ISO 18835:2015
(Main)Inhalational anaesthesia systems — Draw-over anaesthetic systems
Inhalational anaesthesia systems — Draw-over anaesthetic systems
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.
Systèmes d'anesthésie par inhalation — Alimentation en vapeur et équipements annexes
General Information
Relations
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18835
First edition
2015-04-01
Inhalational anaesthesia systems —
Draw-over anaesthetic systems
Systèmes d’anesthésie par inhalation — Alimentation en vapeur et
équipements annexes
Reference number
©
ISO 2015
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Risk management . 2
4.2 Construction . 3
4.3 Performance . 4
4.4 * Components for use with flammable anaesthetic agents . 4
4.5 Materials . 4
4.6 Mechanical hazards . 4
4.7 Particulate matter. 4
4.8 Environmental requirements . 4
5 Draw-over vaporizer . 5
5.1 Construction . 5
5.2 Performance . 5
5.3 * Ports and connectors . 6
6 Breathing system. 6
6.1 Construction . 6
6.2 Performance . 7
6.3 Ports and connectors . 7
7 Reservoir . 7
7.1 Construction . 7
7.2 Performance . 7
7.3 Ports and connectors . 8
8 Bellows-type manual ventilator . 8
8.1 * Construction . 8
8.2 Performance . 8
8.3 Ports and connectors . 9
9 Marking of operator-assembled components . 9
9.1 General . 9
9.2 Marking of the draw-over vaporizer . 9
9.3 Marking of breathing-system attachments .10
9.4 Marking of reservoir .10
9.5 Marking of bellows-type manual ventilator .10
9.6 Marking of packages .11
10 Information supplied by the manufacturer .11
Annex A (informative) Rationale .13
Annex B (normative) Test methods .15
Annex C (informative) Environmental aspects .17
Annex D (informative) Reference to the essential principles .18
Bibliography .22
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
This International Standard cancels and replaces ISO/TS 18835:2004, which has been technically revised.
iv © ISO 2015 – All rights reserved
Introduction
The continuous-flow anaesthetic workstations described in ISO 80601-2-13 rely upon an uninterrupted
supply of compressed medical gases and electricity. These in turn depend upon a highly developed
infrastructure of transport, power generation, and technical services.
The World Health Organization (WHO) and the World Federation of Societies of Anaesthesiologists
(WFSA) have requested ISO ensure that the needs for safe anaesthesia for people in populous and low
to middle income countries of the world are also addressed in ISO standards for anaesthetic equipment.
In accordance with this request, ISO/TC 121/SC 1 has developed a standard for anaesthetic systems
(ISO 8835-7) that can give a safe inhalation anaesthetic without relying on electricity or compressed gas.
To achieve this, it is recognized that the draw-over anaesthetic system is an essential part of this
system. A technical specification for draw-over vaporizers and associated equipment, ISO/TS 18835
has been in publication since 2004 and forms the basis of this International Standard.
Throughout this International Standard, text for which a rationale is provided in Annex A is indicated
by an asterisk (*).
In this International Standard, the following print types are used:
— requirements, compliance with which can be verified, and definitions: roman type;
— notes and examples: smaller roman type;
— test methods: italic type;
— terms defined in this document: small caps.
INTERNATIONAL STANDARD ISO 18835:2015(E)
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.