Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications

ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories. NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. It does not specify requirements for small-bore connectors that are used for the following:
- gastric suction-only medical devices;
- oral-only medical devices;
EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.
- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;
- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;
- gastrointestinal endoscopy equipment;
- skin level gastrostomy medical devices. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3:2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales

Elle a le statut d'une norme horizontale conformément au Guide 108 de la CEI.

Mednarodni elektrotehniški slovar – 725. poglavje: Vesoljske radiokomunikacije

General Information

Status
Published
Publication Date
30-Jun-2016
Current Stage
PPUB - Publication issued
Start Date
30-Jun-2016
Completion Date
01-Jul-2016

Relations

Buy Standard

Standard
ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
English language
39 pages
sale 15% off
Preview
sale 15% off
Preview
Standard – translation
IEC 60050(725):2005
Slovenian language
46 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
Reference number
ISO 80369-3:2016(E)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO 80369-3:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80369-3:2016(E)

Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for the enteral application. 3
4.2 Material used for enteral small-bore connectors . 3
4.3 Type tests . 4
5 Dimensional requirements for enteral small-bore connectors .4
6 Performance requirements . 4
6.1 Fluid leakage . 4
6.1.1 Fluid leakage requirement . 4
6.1.2 Leakage by pressure decay . 4
6.1.3 Positive pressure liquid leakage . 4
6.2 Stress cracking . 4
6.3 Resistance to separation from axial load. 4
6.4 Resistance to separation from unscrewing . 5
6.5 Resistance to overriding . 5
6.6 Disconnection by unscrewing .
...

SLOVENSKI STANDARD
SIST IEC 60050(725)
april 2005








Mednarodni elektrotehniški slovar – 725. poglavje: Vesoljske
radiokomunikacije

International Electrotechnical Vocabulary – Chapter 725: Space
radiocommunications

Vocabulaire Electrotechnique International – Chapitre 725: Radiocommunications
spatiales

Internationales Elektrotechnisches Wörterbuch – Kapitel 725:
Weltraumradiokommunikations


















Ta slovenski standard je enakovreden z IEC 60050(725):1994.



Referenčna oznaka
ICS 33.160.30, 33.160.40 SIST IEC 60050(725):2005 (sl)


Nadaljevanje na straneh od 2 do 47



© 2005-04. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST IEC 60050(725) : 2005
NACIONALNI UVOD
Standard SIST IEC 60050(725) (sl), Mednarodni elektrotehniški slovar – Poglavje 725: Vesoljske
radiokomunikacije, 2005, ima status slovenskega standarda in je enakovreden mednarodnemu
standardu IEC 60050(725) (en), International Electrotechnical Vocabulary – Chapter 725: Space
radiocommunication, 1994.
NACIONALNI PREDGOVOR
Mednarodni standard IEC 60050(725):1994 je pripravil tehnični odbor Mednarodne elektrotehniške
komisije IEC/TC 1 Terminologija.
Slovenski standard SIST IEC 60050(725):2005 je prevod mednarodnega standarda
IEC 60050(725):1994. V primeru spora glede besedila slovenskega prevoda v tem standardu je
odločilen izvirni mednarodni standard v angleškem jeziku. Slovensko izdajo standarda je pripravil
tehnični odbor USM/TC OMS Oprema za mobilne in satelitske telekomunikacijske sisteme.
Odločitev za prevzem tega standarda po metodi prevoda je dne 1998-11-17 sprejel tehnični odbor
USM/TC Oprema za mobilne in satelitske telekomunikacijske sisteme.
OSNOVA ZA IZDAJO STANDARDA
– Prevzem standarda IEC 60050(725):1994
OPOMBA
– Uvod in nacionalni predgovor nista sestavni del standarda.

2

---------------------- Page: 2 ----------------------

SIST IEC 60050(725) : 2005
VSEBINA Stran
Podpoglavje 725-11: Sateliti, vesoljska plovila in orbite.4
Podpoglavje 725-12: Vesoljski radiokomunikacijski sistemi. 14
Podpoglavje 725-13: Antene in antenski snopi (žarki) . 25
Podpoglavje 725-14: Prenos . 28
Abecedni seznam slovenskih izrazov. 34
Abecedni seznam angleških izrazov . 37
Abecedni seznam francoskih izrazov. 40
Abecedni seznam nemških izrazov. 43
3

---------------------- Page: 3 ----------------------

SIST IEC 60050(725) : 2005
Poglavje 725: Vesoljske radiokomunikacije
Podpoglavje 725-11: Sateliti, vesoljska plovila in orbite
Izraz v slovenščini
Izraz v angleščini
Zap. št. Definicija
Izraz v francoščini
Izraz v nemščini
725-11-01 − vesoljsko plovilo Vozilo, ki ga je izdelal človek in je namenjeno
− spacecraft potovanju zunaj zemeljske atmosfere.
− engin spatial; spationef
− Weltraumfahrzeug
725-11-02 − globoko vesolje Prostor na razdalji od Zemlje (po konvenciji),
6
− deep space enaki ali večji od 2 x 10 kilometrov.
− espace lointain
− ferner Weltraum; Tiefraum
725-11-03 − vesoljska sonda Vesoljsko plovilo, izdelano za opazovanje
− space probe vesolja ali izvajanje meritev v vesolju.
− sonde spatiale
− Weltraumsonde
725-11-04 − sonda za globoko vesolje Vesoljska sonda, namenjena raziskovanju v
− deep space probe globokem vesolju.
− sonde spatiale lointaine
− Tiefraumsonde
725-11-05 − satelit Telo, ki se giblje okrog drugega telesa z večjo
− satellite maso, njegovo gibanje pa je predvsem in stalno
− satellite določeno s privlačno silo tega drugega telesa.
− Satellit
OPOMBI: 1. Tako opredeljeno telo, ki se giblje okoli
Sonca, se imenuje planet ali planetoid.
 2. Satelit je lahko naravno telo ali vesoljsko
plovilo.
725-11-06 − osnovno telo (v odnosu do Telo, ki privlači satelit in določa osnovno
satelita) gibanje satelita.
− primary body (in relation to a
satellite)
− corps principal (pour un satellite)
− Zentralkörper (in bezug auf einen
satelliten)
725-11-07 − orbita; tirnica 1) Pot (glede na določen referenčni sistem), ki
− orbit jo opisuje masno središče satelita ali
− orbite drugega objekta v prostoru, katerega
− Umlaufbahn; Orbit gibanj
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.