FprEN ISO 7376

SLOVENSKI STANDARD
oSIST prEN ISO 7376:2018
01-junij-2018
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO/DIS
7376:2018)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO/DIS

Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Matériel d'anesthésie et de réanimation respiratoire — Laryngoscopes pour intubation trachéale

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22 This template allows you to work with default MS Word functions and styles. You can use these if you

23 want to maintain the Table of Contents automatically and apply auto‐numbering if this is your

25 Foreword ...................................................................................................................................................................... 5

26 Introduction ................................................................................................................................................................. 8

27 1  *Scope .................................................................................................................................................................... 9

28 2  Normative references ...................................................................................................................................... 9

29 3  Terms and definitions ...................................................................................................................................... 9

30 4  General requirements ................................................................................................................................... 10

31 5  Materials ............................................................................................................................................................ 10

32 6 Design requirements ..................................................................................................................................... 11

33 7 Performance requirements ......................................................................................................................... 11

34 8 Cleaning disinfection and sterilization .................................................................................................... 16

35 9 Information supplied by the manufacturer ........................................................................................... 16

36 Annex A (informative) Rationale ....................................................................................................................... 17

37 Annex B (normative) Test method for illumination, BLADE rigidity and strength .............................. 19

38 Annex C (normative) BLADE designated sizing ............................................................................................... 22

39 Bibliography ............................................................................................................................................................. 30

42 ISO (the International Organization for Standardization) is a worldwide federation of national

43 standards bodies (ISO member bodies). The work of preparing International Standards is normally

44 carried out through ISO technical committees. Each member body interested in a subject for which a

45 technical committee has been established has the right to be represented on that committee.

46 International organizations, governmental and non‐governmental, in liaison with ISO, also take part in

47 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all

49 The procedures used to develop this document and those intended for its further maintenance are

50 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

51 different types of ISO documents should be noted. This document was drafted in accordance with the

53 Attention is drawn to the possibility that some of the elements of this document may be the subject of

54 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

55 any patent rights identified during the development of the document will be in the Introduction and/or

57 Any trade name used in this document is information given for the convenience of users and does not

59 For an explanation on the meaning of ISO specific terms and expressions related to conformity

60 assessment, as well as information about ISO's adherence to the WTO principles in the Technical

61 Barriers to Trade (TBT) see the following URL: Foreword ‐ Supplementary information

62 The committee responsible for this document is ISO/TC 121 Anaesthetic and respiratory equipment,

64 This is the third edition which has been technically revised and is based on ISO 18190:2016 General

67  The layout has changed to align with ISO 18190:2016 the General standard for airway devices;

68  Removal of the requirements for filament luminaires now almost entirely replaced with LED

70  additional requirement to prevent current surges from batteries with a rated voltage exceeding

74  The strength requirement has been increased to reflect the sort of forces that can be

79  Informative material appearing outside of tables, such as notes, examples and references:

82 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

84 Attention is drawn to the fact that equipment manufacturers and testing organizations may need a

85 transitional period following publication of a new, amended or revised ISO publication in which to make

86 products in accordance with the new requirements and to equip themselves for conducting new or

87 revised tests. Manufacturers may require up to 3 years from the date of publication for equipment

88 newly designed, and 5 years from the date of publication for equipment already in production to

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

92 undated references, the latest edition of the referenced document (including any amendments) applies.

93 For dated references, only the edition cited applies. However, for any use of this standard “within the

94 meaning of Annex ZA", the user should always check that any referenced document has not been

95 superseded and that its relevant contents can still be considered the generally acknowledged state‐of‐

97 When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a

98 normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the

100 NOTE The way in which these references documents are cited in normative requirements determines the extent

103 Table – Correlations between normative references and dated EN and ISO/IEC standards

107 This International Standard specifies requirements for rigid, battery‐powered laryngoscopes used to

108 illuminate the larynx during tracheal intubation. It includes requirements for reusable and single‐use

109 laryngoscope BLADES and HANDLES. Laryngoscopes are manufactured in several forms. There are, for

110 example, single‐piece laryngoscopes, NON‐USER DETACHABLE HINGED BLADES, or detachable hinged BLADES

111 and HANDLES. In the latter case, the light source for illuminating the larynx during use is either a

112 luminaire fixed in the BLADE or a luminaire in the HANDLE with a light guide in the BLADE. The minimum

114 Laryngoscope BLADES are defined and marked by size designation (see annex C), suitable for the patient

115 demographic for which they are designed and ranges from small, premature infants to extra‐large

116 adults. Because there are so many variations the length of BLADE is required to be disclosed on the

117 packaging to allow an informed decision by the operator to select the most appropriate instrument for

118 intubation. Annex B describes test methods for illumination, rigidity and strength. Annex D is an extract

119 from DORSCH, J.A., DORSCH, S.E. Understanding Anaesthesia Equipment and describes the many

127 This International, device‐specific, Standard specifies requirements for laryngoscopes with non‐flexible

128 BLADES and HANDLES, with internal battery‐operated power sources, used for illuminating the larynx

129 during intubation. It also specifies critical dimensions for those HANDLES and BLADES with

135  laryngoscopes connected by light‐transmitting cables to external light sources;

137  video laryngoscopes designed to work with an external, integral or attached video system.

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

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

144 ISO 18190:2016, Anaesthetic and respiratory equipment ‐ General requirements for airways and related

146 IEC 60601‐1, Medical electrical equipment — Part 1: General requirements for basic safety and

148 IEC 60601‐1‐12, Medical electrical equipment Part 1‐12: General requirements for basic safety and

149 essential performance – Collateral Standard: Requirements for medical electrical equipment and medical

150 electrical systems intended for use in the emergency medical services environment

152 For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 18190:2016

162 metallic part that provides the electrical connection between a hinged BLADE and HANDLE

168 mechanical attachment of the blade and HANDLE such that the blade remains coupled to the HANDLE in all

196 Materials shall satisfy appropriate biological safety testing, as specified in ISO 10993‐1, i.e. external

202 6.1.1 Laryngoscopes shall meet the requirements of this standard in their storage or transport

206 6.1.2 Compliance shall be checked by the test given in clause 4.2.1 of ISO 60601‐1‐12:2015 and, when

207 a more restricted range is stated in the instructions for use, inspection of the RISK MANAGEMENT FILE.

209 6.2.1 Laryngoscopes shall meet the requirements of this standard when operated in normal use under

213 6.2.2 Compliance shall be checked by the test given in clause 4.2.2 of ISO 60601‐1‐12:2015 and, when

214 a more restricted range is stated in the instructions for use, inspection of the RISK MANAGEMENT FILE.

218 HANDLES with a rated voltage exceeding 3.6 V and designed for use with HOOK‐ON FITTING, DIRECTLY

219 ILLUMINATING BLADES, shall incorporate a means of preventing the electrical current from exceeding 800

220 mW peak (measured over a period of 100ms) and from exceeding 400 mW continuous.

221 NOTE 1: For a HANDLE rated at 6V, these are equivalent to current limits of 133mA and 67mA

223 NOTE 2: The return electrical circuit is through unspecified parts of the hook‐on joint.

226 The electrical contact of a HANDLE that can accept a HOOK‐ON FITTING, DIRECTLY ILLUMINATING BLADE shall be

230 HANDLES for use with HOOK‐ON FITTING, DIRECTLY ILLUMINATING BLADES and HOOK‐ON FITTING, LIGHT‐GUIDE

235 Figure 1 Dimensions of HANDLE HOOK‐ON FITTING for DIRECTLY ILLUMINATING BLADES and LIGHT‐GUIDE

238 Table 3 Dimensions of HANDLE HOOK‐ON FITTING for DIRECTLY ILLUMINATING BLADES

242 The optical output of HANDLES designed for use with HOOK‐ON FITTING, LIGHT‐GUIDE ILLUMINATED BLADES

247 Dimensions of Figure 3 for HOOK‐ON FITTING, DIRECTLY ILLUMINATING BLADES or LIGHT‐GUIDE ILLUMINATED

248 BLADES shall conform in order to fit the appropriate HANDLE for use with HOOK‐ON FITTING.

250 When subjected to a tensile force of 65 N the illumination centre shall not move by more than 10 mm.

253 When subjected to a tensile force of 150 N the BLADE or HANDLE shall not break.

256 The illumination shall meet the following requirements when measured 20 +/‐ 0,1 mm from the tip of

262 e)for reusable laryngoscopes ‐ the maximum number of cleaning and disinfection or

265 f)for single use laryngoscopes ‐ the maximum storage lifetime specified by the manufacturer

269 The electrical contact of a HOOK‐ON FITTING, DIRECTLY ILLUMINATING BLADE shall not move when a 65 N load

273 7.5.1 The force required to engage a HOOK‐ON FITTING BLADE onto a HANDLE hinge pin shall be between

274 (10 and 45) N in the direction shown in Figure 4. When engaged the BLADE shall be free to rotate about

283 a)lock in the operating position when a torque between 0,35 Nm and 1,35 Nm is applied to the

289 NOTE: Typical HOOK‐ON FITTINGS for DIRECTLY ILLUMINATING BLADES and HANDLES are shown in Figure 5.

293 Figure 3 Typical HOOK‐ON FITTING configurations for DIRECTLY ILLUMINATING BLADES and HANDLES

295 SINGLE‐PIECE LARYNGOSCOPES shall be provided with a means to control the power to the luminaire.

298 Laryngoscope BLADES and HANDLES, not intended for single use, shall be suitable for cleaning,

308 d) “single‐use” or equivalent, which shall be visible in the operating position.

314 b) the number and type of cleaning and disinfection or sterilization cycles for BLADES,

315 HANDLES and removable components for reusable laryngoscopes supplied non‐sterile and

316 if appropriate a warning that batteries should be removed prior to cleaning and

319 c) instructions to check the condition of the battery by activating the LUMINAIRE before use;

320 d) a warning that the power outputs from some rechargeable batteries can fall rapidly

322 e) information concerning the precautions required when disposing of used or defective

324 f) a warning to the effect that only trained personnel or those undergoing training shall use

326 g) instructions for routine servicing of the laryngoscope and for checking its condition prior

333 Battery powered laryngoscopes are classified as electromedical equipment as defined in IEC 60601‐1

334 the General safety standard for medical electrical equipment, however as this standard excludes mains

335 powered laryngoscopes the requirements of IEC 60601‐1 are less formidable. The interchangeability of

336 blades and HANDLES is addressed by specifying the dimensions and tolerances of the HOOK‐ON FITTINGS

340 A.3 Subclause 6.2 
Environmental conditions under normal operating conditions

341 The laryngoscope components are expected to be exposed to the environmental extremes outlined in

342 Table 2, since such extremes are often reached throughout the world in places where laryngoscopes are

343 used and therefore users should expect to be able to use them without question. If a manufacturer

344 claims a wider range of environmental tolerances, this claim should be validated.

345 Although laryngoscopes are designed in a manner that allows them to be used in very dry conditions, no

346 test is specified because it was felt that devices within the scope of this International Standard were

347 unlikely to have their performance affected by very dry ambient conditions. It is expected that the

348 manufacturer will perform a failure analysis to establish the possible effects of the lowest humidity

351 There have been incidents reported of battery short circuits, resulting in excessive heat generation

352 within the laryngoscope HANDLE. The high current capacity of some types of batteries, particularly those

353 which are rechargeable, can result in excessive operating temperatures under a single fault condition

354 (e.g. short circuit). Such batteries can also produce sparks with sufficient energy to ignite flammable

356 There have also been incidents reported in which a BLADE with a 3V filament bulb has been used with a

357 HANDLE intended for a BLADE with a 6V LED light source, and the bulb has shattered as a result of

358 overload current. There are also concerns (but no case reports) that a filament bulb might exceed the

359 safe temperature for patient contact when used with an incorrectly rated voltage source.