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Medical Device Aging Test

Medical Device Aging Test, Total:498 items.

In the international standard classification, Medical Device Aging Test involves: Sterilization and disinfection, Medical equipment, Laboratory medicine, Medical sciences and health care facilities in general, Microbiology, Packaging and distribution of goods in general, First aid, Pharmaceutics, Dentistry, Information sciences. Publishing, Vocabularies, Optical equipment, Hospital equipment, Electronic display devices, Electromagnetic compatibility (EMC), Protective equipment, Mechanical structures for electronic equipment, Technical drawings, Semiconductor devices.

Professional Standard - Medicine, Medical Device Aging Test

YY/T 0681.1-2009 Test methods for sterile medical device package.Part 1:Test guide for accelerated aging
YY/T 1911-2023 Medical device coagulation test methods
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
YY/T 1292.1-2015 Test for reproductive and developmental toxicity of medical devices.Part 1:Screening test
YY/T 0870.1-2013 Test for genotoxicity of medical devices.Part 1:Bacterial reverse mutation test
YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry.Part 11:Pulp capping test
YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Bone implant test
YY/T 0618-2017 Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing
YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1465.1-2016 Immunogenic evaluation method of medical devices.Part 1: T Lymphocyte transformation test in vitro
YY/T 1292.2-2015 Test for reproductive and developmental toxicity of medical devices.Part 2: Prenatal developmental toxicity test
YY/T 1292.3-2016 Test for reproductive/developmental toxicity of medical devices.Part 3: One-generation reproductive toxicity test
YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test
YY/T 1434-2016 Medical devices for human in vitro assisted reproductive technology.In vitro mouse embryo assay
YY/T 0878.1-2013 Test for complement activation of medical devices.Part 1:Serum whole complement activation
YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices
YY/T 0127.12-2008 Dentistry.Biological evaluation of medical devices used in dentistry Part 2:Test method.Micronucleus test
YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test
YY/T 0870.4-2014 Test for genotoxicity of medical devices.Part 4:Mammalian bone marrow erythocyte micronucleus test
YY/T 0870.5-2014 Test for genotoxicity of medical devices.Part 5:Mammalian bone marrow chromosome aberration test
YY/T 0879.2-2015 Test for hypersensitivity of medical devices.Part 2:Murine Local Lymph Node Assay (LLNA):BrdU-ELISA method
YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Oral mucous membrane irritation test
YY/T 0870.2-2013 Test for genotoxicity of medical devices.Part 2:In vitro mammalian chromosome aberration test
YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 0681.11-2014 Test methods for sterile medical device package.Part 11:Determining integrity of seals for medical packaging by visual inspection
YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute oral toxicity test
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 1433-2016 Test method of hot seal strength(hot tack)of flexible webs of medical devices
YY/T 0681.8-2011 Test methods for sterile medical device package.Part 8:Coating/adhesive weight determination
YY/T 0878.2-2015 Test for complement activation of medical devices.Part 2:Serum alternative pathway complement activation
YY/T 1842.1-2022
YY/T 0681.12-2014 Test methods for sterile medical device package.Part 12:Flex durability of flexible barrier films
YY/T 0698.4-2009 Packaging materials for terminally sterilized medical devices - Part 4: Requirements and test methods for paper bags
YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute systemic toxicity:intravenous path
YY/T 0681.10-2011 Test methods for sterile medical device package.Part 10:Test for microbial barrier ranking of porous package material
YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
YY/T 0681.6-2011 Test methods of sterile medical device package.Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
YY/T 0127.18-2016 Biological evaluation of medical devices used in dentistry.Part 18:Dentine barrier cytotoxicity test
YY/T 0681.3-2010 Test methods for sterile medical device package.Part 3:Internal pressurization failure resistance of unrestrained packages
YY/T 0681.12-2022 Test methods for sterile medical device packaging-part 12: rubbing resistance of soft barrier materials
YY/T 0127.10-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)
YY/T 0681.2-2010 Test methods for sterile medical device package. Part 2 ： Seal strength of flexible battier materials
YY/T 0879.1-2013 Test for sensitization of medical devices.Part 1:Murine local lymph node assay (LLNA) : Radioisotope incorporation method
YY/T 0681.9-2011 Test methods for sterile medical device package.Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
YY/T 0681.5-2010 Test methods for sterile medical device package.Part 5 :Detecting gross leaks in medical packaging by internal pressurization (bubble test)
YY/T 0127.16-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method In Vitro mammalian chromosome aberration test
YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry.Part 17: Mouse lymphoma cells (TK) gene mutation test
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
YY/T 1427-2016 Implants for surgery.Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
YY/T 0127.15-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Subacute and subchronic toxicity test.oral route
YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry.Part 2:Test method Cytotxicity tests .Agar diffusion test and filter diffusion test
YY/T 0734.4-2016 Washer-disinfectors.Part 4:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc.
YY/T 0681.13-2014 Test methods for sterile medical device package.Part 13:Slow rate penetration resistance of flexible barrier films and laminates
YY/T 1432-2016 Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices.Part 1:Co-extrusion plastic films used for vacuum forming packaging.Requirements and test methods
YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers
YY/T 0870.3-2013 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
YY/T 0681.4-2010 Test methods for sterile medical device package.Part 4 :Detecting seal leaks in porous packages by dye penetration
YY/T 0127.11-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 2:Biological evaluation test method of dental materials----Pulp capping test

国家药监局, Medical Device Aging Test

YY/T 0681.1-2018 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests
YY/T 1808-2021 In vitro skin irritation test for medical devices
YY/T 1651.1-2019 Hemolysis Testing for Medical Devices Part 1: Material-Mediated Hemolysis Testing
YY/T 1770.1-2021 Medical device thrombosis testing Part 1: In vivo thrombosis testing in dogs
YY/T 0681.15-2019 Test methods for sterile medical device packaging - Part 15: Performance testing of transport containers and systems
YY/T 0870.6-2019 Medical device genotoxicity testing Part 6: In vitro mammalian cell micronucleus test
YY/T 0870.7-2023 Genotoxicity testing for medical devices Part 7: Alkaline comet test in mammals
YY/T 0681.16-2019 Sterile medical device packaging test methods Part 16: Packaging system climate adaptability test
YY/T 0870.2-2019 Medical device genotoxicity testing Part 2: In vitro mammalian cell chromosome aberration testing
YY/T 1649.1-2019 Medical device and platelet interaction testing Part 1: In vitro platelet counting method
YY/T 0870.3-2019 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
YY/T 0878.3-2019 Complement activation test for medical devices Part 3: Determination of complement activation products (C3a and SC5b-9)
YY/T 0734.5-2020 Washer-disinfectors Part 5: Requirements and tests for washer-disinfectors for chemical disinfection of non-invasive medical devices that are not resistant to high temperatures
YY/T 0681.18-2020 Test methods for sterile medical device packaging - Part 18: Non-destructive testing of packaging leakage using vacuum attenuation method
YY/T 0681.17-2019 Test methods for sterile medical device packaging Part 17: Microbial barrier test using aerosol filtration method for breathable packaging materials
YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials
YY/T 1670.1-2019 Neurotoxicity Evaluation of Medical Devices Part 1: Guidelines for Selection of Tests to Assess Potential Neurotoxicity
YY/T 0681.4-2021 Test methods for sterile medical device packaging Part 4: Determination of seal leakage of breathable packaging by dye solution penetration method

RO-ASRO, Medical Device Aging Test

STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS
STAS SR EN 30993-3-1996 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenity and reproductive toxicity

American Society for Testing and Materials (ASTM), Medical Device Aging Test

ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2819-10(2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
ASTM F2819-10(2015)e1 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM F3321-19 Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E2314-03(2014) Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E2314-03(2008) Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM F2382-17e1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F2382-17 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

RU-GOST R, Medical Device Aging Test

GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
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 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST R 56328-2014 Medical equipment. Mobile complexes for medical purpose. General specifications and test methods
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST 31214-2003 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
GOST 31214-2016 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
GOST R 55037-2012 Optics and optical instruments. Medical endoscopes and endotherapy devices. Particular requirements. Test methods
GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST R ISO 11737-2-2003 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST R 56330-2014 Medical equipment. Technical means of placement and transfer of patients in the prehospital. General specifications and test methods
GOST R ISO 16428-2014 Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
GOST R 56330-2016 Medical equipment. Technical means of placement and transfer of patients in the prehospital. General technical requirements and test methods
GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement

German Institute for Standardization, Medical Device Aging Test

DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN 5343:2020 Cleanliness of medical devices - Process design and test methods; Text in German and English
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 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 96298-1:2016 Medical instruments - Terms, measuring methods and tests - Part 1: Terms and definitions
DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN EN 13726-3:2003-08 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness; German version EN 13726-3:2003 / Note: To be replaced by DIN EN 13726 (2021-02).
DIN EN 13795-2:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods ; German version EN 13795-2:2004+A1:2009
DIN EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability; German version EN 13726-4:2003
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 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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 EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness; German version EN 13726-3:2003
DIN 96298-2:2016 Medical instruments - Terms, measuring methods and tests - Part 2: Measuring methods for the determination of basic measurements of surgical standard instruments
DIN 96298-2:2016-10 Medical instruments - Terms, measuring methods and tests - Part 2: Measuring methods for the determination of basic measurements of surgical standard instruments
DIN EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressings - Part 6: Odour control; German version EN 13726-6:2003
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 EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
DIN EN 14079:2003-08 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze; German version EN 14079:2003 / Note: To be replaced by DIN EN 14079 (2004-07), DIN EN 14079-1 (2006-11), DIN EN 14...
DIN EN 14563:2009-02 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2); Ge...
DIN EN 14561:2006-08 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2); German version EN 14561:2006
DIN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
DIN EN 13795:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
DIN EN ISO 15883-7:2016-10 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016); German version EN ISO 15883-7:2016
DIN EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
DIN EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
DIN EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DIN EN ISO 14160:2018 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
DIN EN 13727:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1); German version EN 13727:2012

British Standards Institution (BSI), Medical Device Aging Test

BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS EN ISO 10993-14:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS EN ISO 10993-10:2013 Biological evaluation of medical devices. Tests for irritation and skin sensitization
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
BS EN ISO 10993-4:2017 Biological evaluation of medical devices. Selection of tests for interactions with blood
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS EN ISO 10993-4:2009 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN ISO 10993-4:2002 Biological evaluation of medical devices - Selection of tests for interactions with blood
BS EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11:Tests for systemic toxicity (ISO 10993-11:2006)
BS EN ISO 10993-8:2001 Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests
BS EN 13795:2011 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
20/30377819 DC BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for skin sensitization
BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
BS EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 13727:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (Phase 2/Step 1)
BS EN ISO 10993-3:2014 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
BS EN 13624:2013 Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1)
BS EN 13624:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
BS EN 868-7:2009 Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
BS EN 868-10:2009 Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
BS ISO 27186:2013 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS ISO 27186:2020 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
BS ISO 14117:2013 Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
21/30412844 DC BS EN ISO 22441. Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
BS EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

International Organization for Standardization (ISO), Medical Device Aging Test

ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
ISO/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests
ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 18250-1:2018 Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-10:2002/Amd 1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity; Amendment 1
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-1:1992/Cor 1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests; technical corrigendum 1
ISO 10993-4:1992 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-18:2020/Amd 1:2022 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO/DIS 15883-2 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/CD 15883-7 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
ISO 16428:2005 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
ISO 10993-8:2000 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
ISO/CD 27186 Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO/TR 10993-33:2015 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
ISO 27186:2010 Space systems - Programme management - Quality assurance requirements
ISO 27186:2020 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 10993-1:2009/cor 1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Technical Corrigendum 1

Korean Agency for Technology and Standards (KATS), Medical Device Aging Test

KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
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 17593-2009(2019) Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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 10993-6:2007 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 10993-4:2006 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-10:2007 Biological evaluation of medical devices－Part 10：Tests for irritation and delayed-type hypersensitivity
KS P ISO 10993-4:2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-4:2021 Biological evaluation of medical devices —Part 4: Selection of tests for interactions with blood
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 16428-2007(2017) Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO 16428:2007 Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO TR 10993-33:2019 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
KS P ISO TR 18112-2009(2014) Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacture
KS K ISO 22610-2010(2015) Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinic staff and equipment－Test method to determine the resistance to wet bacterial penetration

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical Device Aging Test

GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
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 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization
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 16886.6-2015 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 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
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

GOSTR, Medical Device Aging Test

GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Association Francaise de Normalisation, Medical Device Aging Test

NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
NF EN ISO 10993-23:2021 Evaluation biologique des dispositifs médicaux - Partie 23 : essais d'irritation
NF S90-461:1982 MEDICAL AND SURGICAL EQUIPMENT. SURGICAL INSTRUMENTS. FORCEPS,NEEDLE-THREADERS AND NEEDLE-HOLDERS. DIMENSIONS AND TESTS.
NF S90-460:1982 Medical and surgical equipment. Surgical instruments. Haemostatic forceps. Dimensions and tests.
NF S99-501-23*NF EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23 : tests for irritation
NF S99-501:1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 1 : GUIDANCE ON SELECTION OF TESTS. (EUROPEAN STANDARD EN 30993-1).
NF S93-004*NF EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
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 S99-501-11:2009 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 S99-501-5*NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S99-501-10*NF EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10 : tests for irritation and skin sensitization
NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
NF S99-510/A1:2006 Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity.
NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
NF S97-165/IN1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
NF S99-504/A1:2006 Biological evaluation of medical devices - Part 4 : selection of tests for interaction with blood.
NF S99-504:1994 Biological evaluation of medical devices. Part 4 : selection of tests for interactions with blood.
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
NF S99-501-4*NF EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood
NF S94-402-1:1992 Examination of the corrosive efect of a decontaminant, cleaning agent or disinfectant on reusable medico-surgical instruments. Part 1 : metallic instruments.
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 C93-547-5*NF EN 61747-5:1999 Liquid crystal and solid-state display devices. Part 5 : environmental endurance and mechanical test methods.
NF T72-600:2013 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
NF S99-501-1*NF EN ISO 10993-1:2020 Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process
NF EN 14079:2004 Dispositifs médicaux non actifs - Exigences de performance et méthodes d'essais pour la gaze de coton absorbante et la gaze de coton et viscose absorbante
NF S98-051-6*NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods
NF EN 13726-3:2003 Dispositifs médicaux non-actifs - Méthodes d'essai pour les pansements primaires en contact avec la plaie - Partie 3 : résistance à la pénétration de l'eau
NF ISO 22441:2022 Stérilisation des produits de santé - Vapeur de peroxyde d'hydrogène à basse température - Exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
NF S98-051-9*NF EN 868-9:2018 Packaging for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods
NF S98-051-7*NF EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods
NF EN ISO 14160:2021 Stérilisation des produits de santé - Agents stérilisants chimiques liquides pour dispositifs médicaux non réutilisables utilisant des tissus animaux et leurs dérivés - Exigences pour la caractérisation, le développement, la validation et le c...
NF C96-013-6-16*NF EN 60191-6-16:2013 Mechanical standardization of semiconductor devices - Part 6-16 : glossary of semiconductor test and burn-in sockets for BGA, LGA, FBGA and FLGA

未注明发布机构, Medical Device Aging Test

NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
YY 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test
YY 0127.9-2009 Biological Evaluation of Oral Medical Devices Unit 2: Test Methods Cytotoxicity Test: Agar Diffusion Method and Filter Diffusion Method
DIN EN 13624:2004 Chemical disinfectants and antiseptics – Quantitative suspension test to test the fungicidal effect of chemical disinfectants for instruments in the human medical sector – Test methods and requirements (Phase 2, Level 1); German version EN 13624:2003

IN-BIS, Medical Device Aging Test

Standard Association of Australia （SAA）, Medical Device Aging Test

AS ISO 10993.11:2002/Amdt 1:2005

国家食品药品监督管理局, Medical Device Aging Test

YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test
YY/T 1500-2016 Medical device pyrogen test Monocyte activation test Human whole blood ELISA method
YY/T 1576-2017 Tissue engineering medical device product absorbable material implantation test
YY/T 1292.4-2017 Medical device reproductive and developmental toxicity testing Part 4: Two generations of reproductive toxicity testing
YY/T 1623-2018 Test method for effectiveness of sterilization processes for reusable medical devices
YY/T 0127.13-2018 Biological evaluation of oral medical devices Part 13: Oral mucosal irritation test
YY/T 1562-2017 Guidelines for Cell Activity Testing of Biomaterial Scaffolds for Tissue Engineering Medical Device Products
YY/T 0127.7-2017 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test
YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
YY/T 0681.14-2018 Test methods for sterile medical device packaging Part 14: Wet and dry microbial barrier tests on breathable packaging materials
YY/T 0972-2016 Dimensions and test requirements for four-pole connector systems for active implantable medical devices and implantable cardiac rhythm regulation devices
YY/T 0127.15-2018 Biological Evaluation of Oral Medical Devices Part 15: Subacute and Subchronic Systemic Toxicity Tests: Oral Route

VN-TCVN, Medical Device Aging Test

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 7391-6-2007 Biological evaluation of medical devices.Part 6: Tests for local effects after implantation
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
TCVN 7391-3-2005 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

TH-TISI, Medical Device Aging Test

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 2395.6-2008 Biological evaluation of medical devices.part 6: tests for local effects after implantation
TIS 2395.4-2008 Biological evaluation of medical devices.part 4: selection of tests for interactions with blood
TIS 2395.10-2008 Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity
TIS 2395.3-2008 Biological evaluation of medical devices.part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity

Danish Standards Foundation, Medical Device Aging Test

DS/ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
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 ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
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 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
DS/EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
DS/EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Comformability
DS/EN 13726-6:2003 Non-active medical devices -Test methods for primary wound dressing - Part 6: Odour control
DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DS/EN 30993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
DS/EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
DS/ISO 27186:2021 Active implantable medical devices – Four-pole connector system for implantable cardiac rhythm management devices – Dimensional and test requirements
DS/EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DS/EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
DS/EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DS/EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

European Committee for Standardization (CEN), Medical Device Aging Test

EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
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 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
CEN EN 13726-3-2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
CEN EN 13726-4-2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
CEN EN 13726-6-2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
FprEN ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/FDIS 10993-10:2021)
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
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 868-4:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
EN 13727:2003 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1)
CEN EN 13624-2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 30993-4:1993 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood (ISO 10993-4 : 1992)
EN 13624:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
EN 13624:2013 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
EN ISO 10993-5:1999 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994
EN 868-2:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 2: Sterilization Wrap - Requirements and Test Methods
EN ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003

IT-UNI, Medical Device Aging Test

UNI EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNI EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

Japanese Industrial Standards Committee (JISC), Medical Device Aging Test

JIS T 0993-1:2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing
JIS T 0993-1:2012 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

国家市场监督管理总局、中国国家标准化管理委员会, Medical Device Aging Test

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

KR-KS, Medical Device Aging Test

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 10993-4-2017 Biological evaluation of medical devices－Part 4：Selection of tests for interactions with blood
KS P ISO 10993-4-2021 Biological evaluation of medical devices —Part 4: Selection of tests for interactions with blood
KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
KS P ISO 10993-3-2018 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
KS P ISO 16428-2007(2022) Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO TR 10993-33-2019 Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

PH-BPS, Medical Device Aging Test

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 10993-6:2021 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
PNS ISO 10993-4:2021 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
PNS ISO 10993-3:2021 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

CEN - European Committee for Standardization, Medical Device Aging Test

EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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
EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity

American National Standards Institute （ANSI), Medical Device Aging Test

ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 27186:2010 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ANSI/AAMI/ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

US-AAMI, Medical Device Aging Test

ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice
ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

CH-SNV, Medical Device Aging Test

SN EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
SN EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

Lithuanian Standards Office , Medical Device Aging Test

LST EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
LST EN 13726-4-2004 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
LST EN 13726-3-2004 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
LST EN 13726-6-2004 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
LST EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
LST EN 14079-2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
LST EN 13624-2004 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
LST EN 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-7-2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-9-2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
LST EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
LST EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

PL-PKN, Medical Device Aging Test

PN-EN ISO 10993-23-2021-08 E Biological evaluation of medical devices -- Part 23: Tests for irritation (ISO 10993-23:2021)
PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)
PN Z55102-1988 Medical instruments Reusable needles with brazen nozzles Common requirements and tests

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, Medical Device Aging Test

GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization

AENOR, Medical Device Aging Test

UNE-EN ISO 9626:2017 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
UNE-EN 13726-3:2003 Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness
UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability
UNE-EN 13726-6:2003 Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control
UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
UNE-EN ISO 10993-6:2017 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
UNE-EN 14079:2004 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
UNE-EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
UNE-EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN ISO 10993-3:2015 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
UNE-EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN ISO 14160:2012 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

Professional Standard - Commodity Inspection, Medical Device Aging Test

SN/T 3062.2-2011 Pachaking materials for terminally sterilized medical devices for import.Part 2:Paper bags.Requirements and test methods

ES-UNE, Medical Device Aging Test

UNE-EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN 14561:2007 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)

Canadian Standards Association (CSA), Medical Device Aging Test

CSA ISO-10993.4-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 4: Choix Des Essais Concernant Les Interactions Avec Le Sang
CSA ISO-10993.6-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 6: Essais Concernant Les Effets Locaux Apres Implantation Premiere Edition
CSA ISO 10993.11-98-CAN/CSA:1998 Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity First Edition; ISO 10993-11: 1993
CSA ISO 10993.6-97-CAN/CSA:1997 Evaluation biologique des dispositifs medicaux - Partie 6: Essais concernant les effets locaux apres i m plantation La Preimere Edition; ISO 10993-6: 1994
CSA ISO 10993.4-97-CAN/CSA:1997 Evaluation biologique des dispositifs medicaux - Partie 4: Choix des essais concernant les interactions avec le sang La Premiere Edition; ISO 10993-4: 1992
CSA ISO 10993.10-98-CAN/CSA:1998 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization First Edition; ISO 1993-10:1995
CSA ISO-10993.3-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 3: Essais Concernant La Genotoxicite, La Cancerogenicite Et La Toxicite Sur La Reproduction Premiere Edition

AT-ON, Medical Device Aging Test

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
OENORM EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

BE-NBN, Medical Device Aging Test

NBN-EN 30993-5-1994 Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992)
NBN EN 30993-6-1995 Biological evaluation of medical devices - Part 6 : Tests for local effects after implantation (ISO 10993-6:1994)
NBN-EN 30993-1-1995 Biological evaluation of medical devices - Part 1 : Guidance on selection of tests (ISO 10993-1:1992 + Technical Corrigendum 1:1992)
NBN-EN 30993-4-1994 Biological evaluation of medical devices - Part 4 : Selection of tests for interactions with blood (ISO 10993-4:1992)

ZA-SANS, Medical Device Aging Test

SANS 10993-10:2004 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

Group Standards of the People's Republic of China, Medical Device Aging Test

T/CAMDI 009.3-2023 Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms
T/CAMDI 009.1-2020 Cleanliness of primary package for sterile medical device - Part 1：Test methods for particulate contamination - Gas elution method
T/CAMDI 009.2-2020 Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method

NL-NEN, Medical Device Aging Test

NEN-ISO 10993-3:1994 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

European Committee for Electrotechnical Standardization（CENELEC）, Medical Device Aging Test

EN 60191-6-16:2007 Mechanical standardization of semiconductor devices - Part 6-16: Glossary of semiconductor tests and burn-in sockets for BGA, LGA, FBGA and FLGA

International Electrotechnical Commission (IEC), Medical Device Aging Test

IEC 60191-6-16:2007 Mechanical standardization of semiconductor devices - Part 6-16: Glossary of semiconductor tests and burn-in sockets for BGA, LGA, FBGA and FLGA