BS EN ISO 17510-1:2009 Sleep apnoea breathing therapy. Sleep apnoea breathing therapy equipment
Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep.
The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equipment has become common.
BS EN ISO 17510-1 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
BS EN ISO 17510-1 applies to equipment intended for use with adults and children, but excludes equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.
ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient.
Contents of BS EN ISO 17510-1:
- Foreword
- Introduction
- Scope
- Normative references
- Terms and definitions
- Requirements
- Classification and designation
- Marking, labelling and packaging
- Power input
- Basic safety categories
- Removable protective means
- Environmental conditions
- Not used
- Not used
- General
- Requirements related to classification
- Limitation of voltage and/or energy
- Enclosures and protective covers
- Separation
- Protective earthing, functional earthing and potential equalization
- Continuous leakage currents and patient auxiliary currents
- Dielectric strength
- Mechanical strength
- Moving parts
- Surfaces, corners and edges
- Stability in normal use
- Expelled parts
- Vibration and noise
- Pneumatic and hydraulic power
- Suspended masses
- X-radiation
- Alpha, beta, gamma, neutron radiation and other particle radiation
- Microwave radiation
- Light radiation (including lasers)
- Infra-red radiation
- Ultra-violet radiation
- Acoustical energy (including ultra-sonics)
- Electromagnetic compatibility
- Locations and basic requirements
- Marking, accompanying documents
- Common requirements for Category AP and Category APG equipment
- Requirements and tests for category AP equipment, parts and components thereof
- Requirements and tests for category APG equipment, parts and components thereof
- Excessive temperatures
- Fire prevention
- Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
- Pressure vessels and parts subject to pressure
- Human errors
- Electrostatic charges
- Biocompatibility
- Interruption of the power supply
- Accuracy of operating data
- Protection against hazardous output
- Abnormal operation and fault conditions
- Environmental tests
- General
- Enclosures and covers
- Components and general assembly
- Mains parts, components and layout
- Protective earthing — Terminals and connections
- Construction and layout
