Medical Equipment Management and Technology

Medical Equipment Management and Technology, Total:165 items.

The international standard classification for "Medical Equipment Management and Technology" includes: Other medical equipment , Applications of information technology in general .

The Chinese standard classification for "Medical Equipment Management and Technology" includes: Public medical equipment , Medical apparatus and devices in general , Social and public safety in general .

Professional Standard - Post and Telecommunication

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

未注明发布机构

AS/NZS 3551:2012(R2016) Medical Equipment Management Program
AS/NZS 3551:2012/AMD 1:2013 Medical Equipment Management Program
DIN EN ISO 15225 E:2015-08 Medical device quality management medical device nomenclature data structure (draft)

Group Standards of the People's Republic of China

T/SHWSHQ 08-2022 Electrical safety technology and management specifications for medical and health institutions
T/CSBME 025-2021 Reliability Management System of Medical Equipment
T/AHEPI 0003-2023 Technical specification for the operation and management of sewage treatment facilities in medical organizations
T/HNAEPI 008-2023 Technical specifications for online monitoring and management platform of wastewater in medical institutions
T/YNCF 004-2024 Medical information system management job skills and evaluation
T/GZBC 38-2020 Technical requirements for IoT of medical institution asset management
T/CADERM 8006-2024 Requirements for establishment and management of medical first-aid support assistant team
T/TAF 107-2022 Security of smart wearable devices—Security technical requirements and testing methods for medical and health wearable devices
T/CAS 842-2024 Evaluation of quality management maturity of medical equipment in medical institutions
T/CHAS 10-4-4-2019 Quality and safety management of Chinese hospital—— Part 4-4: Medical management — medical risk management
T/GDWJ 009-2022 Technical specifications of IoT for logistics management of medical institutions
T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device
T/CHAS 20-4-4-2023 Pharmacy administration and Pharmacy practice in Healthcare institutions —— Part4-4: Pharmacy administration——Automation and information technology
T/CAME 64-2024 Technology and management specification of medical gas pipeline system
T/CASMES 171-2023 Construction and management norms of grassroots medical waste mathematical intelligence system
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/GDC 244-2023 Technical specifications for medical intelligent logistics property management platform
T/CHAS 10-4-7-2021 Quality and safety management of Chinese hospital—— Part 4-7: Medical management —— medical devices management
T/CAMER 024-2024 Standard for operation and maintenance management of sewage treatment in medical institutions

Jiangxi Provincial Standard of the People's Republic of China

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

Professional Standard - Environmental Protection

HJ 516-2009 Technical Specifications for the Supervision and Management to the Operation of Incineration Disposal Facilities for Medical Waste(On Trial)
HJ 1284-2023 Technical specifications for operation and management of medical waste disinfection treatment facilities

Zhejiang Provincial Standard of the People's Republic of China

DB33/T 2568-2023 Medical Security Management and Service Standards for Designated Medical Institutions

Anhui Provincial Standard of the People's Republic of China

DB34/T 4202-2022 Technical specifications for the establishment and management of small animal diagnosis and treatment institutions

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 332-2023 Technical specifications for palliative care in medical institutions
DB4403/T 182-2021 Guidelines for the construction and management of bathrooms in medical and health institutions

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

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

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 3545.4-2021 Technical Management of Blood Purification Therapy Part 4: Medical Quality Management Standards for Blood Purification Medical Institutions
DB3203/T 1037-2023 Medical insurance handling hall management and business specifications

Liaoning Provincial Standard of the People's Republic of China

DB21/T 3886-2023 Medical waste transfer and storage facilities and equipment management specifications

Professional Standard - Urban Construction

CJ/T 3083-1999 Equipment specification for the incineration of medical wastes

Henan Provincial Standard of the People's Republic of China

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

Hubei Provincial Standard of the People's Republic of China

DB42/T 1990-2023 Hubei Provincial Medical Institutions Measurement Equipment Metrology Management Guide

国家密码管理局

GM/T 0050-2016 Cryptography Device Management - Specification of Device Management Technology

Shanghai Provincial Standard of the People's Republic of China

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

司法部

SF/T 0043-2019 Smart detoxification - Technical specification for rehabilitation management information system

British Standards Institution (BSI)

BS EN ISO 14971:2007 Medical devices - Application of risk management 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
BS PAS 131:2007 Terminology for medical, health and personal care applications of nanotechnology
18/30370883 DC BS EN ISO 14971. 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 DD ISO/TS 10993-20:2006 Biological evaluation of medical devices - Principles and methods for immunotoxicology testing of medical devices
BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Standard Association of Australia （SAA）

AS/NZS 3551:2012 Medical Equipment Management Program
AS/NZS 3551:2004 Technical management programs for medical devices

GB-REG

REG NASA NPR 7120-2011 NASA Health and Medical Technical Authority (HMTA) Implementation

German Institute for Standardization

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 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010); German version EN ISO 15225:2010
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 14971 Berichtigung 1:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07
DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
DIN 32541:1977 Management of machines and similar technical equipment; Terminology associated with activities
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

SCC

AAMI EQ93:2019 Medical equipment management - Vocabulary used in medical equipment programs
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog
AS/NZS 3551:1996 Technical management programs for medical devices
CEI UNI EN ISO 13485:2023 Medical devices - Quality management systems - Requirements for regulatory purposes
AENOR UNE-EN ISO 15225:2016 Medical devices. Quality management. Structure of nomenclature data for medical devices. (ISO 15225:2016).
AENOR UNE-EN ISO 13485 ERTA:2004 Medical devices. Quality Management Systems. Requirements for regulatory purposes (ISO 13485:2003)
VDI/VDE 2426 BLATT 1-2019 Catalogues in the maintenance and management of medical technology — Basics
VDI/VDE 2426 BLATT 3-2000 Catalogues in the maintenance and management of medical technology — Error catalogues
VDI/VDE 2426 BLATT 4-2000 Catalogues in the maintenance and management of medical technology — Maintenance measures
BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
BS PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
BS PD ISO/TR 21730:2005 Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for the management of unintentional electromagnetic interference with medical devices
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC TIR80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security
AS 2696:1989 Medical equipment - Single-use urethral catheters (sterile) for general medical use

International Organization for Standardization (ISO)

ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
ISO/CD 5137 Maintenance management program for medical equipment
ISO 15223-1:2021/CD Amd 1:2024 Medical devices
ISO/CD 20417:2024 Medical devices
ISO 9170:1990 Terminal units for use in medical gas pipeline systems
ISO/IEC 17811-2:2015 Information technology - Device control and management - Part 2: Specification of Device Control and Management Protocol
ISO/TS 17371:2023 Healthcare organization management

RU-GOST R

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
GOST R 53918-2010 Medical devices. Implementation of risk management principles and activities within a quality management system
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 55718-2013 Medical electrical equipment. Angiography X-ray equipment. Technical requirements for governmental purchases
GOST R 56316-2014 Medical electrical equipment. Medical electron accelerators. Technical requirements for governmental purchases
GOST R 55771-2013 Medical electrical equipment. Angiography X-ray equipment. Technical requirements for governmental purchases
GOST R 58024-2017 Medical devices. Equipment for thermal disinfection/neutralization of medical waste. Dry hot air method. Technical requirements for governmental purchases
GOST R 56318-2014 Medical electrical equipment. Gamma-therapy distant equipment for radiotherapy. Technical requirements for governmental purchases
GOST R 56319-2014 Medical electrical equipment. Gamma-therapy equipment for brachytherapy. Technical requirements for governmental purchases
GOST R 56314-2014 Medical electrical equipment. Dosimetry equipment for radiotherapy. Technical requirements for governmental purchases
GOST R ISO 13485-2004 Medical devices. Quality management systems. System requirements for requlatory purposes
GOST R 56128-2014 Medical electrical equipment. Operating luminaires. Technical requirements for governmental purchases
GOST R 56107-2014 Medical electrical equipment. Operating tables. Technical requirements for governmental purchases
GOST R 57086-2016 Medical electrical equipment. Devices for laser lithotripsy. Technical requirements for governmental purchases
GOST R 57765-2017 Medical equipment. Products prosthetic-orthopedic. General technical requirements
GOST R 57765-2021 Prosthetic-orthopedic products. General technical requirements
GOST R 56327-2014 Medical electrical equipment. Ultrasonic equipment of expert class. Technical requirements for governmental purchases
GOST R 55719-2013 Medical electrical equipment. Demands to the contents and veneering of technical projects for the competitive documentation at carrying out of the state purchases of the highly technological medical equipment

International Electrotechnical Commission (IEC)

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

CZ-CSN

CSN 85 6009-1980 Medical apparatus. Dental technics. Symbols
CSN ON 91 4270-1967 Household medical technology equipment. cast iron paint stand pool

Indonesia Standards

SNI IEC/TR 60930:2016 Pedoman untuk petugas penatalaksanaan dan paramedis yang berhubungan dengan keselamatan penggunaan peralatan elektromedik dan sistem elektromedik

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI TIR12:2020(R2023) Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

PT-IPQ

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

ZA-SANS

SANS 10248-1:2008 Management of healthcare waste - Part 1: Management of healthcare risk waste from a healthcare facility
SANS 10248-2:2009 Management of healthcare waste - Part 2: Management of healthcare risk waste for healthcare facilities and healthcare providers in rural and remote settings

Korean Agency for Technology and Standards (KATS)

KS P ISO 15225:2014 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 15225:2009 Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
KS C 1103-1990 Glossary of Terms Used in Medical Electrical Equipment (General Terms)
KS X ISO TR 21730-2020 Health informatics－Use of mobile wireless communication and computing technology in healthcare facilities－Recommendations for the management of unintentional electromagnetic interference with medical devices

GOST

GOST R 70987-2023 Medical electrical equipment. Microwave therapy equipment. Technical condition control methods
GOST R 70478-2022 Software as a medical device. Application of quality management system
GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements

HU-MSZT

MNOSZ 14706-1954 Medical equipment. operating table
MNOSZ 15520-1953 Medical equipment. operating table
MNOSZ 14729-1954 Medical equipment. surgical box
MNOSZ 15519-1953 Medical equipment. operating table
MNOSZ 14659-1955 Medical equipment. Examination and surgical chairs

European Committee for Standardization (CEN)

EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure

AENOR

UNE 20901:1995 GUIDELINES FOR ADMINISTRATIVE, MEDICAL AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQUIPMENT.

US-AAMI

ANSI/AAMI EQ56-1999 Recommended practices for a medical equipment management program
ANSI/AAMI EQ56-2013 Recommended practice for a medical equipment management program

VDI - Verein Deutscher Ingenieure

VDI/VDE 2426 Blatt 4-1996 Catalogues in maintenance and management of medical devices - Precautions for maintenance
VDI/VDE 2426 Blatt 3-1996 Catalogues in maintenance and management of medical devices - Catalogues of deficiencies
VDI/VDE 2426 BLATT 1-2017 Catalogues in maintenance and management of medical devices - Basics

PL-PKN

PN Z54514-1954 Przedmiotem normy jest stopa szyny Dietrichsa ujg PN-54/Z-545I1.
PN Z04600-1971 Medical equipmenf ethods for testing technical e?ficiency f s?aem s?erilizers
PN Z78000-1970 Medical equipmen< opular hospital beds

Institute of Electrical and Electronics Engineers (IEEE)

IEEE Unapproved Draft Std P11073-00101/D03, Sep 20 Health Informatics - Point-Of-Care Medical Device Communication - Technical Report - Guidelines for the Use of RF Wireless Technology
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 Unapproved Draft Std P11073-00101/D03, Sep 2007 Health Informatics - Point-Of-Care Medical Device Communication - Technical Report - Guidelines for the Use of RF Wireless Technology
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

Association Francaise de Normalisation

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 S90-316:1987 Medico-surgical equipment. Operating tables.
NF EN ISO 17664-2:2023 Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 2: non-critical medical devices
NF ISO 17664-2:2021 Processing of healthcare products - Information relating to the processing of medical devices to be provided by the device manufacturer - Part 2: non-critical medical devices
NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.
NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of medical devices
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF EN IEC 80001-1:2021 Application of risk management to information technology networks containing medical devices - Part 1: safety, effectiveness and security in the implementation and use of connected medical devices or ...

AT-ON

ONORM K 3010-1979 Gas cylinders, pressure regulators (governors) and hoses tor medico-technical equipment

GSO

GSO IEC/TR 80001-2-2:2013 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
GSO ASTM F2809:2021 Standard Terminology Relating to Medical and Surgical Materials and Devices
GSO IEC/TR 80002-1:2015 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
BH GSO ASTM F2809:2022 Standard Terminology Relating to Medical and Surgical Materials and Devices
GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

ES-UNE

ISO 7101:2023 Healthcare organization management — Management systems for quality in healthcare organizations — Requirements

IEEE - The Institute of Electrical and Electronics Engineers@ Inc.

IEEE P11073-10101/D8-2019 Standard for Health Informatics—Point-of-Care Medical Device Communication—Nomenclature

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.1/4-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES

Danish Standards Foundation

DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1

IX-EU/EC

MEDDEV 2.1/3-2001 GUIDELINES RELATING TO THE APPLICATION OF : THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES

NZ-SNZ

NZS 4304:2002 Management of Healthcare Waste

US-FCR

FCR FED H-08-5 CHAP 246-1978 MEDICAL ADMINISTRATION SERVICE
FCR FED H-08-9 CHAP 246-1980 MEDICAL ADMINISTRATION SERVICE

Others: Medical Equipment Management and Technology,Cutting-edge technologies and products of medical devices