EN ISO 7376:2009

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

Publication date:   Feb 28, 2010

General information

99.60 Withdrawal effective   Sep 23, 2020

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

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EN ISO 7376:2020