CAN CSA Z7376-12:2017 pdf download.Anaesthetic and respiratory equipment一Laryngoscopes for tracheal intubation
1 Scope
CAN CSA Z7376-12 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 interchangeabillity of blades and handles.
It is applicable only to instruments with an internal battery-operated power source for iluminating 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一Part 1: Evaluation and testing
IEC 60601-1, Medical electrical equipment一Part 1: General requirements for basic safety and essential performance
EN 1041, Information supplied by the manufacturer with medical devices
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 ilumination of the larynx during use, and having an electrical connection to the handle in the hook-on ftting
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 iluminate the larynx
NOTE See Figure 2.
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
electrical filament bulb intended to provide ilumination 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.CAN CSA Z7376-12 pdf download.