UNI EN ISO 7376 : 2009-10
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
13-09-2022
01-10-2009
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Superseded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 |
| Standards | Relationship |
| NEN EN ISO 7376 : SEP 2009 | Identical |
| DIN EN ISO 7376:2010-01 | Identical |
| SN EN ISO 7376 : 2010 | Identical |
| NF EN ISO 7376 : NOV 2009 | Identical |
| EN ISO 7376:2009 | Identical |
| I.S. EN ISO 7376:2009 | Identical |
| NS EN ISO 7376 : 2009 | Identical |
| BS EN ISO 7376 : 2009-08 | Identical |
| ISO 7376:2009 | Identical |
| UNE-EN ISO 7376:2010 | Identical |
| ONORM EN ISO 7376 : 2010 | Identical |
| NBN EN ISO 7376 : NOV 2009 | Identical |
| 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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