BS EN ISO 8835-4:2009 Inhalational anaesthesia systems. Anaesthetic vapour delivery devices
BS EN ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
- Part 2: Anaesthetic breathing systems for adults
- Part 3: Anaesthetic gas scavenging systems. Transfer and receiving systems
- Part 4: Anaesthetic vapour delivery devices
- Part 5: Anaesthetic ventilators
BS EN ISO 8835-4 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs). This international standard is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. Part 4 of BS EN ISO 8835 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.
BS EN ISO 8835-4 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).
The requirements of this part of ISO 8835 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 8835-4 include:
- 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
- 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
- Ultraviolet radiation
- 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
- Enclosures and covers
- Components and general assembly
- Mains parts, components and layout
- Protective earthing — Terminals and connections
- Construction and layout
- Additional requirements for AVDDs
- Recommended colours for colour coding of anaesthetic vapour delivery devices
- Test for flammability of anaesthetic agents
- Bibliography