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  • ISO 11197:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical supply units

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  07-11-2019

    Language(s):  French, English

    Published date:  11-02-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

    ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.

    ISO 11197:2016 applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.

    NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.

    Hazards inherent in the intended function of me equipment or me systems within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).

    NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

    General Product Information - (Show below) - (Hide below)

    Development Note DRAFT ISO/DIS 11197 is also available for this standard. (01/2018)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    13/30242951 DC : 0 BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN ISO 7396-1:2016 Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
    BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
    EN 60601-2-16:2015 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    CAN/CSA-ISO 16571:16 SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
    16/30323461 DC : 0 BS EN 60601-2-16 ED 5.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    AAMI IEC 60601-2-16 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT
    I.S. EN 60601-2-16:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    ONORM EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    DIN EN 1789:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    13/30255929 DC : 0 BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CSA Z5359 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS
    DIN EN ISO 7396-1:2016-09 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 60601-2-16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    UNE-HD 60364-7-710:2014 Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations
    I.S. EN 1789:2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    UNE-EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    BS EN 1789 : 2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    UNE-EN 1789:2007 Medical vehicles and their equipment - Road ambulances
    BS EN ISO 5359 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    I.S. EN ISO 5359:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    EN ISO 5359:2014/A1:2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017)
    I.S. HD 60364-7-710:2012 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS (IEC 60364-7-710:2002 (MOD))
    I.S. EN ISO 7396-1:2016 MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
    CSA C22.2 No. 60601.2.16 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    HD 60364-7-710:2012/AC:2013 LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS
    UNI EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 60446:2007 Basic and safety principles for man-machine interface, marking and identification - Identification of conductors by colours or alphanumerics
    IEC 60364-5-54:2011 Low-voltage electrical installations - Part 5-54: Selection and erection of electrical equipment - Earthing arrangements and protective conductors
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    EN 50174-1:2009/A2:2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 1: INSTALLATION SPECIFICATION AND QUALITY ASSURANCE
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 50174-2 : 2009 AMD 2 2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 2: INSTALLATION PLANNING AND PRACTICES INSIDE BUILDINGS
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 60598-1:2014+AMD1:2017 CSV Luminaires - Part 1: General requirements and tests
    EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    IEC 61386-1:2008+AMD1:2017 CSV Conduit systems for cable management - Part 1: General requirements
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
    IEC 61950:2007 Cable management systems - Specifications for conduit fittings and accessories for cable installations for extra heavy duty electrical steel conduit
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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