ISO 18835:2015
Current
The latest, up-to-date edition.
Inhalational anaesthesia systems — Draw-over anaesthetic systems
Hardcopy , PDF
English
02-04-2015
ISO 18835:2015 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.
ISO 18835:2015 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.
ISO 18835:2015 does not specify requirements for monitoring of the equipment or the patient.
| Committee |
ISO/TC 121/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 18835 & ISO TS 18835. ((04/2015)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| BS ISO 18835:2015 | Identical |
| NEN ISO 18835 : 2015 | Identical |
| ISO 5360:2016 | Anaesthetic vaporizers — Agent-specific filling systems |
| ISO 80601-2-13:2011 | Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| ISO 8835-7:2011 | Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
| ISO/TS 18835:2004 | Inhalational anaesthesia systems — Draw-over vaporizers and associated equipment |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| ISO 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
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