• 09/30203808 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2011

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    201.1 Scope, object and related standards
            201.1.1 Scope
            201.1.2 Object
            201.1.3 Collateral standards
            201.1.4 Particular standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
            201.4.3 Essential performance
            201.4.6 ME equipment or ME system parts that contact
                    the patient
            201.4.101 Additional requirements for essential
                      performance
    201.5 General requirements for testing of ME equipment
            201.5.101 Additional requirements for general
                      requirements for testing of ME equipment
    201.6 Classification of ME equipment and ME systems
    201.7 ME equipment identification, marking and documents
    201.8 Protection against electrical hazards from ME equipment
    201.9 Protection against mechanical hazards of ME equipment
            and ME systems
            201.9.101 Additional requirements for suction
                      procedures
    201.10 Protection against unwanted and excessive radiation
            hazards
    201.11 Protection against excessive temperatures and other
            hazards
    201.12 Accuracy of controls and instruments and protection
            against hazardous outputs
            201.12.1 Accuracy of controls and instruments
            201.12.4 Protection against hazardous output
            201.12.101 Protection against accidental adjustments
    201.13 Hazardous situations and fault conditions
            201.13.101 Delivered Oxygen concentration
            201.13.102 Failure of one gas supply to a ventilator
            201.13.103 Independence of ventilation control function
                       and related risk control measures
    201.14 Programmable electrical medical systems (PEMS)
            201.14.101 Software life cycle
    201.15 Construction of ME equipment
            201.15.101 Mode of operation
    201.16 ME systems
    201.17 Electromagnetic compatibility of ME equipment
            and ME systems
            201.17.101 Additional requirements for electromagnetic
                       compatibility of ME equipment ME systems
    201.101 Gas connections
            201.101.1 Reverse gas flow
            201.101.2 High-pressure input ports
            201.101.3 Connection to the medical gas pipeline system
            201.101.4 VBS connectors
    201.102 Requirements for the VBS and accessories
            201.102.1 General
            201.102.2 Labelling
            201.102.3 Breathing tubes
            201.102.4 Water management
            201.102.5 Gas mixers
            201.102.6 Breathing system filters
            201.102.7 Ventilator breathing systems
    201.103 Spontaneous breathing during loss of power
            supply
    201.104 Training
    201.105 Indication of duration of operation
    201.106 Signal input/output part
            201.106.1 General
            201.106.2 Connection to electronic health record
            201.106.3 Connection to a distributed alarm system
            201.106.4 Connection for remote control
    201.107 Display loops
            201.107.1 Pressure-volume loops
            201.107.2 Flow-volume loops
    201.108 Timed ventilatory pause
    202 Medical electrical equipment - Part 1-2: General
        requirements for basic safety and essential performance -
        Collateral standard: Electromagnetic compatibility -
        Requirements and tests
        202.6.2.1.10 Compliance criteria
    206 Medical electrical equipment - Part 1-8: General
        requirements for basic safety and essential performance -
        Collateral Standard: Usability
    208 Medical electrical equipment - Part 1-8: General
        requirements for basic safety and essential performance -
        Collateral Standard: General requirements, tests and
        guidance for alarm systems in medical electrical
        equipment and medical electrical systems
    Annex C (informative) - Guide to marking and labelling
            requirements for ME equipment and ME systems
    Annex D (informative) - Symbols on marking
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Reference to the Essential Principles
    Bibliography
    Alphabetized index of defined terms used in this particular
    standard
    Annex ZA (informative) - Relationship between this Document
             and the Essential Requirements of EU Directive
             93/42/EEC

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
    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
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    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
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for 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
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ASTM D 5466 : 2015 : REDLINE Standard Test Method for Determination of Volatile Organic Compounds in Atmospheres (Canister Sampling Methodology)
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    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
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    IEC 60068-2-29:1987 Environmental testing. Part 2: Tests. Test Eb and guidance: Bump
    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
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
    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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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