BS ISO 18835:2015 pdf download

BS ISO 18835:2015 pdf download

BS ISO 18835:2015 pdf download.Inhalational anaesthesia systems — Draw-over anaesthetic systems
1 * Scope
This International Standard specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.
Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents.
This International Standard also includes requirements for a bellows-type manual ventilator.
NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601-2-13.
NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651-4.
This International Standard does not specify requirements for monitoring of the equipment or the patient.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 5360, Anaesthetic vaporizers — Agent-specific filling systems
ISO 5367, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 23328-2, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
ISO 80369-7 1) , Small bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
EN 13544-2:2002+A1:2009, Respiratory therapy equipment — Part 2: Tubing and connectors
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135:2001 and the following apply.
3.1 carrier gas
respirable gas that carries the anaesthetic agent to the patient
Note 1 to entry: A common example of a car r ier gas is entrained ambient air supplemented with oxygen.
3.2 draw-over anaesthetic system
low-resistance system for administering inhalational anaesthesia that can be used in the absence of compressed gas or electricity
3.3 draw-over valve system
a valve, or combination of valves, that controls unidirectional flow to the patient during inspiration and unidirectional flow from the patient during exhalation under both spontaneous ventilation and intermittent positive pressure ventilation (IPPV)
3.4 draw-over vaporizer
vaporizer from which a sufficient flow of gas vapour mixture is produced by lowering the pressure at the outlet of the vaporizer below that at its inlet by a patient’s inspiratory effort or by a ventilator [SOURCE: ISO 4135:2001, 4.1.8, modified — the breathing system and the vaporizer are treated as
separate devices in this International Standard, and thus, the phrase “either in the breathing system and the vaporizer,” as used in ISO 4135, is inappropriate in this International Standard]