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Standard [WITHDRAWN]

DIN EN ISO 5361:2017-01

Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016); German version EN ISO 5361:2016

German title
Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke (ISO 5361:2016); Deutsche Fassung EN ISO 5361:2016
Publication date
2017-01
Original language
German
Pages
59

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Publication date
2017-01
Original language
German
Pages
59
DOI
https://dx.doi.org/10.31030/2429922

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Overview

The standard contains requirements for tracheal tubes and associated respiratory equipment. The scope includes tracheal tubes with cuffs, Cole-type tracheal tubes as well as speciality tracheal tubes, for example, tracheal tubes with reinforced walls, tracheal tubes with shoulders, tracheal tubes with means for suctioning or delivery of drugs. The general requirements for the risk assessment and safety as well as the essential requirements for the design including materials, marking and packaging are specified. The general requirements are supplemented by the necessary test methods. Furthermore, guidance for hazard identification and risk assessment and for the design of tracheal tube connectors is provided in informative annexes. Another informative annex contains explanations of the essential requirements. Compared to the previous edition from 2013-03, the specifications for tracheal tubes for children in particular have been supplemented by including requirements for depth markings that support the insertion of the tube. The standard has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA) in cooperation with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: BSI, United Kingdom), with the participation of German experts. The responsible German committee is Working Committee NA 053-03-02 AA "Medizinprodukte für das Atemwegssystem" ("Airways and related equipment") at DIN Standards Committee Rescue Services and Hospital (NARK).

Content
ICS
11.040.10
DOI
https://dx.doi.org/10.31030/2429922
Replacement amendments

This document replaces DIN EN ISO 5361:2013-03 .

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