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Principles of medical equipment

Principles of medical equipment, Total:145 items.

In the international standard classification, Principles of medical equipment involves: Laboratory medicine, Medical equipment, Pharmaceutics, Sterilization and disinfection, Applications of information technology, Quality, Vocabularies, Medical sciences and health care facilities in general, Radiation measurements, Surface treatment and coating, Wastes, Dentistry, Hospital equipment, Graphical symbols.

British Standards Institution (BSI), Principles of medical equipment

BS DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
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 62366:2008 Medical devices - Application of usability engineering to medical devices
BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
18/30370883 DC BS EN ISO 14971. Medical devices. Application of risk management to medical devices
BS EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
BS ISO/IEEE 11073-20702:2018 Health informatics. Point-of-care medical device communication. Medical devices communication profile for web services
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 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 PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
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
PD IEC/TR 60601-4-2:2016 Medical electrical equipment. Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices

German Institute for Standardization, Principles of medical equipment

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 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
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 ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016
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 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010); German version EN ISO 15225:2010
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 ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version of DIN EN ISO 14971:2009-10

GOSTR, Principles of medical equipment

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

PT-IPQ, Principles of 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), Principles of 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/CD 5137 Maintenance management program for medical equipment
ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
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 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements

Standard Association of Australia （SAA）, Principles of medical equipment

AS/NZS 3551:2012
AS 2514:1999 Drying cabinets for medical equipment
AS/NZS 2500:2020 Safe use of medical electrical equipment in health care

RU-GOST R, Principles of medical equipment

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 53918-2010 Medical devices. Implementation of risk management principles and activities within a quality management system
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 50326-1992 Basic aspects of the safety philosophy of electrical equipment, used in medical practice
GOST R IEC 62353-2013 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
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 ISO 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 57092-2016 Medical electrical equipment. Equipment for telemedicine videoconferencing. Technical requirements for governmental purchases

International Electrotechnical Commission (IEC), Principles of medical equipment

IEC 60930:1988 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment
IEC TR 60930:2008 Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
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

European Committee for Standardization (CEN), Principles of medical equipment

CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003
EN ISO 11197:2019 Medical supply units (ISO 11197:2019)
EN ISO 11197:2009 Medical supply units
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

Institute of Electrical and Electronics Engineers (IEEE), Principles of 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

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

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
T/CIET 231-2023
T/GDNS 001-2022 Safety code for medical devices

Association Francaise de Normalisation, Principles of medical equipment

NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
NF S98-116:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.
NF EN IEC 62667:2018 Appareils électromédicaux - Appareils médicaux par faisceau d'ions légers - Caractéristiques de performances
NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF EN 1640:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Matériel
FD S99-513*FD ISO/TR 21582:2021 Pyrogenicity - Principles and methods for pyrogen testing of medical devices
NF S99-171:2006 Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM).
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
FD ISO/TR 21582:2021 Pyrogénicité - Principes et méthodes d'essai pour la recherche des pyrogènes sur les 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

American National Standards Institute （ANSI), Principles of medical equipment

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ANSI/AAMI TIR57:2016(R2023) Principles for medical device security - Risk management

PL-PKN, Principles of 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

AENOR, Principles of medical equipment

UNE-EN 62366:2009 Medical devices- Application of usability engineering to medical devices
UNE 20901:1995 GUIDELINES FOR ADMINISTRATIVE, MEDICAL AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQUIPMENT.

VN-TCVN, Principles of medical equipment

TCVN 7008-2008 Medical supply units

Indonesia Standards, Principles of 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, Principles of medical equipment

RO-ASRO, Principles of medical equipment

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

CEN - European Committee for Standardization, Principles of medical equipment

EN ISO 11197:2004 Medical supply units

Society of Automotive Engineers (SAE), Principles of medical equipment

SAE J3020-2014 Medical Device Shot Peening

US-FCR, Principles of medical equipment

FCR UFGS-11 72 13-2006 MEDICAL EQUIPMENT, MISCELLANEOUS
FCR FED FCGS 11702-1986 MEDICAL EQUIPMENT, MISCELLANEOUS

GB-REG, Principles of medical equipment

REG AC 121-33B-2006 Emergency Medical Equipment

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

KS P ISO 10993-20:2009 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
KS C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)

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

GB/T 17995-1999 Guidelines for administrative,medical,and nursing staff concerned with the safe use of medical electrical equipment

Underwriters Laboratories (UL), Principles of medical equipment

UL 544-1998 Medical and dental equipment

ZA-SANS, Principles of medical equipment

SANS 10248-1:2008 Management of healthcare waste - Part 1: Management of healthcare risk waste from a healthcare facility

Lithuanian Standards Office , Principles of medical equipment

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

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

ASHRAE 170 INT 1-2010 Ventilation of Health Care Facilities

Danish Standards Foundation, Principles of medical equipment

DS/ISO/TR 21582:2021 Pyrogenicity – Principles and methods for pyrogen testing of medical devices

SE-SIS, Principles of medical equipment

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

European Committee for Electrotechnical Standardization（CENELEC）, Principles of medical equipment

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

US-AAMI, Principles of medical equipment

AAMI/IEC 62366-1:2015 Medical devices - Part 1 : Application of usability engineering to medical devices
ANSI/AAMI EQ56-1999 Recommended practices for a medical equipment management program
ANSI/AAMI EQ56-2013 Recommended practice for a medical equipment management program

ES-UNE, Principles of medical equipment

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 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.)

Henan Provincial Standard of the People's Republic of China, Principles of medical equipment

DB41/T 2402-2023 Management specification for the use of medical molecular sieve oxygen-generating equipment in medical institutions

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

IEEE 11073-20702-2016 Health informatics-Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services
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

NATO - North Atlantic Treaty Organization, Principles of 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.

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

DB32/T 3549-2019 Specifications for setting up facilities and equipment for temporary storage of medical waste in medical and health institutions