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smart medical equipment

smart medical equipment, Total:258 items.

In the international standard classification, smart medical equipment involves: Telecommunication terminal equipment, Medical equipment, Domestic electrical appliances in general, Miscellaneous domestic and commercial equipment, Vocabularies, Applications of information technology, Radiation protection, Finances. Banking. Monetary systems. Insurance, Pharmaceutics, Radiation measurements, Surface treatment and coating, Buildings, Sterilization and disinfection, Electrical engineering in general, Dentistry, Hospital equipment, Laboratory medicine, Graphical symbols, Information technology (IT) in general, Telecommunication systems, Lamps and related equipment, Wastes, Education, Radiocommunications, Medical sciences and health care facilities in general, Ergonomics, Terminology (principles and coordination), Acoustics and acoustic measurements, Quality.

ES-UNE, smart medical equipment

IEEE 2802-2022 IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
UNE-EN 62366-1:2015/AC:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in February of 2016.)
UNE-EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.)
UNE-EN 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)
UNE-EN 60601-2-64:2015 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (Endorsed by AENOR in July of 2015.)
UNE-EN 60601-1-11:2015/A1:2021 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endor...
UNE-EN 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endor...
IEC 60601-1:2023 SER Medical electrical equipment - ALL PARTS

Group Standards of the People's Republic of China, smart medical equipment

T/TAF 107-2022 Security of smart wearable devices—Security technical requirements and testing methods for medical and health wearable devices
T/NAHIEM 53-2022 Technical standard for the electrical and intelligent equipment of medical buildings
T/SHMHZQ 094-2021 Artificial intelligence specifications for medical CT image analysis system
T/GDNS 001-2022 Safety code for medical devices
T/CSA 071-2022 Performance test method of flexible light source in optical medical equipment
T/SCSS 044-2017 Smart hospital informatization and intelligent design specification
T/CZEIA 01-2019 Intelligent standard of intelligent energy collection equipment
T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device
T/DZJN 157-2023 Standards for evaluating the capabilities of medical equipment installation, maintenance and operation enterprises

Association Francaise de Normalisation, smart medical equipment

NF EN IEC 62667:2018 Appareils électromédicaux - Appareils médicaux par faisceau d'ions légers - Caractéristiques de performances
NF C74-208/A1:2001 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
NF EN 60976:2008 Appareils électromédicaux - Accélérateurs médicaux d'électrons - Caractéristiques fonctionnelles de performance
NF C74-208:2000 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics.
NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF EN 1640:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
NF C74-054-1*NF EN 62366-1:2015 Medical devices - Part 1 : application of usability engineering to medical devices
NF EN 62366-1/A1:2020 Dispositifs médicaux - Partie 1 : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
NF EN 62366-1:2015 Dispositifs médicaux - Partie 1 : application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
NF C74-053:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment.
NF C74-053*NF EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
NF EN 62353:2015 Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
NF EN ISO 17664-1:2021 Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 1 : dispositifs médicaux critiques et semi-critiques
NF C15-211:2006 Low-voltage electrical installations - Installations in medically used rooms
NF C74-211*NF EN 61168:1994 Medical electrical equipment. Functional performance characteristics of radiotherapy simulators.
NF S90-316:1987 Medico-surgical equipment. Operating tables.
NF ISO 17664-2:2021 Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif - Partie 2 : dispositifs médicaux non critiques
NF C74-209:1991 Medical electrical equipment - Medical electron accelerators in the range of 1 MeV to 50 MeV - Guidelines for functional performance characteristics
NF C74-022*NF EN 60601-1-12:2015 Medical electrical equipment - Part 1-12 : general requirements for basic safety and essential performance - Collateral standard : requirements for medical equipment and medical electrical systems intended for use the emergency medical services environmen
NF C74-122/A11*NF EN 60601-2-33/A11:2012 Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
NF C74-122*NF EN 60601-2-33:2011 Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
NF EN 60601-2-64:2015 Appareils électromédicaux - Partie 2-64 : exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers
NF EN 60601-1-12:2015 Appareils électromédicaux - Partie 1-12 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être ut...
NF EN 60601-1-12/A1:2020 Appareils électromédicaux - Partie 1-12 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être ut...
NF C74-352/A1*NF EN 60601-2-52/A1:2015 Medical electrical equipment - Part 2-52 : particular requirements for basic safety and essential performance of medical beds
NF C74-122/A2:2008 Medical electrical equipment - Part 2-33 : particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
NF C74-064*NF EN 60601-2-64:2015 Medical electrical equipment - Part 2-64 : particular requirements for the basic safety and essential performance of light ion beam medical eletrical equipment
NF S90-201:1990 Medico-surgical equipment. Transfusion sets.
NF S90-202:1990 Medico-surgical equipment . Infusion sets.
NF EN ISO 19054:2006 Systèmes de rails de support pour appareils médicaux
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
NF EN 1641:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
NF C74-335/A11*NF EN 60601-2-37/A11:2012 Medical electrical equipment - Part 2-37 : particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.

Japanese Industrial Standards Committee (JISC), smart medical equipment

JIS T 2009:2005 Multiple medical device for home use
JIS Z 4701:1997 General rules for medical X-ray equipment
JIS T 0601-2-201:2015 Medical electrical equipment -- Part 2-201: Particular requirements for the basic safety and essential performance of hydrotherapy and warmbaththerapy equipment

Korean Agency for Technology and Standards (KATS), smart medical equipment

KS C IEC 60976:2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
KS C IEC 62667:2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC TR 60977:2020 Medical electrical equipment — Medical electron accelerators — Guidelines for functional performance characteristics
KS C IEC TR 60977:2017 Medical electrical equipment－Medical electron accelerators－Guidelines for functional performance characteristics
KS C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS C IEC 60601-1-11:2018 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard:Requirements for medical electrical equipment and medical electrical sys
KS C IEC 60601-1-12:2020 Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
KS A 4001-1989(2020) Graphical symbols for medical radiological equipment
KS C IEC 60601-2-37:2011 Medical electrical equipment－Part 2-37：Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

KR-KS, smart medical equipment

KS C IEC 60976-2020 Medical electrical equipment — Medical electron accelerators — Functional performance characteristics
KS C IEC 62667-2019 Medical electrical equipment — Medical light ion beam equipment — Performance characteristics
KS C IEC TR 60977-2020 Medical electrical equipment — Medical electron accelerators — Guidelines for functional performance characteristics
KS C IEC 60601-1-12-2020 Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical sy
KS C IEC 60601-1-11-2018 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard:Requirements for medical electrical equipment and medical electrical sys

British Standards Institution (BSI), smart medical equipment

BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
PD IEC/TR 60601-4-2:2016 Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices
BS EN 60976:2008 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
BS EN 60601-2-64:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
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
PD IEC/TR 60977:2008 Medical electrical equipment. Medical electron accelerators. Guidelines for functional performance characteristics
BS PD IEC/TR 60601-4-1:2017 Medical electrical equipment. Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
BS EN 60601-1-12:2015+A1:2020 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services…
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
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 60601-2-3:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of short-wave therapy equipment
BS EN 60601-2-6:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of microwave therapy equipment
BS EN IEC 60601-2-83:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of home light therapy equipment
BS EN 60601-2-3:2015+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of short-wave therapy equipment
BS EN 60601-2-6:2015+A1:2016 Medical electrical equipment. Particular requirements for the basic safety and essential performance of microwave therapy equipment
BS EN ISO 10079-1:2015 Medical suction equipment. Electrically powered suction equipment
BS EN ISO 10079-2:2000 Medical suction equipment - Manually powered suction equipment
BS EN ISO 10079-2:1997 Medical suction equipment. Manually powered suction equipment
BS EN ISO 10079-1:2015+A1:2019 Medical suction equipment. Electrically powered suction equipment
BS EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
BS EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
BS EN 60601-2-37:2008+A11:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
BS EN 60601-1-12:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
BS EN 60601-1-11:2015+A1:2021 Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
DD ENV 12611-1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
BS EN 60601-2-3:1992 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 60601-2-3:1993 Medical electrical equipment. Particular requirements for safety. Specification for short-wave therapy equipment
BS EN 60601-2-49:2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of multifunction patient monitoring equipment
BS EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Terminal units for use with compressed medical gases and vacuum
BS EN 60601-2-5:2015 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
BS EN IEC 60601-2-50:2021 Tracked Changes. Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant phototherapy equipment
BS EN ISO 10079-3:2000 Medical suction equipment - Suction equipment powered from a vacuum or pressure source
BS EN ISO 10079-3:1997 Medical suction equipment. Suction equipment powered from vacuum or pressure source
19/30394497 DC BS EN 60601-1-12 AMD1. Medical electrical equipment. Part 1-12. General requirements for basic safety and essential performance. Collateral Standard. Requirements for medical electrical equipment and medical electrical systems intended for use in the e...
BS EN 60601-2-52:2010+A1:2015 Medical electrical equipment. Particular requirements for basic safety and essential performance of medical beds

Institute of Electrical and Electronics Engineers (IEEE), smart medical equipment

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device
IEEE P1073.1.3.11/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Capnometer
IEEE P1073.1.3.6/D6.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - ECG
IEEE P1073.1.3.7/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Blood Pressure
IEEE P1073.1.3.8/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Temperature
IEEE P1073.1.3.10/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Cardiac Output
IEEE P1073.1.3.9/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Airway Flow
IEEE Std P1073.1.3.8/D4.0 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Temperature
IEEE P1073.1.3.4/D3.0 IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Medical Device Specializations - Pulse Oximeter
IEEE Std P1073.1.3.10/D3.0-1999 IEEE Draft Standard for Medical Device Communications -- Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -- Cardiac Output
IEEE P1073.1.3.4/D3.0:1999 (Draft)Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Pulse Oximeter
IEEE Std P1073.1.3.5/D0.04 Unapproved IEEE Draft Standard for Medical Device Communications -Medical Device Data Language (MDDL) Virtual Medical Device, Specialized -Cardiac Output (Withdrawn PAR)
IEEE Std P1073.1.3.11/D3.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized Capnometer
IEEE Std 11073-10207-2017 IEEE Health informatics--Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE Std P1073.1.3.9/D3.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Airway Flow (Withdrawn PAR)
IEEE Std P1073.1.3.7/D4.0 Unapproved IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL)Virtual Medical Device, Specialized - Pulse Oximeter (Withdrawn PAR)

IX-EU/EC, smart medical equipment

MEDDEV 2.1/5-1998 MEDICAL DEVICES WITH A MEASURING FUNCTION
MEDDEV 2.4/1 PART 1-2001 Guidelines for the Classification of Medical Devices Rev 8

SE-SIS, smart medical equipment

SIS SS-IEC 976:1991 Medical electrical equipment — Medical electron accelerators — Functionalperformance charactetistics
SIS SS IEC 601-2-3:1988 Medical e/ectrical equipment — Particular requirements for the safety ofshort-wave therapy equipment
SIS SS IEC 601-2-6:1988 Medical electrical equipment — Particular requirements for the safety of microwave therapy equipment
SIS SS 486 03 31-1990 Medical electrical equipment — Particular requirements for the safety of gamma beam therapy equipment
SIS SS-IEC 601-2-14:1991 Medical electrical equipment - Part 2: Particular requirements for the safety ofelectroconvulsive therapy equipment

Standard Association of Australia （SAA）, smart medical equipment

AS/NZS 4434.1:1996 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
AS/NZS 4434.2:1996 Medical electrical equipment - Medical electron accelerators - Periodic function performance testing
AS 2514:1999 Drying cabinets for medical equipment
AS/NZS 3551:2012
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care
AS IEC 60601.1.11:2017 Medical electrical equipment, Part 1.11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

American National Standards Institute （ANSI), smart medical equipment

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices

German Institute for Standardization, smart medical equipment

DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
DIN EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007
DIN EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
DIN EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2008
DIN EN 60601-1-11 Berichtigung 1:2011 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 6060
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009

PL-PKN, smart medical equipment

PN Z78000-1970 Medical equipmen< opular hospital beds
PN Z78006-1972 Medksal tretchers
PN Z78510-1972 Medical e?uipment Gas cylinders for medical use Marking of colours
PN Z54514-1954 Przedmiotem normy jest stopa szyny Dietrichsa ujg PN-54/Z-545I1.

Jiangsu Provincial Standard of the People's Republic of China, smart medical equipment

DB3206/T 1019-2021 Management specification for big data intelligent monitoring system of medical insurance and medical service
DB32/T 3549-2019 Specifications for setting up facilities and equipment for temporary storage of medical waste in medical and health institutions

AENOR, smart medical equipment

UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
UNE 20613-2-14:1993 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTROCONSULSIVE THERAPY EQUIPMENT.
UNE 20613-2-6:1988 MEDICAL ELECTRICAL EQUIPMENT. PARTICULAR REQUIREMENTS FOR THE SAFETY OF MICROWAVE THERAPY EQUIPMENT
UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment

RU-GOST R, smart medical equipment

GOST R IEC 60976-2013 Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
GOST R ISO/TR 16142-2008 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
GOST R ISO 14971-2009 Medical devices. Application of risk management to medical devices
GOST R ISO 14971-2006 Medical devices. Application of risk management to medical devices
GOST R EN 556-1-2009 Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for terminally sterilized medical devices
GOST R 56331-2014 Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases
GOST R 57092-2016 Medical electrical equipment. Equipment for telemedicine videoconferencing. Technical requirements for governmental purchases
GOST R IEC/TR 60788-2009 Medical electrical equipment. Glossary
GOST R 56326-2017 Medical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases
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 60601-2-33-2013 Medical electrical equipment. Part 2-33. Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
GOST R 56326-2014 Medical electrical equipment. Multifunction patient monitoring equipment. Technical requirements for governmental purchases
GOST R ISO 16142-2008 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

VN-TCVN, smart medical equipment

TCVN 7008-2008 Medical supply units

Indonesia Standards, smart medical equipment

SNI 16-4940.1-1998 Electrically powered medical suction equipment
SNI 16-4940.2-1998 Medical suction equipment powered from vacuum or pressure sources

HU-MSZT, smart medical equipment

RO-ASRO, smart medical equipment

STAS 5316-1967
STAS 3952-1987 Medical equipment SANITAHY STIiETCHER

European Committee for Standardization (CEN), smart medical equipment

EN ISO 11197:2019 Medical supply units (ISO 11197:2019)
EN ISO 11197:2009 Medical supply units
EN ISO 11197:2016 Medical supply units
prEN 475-1991 Medical devices; electrically-generated alarms signals
prEN 389-1990 Labelling of non-active medical devices

CEN - European Committee for Standardization, smart medical equipment

EN ISO 11197:2004 Medical supply units

Society of Automotive Engineers (SAE), smart medical equipment

SAE J3020-2014 Medical Device Shot Peening

US-FCR, smart medical equipment

FCR UFGS-11 72 13-2006 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11702-1986 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11700-1981 GENERAL REQUIREMENTS FOR MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

GB-REG, smart medical equipment

REG AC 121-33B-2006 Emergency Medical Equipment
REG 47 CFR PART 18-2011 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

Anhui Provincial Standard of the People's Republic of China, smart medical equipment

DB34/T 1923-2013 Technical specification for medical building intelligent system
DB34/T 1923-2021 Technical standard for medical building intelligent system

PT-IPQ, smart medical equipment

NP EN 556-2000 Sterilization of medical devices Requirements for terminally sterilized medical devices to be labelled"Sterile"
NP EN 1441-2000 Medical devices Risk analysis

International Organization for Standardization (ISO), smart medical equipment

ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO/TR 15223:1998 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14155:1996 Clinical investigation of medical devices
IEC TR 60601-4-1:2017 Medical electrical equipment — Part 4-1: Guidance and interpretation — Medical electrical equipment and medical electrical systems employing a degree of autonomy
ISO/CD 5137 Maintenance management program for medical equipment
ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes

International Electrotechnical Commission (IEC), smart medical equipment

IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
IEC 62353:2007 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 60601-2-33/AMD3:2013 Medical electrical equipment.Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-75:2017 Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
IEC 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
IEC 60601-1-11:2010/COR1:2011 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60930:1988 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment

Underwriters Laboratories (UL), smart medical equipment

UL 544-1998 Medical and dental equipment

Lithuanian Standards Office , smart medical equipment

LST EN 62366-2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)
LST EN 62353-2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)
LST EN 1640-2010 Dentistry - Medical devices for dentistry - Equipment

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), smart medical equipment

ASHRAE 170 INT 1-2010 Ventilation of Health Care Facilities

European Committee for Electrotechnical Standardization（CENELEC）, smart medical equipment

EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
EN 60601-2-33:2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (Incorporating corrigendum October 2010; Incorporates Amendment A11: 2011)
EN 60601-2-33:2010/corrigendum Oct. 2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

US-AAMI, smart medical equipment

AAMI/IEC 62366-1:2015 Medical devices - Part 1 : Application of usability engineering to medical devices

Professional Standard - Medicine, smart medical equipment

YY 0678-2008 Standard performance and safety specification for cryosurgical medical instruments
YY/T 0678-2008 Standard performance and safety specification for cryosurgical medical instruments

American Society for Testing and Materials (ASTM), smart medical equipment

ASTM F882-84(1996) Standard Performance and Safety Specification for Cryosurgical Medical Instruments
ASTM F639-98a Standard Specification for Polyethylene Plastics for Medical Applications

Military Standard of the People's Republic of China-General Armament Department, smart medical equipment

GJB 4574-1990*GJBz 20032-1990 Service ship medical cabin layout and installation of medical equipment
GJB 162-1986 Surface ship medical cabin layout and installation of medical equipment

IEEE - The Institute of Electrical and Electronics Engineers@ Inc., smart medical equipment

IEEE 11073-10207-2017 Health informatics - Point-of-care medical device communication - Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
IEEE P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature

NATO - North Atlantic Treaty Organization, smart medical equipment

STANAG 7112-2011 RECOMMENDED MEDICAL EQUIPMENT FOR AEROMEDICAL EVACUATIONS (ED 1; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int so@ Phone: +32 (0)2 – 707 5556@ email: nso@nso.nato.int.

Shanghai Provincial Standard of the People's Republic of China, smart medical equipment

DB31/T 984-2016 Technical specifications for the construction of intelligent management system for hospital logistics equipment

Professional Standard - Post and Telecommunication, smart medical equipment

YD/T 1253-2003 Test method of intelligent network equipment —Intelligent Peripheral (IP)
YD/T 4350-2023
YD/T 4351-2023

教育部, smart medical equipment

JY/T 0405-2010 Standards for equipping teaching and medical rehabilitation equipment in Peizhi schools during the compulsory education stage

Jiangxi Provincial Standard of the People's Republic of China, smart medical equipment

DB36/T 609-2011 RFID Equipment Technical Criterion for Health Care Application

FI-SFS, smart medical equipment

SFS 4372-1979

CENELEC - European Committee for Electrotechnical Standardization, smart medical equipment

EN 60601-2-33:1995 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (Incorporates Amendment A11: 1997)

Taiwan Provincial Standard of the People's Republic of China, smart medical equipment

CNS 12491-13-1989 Graphical Symbols for Use on Electrical and Electronic Equipment (Medical Equipment)
CNS 12491.13-1989 Graphical Symbols for Use on Electrical and Electronic Equipment (Medical Equipment)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, smart medical equipment

GB/T 42204-2022 Communication specification for clinical medical equipment—Imaging equipment

CZ-CSN, smart medical equipment

CSN 85 6009-1980 Medical apparatus. Dental technics. Symbols

Danish Standards Foundation, smart medical equipment

DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment

GOSTR, smart medical equipment

GOST R 58451-2019 Medical devices. Maintenance. Basic principles

未注明发布机构, smart medical equipment

DIN EN IEC 62667:2020 Medical electrical devices – Medical light ion irradiation devices – Apparatus quality characteristics (IEC 62667:2017)