BS EN ISO 18778:2009 Respiratory equipment. Infant monitors. Particular requirements
BS EN ISO 18778 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age.
BS EN ISO 18778 applies to devices used in home care applications. These monitors are generally used without continual professional supervision. BS EN ISO 18778 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.
BS EN ISO 18778 does not apply to monitors intended for use in health care facilities/institutions. The requirements of BS EN ISO 18778, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.
Contents of BS EN ISO 18778:
- Foreword
- Introduction
- Scope
- Normative references
- Terms and definitions
- General requirements and general requirements for tests
- ClassificationIdentification, 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
- 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)
- Infrared radiation
- Ultraviolet energy
- Acoustical energy (including ultrasonics
- Electromagnetic Compatibility
- Locations and basic requirements
- Marking and 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, disinfection and compatibility
- 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
- Additional requirements
- Rationale
- Environmental aspects
- Index of defined terms
- Bibliography
