15/30273269 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 5366 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART: TUBES AND CONNECTORS FOR USE IN ADULTS
Hardcopy , PDF
English
30-11-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General Requirements for
TRACHEOSTOMY TUBES and connectors
5 Materials
6 Design requirements for TRACHEOSTOMY TUBES
and connectors
7 Requirements for TRACHEOSTOMY TUBES
supplied sterile
8 Marking and labelling
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security
of attachment of a fitted connector and
PLATE to the TRACHEOSTOMY TUBE
Annex C (normative) - Test method for determining
the diameter of the CUFF
Annex D (normative) - Test method for CUFF herniation
Annex E (normative) - Test method for leakage past
the CUFF
Annex F (normative) - Test method for determining
kink resistance
Annex G (informative) - Guidance on materials and design
Annex H (informative) - Hazard identification for risk assessment
Bibliography
Annex ZA (informative) - Relationship between this
document and the Essential Requirements
EU Directive 93/42/EEC
BS EN ISO 5366.
| Committee |
CH/121/5
|
| DocumentType |
Draft
|
| Pages |
40
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ASTM F 2503 : 2013 : REDLINE | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| ISO/TR 11991:1995 | Guidance on airway management during laser surgery of upper airway |
| ISO 4135:2001 | Anaesthetic and respiratory equipment — Vocabulary |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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