DIN EN ISO 5366-1:2009-07

Name: DIN EN ISO 5366-1:2009-07
Brand: DIN

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS

Available format(s)

Hardcopy , PDF

Superseded date

04-01-2017

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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Status	Superseded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	DIN EN ISO 5366:2017-04 DIN EN ISO 5366:2015-10 (Draft)
Supersedes	DIN EN 1282-1:1996-12

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