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UNI EN ISO 7376 : 2009-10

UNI EN ISO 7376 : 2009-10

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION

Superseded date

13-09-2022

Published date

01-10-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
   4.1 Design
   4.2 Materials for laryngoscope blades and single-piece
       laryngoscopes
   4.3 Environmental requirements
   4.4 Internal electrical power source
5 Performance requirements
   5.1 Illumination
   5.2 Blade strength and rigidity
   5.3 Blade and handle hook-on fittings
   5.4 Handle fittings
   5.5 Blade fittings
   5.6 Engagement
   5.7 Operating position
   5.8 Disengagement
6 Lamp for conventional blade
   6.1 Lamp and lamp base contact
   6.2 Screw thread for lamps
7 Lamps for fibre-illuminated laryngoscopes
8 Sockets for conventional blades
   8.1 Dimensions and centre contact
   8.2 Internal screw threads
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
Annex ZA (informative) - Relationship between this International
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Provides general requirements for laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. Also specifies the interchangeability of blades and handles.

DevelopmentNote
Supersedes UNI EN 1819. (08/2004)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

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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