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CEN

EN ISO 80369-3:2016/prA1

(Amendment)

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1

2017-06-16: Project merged in ISO/CS - New WI JT003050

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen (ISO 80369-3:2016/DAM 1:2017); Deutsche und Englische Fassung EN ISO 80369-3:2016/prA1:2017

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales - Amendement 1

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/DAmd 1:2017)

General Information

Status
Not Published
Publication Date
23-Dec-2018
ICS
11.040.25 - Syringes, needles an catheters
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
3098 - Decision to reject - Consensus building
Completion Date
08-Nov-2017
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 80369-3:2016/oprA1:2017 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/DAmd 1:2017)

Relations

Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
19-Jan-2023
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
18-Jan-2023
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
16-Jan-2023
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
11-Jan-2023
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
04-Jan-2023
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
28-Dec-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
21-Dec-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
14-Dec-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
07-Dec-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
30-Nov-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
23-Nov-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
16-Nov-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
09-Nov-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
02-Nov-2022
Parent
EN ISO 80369-3:2016/prA1 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1
Effective Date
26-Oct-2022

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EN ISO 80369-3:2016/oprA1:2017EN ISO 80369-3:2016/oprA1:2017
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80369-3:2016/oprA1:2017
01-maj-2017
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
3ULNOMXþNL]DHQWHUDOQRXSRUDER'RSROQLOR$ ,62'$PG
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/DAmd 1:2017)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen
(ISO 80369-3:2016/DAmd 1:2017)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/DAmd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/prA1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-3:2016/oprA1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 80369-3:2016/oprA1:2017

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

SIST EN ISO 80369-3:2016/oprA1:2017
DRAFT AMENDMENT
ISO 80369-3:2016/DAM 1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-02-24 2017-05-18
Small-bore connectors for liquids and gases in healthcare
applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1: .
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1: .
ICS: 11.040.25
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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 80369-3:2016/DAM 1:2017(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 2017

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

SIST EN ISO 80369-3:2016/oprA1:2017
ISO 80369-3:2016/DAM 1:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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 2017 – All rights reserved

---------------------- Page: 4 -------------------
...

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This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

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SIST EN 80369-5:2017

This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES. Limb cuff inflation APPLICATIONS include CONNECTIONS between a sphygmomanometer [3] [4] 1) and its cuff and CONNECTIONS between inflating equipment and its tourniquet intended for use with a PATIENT.
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 1 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.
NOTE 2 The requirements for SMALL-BORE CONNECTORS intended to be used with neonatal PATIENTS to connect a cuff to a sphygmomanometer are intended to be added to this standard by an amendment or new edition.
NOTE 3 The requirements for SMALL-BORE CONNECTORS intended to be used to connect a tourniquet to its inflating equipment are intended to be added to this standard by an amendment or new edition.

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SIST EN ISO 80369-3:2016

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.

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ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.
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NOTE 2       For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application.
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