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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
09-30-2011
English
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
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