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EN ISO 80369-3:2016/A1:2022

(Amendment)

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd 1:2019)

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/Amd 1:2019)

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)

General Information

Status
Published
Publication Date
29-Nov-2022
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Nov-2022
Due Date
26-Mar-2023
Completion Date
30-Nov-2022
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/A1:2023 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

Relations

Amends
EN ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
Effective Date
14-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 80369-3:2016/A1:2023
01-februar-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del:
Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen -
Änderung 1 (ISO 80369-3:2016/Amd 1:2019)
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/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/A1:2022
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 80369-3:2016/A1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 80369-3:2016/A1:2023

---------------------- Page: 2 ----------------------
SIST EN ISO 80369-3:2016/A1:2023


EUROPEAN STANDARD EN ISO 80369-3:2016/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2022
ICS 11.040.25

English version

Small-bore connectors for liquids and gases in healthcare
applications - Part 3: Connectors for enteral applications -
Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 3: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications entérales - Amendement 1 Anwendungen - Teil 3: Verbindungsstücke für enterale
(ISO 80369-3:2016/Amd 1:2019) Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd
1:2019)
This amendment A1 modifies the European Standard EN ISO 80369-3:2016; it was approved by CEN on 21 November 2022.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.


















CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-3:2016/A1:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST EN ISO 80369-3:2016/A1:2023
EN ISO 80369-3:2016/A1:2022 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 80369-3:2016/A1:2023
EN ISO 80369-3:2016/A1:2022 (E)
European foreword
The text of ISO 80369-3:2016/Amd 1:2019 has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for medical devices” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 80369-3:2016/A1:2022 by
Technical Committee CEN-CENELEC/ JTC 3 “Quality management and corresponding general aspects
for medical devices” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 80369-3:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2023, and
conflicting national standards shall be withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ n
...

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EN ISO 80369-7:2021(Main)
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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.
NOTE 1       Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
NOTE 2       For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application.
EXAMPLES     Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.
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