BS EN ISO 8835-3:2009+A1:2010

BS EN ISO 8835-3:2009 + Amendment 1:2010
Inhalational anaesthesia systems. Transfer and receiving systems of active anaesthetic gas scavenging systems

This part of BS EN ISO 8835 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure). This part of ISO 8835 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

BS EN ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:

Part 2: Anaesthetic breathing systems

Part 3: Transfer and receiving systems of active anaesthetic gas scavenging system

Part 5: Anaesthetic ventilators

Part 1 of BS EN ISO 8835 is intended to ensure that, for all practical purposes, an active AGSS will remove essentially all gases delivered to it and thereby reduce atmospheric pollution to a small fraction of the uncontrolled level.

It is recognized that there are many factors affecting conditions within the operator’s working environment, which are outside the control of manufacturers of active AGSSs. These include room ventilation, leakage from equipment and the choice of anaesthetic technique, all of which are variable. Furthermore, the amount of pollutant taken up by personnel will be affected by other factors, such as the duration of exposure, their position in relation to any source of pollution, etc.

Atmospheric pollution by anaesthetic gases is the subject of considerable discussion, and opinions differ as to the limits that should be allowed in the working environment.

Recommendations on permissible levels are therefore not included in this part of ISO 8835 but can be specified in national standards.

The committee responsible for this part of ISO 8835 has been primarily concerned with limiting the risks to the patient, which the transfer and receiving systems of AGSS can introduce by altering the function of breathing systems. The wide range of anaesthetic machines, ventilators and related equipment in general use today has been taken into account.

BS EN ISO 8835 also contains rationale statements for some of the requirements of this part of the standard. The clauses and subclauses marked with an asterix (*) before their number have corresponding rationale contained in Annex F, included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard.

Contents of BS EN ISO 8835 include:

• Introduction
• Scope
• Normative references
• Terms and definitions
• General requirements and alternative test methods
• Materials
• Means of pressure relief
• Alternative test methods
• Patient and environmental protection
• Normal operating conditions
• Single fault conditions
• Connectors
• Transfer systems
• Inlet of transfer systems
• Outlet of transfer systems
• Receiving systems
• Inlet of receiving systems
• Outlet of receiving systems
• Visual indicator
• Particle filter
• Receiving hoses
• Extract flow resistance
• Low-flow transfer and receiving systems
• High-flow transfer and receiving systems
• Electrical requirements
• Information to be supplied by the manufacturer
• Marking
• Colour coding
• Typical test arrangement and method for pressure measurement at inlet to AGSS
• Typical test arrangement and method for sub-atmospheric pressure limitation
• Typical test arrangement and method for testing of induced flow
• Typical test arrangement and method for resistance to extract flow
• Typical test arrangement and method for spillage
• Rationale
• Environmental aspects
• Bibliography