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CAN/CSA-Z7376:12 (R2017)

Current

Current

The latest, up-to-date edition.

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Adopted ISO 7376:2009, second edition, 2009-08-15, with Canadian deviations)

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2012

€114.86
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General require
5 Performance requirements
6 Lamp for conventional blade
7 Lamps for fibre-illuminated laryngoscopes
8 Sockets for conventional blades
9 Cleaning, disinfection and sterilization
10 Marking and labelling
11 Accompanying documents
Annex A (normative) - Test method for lamp contact security
Annex B (normative) - Test methods for strength, rigidity and
        illumination
Annex C (informative) - Blade size markings
Annex D (informative) - Laryngoscope blade designs
Annex E (informative) - Rationale for inclusion of certain
        requirements
Bibliography

This is the second edition of CAN/CSA-Z7376, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 7376 (second edition, 2009-08-15). Applicable only to instruments with an internal battery-operated power source for illuminating the larynx, the International Standards gives general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes.

DocumentType
Standard
ISBN
978-1-55491-905-5
Pages
0
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Preface This is the second edition of CAN/CSA-Z7376, Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 7376 (second edition, 2009-08-15). It supersedes the previous edition published in 2007 as CAN/CSA-Z7376 (adopted ISO 376:2003). Scope This International Standard 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 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.

ISO/IEC TR 10000-1:1998 Information technology — Framework and taxonomy of International Standardized Profiles — Part 1: General principles and documentation framework
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 5864:1993 ISO inch screw threads Allowances and tolerances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN 980:2008 Symbols for use in the labelling of medical devices

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