BS EN ISO 8835-4 is the standard for inhalational anaesthesia systems. Anaesthetic vapour delivery devices

BS EN ISO 8835-4:2009

Inhalational anaesthesia systems. Anaesthetic vapour delivery devices

Status : Superseded, Withdrawn   Published : June 2009 Replaced By : BS EN ISO 80601-2-13:2012+A2:2019
Conformity to regulation : Designated

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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

Standard NumberBS EN ISO 8835-4:2009
TitleInhalational anaesthesia systems. Anaesthetic vapour delivery devices
StatusSuperseded, Withdrawn
Publication Date30 June 2009
Conformity to regulationDesignated
Withdrawn Date28 February 2013
Normative References(Required to achieve compliance to this standard)ISO 4135, ISO 5356-1, IEC 60601-2-13:2003, ISO 5360, ISO 8835-3, IEC 60079-11, ISO 11196, IEC 60601-1-6, IEC 60601-1-2, IEC 60079-4, IEC 60601-1:1988
Informative References(Provided for Information)93/42/EEC, SS 01 91 02:1996, DIN 6164-2:1980, USA Federal Standard 595a, NFPA 53M, BS 5252:1976
Replaced ByBS EN ISO 80601-2-13:2012+A2:2019
ReplacesBS EN ISO 8835-4:2004
International RelationshipsEN ISO 8835-4:2009,ISO 8835-4:2004
DescriptorsIdentification methods, Marking, Performance testing, Anaesthesiology, Fire tests, Medical breathing apparatus, Electrical medical equipment, Safety measures, Equipment safety, Instructions for use, Occupational safety, Anaesthetic equipment, Flow measurement, Colour codes, Fire safety, Medical equipment, Technical documents
Title in FrenchSystèmes d'anesthésie par inhalation. Dispositifs d'administration de vapeur anesthésique
Title in GermanSysteme für die Inhalationsanästhesie. Anästhesiemittelverdampfer
ISBN978 0 580 65559 3
File Size395 KB

*To ask about withdrawn titles contact the
Customer Relations, +44 345 086 9001
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