Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
German title
Medizinische elektrische Geräte - Teil 2-90: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Geräten für die Beatmungstherapie mit hohem Durchfluss
ME equipment identification, marking and documents
Information to be supplied by the manufacturer
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
Lay operator operating instructions
Healthcare professional operator operating instructions
Cleaning, disinfection and sterilization
Additional requirements for maintenance
Additional requirements for accessories, supplementary equipment, used material
* 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 instability from unwanted lateral movement
Grips and other handling devices
Additional requirements for audible acoustic energy
Protection against unwanted and excessive radiation hazards
Protection against excessive temperatures and other hazards
* Applied parts not intended to supply heat to a patient
Risk of fire in an oxygen rich environment
* Cleaning and disinfection of ME equipment or ME system
Sterilization of ME equipment or ME system
Biocompatibility of ME equipment and ME systems
Interruption of the power supply/supply mains to ME equipment
* Additional requirements for interruption of the power supply/supply mains to ME equipment alarm condition
Alarm conditions
Alternative power supply/supply mains
Accuracy of controls and instruments and protection against hazardous outputs
* Accuracy of controls and instruments
Continuous flow breathing-therapy mode
Flowrate accuracy
Accuracy of delivered oxygen concentration
Usability of ME equipment
Protection against hazardous output
Oxygen monitor
* Maximum limited pressure protection device
Flowrate monitoring
Obstruction alarm condition
* Protection against accidental adjustments
Hazardous situations and fault conditions for ME equipment
* Additional specific single fault conditions
* Independence of delivery control function and related risk control measures
* Failure of one gas supply to respiratory high-flow therapy equipment
* Programmable electrical medical systems (PEMS)
General
Construction of ME equipment
* Mode of operation
Pre-use check
Delivered oxygen concentration
ME systems
Additional general requirements for ME systems
* Accompanying documents of an ME system
Electromagnetic compatibility of ME equipment and ME systems
Gas connections
Breathing system connectors
* General
Other named ports
General
Patient-connection port
Accessory port
Monitoring probe port
Low-pressure oxygen inlet
Flow-direction-sensitive components
Nebulization port
High-pressure oxygen inlet connector
Gas intake port
Requirements for the breathing system and accessories
* General
Labelling
Breathing sets
* Humidification system
Breathing system filter (BSF)
Airway devices
* Indication of duration of operation
Functional connection
General
* Connection to an electronic health record
* Connection to a distributed alarm system
Connection for remote control
Power supply cords
Respiratory high-flow therapy equipment security
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
Selection of default alarm preset
* Operator alarm system logging
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Additional requirements for cleaning, disinfection and sterilization
General requirements for mechanical strength
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 interface requirements (informative)
Background and purpose
Data definition
Reference to the IMDRF essential principles and labelling guidances (informative)
Reference to the essential principles (informative)
Reference to the general safety and performance requirements (informative)
Terminology — Alphabetized index of defined terms (informative)
Bibliography
ICS
11.040.10
Cooperation at DIN
Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.
