Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO 7376:2009)
Abstract
ISO 7376:2009 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.
DIN EN ISO 7376:2010-01 (E)
Anaesthetic and respiratory equipment – Laryngoscopes for tracheal intubation (ISO
7376:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..7
4.1 Design ……………………………………………………………………………………………………………………………7
4.2 Materials for laryngoscope blades and single-piece laryngoscopes …………………………………7
4.3 Environmental requirements …………………………………………………………………………………………..7
4.4 Internal electrical power source ………………………………………………………………………………………7
5 Performance requirements ……………………………………………………………………………………………..8
5.1 Illumination …………………………………………………………………………………………………………………….8
5.2 Blade strength and rigidity ………………………………………………………………………………………………8
5.3 Blade and handle hook-on fittings …………………………………………………………………………………..8
5.4 Handle fittings ………………………………………………………………………………………………………………..8
5.5 Blade fittings …………………………………………………………………………………………………………………11
5.6 Engagement ………………………………………………………………………………………………………………….11
5.7 Operating position ………………………………………………………………………………………………………..11
5.8 Disengagement ……………………………………………………………………………………………………………..11
6 Lamp for conventional blade …………………………………………………………………………………………13
6.1 Lamp and lamp base contact …………………………………………………………………………………………13
6.2 Screw thread for lamps …………………………………………………………………………………………………14
7 Lamps for fibre-illuminated laryngoscopes ……………………………………………………………………15
8 Sockets for conventional blades ……………………………………………………………………………………15
8.1 Dimensions and centre contact ……………………………………………………………………………………..15
8.2 Internal screw threads …………………………………………………………………………………………………..15
9 Cleaning, disinfection and sterilization ………………………………………………………………………….15
10 Marking and labelling …………………………………………………………………………………………………….16
11 Accompanying documents ……………………………………………………………………………………………16
Annex A (normative) Test method for lamp contact security ………………………………………………………….18
Annex B (normative) Test methods for strength, rigidity and illumination ………………………………………19
Annex C (informative) Blade size markings …………………………………………………………………………………..21
Annex D (informative) Laryngoscope blade designs ……………………………………………………………………..22
Annex E (informative) Rationale for inclusion of certain requirements …………………………………………..29
Bibliography ……………………………………………………………………………………………………………………………….. 31
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………… 32