BS EN ISO 8185:2009 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
BS EN ISO 8185 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). BS 6151:1992 specifies other safety and performance requirements for breathing tubes.
BS EN ISO 8185 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. BS EN ISO 8185 does not apply to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture.
ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance.
Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, BS EN ISO 8185 has been prepared as a Particular Standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. Where BS EN ISO 8185 specifies that a clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the humidification system under consideration.
BS EN ISO 8185 does not apply to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
BS EN ISO 8185 does not apply to nebulizers used for the delivery of drugs to patients. In the planning and design of products within the scope of BS EN ISO 8185, it is advisable to give due consideration to the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex GG.
Additional aspects of environmental impact are addressed in BS EN ISO 14971.
Contents of BS EN ISO 8185:
- Foreword
- Introduction
- Scope
- Normative references
- Terms and definitions
- General requirements and general requirements for tests
- Classification
- Identification, marking and documents
- 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
- Surface, 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
- Ultraviolet energy
- Acoustical energy (including ultrasonics)
- 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 error
- Electrostatic charges
- Biocompatibility
- Interruption of power supply
- Accuracy of operating data
- Protection against hazardous output
- Abnormal operation and fault conditions
- Environmental tests
- General
- Enclosure and covers
- Components and general assembly
- Mains parts, components and layout
- Protective earthing — Terminals and connections
- Construction and layout
- Humidification system output
- Liquid container
- Alarm systems
- Rationale
- Determination of the accuracy of the displayed temperature
- Specific enthalpy calculations
- Temperature sensors and mating ports
- Determination of humidification system output
- Standard temperature sensor
- Environmental aspects
- Reference to the essential principals of safety and performance
- Terminology — Index of defined terms
- Bibliography
