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for medical devices for clinical trials in vitro testing

for medical devices for clinical trials in vitro testing, Total:103 items.

In the international standard classification, for medical devices for clinical trials in vitro testing involves: Medical equipment, Laboratory medicine, Medical sciences and health care facilities in general, Dentistry, First aid, Microbiology, Sterilization and disinfection, Hospital equipment, Protective equipment.

US-AAMI, for medical devices for clinical trials in vitro testing

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

Danish Standards Foundation, for medical devices for clinical trials in vitro testing

DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DS/EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration

IT-UNI, for medical devices for clinical trials in vitro testing

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

Association Francaise de Normalisation, for medical devices for clinical trials in vitro testing

NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.
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 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
NF S92-012*NF EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases

Korean Agency for Technology and Standards (KATS), for medical devices for clinical trials in vitro testing

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 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 P ISO 17593:2009 Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
KS P ISO 10993-5:2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
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 K ISO 22610:2018 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration
KS K ISO 22610:2021 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

International Organization for Standardization (ISO), for medical devices for clinical trials in vitro testing

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 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 21474-2:2022 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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 16428:2005 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

PL-PKN, for medical devices for clinical trials in vitro testing

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

British Standards Institution (BSI), for medical devices for clinical trials in vitro testing

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
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
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
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 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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 ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
BS EN ISO 16256:2021 Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
BS EN ISO 22610:2006 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Test method to determine the resistance to wet bacterial penetration

European Committee for Standardization (CEN), for medical devices for clinical trials in vitro testing

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 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
prEN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
FprEN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)

AT-ON, for medical devices for clinical trials in vitro testing

OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
OENORM EN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)

Lithuanian Standards Office , for medical devices for clinical trials in vitro testing

LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

German Institute for Standardization, for medical devices for clinical trials in vitro testing

DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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 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 EN 13975:2003 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 ISO 19001:2013-07 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this stan...
DIN EN ISO 16256:2022-02 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021); German version EN I...
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

AENOR, for medical devices for clinical trials in vitro testing

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
UNE-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

Professional Standard - Medicine, for medical devices for clinical trials in vitro testing

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 1434-2016 Medical devices for human in vitro assisted reproductive technology.In vitro mouse embryo assay
YY/T 0993-2015 Biological evaluation of medical devices.Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
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
YY/T 0870.2-2013 Test for genotoxicity of medical devices.Part 2:In vitro mammalian chromosome aberration test
YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection
YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
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 1465.1-2016 Immunogenic evaluation method of medical devices.Part 1: T Lymphocyte transformation test in vitro
YY/T 0870.3-2013 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells

GOSTR, for medical devices for clinical trials in vitro testing

GOST R ISO 15198-2009 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user control procedures by the manufacturer

KR-KS, for medical devices for clinical trials in vitro testing

KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P ISO 10993-5-2018 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P 2201-2022 In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease — General requirements for test performance
KS K ISO 22610-2021 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration

RU-GOST R, for medical devices for clinical trials in vitro testing

GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
GOST ISO 17593-2011 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
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 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 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

国家药监局, for medical devices for clinical trials in vitro testing

YY/T 1808-2021 In vitro skin irritation test for medical devices
YY/T 0870.6-2019 Medical device genotoxicity testing Part 6: In vitro mammalian cell micronucleus 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 1649.2-2019 Medical device and platelet interaction test Part 2: Determination of in vitro platelet activation products (β-TG, PF4 and TxB2)

Indonesia Standards, for medical devices for clinical trials in vitro testing

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

未注明发布机构, for medical devices for clinical trials in vitro testing

NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.

VN-TCVN, for medical devices for clinical trials in vitro testing

TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity

TH-TISI, for medical devices for clinical trials in vitro testing

TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity

American National Standards Institute （ANSI), for medical devices for clinical trials in vitro testing

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

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, for medical devices for clinical trials in vitro testing

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

PH-BPS, for medical devices for clinical trials in vitro testing

PNS ISO 10993-5:2021 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

国家食品药品监督管理局, for medical devices for clinical trials in vitro testing

YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test
YY/T 1598-2018 Tissue Engineering Medical Device Products Bone Test Guidelines for Evaluation of Bone Repair or Regeneration of Surgical Implants for Spinal Fusion

American Society for Testing and Materials (ASTM), for medical devices for clinical trials in vitro testing

ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

ES-UNE, for medical devices for clinical trials in vitro testing

UNE-EN ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021) (Endorsed by Asociac...
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)