INTERNATIONAL STANDARD
gasesinhealthcareapplications- Small-boreconnectorsforliquidsand
Part 7: Connectorsforintravascular or hypodermicapplications
Raccords de petite taille pour liquides et gaz utilises dans le domainede la sante -
Partie 7: Raccords a 6 % (Luer) destines aux applications intravasculaires ou hypodermiques
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Contents
Page
Foreword. ivIntroduction. vi1 *Scope. 12 Normative references 13 Terms and definitions. 24 General requirements. 4.1 General requirements for LUER CONNECTORS. 3 34.2 Material used for LUER CONNECTORS. 4* Dimensional requirements for LUER CoNNECTORS. 4.3 Type tests. 45 6 Performance requirements. 4 46.1 Fluid leakage. Fluid leakage requirement. 46.1.1 6.1.2 Leakage by pressure decay. 4 Copy6.2 Sub-atmospheric pressure air leakage. 6.1.3 Positive pressureliquid leakage.6.3 Stress cracking 5 56.4 6.5 Resistance to separation from axial load. Resistance to separation from unscrewing. 506.6 Resistance to overridingAnnex A (informative) Rationale and guidanceAnnex B (normative) LUER CONNECToRS.Annex D (informative) Assessment of MEDicAL DEvicEs and their attributes with Annex C (normative) Reference coNNEcToRsCONNECTIONS within this APPLICATION.Annex E (informative) Summary of the usability requirements for LuER coNNEcToRs for intravascular or hypodermic APPLIcATioNs. 30Annex F (informative) Summary of LuER coNNEcroR design requirements for intravascularor hypodermic APPLICATIONS. 34Annex G (informative) Summary of assessment of the design of the LuER coNNEcToR for 37Annex H (informative) Reference to the essential principles. intravascular or hypodermic APPLIcATIoNs. 40Annex I (informative) Terminology - Alphabetized index of defined terms. 41Bibliography. 42
Foreword
bodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISO technical mittees. Each member body interested in a subject for which a technical mittee has been established has the right to be represented on that mittee. InternationalISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of organizations governmental and non-governmental in liaison with ISo also take part in the work.electrotechnical standardization.
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general aspects for medical devices and IEC/SC62D Electromedical equipment. The draft was circulated The mittee responsible for this document is ISO/TC 210 Quality management and correspondingfor voting to the national bodies of both ISO and IEC.
This first edition of ISO 80369-7 cancels and replaces ISO 594-1:1986 and ISO 594-2:1998 clauses subclauses tables figures and annexes of which have been consolidated and technically revised.
This part of ISO 80369 contains the following major technical revisions to ISO 594-1 and ISO 594-2.
ISO 80369 more broadly describes the requirements for the coNNEcroRs used for intravascularor hypodermic APPLICATioNs unlike ISO 594-1 and ISO 594-2 that are replaced by this part of ISO 80369 which only described the requirements for the fittings (intended coNNEcTIoNsurfaces) of these coNNEcToRs. This distinction is important to define here because the previous International Standards do not contain the terms CoNNECToR or CoNNECTION and ISO 80369- seriesdoes not use the term fitting.
b)Requirements for certain dimensions not previously identified in ISO 594-1 and ISO 594-2 areadded to this part of ISO 80369 to reduce the RISK of misconnections between MEDICAL DEVIcES or ACCESSORIEs for different APPLICATIONS with the SMALL-BORE CONNECTORS that are being developedunder other parts of the ISO 80369- series. These new dimensions were selected to represent the current design and dimensions of LuER coNNEcToRs in clinical use at the time this part of ISO 80369was developed. The term “6 % (Luer) taper" used throughout the previous standards has alsobeen clarified to the more monly used equivalent specified diameters separated by a specified distance on a mon axis.
and ring test gauges have been replaced by dimensional requirements which are more preciseand essential for reducing the RisK of misconnection with the other coNNEcToRs identified in ISO 80369-1.
MATERiALs have been eliminated and bined as one mon set of dimensions and requirements.This consolidation of requirements was made to further reduce the RisK of misconnection withother SMALL-BORE CONNECTORS.
ISO 80369 consists of the following parts under the general title Small-bore connectors for liquids andgases in healthcare applications:
-Part 1: General requirements-Part 3: Connectors for enteral applications-Part 5: Connectors for limb cuff inflation applications-Part 6: Connectors for neuraxial applicationsPart 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications-Part 20: Common test methods
Additional parts on connectors for urethral and urinary aplications and for respiratory applications are planned.
This corrected version of ISO 80369-7:2016 incorporates the following corrections:
in the Scope NOTE 1 has been removed and the other notes renumbered accordingly;-in the second paragraph of 6.6 the reference to the annex has been changed; I50the lower-case greek letter “has been changed into a capital greek letter “B" in the notes of CenTables B.5 and B.6; Secretariat- the representation of the angle B has been updated in Figure B.7: values and angles have been corrected in Figures C.1 C.2 C.3 C.4 and C.6.
