DIN EN ISO 5366-1:2009-07
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
Hardcopy , PDF
01-04-2017
English
01-01-2009
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Grössen und Masse
4.1 Innendurchmesser
4.2 Aussendurchmesser
4.3 Länge
4.4 Winkel [theta]
5 Werkstoffe
6 Ausführung
6.1 Maschinenende
6.2 Halsplatte
6.3 Innentubus
6.4 Cuff
6.5 Füllschläuche für Cuffs
6.6 Patientenende
6.7 Einführhilfe
7 Anforderungen an steril gelieferte Tracheotomietuben
7.1 Zusicherung von Sterilität
7.2 Verpackung steril gelieferter Tracheotomietuben
8 Kennzeichnung
8.1 Allgemeines
8.2 Kennzeichnung der Halsplatte
8.3 Kennzeichnung der Einzelpackungen
Anhang A (normativ) Prüfung der sicheren Befestigung
eines Verbindungsstücks und einer
Halsplatte am Tracheotomietubus
Anhang B (normativ) Bestimmung des Durchmessers
des gefüllten, jedoch nicht gedehnten Cuffs
Anhang C (informativ) Leitfaden für Werkstoffe
und Ausführung
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den grundlegenden
Anforderungen der EG-Richtlinie 93/42/EWG
Describes requirements for tracheostomy tubes made of plastics materials and/or rubber having inside diameters of 6.5 mm or greater.
| DevelopmentNote |
Supersedes DIN EN 1282-1. (10/2004)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 5366-1:2000 | Identical |
| BS EN ISO 5366-1:2004 | Identical |
| UNE-EN ISO 5366-1:2009 | Identical |
| NEN EN ISO 5366-1 : 2009 | Identical |
| NS EN ISO 5366-1 : 2009 | Identical |
| UNI EN ISO 5366-1 : 2009 | Identical |
| NF EN ISO 5366-1 : 2009 | Identical |
| SN EN ISO 5366-1 : 2009 | Identical |
| I.S. EN ISO 5366-1:2009 | Identical |
| NBN EN ISO 5366-1 : 2009 | Identical |
| EN ISO 5366-1:2009 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| DIN EN 20594-1:1995-01 | CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 5366-3:2001 | Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| ISO/TR 11991:1995 | Guidance on airway management during laser surgery of upper airway |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| DIN EN ISO 4135:2002-03 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001 |
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