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Medicine and Regenerative Medicine

Medicine and Regenerative Medicine, Total:498 items.

In the international standard classification, Medicine and Regenerative Medicine involves: Vocabularies, Medical sciences and health care facilities in general, Microbiology, Medical equipment, Pharmaceutics, Laboratory medicine, Nuclear energy engineering, Hospital equipment, Protection against crime, Dentistry, Applications of information technology, Radiation protection, Bottles. Pots. Jars, Occupational safety. Industrial hygiene, Software development and system documentation, Clothes, HEALTH CARE TECHNOLOGY, Farming and forestry, Sterilization and disinfection, Quality, Information sciences. Publishing, Aircraft and space vehicles in general, Optical equipment, Road engineering, Standardization. General rules, Services, Sociology. Demography, Veterinary medicine, Construction industry, Test conditions and procedures in general, Packaging and distribution of goods in general, Acoustics and acoustic measurements.

British Standards Institution (BSI), Medicine and Regenerative Medicine

BS PAS 84:2012 Cell therapy and regenerative medicine. Glossary
PAS 84-2008 Regenerative medicine-- Glossary PUBLICLY AVAILABLE SPECIFICATION
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 21043-1:2018 Forensic Sciences - Terms and definitions
BS PD ISO/TS 18790-1:2015 Health informatics. Profiling framework and classification for Traditional Medicine informatics standards development. Traditional Chinese Medicine
BS PD ISO/TS 22077-5:2021 Health informatics. Medical waveform format. Neurophysiological signals
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 5213:1975 Specification for medical specimen containers for microbiology
BS EN IEC 62563-2:2021 Medical electrical equipment. Medical image display systems - Acceptance and constancy tests for medical image displays
BS DD CEN/TS 15127-1:2005 Health informatics — Testing of physiological measurement software — Part 1: General
BS DD CEN/TS 15127-1:2008 Health informatics. Testing of physiological measurement software. General
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 PD ISO/TS 16277-1:2015 Health informatics. Categorial structures of clinical findings in traditional medicine. Traditional Chinese, Japanese and Korean medicine
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 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS 70000:2017 Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence
BS ISO 10109-6:1994 Optics and optical instruments - Environmental requirements - Test requirements for medical optical devices
BS ISO 14199:2015 Health informatics. Information models. Biomedical Research Integrated Domain Group (BRIDG) Model
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
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 10993-12:2004 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
BS EN ISO 15189:2022 Medical laboratories. Requirements for quality and competence
BS ISO 8600-6:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Vocabulary
BS EN ISO 10993-13:1999 Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
BS ISO 10109-6:2005 Optics and photonics - Environmental requirements - Test requirements for medical optical devices
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
19/30378891 DC BS EN IEC 62563-2. Medical electrical equipment. Medical image display systems. Part 2. Acceptance and constancy tests for medical image displays
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
DD ENV 12539:1998 Medical informatics. Request and report messages for diagnostic service departments
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
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
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
BS DD CEN/TS 14822-4:2008 Health informatics. General purpose information components. Message headers
BS EN ISO 7405:2008+A1:2013 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
BS DD CEN/TS 14822-4:2005 Health informatics — General purpose information components — Part 4: Message headers
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 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS DD 264:2007 Packaging - Braille and other formats for medicinal products
BS EN ISO 10993-14:2009 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
23/30461124 DC BS ISO 14199. Health informatics. Information models. Biomedical Research Integrated Domain Group (BRIDG) Model
BS EN ISO 10993-7:2008 Biological evaluation of medical devices - Ethylene oxide sterilization residuals
BS ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Determination of optical resolution of rigid endoscopes with optics
BS ISO 8600-5:2020 Optics and photonics. Medical endoscopes and endotherapy devices. Determination of optical resolution of rigid endoscopes with optics
PD ISO/TS 18790-1:2015 Health informatics. Profiling framework and classification for Traditional Medicine informatics standards development. Traditional Chinese Medicine

German Institute for Standardization, Medicine and Regenerative Medicine

DIN 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58956-2:1986-01 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-3:1986-12 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
DIN 58959-3:2014 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-3:2014-08 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-2:2021 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58959-2:2021-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58956-5:1990 Medical microbiology; medical-microbiological laboratories; hygiene scheme requirements
DIN 58956-2:1986 Medical microbiology; medical microbiological laboratories; requirements for equipment
DIN 58956-10:1986 Medical microbiology; medical-microbiological laboratories; safety marking
DIN 58959-17:2011-03 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria; Text in German and English
DIN 58959-17:2011 Medical microbiology - Quality management in medical microbiology - Part 17: Requirements for the use of control strains for the examination of mycobacteria; Text in German and English
DIN 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
DIN 58959-6 Beiblatt 1:2019-06 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media; Text in German and Eng...
DIN 58959-6:2019-06 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing
DIN 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
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 58959 Bb.1:1997 Quality management in medical microbiology - Overview and index
DIN 58943-5:2011-03 Medical microbiology - Diagnosis of tuberculosis - Part 5: Molecularbiological identification and differentiation of tubercle bacilli; Text in German and English
DIN 58942-6:2008 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58942-6:2008-01 Medical microbiology - Culture media - Part 6: Solid chromogenic culture media; Text in German and English
DIN 58981-1:1984 Medical microbiology; dyes; Azure B thiazine dye
DIN 58959-6 Beiblatt 1:2019 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 1: Recommended test organisms for frequently used culture media; Text in German and Englis
DIN 58942-3:2003-05 Medical microbiology - Culture media - Part 3: Dip slides for microbiological urine analysis
DIN 58959-6 Beiblatt 2:2022 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological ma
DIN 58959-6 Beiblatt 2:2021 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological ma
DIN 58959-6 Beiblatt 2:2022-07 Medical microbiology - Quality management in medical microbiology - Part 6: Requirements relating to test organisms and their use in performance testing; Supplement 2: Recommended test organisms for frequently used testing reagents, dyes and biological...
DIN 58942-2:2004-01 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58969-10:2003 Medical microbiology - Diagnostics of infectious diseases in serological and molecular biology - Part 10: Complement fixation test (CFT)
DIN EN ISO 15189:2023-03 Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022
DIN EN ISO 21043-1:2019-01 Forensic sciences - Part 1: Terms and definitions (ISO 21043-1:2018); German version EN ISO 21043-1:2018
DIN 58959-4:1997 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes
DIN 58942-4:2003-05 Medical microbiology - Culture media - Part 4: Transport systems for specimens containing bacteria
DIN 58959-4:1997-06 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes / Note: To be replaced by DIN 58959-6 Beiblatt 2 (2021-08, t).
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 58942-2:2004 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58943-3:2011-03 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods; Text in German and English
DIN 58943-9:2007-11 Medical microbiology - Diagnostics of tuberculosis - Part 9: Phenotypic differentiation of tubercle bacilli; text in German and English
DIN 58959-20:1997-06 Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
DIN 58942-5:2005-04 Medical microbiology - Culture media - Part 5: Requirements and selection of culture media for the diagnostic of stool specimen
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 EN 455-3:2022-03 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German and English version prEN 455-3:2022 / Note: Date of issue 2022-02-04*Intended as replacement for DIN EN 455-3 (2015-07).
DIN 58943-32:2015-05 Medical microbiology - Diagnosis of tuberculosis - Part 32: Detection of mycobacteria by microscopic methods; Text in German and English
DIN 58940-1:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
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 58943 Bb.1:2003 Medical microbiology - Diagnosis of tuberculosis - Guidance for the specialized use of methods of detection
DIN 58981-3:1985 Medical microbiology; dyes; thionin thiazine dye
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 ISO 10109-6:2007 Optics and photonics - Environmental requirements - Part 6: Test requirements for medical optical instruments (ISO 10109-6:2005) English version of DIN ISO 10109-6:2007-02
DIN 58958-1:2008 Medical microbiology - Microbiological urine analysis - Part 1: Rapidly growing bacteria and yeasts which can be cultured aerobically; Text in German and English
DIN 58940-3:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 3: Agar diffusion test; Text in German and English
DIN 58959-3:1997 Quality management in medical microbiology - Part 3: Requirements for request and report forms

Association Francaise de Normalisation, Medicine and Regenerative Medicine

NF EN ISO 22367:2020 Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale
NF EN ISO 20888:2020 Médecine bucco-dentaire - Vocabulaire et code de désignation des données bucco-dentaires médico-légales
XP ISO/TS 17518:2015 Laboratoire de biologie médicale - Réactifs pour la coloration de matériel biologique - Directives pour les utilisateurs
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 22570:2020 Médecine bucco-dentaire - Cuillères et curettes à os
NF EN IEC 62563-2:2021 Appareils électromédicaux - Systèmes d'imagerie médicale - Partie 2 : essais d'acceptation et de constance des systèmes d'imagerie médicale
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 S99-501-18:2009 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
XP ISO/TS 20914:2020 Laboratoires de biologie médicale - Recommandations pratiques pour l'estimation de l'incertitude de mesure
NF C74-236-2*NF EN IEC 62563-2:2021 Medical electrical equipment - Medical image display systems - Part 2 : acceptance and constancy tests for medical image displays
NF EN ISO 21533:2018 Médecine bucco-dentaire - Seringues à cartouche pour injections intraligamentaires, pouvant être retraitées
NF EN ISO 20608:2018 Médecine bucco-dentaire - Poudres et pièces à main de pulvérisation
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
NF X50-905-1*NF EN ISO 21043-1:2018 Forensic Sciences - Part 1 : terms et definitions
NF EN ISO 15189:2022 Laboratoires médicaux - Exigences concernant la qualité et la compétence
NF S91-888*NF EN ISO 20888:2020 Dentistry - Vocabulary and designation system for forensic oro-dental data
NF S99-510:1996 Biological evaluation of medical devices. Part 10 : tests for irritation and sensitization.
XP S92-042*XP ISO/TS 17518:2015 Medical Laboratories - Reagents for staining biological material - Guidance for users
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
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
XP ISO/TS 10993-19:2022 Évaluation biologique des dispositifs médicaux - Partie 19 : caractérisations physicochimique, morphologique et topographique des matériaux
NF S92-060*NF EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence
NF ISO 20658:2023 Exigences pour le prélèvement et le transport d'échantillons à des fins d'examens en laboratoire médical
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 S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
NF EN ISO 15195:2019 Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence
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 S99-501-10*NF EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization

American Society for Testing and Materials (ASTM), Medicine and Regenerative Medicine

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 F2064-00 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F2064-00(2006)e1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
ASTM F2064-14 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F665-98 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F665-09 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM E2035-12(2017) Standard Terminology Relating to Forensic Psychophysiology
ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F1329-00 Standard Guide for Training the Emergency Medical Technician (Basic) in Basic Anatomy and Physiology (Withdrawn 2006)
ASTM F665-98(2003) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
ASTM F665-09(2015) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

Professional Standard - Medicine, Medicine and Regenerative Medicine

YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1815-2022
YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 0723-2009 Medical electrical equipment—Digital imaging and communications in medicine(DICOM)—Radiotherapy objects
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry.Part 11:Pulp capping test
YY/T 0616-2007 Medical gloves for single use.Requirements and testing for biological evaluation

未注明发布机构, Medicine and Regenerative Medicine

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 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
JIS T 1553:2023 Optics and optical instruments -- Medical endoscopes and endotherapy devices
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity

Shanghai Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

DB31/T 60.3-1991 Format and printing quality of medical and health medical examination report
DB31/T 60.1-1991 Basic Requirements for Medical Inspection Report Form
DB31/T 60.2-1991 Naming rules and classification of inspection items in medical and health medical inspection reports
DB31/T 899-2015 Code of Ethics Review for Biomedical Research Involving Humans

NEMA - National Electrical Manufacturers Association, Medicine and Regenerative Medicine

NEMA MITA RMD P1-2019 Considerations for Remanufacturing of Medical Imaging Devices
NEMA PS 3 SET-2003 Digital Imaging and Communications in Medicine (DICOM)

RU-GOST R, Medicine and Regenerative Medicine

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 ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
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 31228-2014 Adults knitted underwear. Norms of physic hygienic indices
GOST R 57343-2016 Forensic molecular genetic analysis. Terms and definitions
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R 51758-2001 Nutrient media for veterinary purposes. Methods of biological testing
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-11-2011 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 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 14199-2016 Health informatics. Information models. Biomedical Research Integrated Do-main Group (BRIDG) Model
GOST R 56140-2014 Medicine biological remedies for veterinary use. Polymerase chain reaction for the Mycoplasma DNA detection
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R 57344-2016 Forensic psychology examination. Terms and definitions
GOST 24827-1981 Radiators optical medical. Terms and definitions
GOST 31576-2012 Evaluation of biological hazard of medical dental materials and articles. Classification and sampling
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 R ISO 18472-2009 Sterilization of health care products. Biological and chemical indicators. Test equipment
GOST R 59722-2021 Medical laboratories. Reagents for staining biological material. Guidance for users
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
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 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 10993-7-2011 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 10993-14-2001 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
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 ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
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 56702-2015 Medicines for medical applications. Nonclinical toxicology and pharmacokinetic studies of safety
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 ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST 31214-2003 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
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 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 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

U.S. Military Regulations and Norms, Medicine and Regenerative Medicine

ARMY MIL-DTL-3628/110 VALID NOTICE 3-2013 Badge, Occupational, Biomedical Sciences Officer, Air Force
ARMY MIL-DTL-11589/87 F-2010 RIBBON, COMBAT AND EXPERT MEDICAL, U.S. ARMY

International Organization for Standardization (ISO), Medicine and Regenerative Medicine

IWA 35-2020 Quality of learning environments for students in healthcare professions - Requirements for healthcare education providers in care settings
ISO/TS 22077-5:2021 Health informatics — Medical waveform format — Part 5: Neurophysiological signals
ISO/TS 18790-1:2015 Health informatics - Profiling framework and classification for Traditional Medicine informatics standards development - Part 1: Traditional Chinese Medicine
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO/TS 16277-1:2015 Health informatics - Categorial structures of clinical findings in traditional medicine - Part 1: Traditional Chinese, Japanese and Korean medicine
ISO 14199:2015 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model
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/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 15189:2012 Medical laboratories - Requirements for quality and competence
ISO/DIS 14199 Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
ISO 10993-10:1995 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
ISO 21998:2020 Interpreting services - Healthcare interpreting - Requirements and recommendations
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO/TS 10993-19:2020 Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
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 10109-6:2005 Optics and photonics - Environmental requirements - Part 6: Test requirements for medical optical instruments
ISO/TR 24291:2021 Health informatics - Applications of machine learning technologies in imaging and other medical applications
ISO 10109-6:1994 Optics and optical instruments - Environmental requirements - Part 6: Test requirements for medical optical devices
ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medicine and Regenerative Medicine

GB/T 17857-1999 Medical radiology--Terminology(Equipment for radiotherapy,nuclear medicine and radiation dosimetry)
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB 16360-1996 Radiological protection standard for clinical nuclear medicine
GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.19-2022 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 16175-2008 Biological evaluation test methods for medical organic silicon materials
GB/T 16175-1996 Organic silicon material for medical use--Biological evaluation test methods
GB/T 42186-2022 Operational specification for cold chain logistics of medical laboratory biological samples
GB 16361-1996 Radiological protection standards for the patient in clinical nuclear medicine
GB/T 14726-2009 Medical and functional classification for disabled atheletes
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB 29923-2013 Good Manufacturing Practices for Food Enterprises Formulated for Special Medical Purposes
GBZ/T 279-2017 Rules for medical emergency management of nuclear and radiation accidents
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

Taiwan Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

CNS 3820-1975 Classification of Nuclear Science and Technology (Biology and Medical Science)

Federal Aviation Administration (FAA), Medicine and Regenerative Medicine

FAA 14 CFR PART 67-2011 MEDICAL STANDARDS AND CERTIFICATION

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), Medicine and Regenerative Medicine

ASHRAE REFRIGERATION SI CH 49-2010 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION
ASHRAE REF SI CH 40-2002 Biomedical Applications of Cryogenic Refrigeration(ASHRAE Handbook, Refrigeration, SI Edition
ASHRAE REF IP CH 40-2002 Biomedical Applications of Cryogenic Refrigeration(ASHRAE Handbook: Refrigeration, IP Edition

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc., Medicine and Regenerative Medicine

ASHRAE REFRIGERATION SI CH 40-2006 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION SI CH 39-1994 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 39-1994 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 40-2006 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION
ASHRAE REFRIGERATION IP CH 40-2002 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION SI CH 40-2002 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 40-1998 Biomedical Applications of Cryogenic Refrigeration
ASHRAE REFRIGERATION IP CH 49-2010 BIOMEDICAL APPLICATIONS OF CRYOGENIC REFRIGERATION
ASHRAE REFRIGERATION SI CH 40-1998 Biomedical Applications of Cryogenic Refrigeration

Korean Agency for Technology and Standards (KATS), Medicine and Regenerative Medicine

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 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
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 10993-18:2009 Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS X ISO TS 16277-1-2017(2022) Health informatics ― Categorial structures of clinical findings in traditional medicine ― Part 1: Traditional Chinese, Japanese and Korean medicine
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 10993-1:2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process
KS P ISO 15189-2013(2019) Medical laboratories ─ Requirements for quality and competence
KS P ISO TS 17518:2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process
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 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO TS 10993-19:2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-1:2007 Biological evaluation of medical devices－Part 1：Evaluation and testing
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 C IEC 61223-1-2005(2016) Evaluation and routine testing in medical imaging departments－Part 1：General aspects
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 B ISO 10109-6:2002 Optics and optical instruments-Environmental requirements-Part 6:Test requirements for medical optical devices
KS B ISO 10109-6-2002(2017) Optics and optical instruments－Environmental requirements－Part 6：Test requirements for medical optical devices
KS P ISO 10993-12:2007 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
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

Standard Association of Australia （SAA）, Medicine and Regenerative Medicine

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
AS 4700.2:2007/Amdt 1:2009
AS ISO 10993.11:2002/Amdt 1:2005
AS ISO 15189:2013
AS ISO 15189:2023 Medical laboratories — Requirements for quality and competence
ISO 20658:2023 Requirements for the collection and transport of samples for medical laboratory examinations

GOSTR, Medicine and Regenerative Medicine

GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety
GOST 18996-1980 Medical analyzers of biological liquids. Terms and definitions
GOST 34310-2017 Biological medicine remedies for veterinary use. Methods for determination of mertiolyt, phenol, formaldehyde
GOST ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST 33871-2016 Biological medicine remedies for veterinary use. Vaccines against viral diseases of animals. Method of determination of activity

Group Standards of the People's Republic of China, Medicine and Regenerative Medicine

T/ACSC 01-2022 Standard for the construction of assisted reproductive medicine centers
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/CECS 662-2020 Technical standards for construction of medical biosafety secondary laboratories
T/CHSA 009-2019 Digital Vocabulary and Terminology in Interdisciplinary Dentistry

Professional Standard - Public Safety Standards, Medicine and Regenerative Medicine

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

国家质量监督检验检疫总局, Medicine and Regenerative Medicine

SN/T 4621-2016 Coding specifications for medical media biological specimens
SN/T 4710-2016 Technical specifications for species identification of medical vector organisms

Professional Standard - Commodity Inspection, Medicine and Regenerative Medicine

SN/T 4166-2015 Protocol on proficiency testing for morphological identification of vectors
SN/T 1415-2004 Control standards for medical vector organisms at frontier ports
SN/T 1596-2005 Codes of surveillance for medical vectors in entry-exit vehicles
SN/T 1597-2005 Control standards for medical vectors in entry-exit vehicles
SN/T 1432-2004 Monitoring codes for medical vector organisms in entry-exit trains
SN/T 1434-2004 Control standards for medical vector organisms in entry-exit trains
SN/T 1423-2004 Control standard for medical vector organisms in entry-exit ships
SN/T 1560-2005 Codes of surveillance for the medical vectors organisms at entry-exit vessels
SN/T 2788-2011 Requirements for Preservation and Delivery of Medical Media Biological Samples
SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports
SN/T 1422-2004 Control standards for medical vector organisms in entry-exit airplane
SN/T 1553-2005 Codes of surveillance for vector-bonds in entry-exit aircrafts
SN/T 1422-2015 Control Standards for Medical Vectors of Aircraft Entry and Exit
SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 1876-2007 Rules of collecting,making and preserving for specimen of medical vectors
SN/T 1630-2005 Rules of risk analysis for imported medical vectors at frontier ports
SN/T 3302-2012 Code for architectural design of medical vector laboratories at frontier ports
SN/T 2750-2010 Collection of medical vector on entry-exit vehicle
SN/T 2776-2011 Management requirements for medical vector biological testing laboratories at frontier ports

AENOR, Medicine and Regenerative Medicine

UNE-ENV 12924:1998 MEDICAL INFORMATICS. SECURITY CATEGORISATION AND PROTECTION FOR HEALTHCARE INFORMATION SYSTEMS.
UNE-EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
UNE 111912:1990 PROTHECTICS AND ORTHOTICS. MEDICAL ASPECTS. DECRIPTION OF LIMB DEFICIENCIES PRESENT AT BIRTH

North Atlantic Treaty Organization Standards Agency, Medicine and Regenerative Medicine

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS
STANAG 3318-2004 AEROMEDICAL ASPECTS OF AIRCRAFT ACCIDENT AND/OR AEROMEDICAL INCIDENT INVESTIGATION
STANAG 2409-2002 NATO GLOSSARY OF MEDICAL TERMS AND DEFINITIONS - AMedP-13
STANAG 2873-2007 CONCEPT OF OPERATIONS OF MEDICAL SUPPORT IN CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR ENVIRONMENTS - AMedP-7(D)

Professional Standard - Hygiene , Medicine and Regenerative Medicine

WS 233-2002 General biosafety standard for microbiological and biomedical laboratories
WS/T 467-2014 Procedures for medical response during a nuclear or radiological accident
WS 363.10-2011 Health data element dictionary. Part 10: Diagnosis
WS 363.11-2011 Health data element dictionary. Part 11: Medical assessment
WS 457-2014 Basic requirements of radiological protection for using unsealed radioactive material in medical and biological laboratory
WS 376.1-2013 Basic dataset of children's health.Part 1:Birth certificate
WS 364.10-2011 Classification and coding for value domain of health data element. Part 10: Diagnosis
WS 364.11-2011 Classification and coding for value domain of health data element. Part 11: Medical assessment
WS/T 363.10-2023 Health Information Data Metacatalog Part 10: Medical Diagnosis
WS/T 363.11-2023 Health Information Data Metacatalog Part 11: Medical Assessment

CU-NC, Medicine and Regenerative Medicine

NC 20-30-2-1988 Medical Sciences. School Hygiene. Physical Examination to Students. Determination of Audity Acuity. Testing Method
NC 55-07-1986 Veterinary Services. Desinfection Chemical Control and Supervision

Occupational Health Standard of the People's Republic of China, Medicine and Regenerative Medicine

GBZ 120-2006 Radiological protection standards for clinical nuclear medicine
GBZ/T(卫生) 279-2017 Guidelines of medical emergency management for nuclear and radiation accidents

SE-SIS, Medicine and Regenerative Medicine

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

GB-REG, Medicine and Regenerative Medicine

REG 47 CFR PART 18-2011 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

US-FCR, Medicine and Regenerative Medicine

FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR DOD 6055.5-M-2007 OCCUPATIONAL MEDICAL EXAMINATIONS and SURVEILLANCE MANUAL

National Aeronautics and Space Administration (NASA), Medicine and Regenerative Medicine

NASA NPD 8900.3 REV H-2011 ASTRONAUT MEDICAL AND DENTAL OBSERVATION STUDY AND CARE PROGRAM
NASA NPD 1810.2 REV B-2004 NASA OCCUPATIONAL MEDICINE PROGRAM (REVALIDATED 3/29/04)

VN-TCVN, Medicine and Regenerative Medicine

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 7391-12-2007 Biological evaluation of medical devices.Part 12: Sample preparation and reference materials
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity

TH-TISI, Medicine and Regenerative Medicine

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
TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices

中华人民共和国国家卫生和计划生育委员会, Medicine and Regenerative Medicine

GBZ 120-2002 Clinical Nuclear Medicine Hygienic Protection Standards (Abolished)

Yunnan Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

DB53/T 1167.2-2023 Medical donor pigs for xenotransplantation Part 2: Microbiological and parasitological grading and monitoring

PT-IPQ, Medicine and Regenerative Medicine

NP EN ISO 10993-13:2000 Biological evaluation of medical devices Part 13:Identification and quantification of degradation products from polymeric medical devices(ISO 10993-13-1998)

Canadian General Standards Board （CGSB), Medicine and Regenerative Medicine

CAN/CGSB-191.1-2013 Research ethics oversight of biomedical clinical trials

Professional Standard - Judicatory, Medicine and Regenerative Medicine

国家市场监督管理总局、中国国家标准化管理委员会, Medicine and Regenerative Medicine

GB/T 22576.7-2021 Medical laboratories—Requirements for quality and competence—Part 7：Requirements in the field of transfusion medicine
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6: Requirements in the field of clinical microbiological examination

Japanese Industrial Standards Committee (JISC), Medicine and Regenerative Medicine

JIS T 1553:2005 Optics and optical instruments -- Medical endoscopes and endotherapy devices
JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing

NATO - North Atlantic Treaty Organization, Medicine and Regenerative Medicine

AMEDP-7(D)-2007 CONCEPT OF OPERATIONSOF MEDICAL SUPPORT INCHEMICAL BIOLOGICAL RADIOLOGICAL AND NUCLEAR ENVIRONMENTS
AMEDP-13-2000 NATO GLOSSARY OF MEDICAL TERMS AND DEFINITIONS
AMEDP-13(A)-2011 NATO GLOSSARY OF MEDICAL TERMS AND DEFINITIONS
AJMEDP-7-2015 ALLIED JOINT MEDICAL DOCTRINE FOR SUPPORT TO CHEMICAL@ BIOLOGICAL@ RADIOLOGICAL@ AND NUCLEAR (CBRN) DEFENSIVE OPERATIONS (ED A@ Ver. 1)
STANAG 3318-2002 Aeromedical Aspects of Aircraft Accident and/or Aeromedical Incident Investigation (ED 5 AMD 1 Amendment 1@ 01/09/2003; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so
AMEDP-7.3-2016 TRAINING OF MEDICAL PERSONNEL FOR CHEMICAL@ BIOLOGICAL@ RADIOLOGICAL@ AND NUCLEAR (CBRN) DEFENCE (ED A@ Ver. 1)
AMEDP-6(C) VOL II-2005 NATO HANDBOOK ON THE MEDICAL ASPECTS OF NBC DEFENSIVE OPERATIONS (BIOLOGICAL) - VOLUME II (To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Phone: +32 (0)2 – 707 5556@
AMEDP-6(B) PART II-1996 NATO Handbook on the Medical Aspects of NBC Defensive Operations Part II - Biological (To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Phone: +32 (0)2 – 707 5556@ ema

IT-UNI, Medicine and Regenerative Medicine

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

European Committee for Standardization (CEN), Medicine and Regenerative Medicine

FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
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 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 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 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-1:2003
DD ENV 12538-1997 Medical Informatics - Messages for Patient Referral and Discharge
DD ENV 1828-1995 Medical Informatics - Structure for Classification and Coding of Surgical Procedures
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)
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 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
EN ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence ISO 15189: 2003
EN ISO 15189:2022 Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
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)

KR-KS, Medicine and Regenerative Medicine

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 10993-1-2020 Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process
KS P ISO TS 17518-2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
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 TS 10993-19-2021 Biological evaluation of medical devices —Part 19: Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-23-2022 Biological evaluation of medical devices — Part 23: Tests for irritation
KS X ISO TR 24291-2023 Health informatics Applications of machine learning technologies in imaging and other medical applications
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 10993-10-2018 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

ES-UNE, Medicine and Regenerative Medicine

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 21043-1:2019 Forensic Sciences - Part 1: Terms and definitions (ISO 21043-1:2018)
UNE-EN ISO 15189:2023 Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

CEN - European Committee for Standardization, Medicine and Regenerative Medicine

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
DD ENV 12924-1997 Medical Informatics - Security Categorisation and Protection for Healthcare Information Systems
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
EN ISO 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
EN ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence

Danish Standards Foundation, Medicine and Regenerative Medicine

DS/ISO/TS 22077-5:2021 Health informatics – Medical waveform format – Part 5: Neurophysiological signals
DS/EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence
DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DS/ISO 10993-12:2021 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
DS/ISO/TR 10993-22:2021 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials
DS/ISO/TR 24291:2021 Health informatics – Applications of machine learning technologies in imaging and other medical applications
DS/EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

CN-STDBOOK, Medicine and Regenerative Medicine

图书 3-9474 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 2) (Second Edition)
图书 3-9473 Compilation of Common Standards for Microbiology and Biomedical Laboratories (Part 1) (Second Edition)

ES-AENOR, Medicine and Regenerative Medicine

UNE 20-666-1990

Military Standards (MIL-STD), Medicine and Regenerative Medicine

DOD PPP-C-186 C VALID NOTICE 1-1988 CONTAINERS, PACKAGING AND PACKING FOR DRUGS, CHEMICALS, AND PHARMACEUTICALS
DOD PPP-C-186 C-1976 CONTAINERS, PACKAGING AND PACKING FOR DRUGS, CHEMICALS, AND PHARMACEUTICALS

Guangdong Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

DB4403/T 86-2020 Code of Ethics Review for Biomedical Research Involving Humans

Hunan Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

DB43/T 2561-2023 Code of Ethics Review for Biomedical Research Involving Humans

Liaoning Provincial Standard of the People's Republic of China, Medicine and Regenerative Medicine

DB21/T 3838-2023 Hygienic Management Standards for Centralized Isolation Medical Observation Sites

International Telecommunication Union (ITU), Medicine and Regenerative Medicine

ITU-R SM.1056-1-2007 Limitation of Radiation from Industrial Scientific and Medical (ISM) Equipment
ITU-R SM.1056-1 FRENCH-2007 Limitation of radiation from industrial, scientific and medical (ISM) equipment
ITU-R REPORT SM.2180-2010 Impact of industrial, scientific and medical (ISM) equipment on radiocommunication services

国家食品药品监督管理局, Medicine and Regenerative Medicine

YY/T 1512-2017 Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices
YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test

PH-BPS, Medicine and Regenerative Medicine

PNS ISO 21043-1:2021 Forensic sciences - Part 1: Terms and definitions
PNS ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

CZ-CSN, Medicine and Regenerative Medicine

CSN 84 0010-1982 Modical optical radialors. Terminology and clo?initions

Indonesia Standards, Medicine and Regenerative Medicine

SNI ISO 15189:2012 Medical laboratories - Requirements for quality and competence

National Electrical Manufacturers Association（NEMA), Medicine and Regenerative Medicine

NEMA MITA CSP 2-2021 Lifecycle Best Practices Framework for Medical Imaging Devices

AT-ON, Medicine and Regenerative Medicine

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)
ONORM EN 829-1996 In vitro diagnostic systems-Transport packages for medical and biological specimens-Requirements,test

CH-SNV, Medicine and Regenerative Medicine

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)

PL-PKN, Medicine and Regenerative Medicine

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)

未注明发布机构, Medicine and Regenerative Medicine

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 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
JIS T 1553:2023 Optics and optical instruments -- Medical endoscopes and endotherapy devices
DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity

US-AAMI, Medicine and Regenerative Medicine

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

HU-MSZT, Medicine and Regenerative Medicine

MNOSZ 14674-1955

NZ-SNZ, Medicine and Regenerative Medicine

AS/NZS 4580:1999 Medical Electrical Equipment - Digital Imaging and Communications in Medicine (DICOM) - Radiotherapy Objects

ZA-SANS, Medicine and Regenerative Medicine

SANS 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing

中国国家认证认可监督管理委员会, Medicine and Regenerative Medicine

RB/T 209-2017 Implementation Guidelines for Proficiency Testing in the Field of Medical Vector Biological Testing

IX-CISPR, Medicine and Regenerative Medicine

CISPR 23-1987 Determination of limits for industrial, scientific and medical equipment

卫生健康委员会, Medicine and Regenerative Medicine

WS/T 636-2018 Guidelines for medical emergency drills for nuclear and radiation accidents

US-CFR-file, Medicine and Regenerative Medicine

CFR 46-10.302-2013 Shipping. Part10:Merchant mariner credential. Section10.302:Medical and physical requirements.
CFR 42-415.70-2014 Public Health. Part415:Services furnished by physicians in providers, supervising physicians in teaching settings, and residents in certain settings. Section415.70:Limits on compensation for physician services in providers.

Canadian Standards Association (CSA), Medicine and Regenerative Medicine

CSA ISO-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux

IN-BIS, Medicine and Regenerative Medicine

IS 6516-1972

European Committee for Electrotechnical Standardization（CENELEC）, Medicine and Regenerative Medicine

EN IEC 62127-1:2022 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields

IEC - International Electrotechnical Commission, Medicine and Regenerative Medicine

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