medical diagnosis system

medical diagnosis system, Total:494 items.

The international standard classification for "medical diagnosis system" includes: Radiographic equipment , Laboratory medicine , Medical Sciences and health care facilities in general , Diagnostic equipment , Occupational safety. Industrial hygiene .

The Chinese standard classification for "medical diagnosis system" includes: Medical radiographic equipment , Medical laboratory equipment , Medical science , Medical apparatus and devices in general , Medical electronic equipment , Basic standards and general methods .

Group Standards of the People's Republic of China

T/CACM 1407-2022 Guidelines for diagnosis and treatment of colorectal cancer during chemotherapy with traditional Chinese medicine intervention
T/CIATCM 052-2019 Functional specification of teleconsultation information system in Traditional Chinese Medicine section in primary medical and health care institution
T/ZMDS 40002-2021 Guidelines for design and development for in vitro diagnostic medical devices for point-of-care testing（POCT）
T/CASMI 005-2023 Diagnostic criteria for prostate PI-RADS in social medical institutions in Chongqing
T/CACM 1235-2022 TCM Diagnosis and Treatment Guidelines for Frostbite
T/CACM 1576-2024 Guideline on the diagnosis and treatment of live cirrhosis by traditional Chinese medicine
T/CMAM M1-M9-2018 Diagnosis and Treatment Guidelines for Common Diseases of Mongolian Medicine
T/CIATCM 053-2019 Basic datasets for teleconsultation in Traditional Chinese Medicine section in primary medical and health care institution
T/CACM 1275-2019 Clinical guidelines for diagnosis and treatment of internal diseases in TCM Systemic sclerosis
T/CACM 016-2017 Diagnosis and treatment guide for litter
T/CASMI 003-2023 Diagnostic criteria for coronary artery CAD-RAD in social medical institutions in Chongqing
T/CRHA 022-2023 Sepsis diagnosis and treatment guidelines
T/CIATCM 050-2019 Functional specification of the information system for preventive treatment of diseases in Traditional Chinese Medicine section in primary medical and health care institution
T/CACM 017-2017 Guidelines for the diagnosis and treatment of TCM syndromes in different stages of hormone use
T/CASMI 004-2023 Diagnostic criteria for ovarian O-RADS in social medical institutions in Chongqing
T/SZZX 014-2023 Probes for in-vitro diagnostic medical devices
T/CI 055-2022 Systematic diagnosis and treatment system of traditional Chinese medicine for lumbar protrusion and intelligent operation of key technologies
T/EGAG 016-2022 Specification for quality evaluation of intelligent medical image aided diagnosis platform
T/CIATCM 040-2019 Functional specification of electronic medical records in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 054-2019 Guidelines on construction of information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
T/CACM 1578-2024 Guidelines for diagnosis and treatment of Esophageal cancer in TCM
T/CACM 1318.13-2019 TCM Diagnosis and Treatment Guidelines for Common Digestive System Diseases Part 13: Gastroptosis (Grassroots Doctor Edition)
T/CIATCM 093-2020 Guidelines on construction of teleconsultation system in Traditional Chinese Medicine section in primary medical and health care institution
T/CASMI 006-2023 Diagnostic Standards for Colic C-RADS in Chongqing Social Medical Institutions
T/CIATCM 092-2020 Guidelines on construction of the health information for electronic medical records in Traditional Chinese Medicine section in community setting of health services
T/SZKJKH 015-2023 Anorectal Disease Outpatient Intelligent Medical Treatment Standard
T/CIATCM 091-2020 Guidelines on construction of the health information for electronic medical records in Traditional Chinese Medicine section in community setting of health services
T/CESA 1109-2020 Technical requirements and testing and evaluation methods for intelligent medical image aided diagnosis system
T/CADERM 3012-2019 Specifications for diagnosis and treatment of rabies
T/CAME 33-2021 Medical diagnostic display device
T/CIATCM 048-2019 Functional specification of basic medical management information system in Traditional Chinese Medicine section in primary medical and health care institution
T/SAMD 0002-2023 Probes for in-vitro diagnostic medical devices
T/IMAAMM 003-2023 Criteria of diagnosis and therapeutic effect of diseases and syndromes in Mongolian Medicine
T/CASMI 002-2023 Diagnostic Standards for pulmonary nodule Lung-RADS in Chongqing Social Medical Institutions
T/CACM 1554-2023 Guidelines on the diagnosis and treatment of anal fistula by traditional Chinese medicine
T/CIATCM 055-2019 Functional specification of the information system for distance learning in Traditional Chinese Medicine section in primary medical and health care institution
T/CIATCM 044-2019 Functional specification of the information system for knowledge in Traditional Chinese Medicine section in primary medical and health care institution

国家药品监督管理局

YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

国家中医药管理局

ZY/T 001.4-1994 Criteria of Diagnosis and Therapeutic Effect of TCM Pediatrics Diseases
ZY/T 001.8-1994 Standards for diagnosis and efficacy of traditional Chinese medicine dermatology syndromes
ZY/T 001.7-1994 Criteria of Diagnosis and Therapeutic Effect of TCM Anorectal Diseases
ZY/T 001.9-1994 Criteria of Diagnosis and Therapeutic Effect of TCM Orthopedics and Traumatology Diseases
ZY/T 001.6-1994 Criteria of Diagnosis and Therapeutic Effect of TCM Otolaryngology Diseases

Professional Standard - Commodity Inspection

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment
SN/T 1672.6-2013 Rules for the inspection of import and export medical equipment - Part 6: Magnetic resonance imaging equipment for medical diagnosis

National Metrological Technical Specifications of the People's Republic of China

JJF 1746-2019 Calibration Specification for Medical Imaging Diagnosis Display Systems

Professional Standard - Medicine

YY 0008-1990 300MA medical diagnostic X-ray machine
YY/T 0482-2004 Technical requirements and test methods for magnetic resonance equipment for medical diagnosis
YY 0199-1995 30mA medical diagnostic X-ray machine
YY 0201-1995 100mA medical diagnostic X-ray machine
YY/T 0639-2008 In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY 0200-1995 50mA medical diagnostic X-ray machine
YY 0198-1995 10mA medical diagnostic X-ray machine
YY 0319-2000 Medical electrical equipment―Part 2:Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
YY 0009-1990 500MA medical diagnostic X-ray machine
YY 0007-1990 200MA medical diagnostic X-ray machine
YY 91029-1999 400 mA X-ray equipment for medical diagnosis

Henan Provincial Standard of the People's Republic of China

DB41/T 2621-2024 Prenatal diagnosis (screening) technical medical institution service specifications

国家药监局

YY/T 0639-2019 In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Hebei Provincial Standard of the People's Republic of China

DB13/T 1283.12-2020 Medical Imaging Diagnosis and Treatment Technology Part 12: Technical Specifications for Diagnosis of Common Chest Diseases
DB13/T 1283.11-2020 Medical Imaging Diagnosis and Treatment Technology Part 11 Technical Specifications for Diagnosis of Common Diseases of Bone and Joints

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 29791.5-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 5:In vitro diagnostic instruments for selftesting
GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
GB/T 30544.7-2023 Nanotechnologies—Vocabulary—Part 7: Diagnostics and therapeutics for healthcare
GB/T 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.2-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer (labelling)―Part 2:In vitro diagnostic reagents for professional use

Guangxi Provincial Standard of the People's Republic of China

DB45/T 2057-2019 Diagnosis and treatment norms of Yao medical postpartum wind
DB45/T 1345-2016 Diagnosis and Treatment Standards of Sha Disease in Zhuang Medicine
DB45/T 1327-2016 Diagnosis and treatment norms of Gu disease in Zhuang medicine

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2992-2024 Standards for multidisciplinary diagnosis and treatment of medical oncology
DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

Occupational Health Standard of the People's Republic of China

GBZ(卫生) 264-2015 Radiological protection requirements for medical X-ray diagnostic systeminstalled on vehicle
GBZ 264-2015 Radiological protection requirements for medical X-ray diagnostic system installed on vehicle

Zhejiang Provincial Standard of the People's Republic of China

DB3301/T 0407-2023 Rural Medical Circuit Diagnosis and Treatment Service Specifications

Tianjin Provincial Standard of the People's Republic of China

DB12/T 773-2018 Basic medical insurance diagnosis and treatment item code

卫生健康委员会

WS/T 810-2022 Evaluation and referral technical standard of urgent patients for primary health care facilities

石家庄市市场监督管理局

DB1301/T 377-2021 Medical waste management in animal clinics

Professional Standard - Hygiene

WS/T 398-2012 Diagnosis and treatment quality control of ischemic stroke

CZ-CSN

CSN 36 4860-1975 Ultrasonic protes for medical diagnosing
CSN 85 2115-1982 Medical measuring apparatus for functional diagnostics. Nomenclature of basic indices
CSN EN 60601-2-22-1994 Medical electrical equipment.Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment

Association Francaise de Normalisation

NF S92-031:1996 In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices.
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF C74-336:1988 Medical electrical equipment. Ultrasound equipment for diagnostic. Classification of specified diagnostic applications.
NF S92-025*NF EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF S92-040*NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
FD T16-101-7:2011 Nanotechnologies - Vocabulary - Part 7: diagnostics and therapies for healthcare
NF EN IEC 60336:2021 Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des foyers et caractéristiques connexes
NF S92-024*NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S92-040:1999 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.
NF S92-033*NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects.
NF C74-116:1996 X-ray tube assemblies for medical diagnosis. Characteristics of focal spots.
NF C74-114*NF EN 60613:2010 Electrical and loading characteristics of X -ray tube assemblies for medical diagnosis.
NF C74-122/A2:2008 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C74-116*NF EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
NF EN 60613:2010 Electrical and charging characteristics of sheaths equipped for medical diagnosis
NF C74-116*NF EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
NF EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
NF EN ISO 19001:2013 In vitro diagnostic medical devices - Information provided by the manufacturer with in vitro diagnostic staining reagents used in biology
NF C97-904:1994 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment.
NF C74-122:1996 Medical electrical equipment. Part 2 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF S92-010-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.
NF S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
NF S92-010-4*NF 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
NF S92-010-5*NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing
NF S92-010-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use.
NF S92-010-3*NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use
NF S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 2: in vitro diagnostic reagents for professional use
NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 3: in vitro diagnostic instruments for professional use
NF C97-904*NF EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
NF EN 61267:2006 X-ray medical diagnostic equipment - Radiation conditions for use in determining characteristics
NF C97-904/A1*NF EN 61157/A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 5: in vitro diagnostic instruments for self-testing
NF EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information provided by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
NF S92-010-2*NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
NF C74-228-2:2002 Protective devices against diagnostic medical X-radiation - Part 2 : protective glass plates.
NF C74-228-2*NF EN 61331-2:2015 Protective devices against diagnostic medical X-radiation - Part 2 : translucent protective plates

Spanish Association for Standardization (UNE)

UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices.
UNE-EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
UNE-EN 60336:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
UNE 20-570-1989 Characteristics of X-ray tube focus for medical diagnosis
UNE-EN 61157:1996 REQUIREMENTS FOR THE DECLARATION OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT.
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-EN 61157:2007/A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (Endorsed by AENOR in May of 2013.)
UNE-EN 60336:1996 X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS. CHARACTERISTICS OF FOCAL SPOTS.
UNE-EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in March of 2021.)
UNE-EN IEC 60336:2021/AC:2022-07 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (Endorsed by Asociación Española de Normalización in August of 2022.)
UNE-EN 12376:1999 IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
UNE-EN 61331-2:2003 Protective devices against diagnostic medical X-radiation -- Part 2: Protective glass plates.
UNE-EN 61267:1997 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT. RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS.
UNE-EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis (Endorsed by AENOR in August of 2010.)
UNE-EN 60406:2000 CASSETTES FOR MEDICAL X-RAY DIAGNOSIS. RADIOGRAPHIC CASSETTES AND MAMMOGRAPHIC CASSETTES.
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 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

Korean Agency for Technology and Standards (KATS)

KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P IEC 60601-2-33-2003 Magnetic resonance equipment for medical diagnosis
KS C 9708-1997(2017) Phantoms for magnetic resonance equipment for medical diagnosis
KS C 9707-2021 Graphical symbols and sign for magnetic resonance equipment for medical diagnosis
KS P ISO TR 18112-2020 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 manufacturer
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 C IEC 61157:2014 Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
KS C 9707-1996(2021) Graphical symbols and sign for magnetic resonance equipment for medical diagnosis
KS C IEC 61157:2004 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
KS P ISO 19001:2010 In virto diagnostic medical devices－Information supplied by the manufacturer with in vitro gnostic reagents for staining in biology
KS P ISO 18113-5-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
KS P ISO 19001:2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 18113-4-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
KS P ISO 18113-3-2020 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P SIO 18113-2-2012 In vitro diagnostic medical devices--Information supplied by the manufacturer (labelling)--Part 2：In vitro diagnostic reagents for professional use
KS P ISO 18113-2-2023 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 18113-4-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
KS C 9707-1996(2016) Graphical symbols and sign for magnetic resonance equipment for medical diagnosis
KS P ISO 18113-2:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS P ISO 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
KS C IEC 60613:2003 Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis
KS C IEC 60613:2017 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

International Organization for Standardization (ISO)

ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO/DIS 15193:2024 In vitro diagnostic medical devices — Requirements for reference measurement procedures
ISO 14229:1998 Road vehicles - Diagnostic systems - Diagnostic services specification
ISO 19001:2002 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
ISO 23961-1:2021 Traditional Chinese medicine - Vocabulary for diagnostics - Part 1: Tongue

British Standards Institution (BSI)

BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2013 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2011 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
DD ISO/TS 80004-7:2011 Nanotechnologies. Vocabulary. Diagnostics and therapeutics for healthcare
BS DD ISO/TS 80004-7:2011 Nanotechnologies. Vocabulary. Diagnostics and therapeutics for healthcare
BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
BS 7555:1992 Guide to miniaturization of medical diagnostic images on film
BS EN 13612:2002(2003) Performance evaluation of in vitro diagnostic medical devices
PD IEC/TR 62799:2013 Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
BS EN ISO 18113-4:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
BS EN ISO 18113-4:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing
BS EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
BS EN ISO 18113-5:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing
BS EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
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 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
BS EN ISO 19001:2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
BS EN ISO 18113-3:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for professional use
BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
BS EN ISO 18113-2:2024 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use
BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
BS EN IEC 60336:2021 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Focal spot dimensions and related characteristics
BS DD ENV 12539:1998 Medical informatics - Request and report messages for diagnostic service departments
DD ENV 12539-1998 Medical informatics. Request and report messages for diagnostic service departments
BS EN 60601-2-22:1996 Medical electrical equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment
BS 2606:1955 Specification for X-ray protective gloves for medical diagnostic purposes up to 150 kV peak
BS EN 60601-2-33:2010+A12:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
BS EN 61331-2:2014 Protective devices against diagnostic medical X-radiation. Translucent protective plates
BS EN 61157:2007+A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
BS EN 61157:2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
ISO/TS 23961-3:2024 Traditional Chinese medicine. Vocabulary for diagnostics - Abdomen
BS EN 60601-2-37:2008 Medical electrical equipment - Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
BS EN 61331-2:2002 Protective devices against diagnostic medical X-radiation - Protective glass plates
BS ISO 21474-2:2022 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Validation and verification
BS EN 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
18/30372517 DC BS EN 60336. Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots
24/30463717 DC BS EN ISO 15193 In vitro diagnostic medical devices - Requirements for reference measurement procedures
BS EN 12322:1999+A1:2001 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media

German Institute for Standardization

DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN 13612:2002-08 Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
DIN EN 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
DIN ISO/TS 80004-7:2012-07*DIN SPEC 52400-7:2012-07 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare (ISO/TS 80004-7:2011)
DIN EN ISO 18113-3:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 / Note: DIN EN ISO 18113-3 (2010-05) remain...
DIN EN ISO 18113-1:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021 / Note: Date of issue 2021-08-06*I...
DIN EN ISO 18113-3:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-1:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 / Note: DIN EN ISO 18113-1 (2010-05) remains valid a...
DIN EN ISO 18113-2:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-5:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN ISO 18113-4:2021-09 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); German and English version prEN ISO 18113-4:2021 / Note: Date of issue 2021-08-06...
DIN EN ISO 18113-2:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021 / Note: Date of issue 2021-0...
DIN EN ISO 18113-3:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021 / Note: Date of issue 202...
DIN EN ISO 18113-5:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 / Note: DIN EN ISO 18113-5 (2010-05) remains va...
DIN EN ISO 18113-5:2021-09 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021 / Note: Date of issue 2021-08...
DIN EN ISO 18113-1:2010 In vitro diagnostic medical devices Information provided by the manufacturer
DIN EN ISO 18113-4:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 / Note: DIN EN ISO 18113-4 (2010-05) remains valid...
DIN EN ISO 18113-2:2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 / Note: DIN EN ISO 18113-2 (2010-05) remains v...
DIN EN ISO 18113-4:2010 In vitro diagnostic medical devices — information provided by the manufacturer
DIN EN 60336:2020 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 62B/1138/CDV:2019); German and English version prEN 60336:2019
DIN 58962-2:1994 Medical microbiology - Diagnosis of infections of the lower respiratory tract (LRT) - Part 2: Microscopic examination
DIN EN 60336:1996 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
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 19001 E:2010-08 Information provided by manufacturers of in vitro diagnostic reagents for biocoloring of in vitro diagnostic medical devices (draft)
DIN EN 61267:2009 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:2005); German version EN 612167:2006
DIN EN 61157:2013-11 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007 + A1:2013); German version EN 61157:2007 + A1:2013 / Note: DIN EN 61157 (2008-07) and DIN EN 61157 Berichtigung 1 (2009-03) remain valid ...
DIN EN 60336:2020-04 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots (IEC 62B/1138/CDV:2019); German and English version prEN 60336:2019 / Note: Date of issue 2020-03-20*Intended as replacement for DIN EN 60336 (2...
DIN 6870-2:2012 Quality management system in medical radiology - Part 2: Radiological diagnosis and intervention
DIN EN ISO 23640:2012 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
DIN EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
DIN EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
DIN EN 60613:1992 Electrical and loading characteristics of X ray tube assemblies for medical diagnosis
DIN EN 61267:2009-01 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics (IEC 61267:2005); German version EN 612167:2006
DIN EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007); German version EN 61157:2007
DIN EN 61267:1997 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
DIN EN ISO 15193:2024-02 In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023 / Note: Date of issue 2024-01-05*Intended as replacement for DIN EN ISO 15193 (2009-10).
DIN EN 61331-2:2016-09 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates (IEC 61331-2:2014); German version EN 61331-2:2014
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 60613:2011-07 Electrical and loading characteristics of X ray tube assemblies for medical diagnosis (IEC 60613:2010); German version EN 60613:2010
DIN EN 60601-2-22:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995); German version EN 60601-2-22:1996
DIN 58943 Bb.1:2003 Medical microbiology - Diagnosis of tuberculosis - Guidance for the specialized use of methods of detection

KR-KS

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS C IEC 60336-2017 Medical electrical equipment — X-ray tube assemblies for medical diagnosis — Characteristics of focal spots
KS P ISO 19001-2017(2022) In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 19001-2017 In virto diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
KS P ISO 18113-2-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
KS C IEC 60613-2017 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
KS C IEC 60336-2022 Medical electrical equipment — X-ray tube assemblies for medical diagnosis — Focal spot dimensions and related characteristics

SCC

DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NS-EN 928:1995 In vitro diagnostic systems — Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
DANSK DS/EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
NS-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
NS-EN 829:1996 In vitro diagnostic systems — Transport packages for medical and biological specimens — Requirements, tests
AENOR UNE-EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices.
AENOR UNE-EN 13612/AC:1970 Performance evaluation of in vitro diagnostic medical devices.
NS-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
AENOR UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
NS-EN ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
09/30210157 DC BS EN ISO 23640. In vitro diagnostic medical devices. Stability testing of in vitro diagnostic reagents
BS EN 60601-2-33:1996 Medical electrical equipment. Particular requirements for safety-Specification for magnetic resonance equipment for medical diagnosis
DIN EN ISO 23640 E:2013 Draft Document - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
CEI 62-131:2004 Guide to the interpretation of safety indices in medical ultrasound diagnostics
DANSK DS/IEC TR 62799:2015 Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
NS-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
DANSK DS/EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
DANSK DS/ISO/TS 80004-7:2011 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare
BS PD IEC/TR 62799:2013 Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
AENOR UNE-EN 928:1996 In vitro diagnostic systems. Guidelines for the application of Standards EN 29001 and EN 46001, and Standards EN 29002 and EN 46002 to medical devices for in vitro diagnostics.
DANSK DS/EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
BS EN ISO 18113-2:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for professional use
BS EN ISO 18113-3:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for professional use
BS EN ISO 18113-4:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
NEMA XR 19-1993(R1999) Electrical, Thermal and Loading Characteristics of X-Ray Tubes Used for Medical Diagnosis
SN-CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
BS PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
CEI CEN/TR 17223:2019 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
NS-EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects
DANSK DS/CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
CEI EN 61157:2009 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DANSK DS/EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DANSK DS/EN 61157/A1:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
BS EN ISO 18113-5:2009 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
06/30146522 DC BS ISO 18113-4. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
06/30146518 DC BS ISO 18113-3. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
DANSK DS/EN IEC 60336:2021 Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal spot dimensions and related characteristics
CEI EN 61157/A1:2009 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
06/30146515 DC BS ISO 18113-2. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
06/30146526 DC BS ISO 18113-5. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
NS-EN 12376:1999 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DANSK DS/ISO/TR 18112:2006 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 manufacturer
DANSK DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
CAN/CSA-C22.2 No.60601-2-33-2004(C2009) Electromedical devices - Part 2-33: Particular safety requirements for magnetic resonance devices used for medical diagnosis
DANSK DS/EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
06/30084270 DC ISO 11073-90101. Health informatics. Point-of-care medical device communication. Part 90101. Analytical instruments. Point of care test
BS EN 60601-2-33:2010+A1:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
DANSK DS/EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
CEI EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
DANSK DS/EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
DIN 6879:1997 Terms of medical ultrasonic diagnosis
BS EN 61267:1995 Radiation conditions for use in the determination of characteristics for medical diagnostic X-ray equipment
DIN 6859-1:2022 Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring
DIN EN ISO 18113-3 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2006); German version prEN ISO 1...
AENOR UNE-EN 60601-2-28:1996 Electromedical equipment. Part 2: Particular safety requirements for generating devices and x-ray tubes used for medical diagnosis.
DANSK DS/EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
CAN/CSA-C22.2 No.601.2.22-1994 Electromedical devices - Part 2: Particular safety rules for laser therapeutic and diagnostic devices
CAN/CSA-C22.2 No.60601-2-22-2001(C2005) Electromedical devices - Part 2: Particular safety rules for laser therapeutic and diagnostic devices
DANSK DS/EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
CAN/CSA-C22.2 No.601.2.33-1998(C2002) Electromedical devices - Part 2: Particular safety rules relating to magnetic resonance devices for medical diagnosis
IEC 60601-2-33:2002/AMD1:2005 Amendment 1 - Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
AENOR UNE-EN 61331-2:2015 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
CEI EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
AENOR UNE-EN 12376:1999 Medical products for in vitro diagnosis. Information provided by the manufacturer with in vitro diagnostic reagents used for staining in biology.
DANSK DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DANSK DS/EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic medical devices
DANSK DS/EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
NS-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)
10/30228700 DC BS EN ISO 19001. In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DANSK DS/EN 61331-2:2014 Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates
NS-EN 376:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for self-testing
AENOR 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)
CEI EN IEC 60336:2021 Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal spot dimensions and related characteristics
CEI EN IEC 60336/AC:2022 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
DIN EN ISO 18113-4 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2006); German version prEN ISO 18113-4:...
NS-EN 375:1992 In vitro diagnostic systems — Requirements for labelling of in vitro diagnostic reagents for professional use
DIN EN ISO 18113-5 E:2007 Draft Document - Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2006); German version prEN ISO 18113...
NS-EN ISO 18113-5:2024 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
IEC 60601-2-37:2001/AMD2:2005 Amendment 2 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

European Committee for Standardization (CEN)

EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN 928:1995 In Vitro Diagnostic Systems - Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in Vitro Diagnostic Medical Devices
EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
EN 12376:1999 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
prEN 60601-2-28-1992 Medical electrical equipment; part 2: particular requirements for the safety of X-ray source assemblies for medical diagnosis
DD ENV 12539-1997 Medical Informatics - Request and Report Messages for Diagnostic Service Departments
EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
EN 60613:1990 Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis
prEN ISO 15193 In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)
EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

GOSTR

GOST R EN 13612-2010 Performance evaluation of in vitro diagnostic medical devices
GOST R 58437-2019 Examination of quality of medical diagnostic veterinary services. General requirements
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

RU-GOST R

GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST 34244-2017 Telemedicine systems. General requirements for basic safety and essential performance of stationary telemedicine consultative and diagnostic centers
GOST 34243-2017 Telemedicine systems. General requirements for basic safety and essential performance of mobile telemedicine laboratory diagnostic kits
GOST R 56331-2014 Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases
GOST R ISO 19001-2013 In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
GOST EN 13975-2016 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
GOST R 50267.33-1999 Medical electrical equipment. Part 2. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R IEC 60336-1999 X-ray tube assemblies for medical diagnosis. Characteristics of focal spots
GOST R IEC 60601-2-33-2009 Medical electrical equipment. Part 2-33. Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
GOST R ISO 18113-5-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
GOST R ISO 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
GOST R ISO 18113-4-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
GOST 4.178-1985 System of product-quality indices. Medical diagnostic x-ray units. Nomenclature of indices
GOST IEC 60613-2011 Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis
GOST R 50267.22-2002 Medical electrical equipment. Part 2. Particular requirements for the safety of diagnostic and therapeutic laser equipment
GOST R IEC 61267-2001 Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics
GOST R 52122-2003 Technical diagnostics. Mainline locomotives. On-board diagnostic systems. General requirements

BE-NBN

NBN C 74-336-1990 Characteristics of hospital hobs equipped with covers for medical diagnostics

Japanese Industrial Standards Committee (JISC)

JIS Z 4831:2000 Protective devices against diagnostic medical X-radiation
JIS Z 4120:2008 Medical electrical equipment -- X-ray tube assemblies for medical diagnosis -- Characteristics of focal spots
JIS Z 4924:2016 Phantoms for magnetic resonance equipment for medical diagnosis
JIS Z 4924:1995 Phantoms for magnetic resonance equipment for medical diagnosis
JIS Z 4951:1999 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
JIS Z 4950:1995 Graphical symbols and sign for magnetic resonance equipment for medical diagnosis
JIS D 5404:2000 Road vehicles -- Diagnostic systems -- Physical layer and diagnostic connector
JIS D 5404:2006 Road vehicles -- Diagnostic systems -- Physical layer and diagnostic connector
JIS T 61267:2014 Medical diagnostic X-ray equipment -- Radiation conditions for use in the determination of characteristics
JIS T 60613:2013 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

Danish Standards Foundation

DS/EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
DS/ISO/TS 80004-7:2011 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare
DS/EN 61157:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
DS/EN 61157/A1:2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
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 61331-2:2003 Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates
DS/EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
DS/EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
DS/EN IEC 60336:2021 Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal spot dimensions and related characteristics

GSO

GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO ISO/TS 80004-7:2013 Nanotechnologies -- Vocabulary -- Part 7: Diagnostics and therapeutics for healthcare
OS GSO IEC/TR 62799:2017 Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
GSO IEC/TR 62799:2017 Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields
OS GSO ISO/TS 80004-7:2013 Nanotechnologies -- Vocabulary -- Part 7: Diagnostics and therapeutics for healthcare
BH GSO ISO/TS 80004-7:2016 Nanotechnologies -- Vocabulary -- Part 7: Diagnostics and therapeutics for healthcare
GSO IEC 60336:2015 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
GSO ISO 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
OS GSO IEC 61157:2014 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
GSO IEC 62359:2015 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
BH GSO ISO 18113-3:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
OS GSO ISO 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
OS GSO ISO 19001:2015 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
OS GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
GSO ISO 18113-3:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
GSO ISO 18113-4:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
BH GSO ISO 18113-4:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
OS GSO ISO 18113-4:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
GSO ISO 18113-2:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
BH GSO ISO 18113-2:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
BH GSO IEC 61331-2:2016 Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates
GSO IEC TR 60854:2015 Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
OS GSO IEC 61331-2:2014 Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates
GSO IEC 61267:2014 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
BH GSO IEC 61267:2016 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
OS GSO IEC 61267:2014 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
GSO ISO 18113-5:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
OS GSO ISO 18113-5:2016 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
BH GSO ISO 18113-5:2017 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
OS GSO IEC 60613:2014 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
GSO IEC 60613:2014 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

GOST

GOST R 59901-2021 Medical-social expertise. Expert and rehabilitation diagnostics using special diagnostic equipment in federal institutions of medical and social expertise
GOST R 70393-2022 IVD medical devices. Preparation, manufacture, storage and testing of culture media

International Electrotechnical Commission (IEC)

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
ISO/TS 80004-7:2011 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare
ISO TS 80004-7:2011 Nanotechnologies - Vocabulary - Part 7: Diagnostics and therapeutics for healthcare
IEC 60336:2020 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
IEC 61157:1992 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
IEC 60336:2020/COR1:2022 Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
IEC 60336:2005/COR1:2006 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots; Corrigendum 1
IEC 61157:2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
IEC 61157:2007/COR1:2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (Edition 2.0)
IEC 60601-2-33:1995 Medical electrical equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
IEC 61157:2007+AMD1:2013 CSV Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment

European Committee for Electrotechnical Standardization（CENELEC）

HD 509 S1-1988 Characteristics of Focal Spots in Diagnostic X- Ray Tube Assemblies for Medical Use
EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
EN 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
EN 61157:2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (Incorporates Amendment A1: 2013)
EN 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 4274:1995 X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
AS/NZS 4184.2.4:1995 Evaluation and routine testing in medical imaging departments - Constancy tests - Hard copy cameras
AS/NZS 4543.1:1999 Protective Medical Devices Against Diagnostic Medical X-Radiation Part 1: Determination of Attenuation Properties of Materials
AS/NZS 4358:1996 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
AS/NZS IEC 61267:2022 Medical diagnostic X-ray equipment — Radiation conditions for use in the determination of characteristics
AS/NZS IEC 60613:2022 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis
AS/NZS 3200.2.33:2005 Medical electrical equipment Part 2.33: Particular requirements for safetyMagnetic resonance equipment for medical diagnosis

Lithuanian Standards Office

LST EN 60336-2005 Medical electrical equipment. X-ray tube assemblies for medical diagnosis. Characteristics of focal spots (IEC 60336:2005)
LST EN IEC 60336:2021 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (IEC 60336:2020)
LST EN 61157-2008 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007)
LST 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)
LST EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

CENELEC - European Committee for Electrotechnical Standardization

EN 60336:1995 X-Ray Tube Assemblies for Medical Diagnosis Characteristics of Focal Spots
EN 61157:1994 Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment

CEN - European Committee for Standardization

PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing

CN-ZY

ZY/T 10-2024 General rules for the formulation and revision of the diagnosis and efficacy evaluation standards of TCM diseases and syndromes

Indonesia Standards

SNI ISO 19001:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
SNI IEC 60613:2012 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis

PL-PKN

PN-EN IEC 60336-2021-09 E Medical electrical equipment -- X-ray tube assemblies for medical diagnosis -- Focal spot dimensions and related characteristics (IEC 60336:2020)

BSI

DANSK DS/ISO 18113-5:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing
DANSK DS/ISO 18113-3:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use
DANSK DS/ISO 18113-4:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing
DANSK DS/ISO 18113-2:2024 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use

National Electrical Manufacturers Association（NEMA)

NEMA XR 19-1993 Electrical, Thermal and Loading Characteristics of X-Ray Tubes Used for Medical Diagnosis

NL-NEN

NEN 11157-1993 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment (IEC 1157:1992)

Canadian Standards Association (CSA)

CSA C22.2 No.60601-2-37-03 A1-2005 Amendment 1 Medical electrical equipment ?Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

SE-SIS

SIS SS IEC 336:1986 X-ray equipment - Characteristics of focal sp?ts in diagnostic X-ray tube assemblies for medical use

NZ-SNZ

NZS 8151:2004 Accident and Medical Clinic Standard

AT-ON

ONORM EN 375-1993 In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use