09/30203808 DC : 0

Superseded

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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Superseded date

09-30-2011

Language(s)

English

Publisher

British Standards Institution

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

BS EN ISO 80601-2-12

Committee	CH/121/5
DocumentType	Draft
Pages	96
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 80601-2-12:2011

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