ISO 80601-2-12:2023-11

Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege

Englischer Titel: Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Ausgabedatum: 2023-11
Originalsprachen: Englisch
Seiten: 158

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Ausgabedatum: 2023-11
Originalsprachen: Englisch
Seiten: 158

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Inhaltsverzeichnis
ICS
Ersatzvermerk
Normen mitgestalten

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Inhaltsverzeichnis

Inhalt (en)

Foreword
Introduction
Scope, object and related standards
- Scope
- Object
- Collateral standards
- Particular standards
Normative references
Terms and definitions
General requirements
- Additional requirements for essential performance
- System recovery
- Additional requirements for expected service life
- Alternative risk control measures or test methods for ME equipment or ME system
- ME equipment or ME system parts that contact the patient
- Additional requirements for pressurized gas input
  - Overpressure requirement
  - Compatibility requirement for medical gas pipeline systems
General requirements for testing of ME equipment
- Additional requirements for general requirements for testing of ME equipment
  - Ventilator test conditions
  - Gas flowrate and leakage specifications
  - Ventilator testing errors
Classification of ME equipment and ME systems
ME equipment identification, marking and documents
- Information to be supplied by the manufacturer
- Consult accompanying documents
  - Additional requirements for accessories
- External gas source
- Additional requirements for marking on the outside of ME equipment or ME equipment parts
- Units of measurement
- General
- Additional general requirements
- Additional requirements for warnings and safety notices
- Additional requirements for start-up procedure
- Additional requirements for operating instructions
- Cleaning, disinfection, and sterilization
- Additional requirements for accessories, supplementary equipment, used material
- Additional requirements for reference to the technical description
- Additional general requirements
- Additional requirements for the technical description
Protection against electrical hazards from ME equipment
Protection against mechanical hazards of ME equipment and ME systems
- Additional requirements for audible acoustic energy
- Additional requirements for suction procedures
Protection against unwanted and excessive radiation hazards
Protection against excessive temperatures and other hazards
- Applied parts not intended to supply heat to a patient
- Additional requirements for ingress of water or particulate matter into ME equipment or ME system
- Cleaning and disinfection of ME equipment or ME system
- Sterilization of ME equipment or ME system
- Biocompatibility of ME equipment and ME systems
- Additional requirements for interruption of the power supply/supply mains to ME equipment
Accuracy of controls and instruments and protection against hazardous outputs
- Accuracy of controls and instruments
  - Volume-control inflation-type
  - Pressure-control inflation-type
  - Other inflation-types
  - Inspiratory volume monitoring
  - Response of the ventilator to an increase in set oxygen (O) concentration
  - Protection against hazardous output
  - Measurement of expired volume and low volume alarm conditions
  - Expiratory end-tidal CO monitoring equipment
  - Maximum limited pressure protection device
  - High airway pressure alarm condition and protection device
  - PEEP alarm conditions
  - Obstruction alarm condition
  - Disconnection alarm condition
  - Protection against inadvertent setting of high airway pressure
- Protection against accidental or unintentional adjustments
Hazardous situations and fault conditions for ME equipment
- Additional specific single fault conditions
- Failure of one gas supply to a ventilator
- Independence of ventilation control function and related risk control measures
- Failure of functional connection to a ventilator control or monitoring means
Programmable electrical medical systems (PEMS)
- General
- Cybersecurity capabilities of critical care ventilators
Construction of ME equipment
- Additional requirements for rough handling
  - Shock and vibration (robustness)
  - Shock and vibration for a transit-operable ventilator during operation
- Construction of connectors
- Mode of operation
- Delivered oxygen concentration
- Accessory self-check
ME systems
- Additional general requirements for ME systems
- Accompanying documents of an ME system
Electromagnetic compatibility of ME equipment and ME systems
Gas connections
- Protection against reverse gas leakage
- Connection to an inlet
  - Low-pressure hose assembly
  - Filter
- VBSconnectors
  - General
  - Other named ports
Requirements for the VBS and accessories
- General
- Labelling
- Breathing sets
- Water vapour management
  - Humidification system
  - Heat and moisture exchanger (HME)
- Breathing system filters
- Ventilator breathing systems
  - Leakage from complete VBS
  - Non-invasive ventilation
Spontaneous breathing during loss of ventilation
Indication of duration of operation
Functional connection
- General
- Connection to an electronic health record
- Connection to a distributed alarm system or distributed information system about alarm conditions
- Connection for remote control
Display loops
- Pressure-volume loops
- Flow-volume loops
Timed ventilatory pause
- Expiratory pause
- Inspiratory pause
Electromagnetic disturbances — Requirements and tests
- Compliance criteria
- Requirements applicable to all ME equipment and ME systems
- Additional general requirements
Usability
- Primary operating functions
- Training
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- Additional requirements for 1 m (operator’s position) visual alarm signals and information signals
- Additional requirements for global indefinite alarm signal inactivation states
- Additional requirements for termination of alarm signal inactivation
- Operator alarm system logging
- Responsible organization alarm system logging
Guide to marking and labelling requirements for ME equipment and ME systems (informative)
- Marking on the outside of ME equipment, ME systems or their parts
- Accompanying documents, general
- Accompanying documents, instructions for use
- Accompanying documents, technical description
Symbols on marking (informative)
Particular guidance and rationale (informative)
- General guidance
- Rationale for particular clauses and subclauses
Data interfaces (informative)
- Background and purpose
- Data definition
Reference to the IMDRF essential principles and labelling guidances (informative)
Reference to the essential principles (informative)
Bibliography

ICS

11.040.10

Ersatzvermerk

Dieses Dokument ersetzt ISO 80601-2-12:2020-02 .

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