SIST EN ISO 7376:2009
(Main)Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)
This International Standard specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes. It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical safety requirements may be more stringent for instruments connected to mains or external power packs. This International Standard is not applicable to surgical instruments known by the same generic name.
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO 7376:2003)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation trachéale (ISO 7376:2003)
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO 7376:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7376:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 7376:2004
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO
7376:2003)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO
7376:2003)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO
7376:2003)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale (ISO 7376:2003)
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 7376:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7376:2009
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SIST EN ISO 7376:2009
EUROPEAN STANDARD
EN ISO 7376
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.55 Supersedes EN ISO 7376:2003
English Version
Anaesthetic and respiratory equipment - Laryngoscopes for
tracheal intubation (ISO 7376:2003)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für
Laryngoscopes pour intubation trachéale (ISO 7376:2003) Trachealintubation (ISO 7376:2003)
This European Standard was approved by CEN on 21 March 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 7376:2009
EN ISO 7376:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 7376:2009
EN ISO 7376:2009 (E)
Foreword
The text of ISO 7376:2003 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 7376:2009 by 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 October 2009, 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 7376:2003.
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 EC Directive.
For relationship with EC 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 7376:2003 has been approved by CEN as a EN ISO 7376:2009 without any modification.
3
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SIST EN ISO 7376:2009
EN ISO 7376:2009 (E)
Annex ZA
(Informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European 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 on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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 European Standard and EU Directives
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
4.1 1 (first paragraph), 2, 12.9
4.2.1 1 (first paragraph), 2, 7.1, 7.3
4.2.2 1 (first paragraph), 2, 9.2 As per CEN
4.2.3 1 (first paragraph), 2, 7.1, 7.3, 9.2
4.2.4 1 (first paragraph), 2
4.3 4, 5, 7.1, 7.2, 8.6, 9.2,
4.3.a 4, 5, 7.2
4.3.b 4, 5, 7.2
4.3.c 4, 5, 7.2
4.4 2, 12.7.4, 12.8.2
5.1 1 (first paragraph), 2, 3, 9.2
5.2.1.1 3, 9.2
5.2.1.2 3, 9.2
5.2.2.1 3, 12.7.4
5.2.2.2 3, 12.7.4
5.2.2.3 3, 12.7.4
5.2.2.4 3, 12.7.4
5.2.3 3, 12.7.4
5.3.1 2, 3
5.3.2 2, 3
5.3.3 2, 3
5.4 3, 12.7.1
5.5.1 3, 12.7.1
5.5.2 3, 12.7.1
4
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SIST EN ISO 7376:2009
EN ISO 7376:2009 (E)
5.6 3, 12.7.1
6.1.1 3, 12.7.4
6.1.2 3, 9.2
6.1.3 3, 12.7.4
6.1.4 7.5, 7.6
6.1.5 3, 12.7.4
6.2.1 2
6.2.2 2
7.1 2
7.2 2, 3, 12.7.4
8.1.1 3, 12.7.1
8.1.2 2, 3, 12.7.1
8.1.3 3, 12.7.4
8.1.4 7.1
8.2.1 2, 12.7.1
8.2.2 2, 12.7.1
9.1 1 (first paragraph), 8.1, 13.6(h)
9.2 2, 8.1, 13.6(h)
10.1 13.1, 13.3(a), 13.6(a)
10.2 13.1, 13.3(a)
- 1 (first paragraph and 2nd paragraph, This relevant Essential
1st dash) Requirement is not
addressed in this
European Standard
- 1 (first paragraph and 2nd paragraph, This relevant Essential
2nd Requirement is not
addressed in this
dash)
European Standard
- 6a) This relevant Essential
Requirement is not
addressed in this
European Standard
- 7.1 (3rd dash) This part of this Essential
Requirement is not
addressed in this
European Standard
10.2 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this
European Standard
10.3 a 13.1, 13.3(b)
10.3 b 13.1, 13.3(b)
10.3 c 2, 3
10.3 d 2, 3, 12.9, 13.3(b)
10.3 e 2, 13.2
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SIST EN ISO 7376:2009
EN ISO 7376:2009 (E)
10.4 2, 13.5
10.5 2, 13.2
10.6 a 13.3(d), 13.5
10.6 b 3, 8.3, 8.4, 8.7, 13.3 (c)
10.6 c 8.3, 8.7, 13.1, 13.3(f)
10.6 c) 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.6 (h)(3rd paragraph) This relevant Essential
Requirement is not
addressed in this
European Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this
European Standard
11 2, 13.1, 13.2, 13.3(i, j, k), 13.6(b)
11 a) 13.6(d)
11 b) 3, 8.1, 13.3(m), 13.6(h, i)
11 c) 2, 6, 13.6(h)
11 d) 13.6(g, i)
11 e) 12.2, 12.6(d)
11 f) 3, 12.2, 12.3
11 g) 7.5
11 h) 2, 13.3(j, k), 13.4, 13.6(h)
11 i) 4, 9.2, 13.6(f)
11 j) 4, 5, 13.3(c, f), 13.6(d, h)
11 k) 4, 13.6(d)
11 l) 2, 6, 12.7.5
A 1 (first paragraph),2,7.1, 12.7.1
B 13.1
C
Annex ZB Bibliography
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
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SIST EN ISO 7376:2009
INTERNATIONAL ISO
STANDARD 7376
First edition
2003-12-15
Anaesthetic and respiratory equipment —
Laryngoscopes for tracheal intubation
Matériel d'anesthésie et de réanimation respiratoire — Laryngoscopes
pour intubation trachéale
Reference number
ISO 7376:2003(E)
©
ISO 2003
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SIST EN ISO 7376:2009
ISO 7376:2003(E)
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ii © ISO 2003 – All rights reserved
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SIST EN ISO 7376:2009
ISO 7376:2003(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 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 . 3
5.1 Blade and handle hook-on fittings . 3
5.2 Handle fittings . 3
5.3 Blade fittings . 6
5.4 Engagement. 6
5.5 Operating position . 6
5.6 Disengagement . 6
6 Lamp for conventional blade . 8
6.1 Lamp and lamp base contact. 8
6.2 Screw threads for lamps . 8
7 Lamps for fibre-illuminated laryngoscopes . 10
8 Sockets for conventional blades. 10
8.1 Dimensions and centre contact. 10
8.2 Internal screw threads. 10
9 Cleaning, disinfection and sterilization . 10
10 Marking and labelling . 10
11 Accompanying documents . 11
Annex A (normative) Test method for security of lamp contact . 12
Annex B (normative) Blade markings . 13
Annex C (informative) Rationale .14
Bibliography . 15
© ISO 2003 – All rights reserved iii
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SIST EN ISO 7376:2009
ISO 7376:2003(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 first edition of ISO 7376 cancels and replaces ISO 7376-1:1994, ISO 7376-2:1997 and ISO 7376-3:1996,
which have been technically revised.
iv © ISO 2003 – All rights reserved
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SIST EN ISO 7376:2009
ISO 7376:2003(E)
Introduction
This International Standard gives requirements for laryngoscopes for tracheal intubation, hereinafter referred
to as laryngoscopes, during anaesthesia, intensive care, emergency care and similar procedures.
Laryngoscopes are manufactured in several forms, including single-piece handle and blade construction, and
detachable blade and handle. In the latter case, the light source to illuminate 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 forms and dimensions of blades for laryngoscopes are selected by the operator on the basis of clinical
judgement and are not covered by this International Standard. Annex A describes a test method for security of
lamp contact. A conventional marking system for indicating the size and form of blades is given in Annex B.
Annex C of this International Standard gives rationales for some of the clauses which are identified by the
inclusion of an asterisk (*) after the clause number.
© ISO 2003 – All rights reserved v
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SIST EN ISO 7376:2009
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SIST EN ISO 7376:2009
INTERNATIONAL STANDARD ISO 7376:2003(E)
Anaesthetic and respiratory equipment — Laryngoscopes for
tracheal intubation
1 Scope
This International Standard specifies general requirements for laryngoscopes and critical dimensions for the
handle and lamp of hook-on type laryngoscopes.
It is applicable only to instruments with an electrical power source for illuminating the larynx, since electrical
safety requirements may be more stringent for instruments connected to mains or external power packs.
This International Standard is not applicable to surgical instruments known by the same generic name.
This International Standard does not apply to:
a) the blade form or handle design, except for general requirements and the interchangeability aspects of
the connection between the blade and the handle;
b) the measurement and specification of the lamp illumination intensity;
c) flexible laryngoscopes, or laryngoscopes designed for surgery;
d) laryngoscopes powered from mains electricity supply;
e) laryngoscopes connected by light-transmitting cables to external light sources.
NOTE Instruments connected by light guides to an external light source may be subject to other International
Standards for endoscopes.
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 10993-1:2003, Biological evaluation of medical devices – Part 1: Evaluation and testing
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
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 view of the larynx
3.2
detachable blade
blade that can be separated from a handle by the operator
© ISO 2003 – All rights reserved 1
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SIST EN ISO 7376:2009
ISO 7376
...
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