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  1. HOME
  2. Standards for Principles of medical equipment

Principles of medical equipment

Principles of medical equipment, Total:200 items.

The international standard classification for "Principles of medical equipment" includes: Other medical equipment .

The Chinese standard classification for "Principles of medical equipment" includes: Medical apparatus and devices in general .

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

  • DB4401/T 277.1-2024 Medical Equipment Preventive Maintenance Management Regulations Part 1: General Provisions

Group Standards of the People's Republic of China

  • T/CAS 842-2024 Evaluation of quality management maturity of medical equipment in medical institutions
  • T/CIET 231-2023 Integrated equipment for advanced treatment of medical sewage
  • T/GDMDMA 0012.12-2022 Specifications for the Management of Medical Equipment in Hospitals - Part 12: Performance Evaluation Management
  • T/CHAS 10-3-4-2019 Quality and safety management of Chinese hospital—Part 3-4: Medical service support —Medical device
  • T/CSBME 025-2021 Reliability Management System of Medical Equipment

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

British Standards Institution (BSI)

  • 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
  • PD ISO/TR 25555:2024 Ageing societies. Accessibility and usability considerations for home healthcare products, related services and environments
  • PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
  • BS ISO 24163-2:2024 Clamp-in tyre valves for tyre pressure monitoring systems - Test methods and performance
  • 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
  • BS EN 1640:1997 Dentistry. Medical devices for dentistry. Equipment

Association for the Advancement of Medical Instrumentation

American National Standards Institute （ANSI)

Gosstandart of Russia

  • GOST R 58451-2019 Medical devices. Maintenance. Basic principles
  • GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing 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 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

German Institute for Standardization

Ente Nazionale Italiano di Unificazione

  • UNI CEI EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • UNI EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • UNI EN 1640:2004 Dentistry - Medical devices for dentistry - Equipment

Portuguese Institute of Quality

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

International Organization for Standardization (ISO)

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

European Committee for Standardization (CEN)

International Electrotechnical Commission (IEC)

GCC Standardization Organization

Swedish Institute for Standards

  • SS-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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 P1073.1.3.6/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 P1073.1.3.11/D3.0:1999 Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Capnometer
  • 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
  • P1073.1.3.4/D3.0 IEEE Draft Standard for Medical Device Communications - Medical Device Data Language (MDDL) Medical Device Specializations - Pulse Oximeter
  • 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

Association Francaise de Normalisation

  • 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 Medical electrical devices - Light ion beam medical devices - Performance characteristics
  • NF EN 1640:2009 Dental art - Medical devices for dentistry - Equipment
  • NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS

National Electrical Manufacturers Association（NEMA)

Polski Komitet Normalizacyjny (PKN)

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 10993-20:2009 Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices

Spanish Association for Standardization (UNE)

Association of German Mechanical Engineers

Canadian Standards Association (CSA)

Indonesia Standards

US Federal Contractor Registration (USFCR)

Magyar Szabványügyi Testület

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

Society of Automotive Engineers (SAE)

GB-REG

Standard Association of Australia （SAA）

  • AS 2684:1984 Medical equipment - Humidifiers, for medical use

National Standardisation Body (ASRO)

Danish Standards Foundation

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