prEN ISO 80369-2

Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications

This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in breathing systems applications and driving gases applications of medical devices and accessories that contain or directly or indirectly convey liquids or gases to or from a patient or to provide driving power to medical devices or accessories.
This part of ISO 80369 does not specify 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.
NOTE Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems or accessories, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 2: Verbindungsstücke für respiratorische Anwendungen

Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 2 : Joints pour systèmes respiratoires et applications au gaz propulseur

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del: Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)

General Information

• Status: Not Published
• Publication Date: 02-Mar-2017
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 4098 - Decision to abandon - Enquiry
• Completion Date: 12-Sep-2019
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 80369-2:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO/DIS 80369-2:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 80369-2:2021
01-julij-2021
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del:
Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)
Small-bore connectors for liquids and gases in healthcare applications - Part 2:
Connectors for respiratory applications (ISO/DIS 80369-2:2021)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und
Antriebsgasanwendungen (ISO/DIS 80369-2:2021)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
2: Raccords destinés à des applications respiratoires (ISO/DIS 80369-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 80369-2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80369-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80369-2:2021

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oSIST prEN ISO 80369-2:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80369-2
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-05-03 2021-07-26
Small-bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory applications
ICS: 11.040.20; 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80369-2:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 80369-2:2021
ISO/DIS 80369-2:2021(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 respiratory application . 3
4.2 Material used for small-bore connectors . 3
4.3 Type tests .
...