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EN 80369-5:2016/AC:2021-06

(Corrigendum)

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

2021-06-25 - IEC Corrected version

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 5: Verbindungsstücke für Anwendungen mit aufblasbaren Manschettensystemen für Gliedmaßen

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 5: Raccords destinés à des applications au gonflage de brassard

Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 5. del: Priključki z raztegljivo manšeto za okončine - Popravek AC

General Information

Status
Published
Publication Date
24-Jun-2021
ICS
11.040.20 - Transfusion, infusion and injection 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
6060 - Definitive text made available (DAV) - Publishing
Start Date
25-Jun-2021
Completion Date
25-Jun-2021
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
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
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
SIST EN 80369-5:2017/AC:2022 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

Relations

Corrects
EN 80369-5:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
Effective Date
02-Jun-2021

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EN 80369-5:2017/AC:2022EN 80369-5:2017/AC:2022
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EN 80369-5:2017/AC:2022
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 80369-5:2017/AC:2022
01-februar-2022
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 5. del:
Priključki z raztegljivo manšeto za okončine - Popravek AC
Small-bore connectors for liquids and gases in healthcare applications - Part 5:
Connectors for limb cuff inflation applications
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 5: Verbindungsstücke für Anwendungen mit
aufblasbaren Manschettensystemen für Gliedmaßen
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
5: Raccords destinés à des applications au gonflage de brassard
Ta slovenski standard je istoveten z: EN 80369-5:2016/AC:2021-06
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN 80369-5:2017/AC:2022 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 80369-5:2017/AC:2022

---------------------- Page: 2 ----------------------
SIST EN 80369-5:2017/AC:2022

EUROPEAN STANDARD EN 80369-5:2016/AC:2021-06

NORME EUROPÉENNE
June 2021

EUROPÄISCHE NORM
ICS 11.040.20
English Version
Small-bore connectors for liquids and gases in healthcare
applications - Part 5: Connectors for limb cuff inflation
applications
(IEC 80369-5:2016/COR2:2021)
Raccords de petite taille pour liquides et gaz utilisés dans le Verbindungsstücke mit kleinem Durchmesser für
domaine de la santé - Partie 5: Raccords destinés à des
Flüssigkeiten und Gase in medizinischen Anwendungen -
applications au gonflage de brassard Teil 5: Verbindungsstücke für Anwendungen mit
(IEC 80369-5:2016/COR2:2021) aufblasbaren Manschettensystemen für Gliedmaßen
(IEC 80369-5:2016/COR2:2021)
This co
...

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This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include, but are not limited to:
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This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1    Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2    Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3    The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4    Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

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