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biomedical testing

biomedical testing, Total:498 items.

In the international standard classification, biomedical testing involves: Sterilization and disinfection, Microbiology, Laboratory medicine, Fuels, Petroleum products in general, Information sciences. Publishing, Pharmaceutics, Dentistry, Medical equipment, Quality, Medical sciences and health care facilities in general, Software development and system documentation, Applications of information technology, Water quality, Nuclear energy engineering, Hospital equipment, Bottles. Pots. Jars, Farming and forestry, Services, Packaging and distribution of goods in general, Veterinary medicine, HEALTH CARE TECHNOLOGY, Animal feeding stuffs, Road engineering, Standardization. General rules, Sociology. Demography, Analytical chemistry, Wood, sawlogs and sawn timber, Geology. Meteorology. Hydrology, Radiation protection, Products of the chemical industry, Construction industry, Ergonomics, Protection against dangerous goods, Environmental protection.

German Institute for Standardization, biomedical 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 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 58956-10:1986-01 Medical microbiology; medical-microbiological laboratories; safety marking
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 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 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 58940-3:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 3: Agar diffusion test; Text in German and English
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 58959-3:2014 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58940-1:2002-10 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 1: Terminology
DIN 58959-3:2014-08 Medical microbiology - Quality management in medical microbiology - Part 3: Requirements for request and report forms
DIN 58959-4:1997 Quality management in medical microbiology - Part 4: Requirements for investigations using light microscopes
DIN 58956-4:1986 Medical microbiology; medical-microbiological laboratories; waste disposal; safety requirements and testing
DIN 58959-2:2021 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58940-2:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 2: Active substance carriers for the agar diffusion test; Text in German and English
DIN 58959-2:2021-09 Medical microbiology - Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens
DIN 58956-3:1986 Medical microbiology; medical microbiological laboratories; requirements for the organization scheme
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 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 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 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
DIN 58969-10:2003 Medical microbiology - Diagnostics of infectious diseases in serological and molecular biology - Part 10: Complement fixation test (CFT)
DIN EN 455-3:2015-07 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German version EN 455-3:2015 / Note: To be replaced by DIN EN 455-3 (2022-03).*To be amended by DIN EN 455-3/A1 (2016-11).
DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
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 58942-3:2003-05 Medical microbiology - Culture media - Part 3: Dip slides for microbiological urine analysis
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 58943-3:2011-03 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods; Text in German and English
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 58959 Bb.1:1997 Quality management in medical microbiology - Overview and index
DIN 58981-1:1984 Medical microbiology; dyes; Azure B thiazine dye
DIN EN ISO 10993-1:2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN ISO 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
DIN 58943-32:2015-05 Medical microbiology - Diagnosis of tuberculosis - Part 32: Detection of mycobacteria by microscopic methods; 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 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 58959-10:1997 Quality management in medical microbiology - Part 10: Requirements for the use of control strains for testing reagents, dyes and biological materials
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 58940-7:2009 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 7: Determination of the minimum bactericidal concentration (MBC) with the method of microbouillondilution; Text in German and English
DIN EN 455-3:2022 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German and English version prEN 455-3:2022
DIN EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
DIN EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
DIN EN ISO 10993-23:2019 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019
DIN 58940-3 Bb.1:2000 Medical microbiology - Susceptibility testing of pathogens to antimicrobial agents - Part 3: Agar diffusion test; data for the interpretation of inhibition zone diameters
DIN EN ISO 10993-4:2017-12 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
DIN 58942-2:2004-01 Medical microbiology - Culture media - Part 2: Ready-to-use blood culture systems
DIN 58940-31:2007 Medical microbiology - Susceptibility testing of microbial pathogens to antimicrobial agents - Part 31: Supplementing methods for susceptibility testing; Text in German and English
DIN 58969-44:2005 Medical microbiology - Diagnostics of infectious diseases in serology and molecular biology - Part 44: Immunoblot (IB); Special requirements for the detection of antibodies against Borrelia burgdorferi
DIN 58959-2:1997 Quality management in medical microbiology - Part 2: Requirements for sample collection, transport and acceptance of specimens

Association Francaise de Normalisation, biomedical testing

XP ISO/TS 17518:2015 Laboratoire de biologie médicale - Réactifs pour la coloration de matériel biologique - Directives pour les utilisateurs
NF EN ISO 22367:2020 Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale
NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
NF EN ISO 10993-5:2010 Évaluation biologique des dispositifs médicaux - Partie 5 : essais concernant la cytotoxicité in vitro
NF EN ISO 10993-6:2017 Évaluation biologique des dispositifs médicaux - Partie 6 : essais concernant les effets locaux après implantation
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
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 S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
XP ISO/TS 20914:2020 Laboratoires de biologie médicale - Recommandations pratiques pour l'estimation de l'incertitude de mesure
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 S98-118-1:2006 Sterilization of medical devices - Microbiological methods - Part 1 : determination of a population of microorganisms on products.
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.
NF EN ISO 10993-4:2018 Évaluation biologique des dispositifs médicaux - Partie 4 : choix des essais pour les interactions avec le sang
NF EN 455-3:2015 Gants médicaux non réutilisables - Partie 3 : exigences et essais pour évaluation biologique
NF EN ISO 10993-1:2020 Évaluation biologique des dispositifs médicaux - Partie 1 : évaluation et essais au sein d'un processus de gestion du risque
NF S92-501:2013 Laboratoire de biologie médicale - Mesures anthroporadiométriques - Corps entier - Mesures des émissions gamma d'énergie supérieure à 100 keV
NF S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF EN ISO 15195:2019 Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage utilisant des procédures de mesure de référence
NF S91-224:2009 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
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 S99-506:1995 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 S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
NF S99-501-3*NF EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity
NF S99-503:1994 Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
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 EN 14735:2021 Caractérisation des déchets - Préparation des échantillons de déchets en vue d'essais écotoxicologiques
NF S94-071:2013 Materials for surgical implants - Determination of surface finish of coatings used for biomedical applications
NF S99-501-6:2007 Biological evaluation of medical devices - Part 6 : tests for local effects after implantation.
NF S99-501-6:2009 Biological evaluation of medical devices - Part 6 : tests for local effects after implantation.
NF S99-501-6*NF EN ISO 10993-6:2017 Biological evaluation of medical devices - Part 6 : tests for local effects after implantation
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
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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, biomedical testing

GB/T 24628-2009 Sterilization of health care products.Biological and chemical indicators.Test equipment
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 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
GB/T 42186-2022 Operational specification for cold chain logistics of medical laboratory biological samples
GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
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 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
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 17999.1-2008 SPF chicken.Microbiological surveillance.Part 1:General rules for the microbiological surveillance for SPF chicken
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 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 27851-2011 Chemicals. Terrestrial plant test. Vegetative vigour test
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods

ZA-SANS, biomedical testing

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
SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity
SANS 10993-11:2003 Biological evaluation of medical devices Part 11: Tests for systemic toxicity

未注明发布机构, biomedical testing

DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
DIN EN ISO 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
BS EN 829:1997 In vitro diagnostic systems - Transport packages for medical and biological specimens - Requirements , tests
DIN EN ISO 10993-1 Berichtigung 1:1999 Biological assessment of medical devices – Part 1: Assessment and testing (ISO 10993-1: 1997)
DIN EN 30993-6:1994 Biological assessment of medical devices DIN Part 6: Tests for local effects after implantation
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
BS EN ISO 10993-1:2020 Tracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process
YY 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test

RU-GOST R, biomedical testing

GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
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 R 51758-2001 Nutrient media for veterinary purposes. Methods of biological testing
GOST R ISO 18472-2009 Sterilization of health care products. Biological and chemical indicators. Test equipment
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/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R 59722-2021 Medical laboratories. Reagents for staining biological material. Guidance for users
GOST R 57688-2017 Medicines for medical applications. Stability testing of biotechnological/biological medications
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993.4-1999 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R 56140-2014 Medicine biological remedies for veterinary use. Polymerase chain reaction for the Mycoplasma DNA detection
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R 57647-2017 Medicines for medical applications. Pharmacogenomics. Biomarkers
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 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST 31928-2013 Probiotics medicine remedies for veterinary use. Methods for determination of the probiotics microorganisms
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
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 R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST 32477-2013 Testing of chemicals of environmental hazard. Bioaccumulation in Sediment-dwelling Benthic Oligochaetes
GOST R ISO 10993.7-1999 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 11138-3-2012 Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
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 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST 31576-2012 Evaluation of biological hazard of medical dental materials and articles. Classification and sampling
GOST 24061-2012 Medicine remedies biological lyophilized for veterinary use. Method for determination mass moisture
GOST R ISO 14199-2016 Health informatics. Information models. Biomedical Research Integrated Do-main Group (BRIDG) Model
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 31214-2003 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests

CZ-CSN, biomedical testing

CSN 65 6174-1971 Liquid fuels and technical gasoline. Test for sulphur compounds (Doctor-test)

CU-NC, biomedical testing

NC 20-30-2-1988 Medical Sciences. School Hygiene. Physical Examination to Students. Determination of Audity Acuity. Testing Method
NC 80-05-2-1987 Fish and Shellfish. Microbiological Testing Methods. Determination of the Most Probable Number of Coliform Microorganism

American Society for Testing and Materials (ASTM), biomedical testing

ASTM UOP41-74 Doctor Test for Petroleum Distillates
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 F2150-19 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
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 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 F2027-08 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
ASTM E1604-12 Standard Guide for Behavioral Testing in Aquatic Toxicology

Universal Oil Products Company (UOP), biomedical testing

UOP 41-2007 DOCTOR TEST FOR PETROLEUM DISTILLATES

European Committee for Standardization (CEN), biomedical testing

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
EN 829:1996 In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests
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
PD CEN/TS 15127-1-2005_ Health informatics - Testing of physiological measurement software - Part 1: General
PD CEN/TS 15127-1:2005 Health informatics - Testing of physiological measurement software - Part 1: General
EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 10993-11:2018 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 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
EN 30993-6:1994 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation (ISO 10993-6 : 1994)
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)
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 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)
prEN 30993-7-1993 Biological testing of medical and dental materials and devices; part 7: ethylene oxide sterilization residuals (ISO/DIS 10993-7)

CEN - European Committee for Standardization, biomedical testing

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 10993-13:2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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
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 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
EN ISO 10993-4:2002 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

Korean Agency for Technology and Standards (KATS), biomedical 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 TS 17518:2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
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 10993-8:2002 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 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS P ISO 10993-6:2018 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
KS P ISO 10993-1:2007 Biological evaluation of medical devices－Part 1：Evaluation and testing
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-5:2007 Biological evaluation of medical devices－Part 5：Tests for in vitro cytotoxicity
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-11:2007 Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-18-2009(2019) Biological evaluation of medical devices－Part 18：Chemical characterization of materials
KS P ISO 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 M 8008-2012 General rules for biochemical reagents
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 10993-19:2009 Biological evaluation of medical devices－Part 19：Physico-chemical, morphological and topographical characterization of materials
KS P ISO 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
KS P ISO 10993-3:2007 Biological evaluation of medical devices－Part 3：Tests for genotoxicity, carcinogenicity and reproductive toxicity
KS P ISO 10993-3:2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
KS P ISO 10993-18:2009 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 J 1002-1997 AMMONIUM SULFATE
KS P ISO 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS A 5552-2002 ERGONOMICS-ANTHROPOMETIC AND BIOMECHANIC MEASUREMENTS

KR-KS, biomedical 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 TS 17518-2018 Medical laboratories ─ Reagents for staining biological material ─ Guidance for users
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 10993-6-2018 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
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 10993-10-2022 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO 10993-10-2018 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ES-UNE, biomedical testing

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 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
UNE-EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

British Standards Institution (BSI), biomedical testing

BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
BS EN ISO 10993-10:2023 Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization
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
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
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-6:2016 Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
BS PD ISO/TS 22456:2021 Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
19/30372368 DC BS EN ISO 10993-23. Biological evaluation of medical devices. Part 23. Tests for irritation
BS EN ISO 10993-10:2002 Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
BS 5213:1975 Specification for medical specimen containers for microbiology
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 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 ISO 21703:2019 Surface active agents. Microbiology. Microbiological test methods for liquid hand dishwashing
22/30427685 DC BS EN 455-3. Medical gloves for single use. Part 3. Requirements and testing for biological evaluation
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
16/30343252 DC BS EN 455-3 AMD1. Medical gloves for single use. Part 3. Requirements and testing for biological evaluation
PD ISO/TR 10993-33:2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
BS EN ISO 10993-12:2004 Biological evaluation of medical devices - Sample preparation and reference materials
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS PD ISO/TR 15499:2016 Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
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 EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
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
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
PD ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
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 ISO 14199:2015 Health informatics. Information models. Biomedical Research Integrated Domain Group (BRIDG) Model
BS EN ISO 7405:2008+A1:2013 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

Canadian General Standards Board （CGSB), biomedical testing

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

Professional Standard - Commodity Inspection, biomedical testing

SN/T 1862-2007 Standard of biosafety for pathogens test in medical vector laboratory entry-exit ports
SN/T 1596-2005 Codes of surveillance for medical vectors in entry-exit vehicles
SN/T 1432-2004 Monitoring codes for medical vector organisms in entry-exit trains
SN/T 1560-2005 Codes of surveillance for the medical vectors organisms at entry-exit vessels
SN/T 1553-2005 Codes of surveillance for vector-bonds in entry-exit aircrafts
SN/T 1823-2006 Common drugs and methods of sanitary treatment for medical vectors
SN/T 4166-2015 Protocol on proficiency testing for morphological identification of vectors
SN/T 2776-2011 Management requirements for medical vector biological testing laboratories at frontier ports
SN/T 1415-2004 Control standards for medical vector organisms at frontier ports
SN/T 1597-2005 Control standards for medical vectors in entry-exit vehicles
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 2788-2011 Requirements for Preservation and Delivery of Medical Media Biological Samples
SN/T 1422-2004 Control standards for medical vector organisms in entry-exit airplane
SN/T 1422-2015 Control Standards for Medical Vectors of Aircraft Entry and Exit
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

Professional Standard - Hygiene , biomedical testing

WS 233-2002 General biosafety standard for microbiological and biomedical laboratories
WS/T 253-2005 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Description of reference materials
WS 457-2014 Basic requirements of radiological protection for using unsealed radioactive material in medical and biological laboratory

GOSTR, biomedical testing

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 33871-2016 Biological medicine remedies for veterinary use. Vaccines against viral diseases of animals. Method of determination of activity
GOST 18996-1980 Medical analyzers of biological liquids. Terms and definitions
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 ISO/TR 10993-22-2020 Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

Standard Association of Australia （SAA）, biomedical testing

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

RO-ASRO, biomedical testing

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

Professional Standard - Medicine, biomedical testing

YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
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
YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 1815-2022
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 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 0616.1-2016 Medical gloves for single use.Part 1:Requirements and testing for biological evaluation
YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Oral mucous membrane irritation test

BE-NBN, biomedical testing

NBN 52.091-1965

U.S. Military Regulations and Norms, biomedical testing

ARMY MIL-DTL-3628/110 VALID NOTICE 3-2013 Badge, Occupational, Biomedical Sciences Officer, Air Force
ARMY MIL-HDBK-1200-1992 CHEMICAL AND BIOLOGICAL (CB) AGENTS DETECTION AND MONITORING SYSTEMS

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), biomedical testing

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., biomedical testing

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

Professional Standard - Nuclear Industry, biomedical testing

EJ/T 520-1990 Bio-chemiluminescence tester

International Organization for Standardization (ISO), biomedical testing

ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO/TS 22456:2021 Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO/CD 10993-1:2011 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
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/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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 10993-13:2010 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 14199:2015 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model

国家食品药品监督管理局, biomedical testing

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
YY/T 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test

Taiwan Provincial Standard of the People's Republic of China, biomedical testing

CNS 3820-1975 Classification of Nuclear Science and Technology (Biology and Medical Science)
CNS 14393-11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
CNS 14393.11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

PT-IPQ, biomedical testing

NP EN ISO 10993-1:2001 Biological evaluation of medical devices Part 1:Evaluation and testing(ISO 10993-1:1997)
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)

国家质量监督检验检疫总局, biomedical testing

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

VN-TCVN, biomedical testing

TCVN 7391-1-2004 Biological evaluation of medical devices.Part 1: Evaluation and testing
TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity
TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
TCVN 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
TCVN 7391-10-2007 Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity
TCVN 7391-4-2005 Biological evaluation of medical devices.Part 4: Selection of test for interactions with blood

TH-TISI, biomedical testing

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 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity
TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials
TIS 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation
TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements

Danish Standards Foundation, biomedical testing

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
DS/ISO/TS 22456:2021 Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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/EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
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 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
DS/EN 455-3:2007 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

中国国家认证认可监督管理委员会, biomedical testing

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

IT-UNI, biomedical testing

UNI EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
UNI EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Japanese Industrial Standards Committee (JISC), biomedical testing

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

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

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
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood

Yunnan Provincial Standard of the People's Republic of China, biomedical testing

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

AT-ON, biomedical testing

ONORM EN 829-1996 In vitro diagnostic systems-Transport packages for medical and biological specimens-Requirements,test
ONORM N 1500-1-1996 Food microbiology - Food hygienic microbiological laboratories - Classification, areas ol risk, localities - Safety requirements and testing

PH-BPS, biomedical testing

PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements
PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
PNS ISO 10993-6:2021 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

CN-STDBOOK, biomedical testing

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)

American National Standards Institute （ANSI), biomedical testing

ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

North Atlantic Treaty Organization Standards Agency, biomedical testing

STANAG 2478-2006 MEDICAL SUPPORT PLANNING FOR NUCLEAR, BIOLOGICAL AND CHEMICAL ENVIRONMENTS

Professional Standard - Judicatory, biomedical testing

US-AAMI, biomedical testing

ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
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 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI/AAMI/ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

PL-PKN, biomedical testing

PN P04992-1989 Methods of chemical tests Knitted medical articles Determination of ammonia and ammonium salts
PN-EN ISO 10993-23-2021-08 E Biological evaluation of medical devices -- Part 23: Tests for irritation (ISO 10993-23:2021)
PN P04991-1989 Methods of chemical tests Knitted medical articles Determination of heavy metals jons
PN P04990-1989 Methods of chemical tests Knitted medical articles Determination of ultraviolet radiation absorbance

Group Standards of the People's Republic of China, biomedical testing

T/CAMDI 034-2020 Biological evaluation of medical devices Medical catheter with hydrophilic polymer coating：Sample preparation
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CECS 662-2020 Technical standards for construction of medical biosafety secondary laboratories

CH-SNV, biomedical testing

SN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

Lithuanian Standards Office , biomedical testing

LST EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
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 455-3-2007 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

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, biomedical testing

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

Canadian Standards Association (CSA), biomedical testing

CSA ISO-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux
CSA ISO-10993.4-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 4: Choix Des Essais Concernant Les Interactions Avec Le Sang

Guangdong Provincial Standard of the People's Republic of China, biomedical testing

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

Hunan Provincial Standard of the People's Republic of China, biomedical testing

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

Shanghai Provincial Standard of the People's Republic of China, biomedical testing

DB31/T 899-2015 Code of Ethics Review for Biomedical Research Involving Humans

Professional Standard - Forestry, biomedical testing

LY/T 2369-2014 Testing methods for physical and mechanical properties of desert shrub

AENOR, biomedical testing

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 51003:1978 DOCTOR TESTS IN GASOLINES, MAPHTAS AND KEROSENS
UNE-EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
UNE-EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

工业和信息化部, biomedical testing

HG/T 5271-2017 Biochemical reagent ammonium sulfate

NATO - North Atlantic Treaty Organization, biomedical testing

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

ET-QSAE, biomedical testing

ES 544-2000