ISO 11712:2023
(Main)Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
This document provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to provide a distinct respiratory pathway to the top of the larynx to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. This document specifies the dimensions, basic properties and method of size designation of the available types of supralaryngeal airways. Airways devised for specialized applications are not specifically covered, although most may be classified by the sizing and dimensions (or other characteristics) required by this document. The following devices are outside the scope of this document: nasal and oropharyngeal airways, anesthetic masks, oro- and naso-tracheal tubes, cricothyrotomy devices, dental appliances, tracheal stents, tracheal tubes, ventilating laryngoscopes, CPAP devices, esophageal obturators, bougies and devices that require surgical placement. This document specifies dimensional disclosure so the operator will know which auxiliary devices, such as tracheal tubes and bronchoscopes will be size-compatible. Flammability of airways, for example if used with certain flammable anesthetic gases, electrosurgical units or lasers, is a well-recognized hazard that is outside the scope of this document. (See E.1.7).
Matériel d'anesthésie et de réanimation respiratoire — Canules supralaryngées et raccords
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INTERNATIONAL ISO
STANDARD 11712
Second edition
2023-11
Anaesthetic and respiratory
equipment — Supralaryngeal airways
and connectors
Matériel d'anesthésie et de réanimation respiratoire — Canules
supralaryngées et raccords
Reference number
ISO 11712:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 11712:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 11712:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 General . 3
4.2 Test methods . 3
5 Materials . 3
5.1 General . 3
5.2 Biological safety testing . 3
5.3 Guidance on materials specific to supralaryngeal airways and connectors . 3
6 Design requirements .3
6.1 General . 3
6.2 Ventilation positions of use . 3
6.3 Size designation . 4
6.4 Ventilatory openings . 4
6.5 Safeguards against collapse of the ventilatory pathway . 4
6.6 Seating mechanisms .
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11712
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Supralaryngeal airways
Voting begins on:
2023-07-25 and connectors
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire — Canules
2023-09-19
supralaryngées et raccords
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 11712:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 11712:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11712
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Supralaryngeal airways
Voting begins on:
and connectors
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire — Canules
supralaryngées et raccords
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 11712:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 11712:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 General . 3
4.2 Test methods . 3
5 Materials . 3
5.1 General . 3
5.2 Biological safety testing . 3
5.3 Guidance on materials spec
...
ISO DIS/FDIS 11712:2021
Date: 2023-03-24
ISO /TC 121/SC 2/WG 13
Secretariat: ANSI
Date: 2023-06-16
Anaesthetic and respiratory equipment – — Supralaryngeal
airways and connectors
Matériel d'anesthésie et de réanimation respiratoire — Canules supralaryngées et raccords
FDIS Stagestage
---------------------- Page: 1 ----------------------
ISO/DIS FDIS 11712:20212023(E)
© ISO 20212023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 • CP 401 • Ch. de Blandonnet 8
CH-12111214 Vernier, Geneva 20
Tel. Phone: + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail: copyright@iso.org
Web www.iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS FDIS 11712:20212023(E)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 General . 3
4.2 Test methods . 3
5 Materials . 3
5.1 General . 3
5.2 Biological safety testing . 3
5.3 Guidance on materials specific to supralaryngeal airways and connectors . 3
6 Design requirements . 3
6.1 General . 3
6.2 Ventilation positions of use . 3
6.3 Size designation . 4
6.4 Ventilatory openings . 4
6.5 Safeguards against collapse of the ventilatory pathway . 4
6.6 Seating mechanisms. 4
6.7 Cuff inflation/deflation system . 5
6.8 Internal volume .
...
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