respiratory tract (LRT) - Part 2: Microscopic examination
DIN EN 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
DIN EN ISO 10993-6:2017-09 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021
DIN 58940-1:2002 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
DIN EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
DIN EN ISO 10993-18/A1:2021-10 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021); German and English version...
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 58959-3:1997 Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-1:1997 Quality management in medical microbiology - Part 1: Requirements for the QM system
DIN EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2006
DIN EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); English version of DIN EN ISO 10993-7:2009-02
DIN EN ISO 10993-23:2021-10 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021

Standard Association of Australia （SAA）, regenerative medicine therapy

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
AS/NZS 4187:2014
AS ISO 10993.11:2002/Amdt 1:2005
AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

Association Francaise de Normalisation, regenerative medicine therapy

NF EN ISO 16954:2015 Médecine bucco-dentaire - Méthodes d'essai pour le traitement du biofilm dans les conduites d'eau de l'unit dentaire
NF EN 16872:2016 Services de santé des docteurs en médecine ayant une qualification complémentaire en homéopathie - Exigences relatives aux prestations de soins de santé fournies par les docteurs en médecine ayant une qualification complémentaire en homéopathie
NF S99-803*NF EN 16872:2016 Services of medical doctors with additional qualification in homeopathy (MDQH) - Requirements for health care provision by medical doctors with additional qualification in homeopathy
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF S97-512*NF EN 1614:2006 Health Informatics - Representation of dedicated kinds of property laboratory medicine
NF S99-501-18*NF EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process
NF EN ISO 10993-18:2020 Évaluation biologique des dispositifs médicaux - Partie 18 : caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de gestion du risque
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
NF EN ISO 10993-13:2010 Évaluation biologique des dispositifs médicaux - Partie 13 : identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
NF S98-118-1:2006 Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products.
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF EN ISO 10993-11:2018 Évaluation biologique des dispositifs médicaux - Partie 11 : essais de toxicité systémique
NF EN ISO 10993-10:2023 Évaluation biologique des dispositifs médicaux - Partie 10 : essais de sensibilisation cutanée
NF EN ISO 13120:2019 Informatique de santé - Syntaxe de représentation du contenu des systèmes de classification des soins de santé - Langage de marquage de la classification (ClaML)
NF S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
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 S99-510:1996 Biological evaluation of medical devices. Part 10 : tests for irritation and sensitization.
FD S99-501-22*FD ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22 : guidance on nanomaterials
FD ISO/TR 10993-22:2017 Évaluation biologique des dispositifs médicaux - Partie 22 : lignes directrices sur la nanomatériaux
NF C74-236-1*NF EN 62563-1:2010 Medical electrical equipment - Medical image display systems - Part 1 : evaluation methods.
FD S99-516*FD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
NF EN ISO 10993-2:2022 Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives à la protection des animaux
FD ISO/TR 37137:2014 Évaluation biologique cardiovasculaire des dispositifs médicaux - Directives pour les implants absorbables
NF EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
NF EN ISO 10993-18/A1:2023 Évaluation biologique des dispositifs médicaux - Partie 18 : caractérisation chimique des matériaux des dispositifs médicaux au sein d\'un processus de gestion du risque - Amendement 1 : détermination du coefficient d\'incertitude
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF S99-507:1996 Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.
NF EN ISO 10993-6:2017 Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
NF EN ISO 10993-7:2008 Évaluation biologique des dispositifs médicaux - Partie 7 : résidus de stérilisation à l'oxyde d'éthylène
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF EN ISO 10993-3:2014 Évaluation biologique des dispositifs médicaux - Partie 3 : essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction
NF S99-501-12:2012 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.
NF S99-501-7*NF EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals.
NF S99-501-12*NF EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
NF S99-506:1995 Biological evaluation of medical devices. Part 6 : tests for local effects after implantation.
NF S99-501-10*NF EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization
NF EN 12322/A1:2002 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
NF EN ISO 10993-17:2009 Évaluation biologique des dispositifs médicaux - Partie 17 : établissement des limites admissibles des substances relargables
AFNOR SPEC S93-250:2022 Néonatalogie - Exigences relatives aux dispositifs médicaux destinés à l'administration de l'alimentation et des médicaments par voie entérale
NF EN 12322:1999 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture.
NF EN ISO 10993-12:2021 Evaluation biologique des dispositifs médicaux - Partie 12 : préparation des échantillons et matériaux de référence
NF X30-504:2013 Déchets d'activités de soins - Bonnes pratiques de collecte des déchets d'activités de soins à risques infectieux

European Committee for Standardization (CEN), regenerative medicine therapy

EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
EN ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
PD CEN/TS 15127-1-2005_ Health informatics - Testing of physiological measurement software - Part 1: General
EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
PD CEN/TS 15127-1:2005 Health informatics - Testing of physiological measurement software - Part 1: General
EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 10993-18:2020/prA1 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 10993-1:1997 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Supersedes EN 30993-1: 1994; ISO 10993-1 : 1997
EN ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-1:2003
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
EN ISO 10993-8:2000 Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests ISO 10993-8:2000
EN ISO 11737-1:2018/A1:2021 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
EN ISO 10993-18:2020/prA1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021)
EN ISO 7405:2008/A1:2013 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
EN 15354:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
EN 12929-2:2015+A1:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

International Organization for Standardization (ISO), regenerative medicine therapy

ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-1:1995 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO/TS 21726:2019 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
ISO 10993-10:1995 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 11737-3:2004 Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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/TR 37137:2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
ISO 10993-18:2020 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-7:1995 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

AENOR, regenerative medicine therapy

UNE-ENV 12388:1997 MEDICAL INFORMATICS. ALGORITHM FOR DIGITAL SIGNATURE SERVICES IN HEALTH CARE.
UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE-EN ISO 11737-1:2007 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
UNE-EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
UNE 111912:1990 PROTHECTICS AND ORTHOTICS. MEDICAL ASPECTS. DECRIPTION OF LIMB DEFICIENCIES PRESENT AT BIRTH

ES-UNE, regenerative medicine therapy

UNE-EN 16872:2016 Services of Medical Doctors with additional qualification in Homeopathy (MDQH) - Requirements for health care provision by Medical Doctors with additional qualification in Homeopathy (Endorsed by AENOR in December of 2016.)
UNE-EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
UNE-EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
UNE-EN ISO 10993-12:2022 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
UNE-EN ISO 10993-2:2023 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

North Atlantic Treaty Organization Standards Agency, regenerative medicine therapy

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS
STANAG 2873-2007 CONCEPT OF OPERATIONS OF MEDICAL SUPPORT IN CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ENVIRONMENTS - AMedP-7(D)

国家药监局, regenerative medicine therapy

YY/T 1636-2018 In vivo magnetic resonance evaluation method for tissue engineering medical device products to regenerate knee joint cartilage
YY/T 1737-2020 Analytical methods for bioburden control levels of medical devices

IT-UNI, regenerative medicine therapy

UNI EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
UNI EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
UNI EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

KR-KS, regenerative medicine therapy

KS P ISO 10993-18-2021 Biological evaluation of medical devices —Part 18: Chemical characterization of medical device materials within a risk management process
KS P ISO 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-1-2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process
KS P ISO 10993-23-2022 Biological evaluation of medical devices — Part 23: Tests for irritation
KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO TR 10993-22-2020 Biological evaluation of medical devices —Part 22: Guidance on nanomaterials
KS P ISO 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
KS C IEC 62563-1-2019 Medical electrical equipment — Medical image display systems — Part 1: Evaluation methods
KS P ISO 10993-8-2002 Biological evaluation of medical devices－Part 8：Selection and qualification of reference materials for biological tests
KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-7-2017 Biological evaluation of medical devices－Part 7：Ethylene oxides sterilization residuals
KS P ISO TR 37137-2019 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
KS P ISO 10993-10-2018 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
KS P ISO 10993-7-2022 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

VN-TCVN, regenerative medicine therapy

TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
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
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7391-12-2007 Biological evaluation of medical devices.Part 12: Sample preparation and reference materials
TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation
TCVN 7391-7-2004 Biological evaluation of medial devices.Part 7: Etylen oxide sterilization residuals
TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

TH-TISI, regenerative medicine therapy

TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices
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
TIS 2279.3-2006 Sterilization of medical devices.microbiological methods.part 3: guidance on evaluation and interpretation of bioburden data
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements
TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation
TIS 2395.7-2008 Biological evaluation of medical devices.part 7: ethylene oxide sterilization residuals
TIS 2395.12-2008 Biological evaluation of medical devices.part 12: sample preparation and reference materials
TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

Institute of Electrical and Electronics Engineers (IEEE), regenerative medicine therapy

IEEE P1073.1.1.1/D04:2002 Draft Standard for Health Informatics Point-of-Care Medical Device Communication, Nomenclature DS5902
IEEE P1073.1.1.1/D05D:2002 Draft Standard for Health Informatics Point-of-Care Medical Device Communication, Nomenclature DS5902
IEEE P11073-10101/D1, June 2018 IEEE Draft Standard for Health Informatics—Point-of-Care Medical Device Communication—Part 10101: Nomenclature

SE-SIS, regenerative medicine therapy

SIS SEN 47 10 02-1973 Interference from R.F. equipment for industrial, scientific and medical purposes

Group Standards of the People's Republic of China, regenerative medicine therapy

T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CSBM 0029-2022 Standard guide for in vivo assessment of implantable devices intended to repair or regenerate articular cartilage
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/ZJSES 001-2023 Polyester Chemical Recycling Engineering Resin Raw Materials

CEN - European Committee for Standardization, regenerative medicine therapy

EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
EN ISO 10993-11:2006 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
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

CZ-CSN, regenerative medicine therapy

CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.

国家食品药品监督管理局, regenerative medicine therapy

YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test
YY/T 1512-2017 Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices
YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
YY/T 0127.13-2018 Biological evaluation of oral medical devices Part 13: Oral mucosal irritation test

European Committee for Electrotechnical Standardization（CENELEC）, regenerative medicine therapy

prEN IEC 63120:2021 Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

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, regenerative medicine therapy

GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

AT-ON, regenerative medicine therapy

OENORM EN ISO 10993-18:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
OENORM EN ISO 10993-18/A1:2021 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/DAM 1:2021) (Amendment)
ONORM K 2020 Teil.2-1981 Freeze-drying of substances of biological origin for medical use; methods

CH-SNV, regenerative medicine therapy

SN EN ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
SN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

PL-PKN, regenerative medicine therapy

PN-EN ISO 10993-18-2020-11 E Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
PN-EN ISO 10993-23-2021-08 E Biological evaluation of medical devices -- Part 23: Tests for irritation (ISO 10993-23:2021)

ZA-SANS, regenerative medicine therapy

SANS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing
SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

NATO - North Atlantic Treaty Organization, regenerative medicine therapy

AMEDP-7(D)-2007 CONCEPT OF OPERATIONSOF MEDICAL SUPPORT INCHEMICAL BIOLOGICAL RADIOLOGICAL AND NUCLEAR ENVIRONMENTS

Japanese Industrial Standards Committee (JISC), regenerative medicine therapy

JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing
JIS T 11737-1:2013 Sterilization of medical devices.Microbiological methods.Part 1: Determination of a population of microorganisms on products
JIS G 0580:1986 Method of electrochemical potentiokinetic reactivation ratio measurement for stainless steels
JIS T 0993-7:2012 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

国家市场监督管理总局、中国国家标准化管理委员会, regenerative medicine therapy

GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
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

National Fire Protection Association (NFPA), regenerative medicine therapy

NFPA 99 AMD 1-2020 Health Care Facilities Code (Effective Date: 12/23/2020)
NFPA 99 AMD 3-2012 Health Care Facilities Code Effective Date: 8/29/2012
NFPA 99-2015 Health Care Facilities Code (Effective Date: 9/3/2014)
NFPA 99-2021 Health Care Facilities Code (Effective Date: 8/31/2020)

US-AAMI, regenerative medicine therapy

ANSI/AAMI/ISO TIR15499:2012 Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

IN-BIS, regenerative medicine therapy

PH-BPS, regenerative medicine therapy

PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements
PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
PNS ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
PNS ISO 10993-7:2021 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

American National Standards Institute （ANSI), regenerative medicine therapy

ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

International Electrotechnical Commission (IEC), regenerative medicine therapy

IEC 62563-1:2009 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

Lithuanian Standards Office , regenerative medicine therapy

LST EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
LST EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
LST EN 12322-2000 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
LST EN ISO 11737-1:2006/AC:2009 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor 1:2007)

RO-ASRO, regenerative medicine therapy

STAS SR EN 30993-1-1996 Biological evaluation of medical devices -Part 1: Guidance on selection of tests
STAS SR EN 30993-5-1996 Biological evaluation of medical devices -Part 5: Tests for cytotoxicity: in vitro methods
STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity

Professional Standard - Public Safety Standards, regenerative medicine therapy

GA/T 151-2019 Forensic newborn autopsy norms
GA/T 1967-2021 Specifications for Forensic Visual Electrophysiological Examination

AT-OVE/ON, regenerative medicine therapy

OVE EN IEC 63120:2021 Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle (IEC 62A/1424/CDV) (english version)

IEEE - The Institute of Electrical and Electronics Engineers@ Inc., regenerative medicine therapy

IEEE P11073-10101/D9-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature
IEEE P11073-10101/D7-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature
IEEE P11073-10101/D5-2019 Standard for Health Informatics-Point-of-Care Medical Device Communication-Nomenclature

IX-EU/EC, regenerative medicine therapy

84/539/EEC-1984 Council Directive on the Approximation of the Laws of the Member States Relating to Electro-Medical Equipment Used in Human or Veterinary Medicine

PT-IPQ, regenerative medicine therapy

NP EN 1174-3-2000 Sterilization of medical devices Estimation of the population of micro-organisms on product Part 3:Guide to the methods for validation of microbiological techniques