medical equipment

medical equipment, Total:217 items.

The international standard classification for "medical equipment" includes: IT applications in health care technology , Electromagnetic compatibility(EMC) .

The Chinese standard classification for "medical equipment" includes: Computer application , Electromagnetic compatibility .

Group Standards of the People's Republic of China

T/GDNS 012-2023 Safety code for medical devices
T/GDNS 001-2022 Safety code for medical devices
T/CSBME 025-2021 Reliability Management System of Medical Equipment
T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device

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

GB/T 42204-2022 Communication specification for clinical medical equipment—Imaging equipment
GB/Z 18732-2002 Determine the methods of the industrial, scientific and medical equipment limits
GB/T 18732-2002 Determination of limits for industrial,scientific and medical equipment

Jiangsu Provincial Standard of the People's Republic of China

DB3205/T 1127-2024 Network security management specifications for networked medical devices

Professional Standard-Ships

CB 20255-2016 Installation process requirements for medical equipment on surface ships

Professional Standard - Post and Telecommunication

YD/T 4899-2024 Technical requirements for medical equipment management platform for digital hospitals

Guangdong Provincial Standard of the People's Republic of China

DB44/T 2032-2017 On-site test method for electromagnetic compatibility of large medical equipment or system
DB4401/T 277.1-2024 Medical Equipment Preventive Maintenance Management Regulations Part 1: General Provisions

Jiangxi Provincial Standard of the People's Republic of China

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

未注明发布机构

AAMI TIR57-2016(2023) Medical Device Safety Risk Management
AAMI/IEC TIR62366-2:2016 Medical devices Part 2: Guidelines on how to apply usability engineering to medical devices

British Standards Institution (BSI)

BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices
BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
BS EN 1441:1998 Medical Device Risk Analysis
BS EN 1640:1997 Dentistry. Medical devices for dentistry. Equipment
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 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS PD ISO/TR 24971:2013 Medical devices. Guidance on the application of ISO 14971
BS EN 1641:1997 Dentistry. Medical devices for dentistry. Materials
BS PD ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
BS PD CEN ISO/TR 24971:2020 Medical devices. Guidance on the application of ISO 14971
BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 19054:2006+A1:2016 Rail systems for supporting medical equipment
BS ISO /IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication-Medical devices communication profile for web services
BS ISO/IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication. Medical devices communication profile for web services

International Organization for Standardization (ISO)

ISO 15223-1:2021/CD Amd 1:2024 Medical devices
ISO/CD 20417:2024 Medical devices
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/TR 15223:1998 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 13485:2016 - Medical Devices - A Practical Guide Medical devices - A practical guide
ISO/IEEE 11073-20702:2018 Health informatics — Point-of-care medical device communication — Part 20702: Medical devices communication profile for web services
ISO 14155:1996 Clinical investigation of medical devices
ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
ISO/CD 5137 Maintenance management program for medical equipment
ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
ISO 19054:2005 Rail systems for supporting medical equipment

German Institute for Standardization

DIN EN 62366-1:2021-08*VDE 0750-241-1:2021-08 Medical devices
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 ISO 15225 E:2015-08 Medical device quality management medical device nomenclature data structure (draft)
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
DIN EN 55011:2022-05*VDE 0875-11:2022-05 Industrial, scientific and medical equipment
DIN EN 62366 E:2006 Draft Document - Medical devices - Application of usability engineering to medical devices (IEC 62A/535/CDV:2006); German version prEN 62366:2006
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
DIN EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005); English version of DIN EN ISO 19054:2006-09
DIN EN 62366-1/A1 E:2019 Draft Document - Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62A/1288/CDV:2018); German and English version EN 62366-1:2015/prA1:2018
DIN EN 62366-1 E:2014 Draft Document - Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62A/900A/CDV:2014); German version FprEN 62366-1:2013
DIN EN ISO 19054:2017-04 Rail systems for supporting medical equipment (ISO 19054:2005 + Amd1:2016); German version EN ISO 19054:2006 + A1:2016
DIN EN 62366:2016 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007 + A1:2014); German version EN 62366:2008 + A1:2015
DIN EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010); German version EN ISO 15225:2010
DIN EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004
DIN EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI/AAMI EQ93-2019 Medical equipment management—Vocabulary used in medical equipment programs
ANSI/AAMI/ISO 13488:1996 Quality systems—Medical devices—Particular requirements for the application of ISO 9002
ANSI/AAMI UL 2800-1-2022 Standard for Medical Device Interoperability
ANSI/AAMI SW91-2018 Classification of defects in health software
ANSI/AAMI HE75-2009 Human factors engineering - Design of medical devices
ANSI/AAMI HE75-2009(R2018) Human Factors Engineering in Medical Device Design
AAMI TIR18:2010 Guidance on electromagnetic compatibility of medical devices in healthcare facilities

Association Francaise de Normalisation

NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
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 Medical devices - Part 1: application of usability engineering to medical devices
NF EN 62366-1:2015 Medical devices - Part 1: application of usability engineering to medical devices
NF EN 62353:2015 Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
NF EN 1640:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
NF EN IEC 62667:2018 Medical electrical devices - Light ion beam medical devices - Performance characteristics
NF S90-316:1987 Medico-surgical equipment. Operating tables.
NF EN 1641:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
NF S90-202:1990 Medico-surgical equipment . Infusion sets.
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
NF EN ISO 19054:2006 Support rail systems for medical devices
NF S90-201:1990 Medico-surgical equipment. Transfusion sets.
NF S97-317:1998 Rail systems for supporting medical equipment.
NF S97-317/A1:2002 Rail systems for supporting medical equipment.
NF S95-317*NF EN ISO 19054:2006 Rail systems for supporting medical equipment

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device
IEEE P1073.1.3.7/D4.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Blood Pressure
IEEE P1073.1.3.11/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 P1073.1.3.8/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
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 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)
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 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 Std P1073.2.0/D0.05 Proposed Draft IEEE Standard - Medical Device Communications - Medical Device Application Profiles (MDAP) - Base Standard
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 P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature

GCC Standardization Organization

GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
GSO IEC TR 62366-2:2021 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
GSO EN 1639:2021 Dentistry — Medical devices for dentistry —Instruments
GSO IEC/TR 80002-1:2015 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
GSO EN 1641:2021 Dentistry. Medical devices for dentistry. Materials

Ente Nazionale Italiano di Unificazione

UNI CEI EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
UNI EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment
UNI EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment
UNI EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNI EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
UNI EN 1641:1997 Dentistry. Medical devices for dentistry . Materials.
UNI EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments
UNI EN 12218:2000 Rail systems for supporting medical equipment
UNI EN ISO 8536-1:2001 Infusion equipment for medical use - Infusion glass bottles.
UNI EN 1640:1997 Dentistry. Medical devices for dentistry . Equipment.

SCC

AAMI EQ93:2019 Medical equipment management - Vocabulary used in medical equipment programs
AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

Spanish Association for Standardization (UNE)

UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
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 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 1640:2004 Dentistry - Medical devices for dentistry - Equipment
UNE-EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
UNE-EN 1041:1998 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES.

PT-IPQ

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
NP EN 12218-2000 Rail systems for supporting medical equipment

Canadian Standards Association (CSA)

CSA C22.2 No.125-1979 Electromedical equipment
CSA C22.2 No.125-M1984-1984(R2004) Electromedical Equipment
CSA C22.2 No.125-1973 Electro-Medical Equipment
CSA C22.2 No.125-M1984-1984(C2004) Electromedical equipment
CAN/CSA-IEC 62366-2014 Medical devices - Application of usability engineering to medical devices (Adopted IEC 62366:2007, first edition, 2007-10)

Indonesia Standards

SNI 16-4940.1-1998 Electrically powered medical suction equipment

US-FCR

FCR UFGS-11 72 13-2006 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11702-1986 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR 47 CFR PART 18-2014 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2012 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR 47 CFR PART 18-2013 INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
FCR FED FCGS 11700-1981 GENERAL REQUIREMENTS FOR MEDICAL EQUIPMENT
FCR UFGS-01 73 19-2006 INSTALLATION OF GOVERNMENT-FURNISHED MEDICAL EQUIPMENT

GB-REG

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

RO-ASRO

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

Society of Automotive Engineers (SAE)

SAE J3020-2014 Medical Device Shot Peening

International Electrotechnical Commission (IEC)

IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices

Magyar Szabványügyi Testület

MNOSZ 15520-1953 Medical equipment. operating table
MNOSZ 14729-1954 Medical equipment. surgical box
MNOSZ 4049-1952 Medical equipment. metal plate
MNOSZ 14706-1954 Medical equipment. operating table
MNOSZ 15519-1953 Medical equipment. operating table
MNOSZ 14676-1955 Expansion rack for medical equipment
MNOSZ 14725-1954 Medical equipment. internal medicine examination table
MNOSZ 14709-1954 Medical equipment. pediatric examination table
MNOSZ 14746-1954 Medical equipment. baby placing table
MNOSZ 14728-1954 Medical equipment. sink. Bracket
MNOSZ 15514-1953 Medical equipment, cylindrical examination light
MNOSZ 14659-1955 Medical equipment. Examination and surgical chairs
MNOSZ 14658-1955 Medical equipment gynecological examination tools

Standard Association of Australia （SAA）

AS 2514:1981 Drying cabinets for medical equipment
AS 2514:1999 Drying cabinets for medical equipment
AS 2684:1984 Medical equipment - Humidifiers, for medical use

The Directorate General of Specifications and Metrology (DGSM)

OS GSO IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Lithuanian Standards Office

LST EN 62366-2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)

Gosstandart of Russia

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 58451-2019 Medical devices. Maintenance. Basic principles
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 14971-2006 Medical devices. Application of risk management to medical devices
GOST R ISO 14971-2009 Medical devices. Application of risk management to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO IEC 62366-1:2017 Medical devices - Part 1: Application of usability engineering to medical devices
BH GSO IEC TR 62366-2:2022 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
BH GSO IEC/TR 80002-1:2016 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
BH GSO EN 1641:2022 Dentistry. Medical devices for dentistry. Materials
BH GSO EN 1639:2022 Dentistry — Medical devices for dentistry —Instruments

US-AAMI

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

Danish Standards Foundation

DANSK DS/EN 62366-1/A1:2020 Medical devices – Part 1: Application of usability engineering to medical devices
DANSK DS/EN 62366-1/AC:2019 Medical devices – Part 1: Application of usability engineering to medical devices
DANSK DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
DANSK DS/IEC TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
DANSK DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
DANSK DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
DANSK DS/IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes
DANSK DS/EN ISO 19054/A1:2006 Rail systems for supporting medical equipment
DS/EN ISO 19054:2006 Rail systems for supporting medical equipment
DANSK DS/EN ISO 19054:2006 Rail systems for supporting medical equipment

European Committee for Electrotechnical Standardization（CENELEC）

EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

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

AS/NZS 3551:2012(R2016) Medical Equipment Management Program
AS/NZS 3551:2012/AMD 1:2013 Medical Equipment Management Program
AS/NZS 3551:2012 Medical Equipment Management Program

Japanese Industrial Standards Committee (JISC)

JIS T 2009:2005 Multiple medical device for home use

FI-SFS

SFS 4372-1979 Electrical installation of medical equipment

European Committee for Standardization (CEN)

prEN 475-1991 Medical devices; electrically-generated alarms signals
prEN 389-1990 Labelling of non-active medical devices
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

PL-PKN

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

CZ-CSN

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

IX-EU/EC

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

Standards Norway

NS-EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments
NS-EN 1642:2009 Dentistry - Medical devices for dentistry - Dental implants

American Society for Testing and Materials (ASTM)

ASTM F639-98a Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F997-98a Standard Specification for Polycarbonate Resin for Medical Applications
ASTM F997-98ae1 Standard Specification for Polycarbonate Resin for Medical Applications

Compressed Gas Association (U.S.)

CGA M-20-2017 Guidelines for Unique Identification of Medical Devices

AT-OVE/ON

OVE EN 62366-1-2021 Medical devices - Part 1: Application of usability engineering to medical devices ( IEC 62366-1:2015) (german version)

AT-ON

ONORM EN 540-1993 Clinical investigation of medical devices for human subjects

Underwriters Laboratories (UL)

UL 416-2013 UL Standard for Safety Refrigerated Medical Equipment

Bureau of Indian Standards

IS/ISO/IEEE 11073-20702-2018 Health Informatics — Point-of-Care Medical Device Communication Part 20702 Medical Devices Communication Profile for Web Services