Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors

ISO 11712:2009 provides the essential requirements for the design of supralaryngeal airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation. ISO 11712:2009 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 International Standard. ISO 11712:2009 requires dimensional disclosure so the operator will know which auxiliary instruments, such as tracheal tubes and bronchoscopes will be size-compatible.

Matériel d'anesthésie et de réanimation respiratoire — Canules supralaryngées et raccords

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Status
Published
Publication Date
14-May-2009
Current Stage
9092 - International Standard to be revised
Start Date
28-Jul-2020
Completion Date
28-Jul-2020
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INTERNATIONAL ISO
STANDARD 11712
First edition
2009-05-15
Anaesthetic and respiratory equipment —
Supralaryngeal airways and connectors
Matériel d'anesthésie et de réanimation respiratoire — Canules
supralaryngées et raccords
Reference number
ISO 11712:2009(E)
ISO 2009
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ISO 11712:2009(E)
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© ISO 2009

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Published in Switzerland
ii © ISO 2009 – All rights reserved
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ISO 11712:2009(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

1 Scope ..................................................................................................................................................... 1

2 Normative references ........................................................................................................................... 1

3 Terms and definitions........................................................................................................................... 2

4 General requirements........................................................................................................................... 3

5 *Requirements....................................................................................................................................... 4

5.1 Supralaryngeal airways........................................................................................................................ 4

5.1.1 *Size designation .................................................................................................................................. 4

5.1.2 Materials ................................................................................................................................................ 4

5.1.3 *Ventilatory opening............................................................................................................................. 4

5.1.4 *Safeguards against collapse of the ventilatory pathway ................................................................ 5

5.1.5 *Sealing mechanism............................................................................................................................. 5

5.1.6 *Internal volume.................................................................................................................................... 5

5.1.7 Maximum instrument size.................................................................................................................... 5

5.2 Supralaryngeal airway connectors ..................................................................................................... 6

6 Requirements for supralaryngeal airways and connectors supplied sterile ................................. 6

6.1 Sterility assurance................................................................................................................................ 6

6.2 Packaging for supralaryngeal airways and connectors supplied sterile........................................ 6

7 Cleaning and disinfection or sterilization .......................................................................................... 6

8 Markings ................................................................................................................................................ 6

8.1 Use of symbols ..................................................................................................................................... 6

8.2 Marking of the supralaryngeal airway ................................................................................................ 6

8.3 Marking on the supralaryngeal airway individual pack .................................................................... 7

9 Accompanying documents.................................................................................................................. 7

Annex A (informative) Rationale ..................................................................................................................... 10

Annex B (normative) Evaluation and documentation of the clinical performance in human

subjects ............................................................................................................................................... 15

Annex C (normative) Test methods to determine kink resistance.............................................................. 17

Annex D (informative) Hazard identification for risk assessment............................................................... 22

Annex E (informative) Guidance on materials and design........................................................................... 26

Bibliography ..................................................................................................................................................... 28

© ISO 2009 – All rights reserved iii
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ISO 11712:2009(E)
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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11712 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 2, Tracheal tubes and other equipment.
iv © ISO 2009 – All rights reserved
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ISO 11712:2009(E)
Introduction

* A supralaryngeal airway is a device placed through the mouth, intended to seal the supralaryngeal area to

maintain airway patency without passing through the vocal cords and to independently facilitate ventilation

with or without delivery of anesthesia gases. Devices intended to provide a breathing airway and/or to

simultaneously provide a guide for the intubation of tracheal tubes, bronchoscopes and suction devices are

also included in the scope of this International Standard, as are the connectors inserted into the machine end

of these devices.

* Examples of supralaryngeal airway devices are laryngeal masks, laryngeal tubes, airways and seals,

cuffed oropharyngeal airways, and pharyngeal airways, and combination airway/esophageal obturators.

The requirements of this International Standard were developed using the hazard identification for risk

assessment in Annex D.

The requirements for testing and disclosure apply to devices introduced to the market after the publication of

this International Standard.

Throughout this International Standard, terms defined in ISO 4135 or in this International Standard appear in

bold type.

Throughout this International Standard, text for which a rationale is provided in Annex A is indicated by an

asterisk (*).
© ISO 2009 – All rights reserved v
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INTERNATIONAL STANDARD ISO 11712:2009(E)
Anaesthetic and respiratory equipment — Supralaryngeal
airways and connectors
1 Scope

1.1 This International Standard provides the essential requirements for the design of supralaryngeal

airways and connectors. These devices are intended to open and seal the supralaryngeal area to provide an

unobstructed airway in patients during spontaneous, assisted or controlled ventilation.

1.2 This International Standard 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 International Standard.

1.3 The following devices are outside the scope of this International Standard: 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.

1.4 This International Standard requires dimensional disclosure so the operator will know which auxiliary

instruments, such as tracheal tubes and bronchoscopes will be size-compatible.

1.5 Flammability of airways, for example if used with certain flammable anesthetics, electrosurgical units or

lasers, is a well-recognized hazard that is outside the scope of this International Standard. See E.1.7.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary

ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 5361:1999, Anaesthetic and respiratory equipment — Tracheal tubes and connectors

ISO 7000, Graphical symbols for use on equipment — Index and synopsis

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process
ISO 11607:2003, Packaging for terminally sterilized medical devices

ISO 11134, Sterilization of health care products — Requirements for validation and routine control —

Industrial moist heat sterilization
© ISO 2009 – All rights reserved 1
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ISO 11712:2009(E)

ISO 11135:1994, Medical Devices — Validation and routine control of ethylene oxide sterilization

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11990, Optics and optical instruments — Lasers and laser-related equipment — Determination of laser

resistance of tracheal tube shafts
ISO/TR 11991, Guidance on airway management during laser surgery of upper airway

ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements

ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation

plans

ISO 14408, Tracheal tubes designed for laser surgery — Requirements for marking and accompanying

information
3 Terms and definitions

For the purposes of this document, the terms and definitions in ISO 4135 and the following apply.

3.1
auxiliary ventilatory opening

secondary opening in the ventilatory pathway intended for passage of ventilatory gases at or near the patient

end
3.2
cuff

compliant seal permanently attached to the supralaryngeal airway to provide a seal between the tube and the

oropharynx
3.3
external seal
seal that is positioned outside the patient
EXAMPLE A seal between a face mask and the face.
3.4
internal seal

seal that is positioned inside the patient at some point in the respiratory tract

NOTE For supralaryngeal airways the internal seal is typically located in proximity to the glottic inlet.

3.5
patency
openness (lack of obstruction) of the supralaryngeal airway
3.6
patient end
that end of the supralaryngeal airway intended to be inserted into the patient
3.7
machine end

that end of the supralaryngeal airway or the supralaryngeal airway connector intended to connect to the

breathing system
2 © ISO 2009 – All rights reserved
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ISO 11712:2009(E)
3.8
pressure drop
pressure differential at a specified flow
3.9
sealing mechanism

that portion of the device in contact with the patient that enables isolation of ventilatory gases

3.10
supralaryngeal airway

device placed through the mouth but not through the vocal cords, which is intended to form an internal seal in

the supralaryngeal area to maintain airway patency
3.11
supralaryngeal airway connector

tubular component of an supralaryngeal airway intended for connection to a breathing system or ventilation

bag
3.12
ventilatory opening

opening in the supralaryngeal airway near the patient end and intended to allow passage of gases and/or

devices such as a tracheal tube, suction catheter or endoscope
NOTE A supralaryngeal airway can have more than one ventilatory opening.
3.13
ventilatory pathway
part of the supralaryngeal airway through which gases are intended to pass
4 General requirements

4.1 This International Standard specifies requirements that are generally applicable to risks associated with

supralaryngeal airways. An established risk management process shall be applied to the design of the

device. See Annex D for an informative list of identified hazards.

4.2 The supralaryngeal airway shall permit ventilation in those head and neck positions, and in those

patient positions for which the device is intended.

4.3 The supralaryngeal airway shall permit ventilation when the patient is in the supine position and the

head and neck are at neutral positions and at least ± 30° of:
a) flexion;
b) extension;
c) right and left rotation;
d) right and left lateral flexion (tilt).

4.4 The supralaryngeal airway shall also permit ventilation in the following positions and in any position

intended for use:
a) Trendelenburg's (head down, 10°);
b) sitting (45°).

Compliance shall be tested by examination of the mitigations described in a risk assessment and associated

verification and validation studies.
NOTE 1 See Annex A and Annex D.
© ISO 2009 – All rights reserved 3
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ISO 11712:2009(E)

If clinical studies are performed, these studies shall document measurements taken during the conditions for

which performance is claimed. The clinical studies shall comply with the requirements of ISO 14155-1, and

ISO 14155-2.

NOTE 2 See also Annex B for evaluating and documenting the clinical performance of supralaryngeal airways in

human subjects.

4.5 The supralaryngeal airway shall, when transported, stored and used as intended by the manufacturer,

minimize safety hazards which could reasonably be foreseen in normal and single-fault condition.

4.6 Where the requirements of this International Standard refer to freedom from unacceptable risk,

acceptability or unacceptability of this risk is determined by the manufacturer in accordance with the

manufacturer's policy for determining acceptable risk.

4.7 The manufacturer may use type tests different from those detailed within this International Standard, if

an equivalent degree of safety is obtained. However, in the event of dispute, the methods specified herein

shall be used as the reference methods.

4.8 Many of the test clauses within this International Standard establish acceptance criteria for performance

aspects. These acceptance criteria shall always be met. If the manufacturer chooses to specify in the

accompanying documents higher performance levels than those specified within this International Standard

these manufacturer-specified levels become the acceptance levels and shall also be met.

5 *Requirements
5.1 Supralaryngeal airways
5.1.1 *Size designation

The size of a supralaryngeal airway shall be designated using the following convention:

a) the range of sizes shall be from 0 to 6; the smallest increment permitted is 0,5;

b) sizes from 0 to 6 shall be designated for the smallest to largest size devices; the transition size from

pediatric to adult is size 3.
5.1.2 Materials

5.1.2.1 Supralaryngeal airways, including the sealing mechanism and connector in its ready-for-use

state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological

safety testing, as indicated in ISO 10993-1. Initial biocompatibility evaluation tests shall include all materials in

the supralaryngeal airway and be tested as external communicating, tissue/bone/dentin communicating,

< 24 h contact devices. If the proposed contact duration is greater than 24 h, biocompatibility tests shall

include those tests for > 24 hr duration.
5.1.2.2 The marking of the supralaryngeal airway shall be durable and legible.
NOTE See Annex E.
5.1.3 *Ventilatory opening

An opening intended to allow ventilation shall be provided at or near the patient end of the device. Auxiliary

ventilatory openings may be provided to reduce the risk from obstruction.
Compliance shall be determined by inspection.
4 © ISO 2009 – All rights reserved
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ISO 11712:2009(E)
5.1.4 *Safeguards against collapse of the ventilatory pathway

Means shall be provided to resist collapse of the ventilatory pathway from kinking or compression.

The kink resistance of the supralaryngeal airway lumen shall be tested in accordance with Annex C.

The resistance to compression shall be evaluated by examination of the mitigations described in a risk

assessment and associated verification and validation studies.
5.1.5 *Sealing mechanism

5.1.5.1 A sealing mechanism shall be integrally attached to the supralaryngeal airway.

5.1.5.2 The sealing mechanism shall produce no audible leak under a positive pressure of 10 cm/H O for

a minimum of 3 s.

Compliance shall be tested by clinical study measurements. Functional testers or patient simulators shall

not be used to validate the performance of the supralaryngeal airway. The clinical studies shall document

measurements taken during the conditions for which performance is claimed. The clinical studies shall comply

with the requirements of ISO 14155-1 and ISO 14155-2.
NOTE See also Annex B.

5.1.5.3 The sealing mechanism shall not occlude the ventilatory opening nor collapse the ventilatory

pathway.

Compliance shall be tested by a method chosen by the manufacturer based upon an examination of the

mitigations described in a risk assessment and associated verification and validation studies.

5.1.5.4 Inflation/deflation system.

If provided, the inflation system shall include an inflating tube, a pilot balloon or other device to indicate

inflation or deflation.

NOTE This (these) device(s) may also serve as a pressure-indicating or pressure-limiting device.

5.1.5.5 *The free end of the inflation tube shall be either open or sealed with a closure device or inflation

valve. If interface with an external inflation device is required, the free end of the inflation tube shall be

capable of accepting a male conical fitting with a 6 % (Luer) taper, complying with ISO 594-1.

5.1.5.6 The intentional deflation of the sealing mechanism shall not be prevented by the inflation tube,

inflation valve or any closure device acting as a non-return valve.
5.1.6 *Internal volume

The internal volume of the ventilatory pathway shall be measured in accordance with the following test

method.

Cap one end of the ventilatory pathway. Measure the volume of water in millilitres required to fill the

ventilatory pathway from the ventilatory opening up to and including the 15 mm connector at the machine

end of the device.
5.1.7 Maximum instrument size

The maximum size of devices that will easily pass through the ventilatory pathway shall be specified by the

manufacturer. Devices may include (but are not limited to) tracheal tubes, suction catheters, fiberoptic scopes,

bougies, etc. The instrument may be lubricated with water or water-soluble lubricant to assist the passage

[see 9 e)].
Compliance shall be determined by functional testing.
© ISO 2009 – All rights reserved 5
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ISO 11712:2009(E)
5.2 Supralaryngeal airway connectors

5.2.1 The machine end of a supralaryngeal airway connector shall be a male 15 mm conical connector

complying with ISO 5356-1. Any transition in the inside diameter shall be smooth to permit an adequate lead-

in for smooth passage and removal of an instrument.

5.2.2 The opening at the patient end shall have a plane at 90° ± 5° to the long axis of the patient end of

the connector.
6 Requirements for supralaryngeal airways and connectors supplied sterile
6.1 Sterility assurance

Supralaryngeal airways with connectors supplied and marked as “STERILE” shall satisfy the requirements of

ISO 11134, ISO 11135 or ISO 11137-1, if applicable.
6.2 Packaging for supralaryngeal airways and connectors supplied sterile

Each supralaryngeal airway and connector (if supplied) and marked as “STERILE” shall be contained in an

individual pack. The pack shall serve as an effective barrier to the penetration of microorganisms and

particulate material, in accordance with ISO 11607. The pack shall permit the aseptic extraction of the

contents and shall not be capable of reclosure without clearly revealing that the pack has been opened.

7 Cleaning and disinfection or sterilization

Supralaryngeal airways and connectors not intended for single use shall be designed to be suitable for

cleaning and disinfection or sterilization by methods described in the accompanying documents.

NOTE See Annex E.
8 Markings
8.1 Use of symbols

Symbols shall be accompanied by equivalent text in United States English on devices intended for use in the

United States. The requirements of 8.2 may be met by the appropriate symbols as given in ISO 7000.

8.2 Marking of the supralaryngeal airway
8.2.1 Marking of the supralaryngeal airways shall include the following:
a) the name and/or trademark of the manufacturer or supplier;

b) the designated size in bold type in accordance with 5.1.1; devices that encompass a range of sizes shall

be marked with the corresponding range;

c) the words “SINGLE USE” or equivalent, for supralaryngeal airways not intended for re-use;

d) *normal depth of insertion marking(s) or indicator(s) visible around the shaft of the supralaryngeal

airway corresponding to patient's incisors or gums to show the typical range of intended depth of

insertion;

NOTE Depth of insertion range marking(s) need not be continuously circumferential around the tube.

e) depth mark(s), if provided, in centimeters measured from the patient end of the ventilatory opening.

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ISO 11712:2009(E)
8.2.2 Marking materials shall:
a) be nontoxic and tissue-compatible;
b) resist deterioration by anaesthetic agents;
c) remain legible during use.
8.3 Marking on the supralaryngeal airway individual pack

The following shall be marked on, or be visible through, the supralaryngeal airway individual pack:

a) a description of contents;

b) the designated size in accordance with 5.1.1; devices that encompass a range of sizes shall be marked

with the corresponding range;
c) the name and/or trademark of the manufacturer and/or supplier;
d) the batch number or serial number;
e) the word “STERILE” if appropriate;
NOTE It is recommended that the method of sterilization be given.

f) for supralaryngeal airways not intended for re-use, the words “SINGLE USE” or equivalent;

g) instructions for action in the event of damage to the sterile packaging for supralaryngeal airways

supplied sterile;
h) expiration date, if appropriate.
9 Accompanying documents

The manufacturer shall disclose the following information in the accompanying documents:

a) instructions for use, including proper insertion and stabilization techniques for the supralaryngeal

airway;

b) instructions for use with other instruments such as tracheal tubes or bronchoscopes, where indicated;

c) the internal volume in millilitres as tested in 5.1.6;

d) the pressure drop in centimetres H O at a specified test flow, as determined in Annex C;

e) the maximum device size, as tested in 5.1.7, for tracheal tubes and fiberoptic bronchoscopes;

f) whether the device is intended for single use or is re-usable;

g) instructions for action in the event of damage to the packaging for supralaryngeal airways supplied

sterile;
h) minimum interdental gap, in millimeters, required for insertion;

i) a diagram of the device, showing the major components, including the nominal length of the internal

pathway(s), in centimeters from the machine end of the connector to the ventilatory opening and any

other working channels within the device;
© ISO 2009 – All rights reserved 7
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ISO 11712:2009(E)

j) a diagram showing the intended position of the supralaryngeal airway with the anatomic landmarks

listed in Figure 1; other landmarks shall be included when identified as mitigations in a risk assessment

and associated verification and validation studies;

k) a warning if the supralaryngeal airway does not protect the trachea or lungs from the risk of aspiration;

l) a precaution that the patency of the supralaryngeal airway should be reconfirmed after any change in

the patient's head or neck position;

m) a statement that a summary of the methods, materials, data and results of clinical studies that validate the

requirements of this International Standard is available on request, if applicable;

n) a warning that the supralaryngeal airway contains natural rubber latex, if applicable;

o) a statement that use of a bite block is recommended, unless a bite block is an integral part of the

supralaryngeal airway;

p) a warning that the cuff volume or pressure may change in the presence of nitrous oxide, oxygen or other

medical gases, if applicable;

q) a warning that supralaryngeal airways may be flammable in the presence of lasers and electrocautery

equipment;

r) information regarding precautions necessary for the disposal of biohazardous materials;

s) the manufacturer shall disclose appropriate storage conditions;

t) instructions for cleaning and disinfection or sterilization, and the maximum number of reuses, if the device

is re-usable.
8 © ISO 2009 – All rights reserved
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ISO 11712:2009(E)
Key
Anatomic landmarks
1 esophagus
2 trachea
3 vocal cords/folds
4 thyroid cartilage
5 laryngeal inlet
6 epiglottis
7 hyoid bone
8 tongue
9 incisors
Supralaryngeal airway components to be labelled (but not shown here):
10 sealing mechanism
11 ventilatory opening
12 normal depth of insertion marks

NOTE This diagram is for use in the depiction of the intended position of the supralaryngeal airway in relation to

anatomic landmarks.
Figure 1 — Diagram of the airway
© ISO 2009 – All rights reserved 9
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ISO 11712:2009(E)
Annex A
(informative)
Rationale

NOTE The subclause numbering in this annex corresponds that in the main body of the text and hence does not

follow a logical numerical order.
A.1 Introduction

Supralaryngeal airways represent a class of medical devices that are designed to facilitate spontaneous,

assisted or controlled ventilation. Supralaryngeal airways differ from other airway devices, such as

oropharyngeal airways and tracheal tubes, in that they do not require a facial seal or tracheal insertion f

...

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