EN ISO 80369-1:2010
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
ISO 80369-1:2010 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. ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for: breathing systems and driving gases, enteral and gastric, urethral and urinary, limb cuff inflation, neuraxial devices, and intravascular or hypodermic. Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with: the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and the nipples of EN 13544-2:2002. ISO 80369-1:2010 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 and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. It 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.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
Dieser Teil von ISO 80369 legt allgemeine Anforderungen für Verbindungsstücke mit kleinem Durchmesser fest, die Flüssigkeiten oder Gase in Anwendungen der medizinischen Versorgung führen. Diese Verbindungsstücke mit kleinem Durchmesser werden in Medizinprodukten oder in Zubehörteilen zur Anwendung am Patienten eingesetzt. Diese Internationale Norm legt auch die medizinischen Bereiche fest, für die diese Verbindungsstücke mit kleinem Durchmesser zweckbestimmt sind. Diese Anwendungsbereiche in der medizinischen Versorgung umfassen, sind jedoch nicht beschränkt auf Anwendungen für ⎯ Atemsysteme und Antriebsgase, ⎯ enterale und gastrische Anwendungen, ⎯ urethrale und urologische Anwendungen, ⎯ Anwendungen mit aufblasbaren Manschetten für Gliedmaßen ⎯ neuroaxiale Produkte und ⎯ intravaskuläre oder hypodermische Anwendungen. Verbindungsstücke mit kleinem Durchmesser nach den Festlegungen in dieser Internationalen Norm sind nicht miteinander verbindbar mit: ⎯ den männlichen und weiblichen Konen der ISO 5356-1:2004 und ISO 5356-2:2006; ⎯ dem Temperaturfühler-Verbindungsstück und den passenden Anschlüssen nach ISO 8185:2007, Anhang DD; und ⎯ den Nippeln der EN 13544-2:2002. Diese Internationale Norm liefert die Methodologie, um die Merkmale der nicht miteinander Verbindbarkeit von Verbindungsstücken mit kleinem Durchmesser auf der Grundlage ihrer Ausführung und Maße zu beurteilen, um das Risiko von Verbindungsfehlern zwischen Medizinprodukten oder zwischen den Zubehörteilen für unterschiedliche Anwendungen zu verringern und um das Risiko von Verbindungsfehlern zwischen Medizinprodukten mit 6 %-Luer-Verbindungsstücken und allen anderen Nicht-Luer(6 %)-Verbindungsstücken zu verringern, die unter zukünftigen Teilen dieser Normenreihe entwickelt werden.
Raccords de petite taille pour liquides et gaz dans les applications médicales - Partie 1: Exigences générales (ISO 80369-1:2010)
L'ISO 80369-1:2010 spécifie les exigences générales pour les raccords de petite taille, qui conduisent des liquides ou des gaz dans le domaine de la santé. Ces raccords de petite taille sont utilisés dans les dispositifs médicaux ou les accessoires destinés à être employés avec un patient. L'ISO 80369-1:2010 spécifie également les domaines de la santé dans lesquels ces raccords de petite taille sont destinés à être employés. Ces domaines comprennent, mais sans s'y limiter, les applications suivantes: systèmes respiratoires et gaz d'entraînement; dispositifs entéraux et gastriques; dispositifs urétraux et urinaires; gonflage de brassards et de cuissards; dispositifs en contact avec le système nerveux; et applications intravasculaires ou hypodermiques. Les raccords de petite taille tels que spécifiés dans la présente Norme internationale sont non raccordables avec les raccords mâles et femelles de l'ISO 5356-1:2004 et de l'ISO 5356-2:2006, le raccord de sonde de température et les ports de raccordement spécifiés dans l'Annexe DD de l'ISO 8185:2007, les embouts de l'EN 13544-2:2002. L'ISO 80369-1:2010 indique la méthodologie pour l'évaluation des caractéristiques de non‑raccordabilité des raccords de petite taille en s'appuyant sur leur conception et leurs dimensions inhérentes afin de réduire le risque d'erreur de raccordement entre les dispositifs médicaux ou entre les accessoires destinés à différentes applications et pour réduire le risque d'erreur de raccordement entre les dispositifs médicaux avec des raccords Luer à 6 % et tous les autres raccords (à 6 %) qui seront développés dans les futures parties de la présente série de normes. Elle ne spécifie pas les exigences pour les dispositifs médicaux ou les accessoires utilisant ces raccords de petite taille. Ces exigences figurent dans les Normes internationales traitant des dispositifs médicaux ou des accessoires.
Konektorji z majhnim premerom za tekočine in pline za medicinsko uporabo - 1. del: Splošne zahteve
Ta del standarda ISO 80369 določa splošne zahteve za KONEKTORJE Z MAJHNIM PREMEROM, ki se uporabljajo za prenos tekočin in plinov, za medicinsko UPORABO. Ti KONEKTORJI Z MAJHNIM PREMEROM se uporabljajo v MEDICINSKIH PRIPOMOČKIH ali OPREMI, predvideni za uporabo s PACIENTOM. Ta mednarodni standard tudi določa področja v medicini, na katerih je predvidena uporaba teh KONEKTORJEV Z MAJHNIM PREMEROM. Ta področja v medicini vključujejo v nadaljevanju navedene UPORABE, vendar niso omejena nanje:
– SISTEMI ZA VDIHAVANJE in pogonski plini,
– enteralne in gastrične,
– uretralne in uropoetske,
– polnjenje manšet,
– nevraksialni pripomočki in
– intravaskularne ali hipodermične.
KONEKTORJI Z MAJHNIM PREMEROM, kot so opredeljeni v tem mednarodnem standardu, so MEDSEBOJNO NEPOVEZLJIVI z naslednjimi elementi:
– stožci in vtičnice iz standardov ISO 5356-1:2004 in ISO 5356-2:2006;
– PRIKLJUČEK in stikalni vhodi, določeni v dodatku DD standarda ISO 8185:2007; in
– priključki iz EN 13544-2:2002.
Ta mednarodni standard podaja metodologijo za ocenjevanje lastnosti MEDSEBOJNE NEPOVEZLJIVOSTI KONEKTORJEV Z MAJHNIM PREMEROM na podlagi njihove temeljne oblike in dimenzij, z namenom zmanjševanja TVEGANJ za napačno povezovanje MEDICINSKIH PRIPOMOČKOV ali OPREME, kar zadeva namene UPORABE, in zmanjševanja TVEGANJ za napačno povezovanje MEDICINSKIH PRIPOMOČKOV s KONEKTORJI Luer 6 % in tistih s kakršnimi koli KONEKTORJI, ki niso vrste Luer in bodo pripravljeni v okviru prihodnjih delov te skupine standardov.
Standard ne določa zahtev za MEDICINSKE PRIPOMOČKE ali OPREMO, v katerih se uporabljajo ti KONEKTORJI Z MAJHNIM PREMEROM. Takšne zadeve so podane v zadevnih mednarodnih standardih za posamezne MEDICINSKE PRIPOMOČKE ali OPREMO.
OPOMBA 1: Predvideno je, da se bodo novi modeli KONEKTORJEV Z MAJHNIM PREMEROM vključili v to skupino standardov po opravljenem ocenjevanju po POSTOPKU, podanem v točki 6.
OPOMBA 2: PROIZVAJALCEM se priporoča, da vključijo KONEKTORJE Z MAJHNIM PREMEROM, določene v tej skupini standardov, v MEDICINSKE PRIPOMOČKE, medicinske sisteme ali OPREMO, čeprav tega zadevni posamezni standardi za MEDICINSKE PRIPOMOČKE trenutno ne zahtevajo. Predvideva se, da bodo ob reviziji zadevnih posameznih standardov za MEDICINSKE PRIPOMOČKE vanje vključene zahteve za KONEKTORJE Z MAJHNIM PREMEROM, kot so določene v skupini standardov.
OPOMBA 3: PROIZVAJALCEM in ODGOVORNIM ORGANIZACIJAM se priporoča, da poročajo o izkušnjah s KONEKTORJI Z MAJHNIM PREMEROM, določenih v tej skupini standardov, sekretariatu ISO/TC 210, ki bo povratne informacije upošteval ob reviziji zadevnega dela te skupine standardov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2013
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Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 1:
Exigences générales
Ta slovenski standard je istoveten z: EN ISO 80369-1:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008
English version
Small bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-1:2010)
Raccords de petite taille pour liquides et gaz utilisés dans Verbindungsstücke mit kleinem Durchmesser für
le domaine de la santé - Partie 1: Exigences générales Flüssigkeiten und Gase in medizinischen Anwendungen -
(ISO 80369-1:2010) Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
This European Standard was approved by CEN on 14 December 2010.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
CEN Management Centre: CENELEC Central Secretariat:
Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels
© 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80369-1:2010 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword .3
Annex ZA .5
Foreword
This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at
the latest by June 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 15546-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
Compared to EN 15546-1:2008 the following changes were implemented:
a) Clause 3 "Terms and definitions" has been editorially revised and amended by the terms "accessory",
"breathing system", "non-interconnectable", "patient" and "responsible organization". The terms "risk" and
"safety" have been cancelled and replaced by a general reference to the appropriate terms given in EN
ISO 14971 and IEC 62366;
b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity;
c) Clause 5 on the requirements has been completely revised and amended by a sub-section on
incompatibility;
d) A new Clause 6 on additional applications has been added;
e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been
completely revised, more detailed in the structure and amended. Especially the sections on the proposal
initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)
have been stated more detailed;
f) Annex A "Rationale" has been completely revised by providing the reasons for this standard by clauses.
In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;
g) A new Annex B "Mechanical tests for verifying non-interconnectable characteristics" has been added;
h) Annex C "Applications" (respectively Clause B in EN 15546-1) has been editorially revised;
i) Annex C "Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;
j) A new Annex D "Reference to the Essential Principles" according ISO/TR 16142 has been added;
k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;
l) The Bibliography has been updated and amended;
m) A new clause Terminology has been added at the end of the standard;
n) Editorial revision in alignment with the overtaking of the original European Standard into an International
Standard.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Union and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
576 Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Corresponding Essential
Clause/subclause
Requirement Qualifying remarks/notes
of this Document
of Directive 93/42/EEC
all 1, 2
4, 5 7.5, 7.6, 9.1, 12.7.4
6 6 a, 7.5, 7.6, 9.1, 12.7.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
585 scope of this International Standard.
INTERNATIONAL ISO
STANDARD 80369-1
First edition
2010-12-15
Small-bore connectors for liquids and
gases in healthcare applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 1: Exigences générales
Reference number
ISO 80369-1:2010(E)
©
ISO 2010
ISO 80369-1:2010(E)
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ISO 80369-1:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
4 Materials used for SMALL-BORE CONNECTORS.3
5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS.4
5.1 SMALL-BORE CONNECTOR incompatibility.4
5.2 BREATHING SYSTEMS and driving gases APPLICATIONS.4
5.3 Enteral and gastric APPLICATIONS.4
5.4 Urethral and urinary APPLICATIONS.4
5.5 Limb cuff inflation APPLICATIONS.4
5.6 Neuraxial APPLICATIONS.5
5.7 Intravascular or hypodermic APPLICATIONS .5
5.8 Alternative SMALL-BORE CONNECTORS .5
6 Additional SMALL-BORE CONNECTOR APPLICATIONS.5
7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in
this series of standards .6
7.1 General .6
7.2 Proposal initiation .6
7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics.6
7.3.1 Design.6
7.3.2 Design realization.6
7.3.3 Design VERIFICATION .7
7.3.4 Design validation.7
7.4 Design review .
...
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