EN 80369-5:2016
(Main)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
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
Relations
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
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
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 80601-2-30:2010 (not modified). IEC 80601-2-30:2009/A1:2013 NOTE Harmonized as EN 80601-2-30:2010/A1:2015 (not modified). ISO 80369-20:2015 NOTE Harmonized as EN ISO 80369-20:2015 (not modified). ISO 80369-6:2016 NOTE Harmonized as EN ISO 80369-6:2016 (not modified). ISO 80369-2 2) NOTE Harmonized as EN ISO 80369-2 2) (not modified). ISO 80369-3:2016 NOTE Harmonized as EN ISO 80369-3:2016 (not modified).
1) Superseded by EN ISO 3040:2016 (ISO 3040:2016). 2) At draft stage. SIST EN 80369-5:2017
Normative references to international publications with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu
Publication Year Title EN/HD Year
- - Respiratory therapy equipment -
Part 2: Tubing and connectors EN 13544-2 +A1 2002 2009 ISO 5356-1 2004
Anaesthetic and respiratory equipment - Conical connectors -
Part-1: Cones and sockets EN ISO 5356-1 2004 3) ISO 5356-1 2015 Anaesthetic and respiratory equipment - Conical connectors -
Part 1: Cones and sockets EN ISO 5356-1 2015
ISO 5356-2 2006 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors EN ISO 5356-2 2007 4) ISO 5356-2 2012 Anaesthetic and respiratory equipment - Conical connectors -
Part 2: Screw-threaded weight-bearing connectors EN ISO 5356-2 2012
ISO 8185 2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems EN ISO 8185 2009
ISO 14971 2007
Medical devices - Application of risk management to medical devices EN ISO 14971 2012 ISO 80369-1 2010 Small bore connectors for liquids and gases in healthcare applications -
Part 1: General requirements EN ISO 80369-1 2010
ASTM D638-14 -
Standard test method for tensile properties of plastics - -
ASTM D790-10 -
Standard test methods for flexural properties of unreinforced and reinforced plastics and electrical insulating materials - -
3) Superseded by EN ISO 5356-1:2015 (ISO 5356-1:2015). 4) Superseded by EN ISO 5356-2:2012 (ISO 5356-2:2012). SIST EN 80369-5:2017
Relationship between this European standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered This European standard has been prepared under a Commission’s standardisation request M/0231 to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169]. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZZ is based on normative references according to Annex ZA of this document. NOTE 4 When an Essential Requirement does not appear in Table ZZ.1, it means that it is not addressed by this European Standard. Table ZZ.1 – Correspondence between this European standard and Annex I of Directive 93/42/EEC [OJ L 169] Essential Requirements of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks / Notes 9.1 5, 6.2 ER 9.1 is met with respect to the connector dimensions and disconnection only. 12.7.4 6.3 ER 12.7.4 is met with respect to stress cracking only.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this standard.
1 Replace with ‘M/023 concerning the development of European standards related to medical devices’ or with ‘M/295 concerning the development of European standards related to medical devices’, or with the reference number and title of any other standardization request as relevant. SIST EN 80369-5:2017
IEC 80369-5 Edition 1.0 2016-03 INTERNATIONAL STANDARD NORME INTERNATIONALE Small-bore connectors for liquids and gases in healthcare applications –
Part 5: Connectors for limb cuff inflation applications
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
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE
ICS 11.040.20
ISBN 978-2-8322-3211-8
– 2 – IEC 80369-5:2016 © IEC 2016 CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 * Scope . 7 2 Normative references. 7 3 Terms and definitions . 8 4 General requirements . 9 4.1 General requirements for the limb cuff inflation APPLICATION . 9 4.2 Materials used for SMALL-BORE CONNECTORS . 9 4.3 TYPE TESTS . 10 5 Dimensional requirements for sphygmomanometer and cuff SMALL-BORE CONNECTORS . 10 5.1 * Requirements for adult or paediatric PATIENT SMALL-BORE CONNECTORS (S1) . 10 5.2 Void . 10 6 Performance requirements . 10 6.1 Air leakage. 10 6.2 * Resistance to separation from axial load . 10 Annex A (informative)
Rationale and guidance . 11 A.1 General guidance . 11 A.2 Rationale for particular clauses and subclauses . 11 Annex B (normative)
SMALL-BORE CONNECTORS for the limb cuff inflation APPLICATION . 13 Annex C (normative)
Reference CONNECTORS . 17 C.1 General requirements for reference CONNECTORS . 17 C.2 * Sphygmomanometer and cuff S1 reference CONNECTORS . 17 Annex D (informative)
Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION . 18 Annex E (informative)
Summary of the usability requirements for SMALL-BORE CONNECTORS for limb cuff inflation APPLICATIONS . 19 E.1 USER PROFILE . 19 E.2 Use scenarios . 19 E.3 Use environments and scenarios . 20 E.4 Generic USER needs . 20 Annex F (informative)
Summary of SMALL-BORE CONNECTOR design requirements for limb cuff inflation APPLICATIONS . 21 Annex G (informative)
Summary of assessment of the design of the CONNECTORS for limb cuff inflation APPLICATION . 29 G.1 General .
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