I.S. EN 1819:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
Hardcopy , PDF
22-04-2004
English
01-01-1998
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Performance requirements
6 Lamps for conventional blades
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 methods
Annex B (normative) Conventional marking of laryngoscope
blades to indicate type and size
Annex C (informative) Rationale
Annex D (informative) Recommendations for design and materials
Annex E (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements
or other provisions of EU Directives
Defines general requirements for laryngoscopes and critical dimensions for the handle and lamp of hook-on type laryngoscopes.
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 1819:1998 | Identical |
| NS EN 1819 : 1ED 1997 | Identical |
| SN EN 1819 : 1998 | Identical |
| NEN EN 1819 : 1997 | Identical |
| UNI EN 1819 : 1999 | Identical |
| EN 1819 : 1997 | Identical |
| NF EN 1819 : 1997 | Identical |
| NBN EN 1819 : 1998 | Identical |
| DIN EN 1819:1998-01 | Identical |
| UNE-EN 1819:1998 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| ISO 5864:1993 | ISO inch screw threads Allowances and tolerances |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ISO 7376-3:1996 | Laryngoscopic fittings Part 3: Fibre-illuminated re-usable rigid laryngoscopes |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| EN 30993-1 : 1994 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS |
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