EN 80369-5:2016

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

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.

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

L'IEC 80369-5:2016 spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles des raccords de petite taille destinés à être utilisés pour les raccordements dans des applications au gonflage de brassard des dispositifs médicaux et des accessoires. Les applications au gonflage de brassard comprennent les raccordements entre un sphygmomanomètre et son brassard.

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

Ta del standarda ISO 80369 določa zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, namenjene UPORABI za PRIKLJUČKE z raztegljivo manšeto za okončine pri MEDICINSKIH PRIPOMOČKIH in DODATKIH. UPORABA priključkov z raztegljivo manšeto za okončine zajema PRIKLJUČKE med sfigmomanometrom [3] [4] 1) in njegovo manšeto ter PRIKLJUČKE med napihljivo opremo in njeno zažemko, namenjeno uporabi pri BOLNIKU. Ta del standarda ISO 80369 ne določa zahtev za MEDICINSKE PRIPOMOČKE ali DODATKE, v katerih se uporabljajo ti PRIKLJUČKI. Takšne zahteve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali DODATKE. OPOMBA 1: PROIZVAJALCEM se priporoča, da PRIKLJUČKE Z MAJHNIM PREMEROM, ki so določeni v tem delu standarda ISO 80369, vključijo v MEDICINSKE PRIPOMOČKE, medicinske sisteme ali DODATKE, tudi če zadevni posamezni standardi za pripomočke tega trenutno ne zahtevajo. Predvideva se, da bodo ob reviziji zadevnih posameznih standardov za pripomočke vanje vključene zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, kot so določene v tem delu standarda ISO 80369. OPOMBA 2: Zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, ki so namenjeni za uporabo pri neonatalnih BOLNIKIH za povezavo manšete s sfigmomanometrom, bodo dodane temu standardu z amandmajem ali novo izdajo. OPOMBA 3: Zahteve za PRIKLJUČKE Z MAJHNIM PREMEROM, ki so namenjeni za povezavo zažemke z napihljivo opremo, bodo dodane temu standardu z amandmajem ali novo izdajo.

General Information

• Status: Published
• Publication Date: 03-Nov-2016
• Withdrawal Date: 03-Nov-2019
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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: 04-Nov-2016
• Completion Date: 04-Nov-2016
• 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 80369-5:2017 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

Relations

• Corrected By: EN 80369-5:2016/AC:2021-06 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
• Effective Date: 02-Jun-2021
• Corrected By: EN 80369-5:2016/AC:2017-02 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
• Effective Date: 22-Feb-2017

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 5: Verbindungsstücke für Anwendungen mit aufblasbaren Manschettensystemen für GliedmaßenRaccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 5: Raccords destinés à des applications au gonflage de brassardSmall-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:EN 80369-5:2016SIST EN 80369-5:2017en01-februar-2017SIST EN 80369-5:2017SLOVENSKI
STANDARD



SIST EN 80369-5:2017



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 80369-5
November 2016 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)
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 (IEC 80369-5:2016)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 5: Verbindungsstücke für Anwendungen mit aufblasbaren Manschettensystemen für Gliedmaßen (IEC 80369-5:2016) This European Standard was approved by CENELEC on 8 April 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a 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 European Standard 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17,
B-1000 Brussels © 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members.
Ref. No. EN 80369-5:2016 E SIST EN 80369-5:2017



EN 80369-5:2016 2 European foreword The text of document 62D/1306/FDIS, future edition 1 of IEC 80369-5, prepared by SC 62D “Electromedical equipment” of IEC/TC 62 “Electrical equipment in medical practice”, ISO/TC 210 “Quality management and corresponding general aspects for medical devices” and CEN/CENELEC TC 3/WG 2 “Smallbore connectors”, was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 80369-5:2016.
The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-05-04 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2019-11-04
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document.
Endorsement notice The text of the International Standard IEC 80369-5:2016 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated:
ISO 3040:2009 NOTE Harmonized as EN ISO 3040:2012 1) (not modified). ISO 81060-1:2007 NOTE Harmonized as EN ISO 81060-1:2012 (not modified). IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified). IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:2015 (not modified). IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified). IEC 80601-2-30:2009 NOTE Harmonized as EN
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