SIST EN ISO 7376:2010

SLOVENSKI STANDARD
SIST EN ISO 7376:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 7376:2009
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO
7376:2009)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO
7376:2009)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO
7376:2009)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale (ISO 7376:2009)
Ta slovenski standard je istoveten z: EN ISO 7376:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7376:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7376:2010

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SIST EN ISO 7376:2010


EUROPEAN STANDARD
EN ISO 7376

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2009
ICS 11.040.10 Supersedes EN ISO 7376:2009, April
English Version
Anaesthetic and respiratory equipment - Laryngoscopes for
tracheal intubation (ISO 7376:2009)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für
Laryngoscopes pour intubation trachéale (ISO 7376:2009) Trachealintubation (ISO 7376:2009)
This European Standard was approved by CEN on 8 August 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7376:2009: E
worldwide for CEN national Members.

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SIST EN ISO 7376:2010
EN ISO 7376:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 7376:2010
EN ISO 7376:2009 (E)
Foreword
This document (EN ISO 7376:2009) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and
anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2010, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7376:2009, April.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7376:2009 has been approved by CEN as a EN ISO 7376:2009 without any modification.
3

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SIST EN ISO 7376:2010
EN ISO 7376:2009 (E)
Annex ZA
(informative)


Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/subclause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4.1.1 1,2, 12.2, 12.9
4.1.2 1, 2, 12.9
4.2 7.1, 7.3
4.3.1 3, 4, 5
4.3.2 3, 4, 5
4.4 2, 9.3, 12.7.5, 12.8.2
5.1.1 3, 9.1
5.1.2 3
5.1.3 3, 7.1
5.1.4 7.1
5.2.1 3, 7.1
5.2.2 3, 7.1
5.3 5
5.4.1.1 3
5.4.1.2 3
5.4.2.1 3, 4, 12.2
5.4.2.2 12.7.4
5.4.2.3 12.7.4
5.4.2.4 12.7.4
5.4.3 3, 4, 12.2
5.5.1 2, 3
5.5.2 2, 3
5.5.3 2, 3
5.5.4 3
5.6 12.7.1
4

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SIST EN ISO 7376:2010
EN ISO 7376:2009 (E)
Clause(s)/subclause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
5.7.1 12.7.1
5.7.2 12.7.1
5.8 12.7.1
6.1.1 12.7.4
6.1.2 2, 9.2
6.1.3 12.7.4
6.1.4 7.5, 7.6, 9.2, 12.7.1
6.1.5 12.7.4
6.2.1 2, 12.7.1
6.2.2 2, 12.7.1
7.1 2
7.2 12.7.4
8.1.1 2
8.1.2 12.7.1
8.1.3 12.7.1, 12.7.4
8.1.4 12.7.4
8.2.1 12.7.1
8.2.2 12.7.1
9.1 4, 8.1, 8.5
9.2 8.1, 13.6 (h)
10.1 13.1, 13.2
10.2 13.3 (a) The ER is not fully addressed.
10.3 13.1, 13.3 (b ,c, f)
10.4 13.6 (c)
10.5 13.6 (b)
10.6 13.3 (c, d, f), 13.5 ER 13.3 (f) is only partly addressed.
11 a) 13.6 (q)
11 b) 13.6 (c)
11 c) 13.3 (m), 13.6 (h)
11 d) 13.6 (g)
11 e) 13.6 (d)
11 f) 13.6 (d, k)
11 g) 13.1, 13.4, 13.6 (n)
11 h) 13.3 (k), 13.4
11 i) 6, 13.6 (h) ER 6 (a) is not addressed.
11 j) 13.1, 13.3 (k), 13.6 (I)
11 k) 13.3 (e)
11 l) 12.2, 13.6 (d, h)
11 m) 13.3 (j)
11 n) 9.3, 13.6 (c)

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this International standard.
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SIST EN ISO 7376:2010

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SIST EN ISO 7376:2010

INTERNATIONAL ISO
STANDARD 7376
Second edition
2009-08-15


Anaesthetic and respiratory equipment —
Laryngoscopes for tracheal intubation
Matériel d'anesthésie et de réanimation respiratoire — Laryngoscopes
pour intubation trachéale




Reference number
ISO 7376:2009(E)
©
ISO 2009

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
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©  ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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Published in Switzerland

ii © ISO 2009 – All rights reserved

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 3
4.1 Design . 3
4.2 Materials for laryngoscope blades and single-piece laryngoscopes. 3
4.3 Environmental requirements . 3
4.4 Internal electrical power source. 3
5 Performance requirements . 4
5.1 Illumination. 4
5.2 Blade strength and rigidity . 4
5.3 Blade and handle hook-on fittings. 4
5.4 Handle fittings . 4
5.5 Blade fittings . 7
5.6 Engagement . 7
5.7 Operating position. 7
5.8 Disengagement . 7
6 Lamp for conventional blade. 9
6.1 Lamp and lamp base contact . 9
6.2 Screw thread for lamps . 10
7 Lamps for fibre-illuminated laryngoscopes. 11
8 Sockets for conventional blades. 11
8.1 Dimensions and centre contact . 11
8.2 Internal screw threads. 11
9 Cleaning, disinfection and sterilization. 11
10 Marking and labelling . 12
11 Accompanying documents. 12
Annex A (normative) Test method for lamp contact security. 14
Annex B (normative) Test methods for strength, rigidity and illumination . 15
Annex C (informative) Blade size markings. 17
Annex D (informative) Laryngoscope blade designs . 18
Annex E (informative) Rationale for inclusion of certain requirements . 25
Bibliography . 27

© ISO 2009 – All rights reserved iii

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SIST EN ISO 7376:2010
ISO 7376:2009(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 7376 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 2, Tracheal tubes and other equipment.
This second edition cancels and replaces the first edition (ISO 7376:2003), which has been technically revised.
iv © ISO 2009 – All rights reserved

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
Introduction
This International Standard gives requirements for laryngoscopes in tracheal intubation, hereinafter referred to
as laryngoscopes, during anaesthesia, intensive care, emergency care and similar procedures, including
requirements for reusable and single-use laryngoscope blades and handles.
Laryngoscopes are manufactured in several forms and can, for example, be of single-piece handle and blade
construction or have a detachable blade and handle. In the latter case, the light source for illuminating the
larynx during use is either a lamp attached to a blade or a lamp in the handle with a light guide in the blade.
The minimum illumination from the laryngoscope is defined/disclosed.
The dimensions of laryngoscope blades are defined and disclosed to allow an informed decision by the
operator to select the most appropriate instrument for intubation. Annexes A and B describe test methods.
While Annexes C and D give blade markings and designs respectively, Annex E presents a rationale for
certain subclauses in the main body of the document.

© ISO 2009 – All rights reserved v

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SIST EN ISO 7376:2010

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SIST EN ISO 7376:2010
INTERNATIONAL STANDARD ISO 7376:2009(E)

Anaesthetic and respiratory equipment — Laryngoscopes for
tracheal intubation
1 Scope
This International Standard gives general requirements for laryngoscopes used for intubation, and specifies
critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the
interchangeability of blades and handles.
It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx,
since electrical safety requirements can be more stringent for instruments connected to mains or external
power packs.
It is not applicable to surgical instruments known by the same generic name, nor is it applicable to
⎯ flexible laryngoscopes or laryngoscopes designed for surgery,
⎯ laryngoscopes powered from mains electricity supply,
⎯ laryngoscopes connected by light-transmitting cables to external light sources, or
⎯ video laryngoscopes designed to work with an external video system.
NOTE Instruments connected by light guides to an external light source could be subject to other International
Standards.
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 5864, ISO inch screw threads — Allowances and tolerances
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
EN 1041, Information supplied by the manufacturer with medical devices
© ISO 2009 – All rights reserved 1

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blade
rigid laryngoscope component shaped to provide a direct view of the larynx
3.2
contact
metallic part of a hook-on fitting that completes an electrical circuit between the handle and lamp when a
detachable blade and handle are placed in the operating position
3.3
conventional blade
detachable blade incorporating a lamp, positioned to provide direct illumination of the larynx during use, and
having an electrical connection to the handle in the hook-on fitting
NOTE See Figure 1.
3.4
detachable blade
blade that can be separated from a handle by the operator
3.5
engagement
mechanical attachment of the blade and handle such that the blade remains coupled to the handle in all
positions
3.6
fibre-illuminated blade
blade incorporating optical fibres to transmit light from a source to illuminate the larynx
NOTE See Figure 2.
3.7
handle
component held in the hand during use, one end forming the connection to the blade
3.8
hook-on fitting
fitting on a laryngoscope handle that allows connection of a detachable blade to the handle and that
incorporates an electrical contact or optical pathway
3.9
lamp
electrical filament bulb intended to provide illumination during laryngoscopy
3.10
lamp base
metallic outer housing of the lamp, which provides electrical contact and mechanical engagement of the lamp
by means of a male screw thread
3.11
locking mechanism
mechanism that retains the blade in the operating position
2 © ISO 2009 – All rights reserved

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
3.12
operating position
position of the engaged blade and handle when the laryngoscope is ready for use
3.13
single-piece laryngoscope
laryngoscope with a handle and non-detachable blade
3.14
socket
component with a female screw thread attached to a laryngoscope blade and intended to provide electrical
contact and mechanical engagement with a lamp
4 General requirements
4.1 Design
4.1.1 Except for a single-piece laryngoscope, the lamp shall light when the blade and handle are placed in
the operating position.
4.1.2 A single-piece laryngoscope shall have a switch that latches in both the ON and OFF positions to
control power to the lamp, and that is marked accordingly.
4.2 Materials for laryngoscope blades and single-piece laryngoscopes
Materials shall satisfy appropriate biological safety testing, as specified in ISO 10993-1, i.e. external
communicating, tissue/bone/dentin communicating, and of less than 24 hour duration.
4.3 Environmental requirements
4.3.1 A laryngoscope component, other than a battery, shall be capable of meeting the requirements of
Clauses 5, 6, 7, 8, 10 and 11 after being exposed for 14 days in its storage and/or transport packaging in
environmental conditions over the following ranges:
a) ambient temperature range of −40 °C to +70 °C;
b) relative humidity up to 95 % non-condensing;
c) atmospheric pressure range of 50 kPa to 106 kPa.
NOTE See Annex E for the rationale for inclusion of these requirements.
4.3.2 A laryngoscope component, other than a battery, shall be capable of functioning in its intended use
after being exposed for 14 days in its storage and/or transport packaging in environmental conditions.
4.3.3 Compliance with 4.3.1 and 4.3.2 shall be checked by functional testing.
4.4 Internal electrical power source
If the handle is intended for use with rechargeable cells, a current-limiting device that prevents more than
three times normal current flowing in a single fault condition shall be incorporated into the handle.
NOTE See Annex E for the rationale for inclusion of this requirement.
© ISO 2009 – All rights reserved 3

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
5 Performance requirements
5.1 Illumination
5.1.1 The manufacturer of the detachable laryngoscope blade shall specify the design of the handle to be
used with the blade.
5.1.2 Except for a single-piece laryngoscope, the lamp shall light when the blade and handle are placed in
the operating position.
5.1.3 When tested in accordance with Annex B, the illumination shall have the following characteristics.
a) The distance between the upper illumination edge and the blade tip on the screen shall be
less than 3 mm.
b) The distance between the upper and lower illumination edges shall be greater than 30 mm but
less than 80 mm.
c) The distance between the right edge and the centre of the blade tip shall be greater than 25 mm but
less than 50 mm.
d) The distance between the left edge and the centre of the blade tip shall be greater than 25 mm but
less than 50 mm.
5.1.4 When tested in accordance with B.2, illumination shall exceed 500 lx for at least 10 min. This
requirement for the illumination test for reusable fibre-optic laryngoscopes shall be met after the number of
cleaning and disinfection or sterilization cycles specified by the manufacturer have been performed and
disclosed as per 9.2.
5.2 Blade strength and rigidity
5.2.1 When tested in accordance with B.2, the tip of the blade shall not move more than 10 mm and the
illumination centre shall not move more than 10 mm.
5.2.2 When tested in accordance with B.2, the blade shall not break.
5.3 Blade and handle hook-on fittings
Detachable hook-on blade and handle combinations that engage shall lock and illuminate when in the
operating position, and shall stay illuminated when the laryngoscope is held in any orientation.
Compliance with these requirements shall be checked by functional testing.
5.4 Handle fittings
5.4.1 Handle dimensions
5.4.1.1 The hook-on fitting forming part of the handle for use with a conventional blade shall conform to
the dimensions of Figure 1.
5.4.1.2 The hook-on fitting forming part of the handle for use with a fibre-illuminated blade shall conform
to the dimensions of Figure 2.
5.4.2 Electrical contact — Conventional system
5.4.2.1 The electrical contact between a handle and conventional blade shall ensure that the lamp lights
when the blade is placed in the operating position.
Compliance shall be checked by functional testing.
4 © ISO 2009 – All rights reserved

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
5.4.2.2 The electrical contact of a conventional blade shall be rigid. The electrical contact of a handle that
can accept a conventional blade shall be either flexible or spring-loaded.
5.4.2.3 Electrical continuity of a contact for a small lamp shall be achieved when the sealing washer is
compressed by (35 ± 10) % during installation.
5.4.2.4 Electrical continuity of a contact for the large lamp shall be achieved when either the sealing
washer is compressed by (15 ± 5) % or the O-seal is compressed by (65 ± 5) % during installation.
NOTE The return electrical circuit is through unspecified parts of the hook-on joint.
Dimensions in millimetres

NOTE Drawing not to scale.
Figure 1 — Handle hook-on fitting of conventional system
© ISO 2009 – All rights reserved 5

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
Dimensions in millimetres

Key
1 spring-loaded switch: OFF position, 3,5 to 2,2; ON position, 2,2 to 0,5; bottomed at u 0,5
NOTE Drawing not to scale.
a
Two positions.
b
Four positions.
Figure 2 — Handle hook-on configuration of green fibre-illuminated system
5.4.3 Electrical contact — Fibre-illuminated system
The electrical contact forming part of the electrical circuit in the handle of a fibre-illuminated system shall
ensure that the lamp lights when the blade is placed in the operating position.
Compliance shall be checked by functional testing.
6 © ISO 2009 – All rights reserved

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
5.5 Blade fittings
5.5.1 A conventional blade shall not engage with a handle made in accordance with a fibre-illuminated
system, as specified in 5.4.1.2 and as shown in Figure 2.
5.5.2 A blade that engages a handle made in accordance with the fibre-illuminated system, as specified in
5.4.1.2, shall not engage with a handle of a conventional system, as specified in 5.4.1.1 and as shown in
Figure 1.
5.5.3 Conventional blade hook-on fittings shall engage with any conventional handle hook-on fittings, as
specified in 5.4.1.1 and 5.4.2, and as shown in Figure 1.
5.5.4 When engaged, the clearance between the handle slot and the handle blade shall not exceed
0,28 mm.
NOTE Typical hook-on fittings are shown in Figure 3.
5.6 Engagement
The force required to engage a blade onto any handle hinge pin dimensioned in Figure 1 or Figure 2 shall be
between 10 N and 45 N (see Figure 4). The engaged blade shall be free to rotate about the pin under gravity.
5.7 Operating position
5.7.1 Locking
When a torque between 0,35 Nm and 1,35 Nm is applied to the blade, it shall lock into the operating position.
Compliance shall be checked by functional testing.
5.7.2 Unlocking
When a torque between 0,25 Nm and 1,35 Nm is applied to the blade, it shall unlock from the operating
position.
Compliance shall be checked by functional testing.
5.8 Disengagement
When a disengagement force between 10 N and 45 N is applied along the force axis shown in Figure 4, the
blade shall disengage from the handle.
Compliance shall be checked by functional testing.

© ISO 2009 – All rights reserved 7

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SIST EN ISO 7376:2010
ISO 7376:2009(E)
Key
1 end portion of hinge slot (shape not
specified)
2 retainer (shape not specified)
3 seating s
...