Sterile hypodermic needles for single e use - Requirements and test methods (Is0 7864:2016)
National foreword
ISBN9780580856273
ICS 11.040.25
ThisBritishStandard is the UKimplementation of EN ISO7864:2016.ItsupersedesBSENIsO7864:1996whichiswithdrawn.
The UK participation in its preparation was entrusted to TechnicalCommittee CH/84 Catheters and syringes.
A list of organizations represented on this mittee canbeobtained onrequest toits secretary.
This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication.
TheBritishStandardsInstitution2016.PublishedbyBSIStandardsLimited2016
CompliancewithaBritishStandard cannotconferimmunityfromlegal obligations.
ThisBritishStandardwaspublished under theauthority of theStandards Policy and Strategy Committee on 30 September 2016.
Amendments/corrigenda issued sincepublicationDate Text affected
EN ISO 7864
Supersedes ENISO 7864:1995
English Version
and test methods (Is0 7864:2016)
Sterile hypodermic needles for single use -Requirements
Aiguilleshypodermiquessteriles nonreutilisables-Exigences et methodes d'essai (Is0 7864:2016)
Sterile Injektionskanulenfur den Einmalgebrauch-Anforderungen und Prufverfahren(ISO7864:2016)
CENmembers are bound to ply with the CEN/CENELECInternalRegulationswhich stipulate theconditionsforgiving thisEuropeanStandard thestatus of a national standardwithout anyalteration.Up-to-datelists and bibliographical referencesconcerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENmember.
Centre hasthesamestatus asthe officialversions.
CEN members are the national standards bodies ofAustria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland FormerugoslavRpublicofMacedonia France Germany Grce Hungary Iceland rland Italy atvia ithuania Luxembourg Malta etherlands Norway Poland ortugalRomania lovakia oveniapain weden witzerland Turky anUnited Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17 B-1000 Brussels
European foreword
This document(ENISO7864:2016)hasbeenprepared byTechnicalCommitteeISO/TC76"Transfusion infusion and injection and blood processing equipment for medical and pharmaceutical use" incollaboration with Technical Committee CEN/TC 205“Non-active medical devices"the secretariat ofwhich is held by DIN.
ThisEuropeanStandard shall be given the status of a national standard either bypublication of anidenticaltextorbyendorsement atthelatestbyFebruary2017 andconflictingnationalstandardsshall bewithdrawn atthelatest byFebruary2017.
Attention is drawntothepossibility thatsome of theelementsof thisdocument maybe thesubject ofpatent rights.CEN[and/or CENELEC]shall not be held responsibleforidentifying any or all such patentrights.
This document supersedesENISO7864:1995.
This document has been prepared under a mandate given to CEN by the European Commission and the
document.
The following referenced documents are indispensable for the application of this document. Forundated references thelatest edition of the referenced document(including any amendments) applies.For dated references only the edition cited applies.However for anyuse of this standard‘within themeaningof AnnexZA'theuser should always check that any referenced document has not beensuperseded and that its relevant contents can still be considered the generally acknowledged state-of-art.
When anIEC or ISOstandard isreferredto in theISO standard text this shallbe understood as anormative reference to thecorrespondingENstandard if available and otherwise to the datedISO orIEC standard as listed in Table 1.
the extent(inwhole orinpart) towhich they apply.
Table1-CorrelationsbetweenundatednormativereferencesanddatedENandIsOstandards
Normativereferencesaslistedin EquivalentdatedstandardClause2oftheISOstandardEN ISO or IECISO 594-1 EN20594-1:1993/AC:1996/ ISO 594-1:1986A1:1997ISO 594-2 EN 1707:1996 ISO594-2:1998ISO 3696 EN ISO 3696:1995 ISO3696:1987ISO 6009 ENISO6009:1994/AC:2008 ISO6009:2016ISO8601 --. ISO8601:2004ISO 9626 ENISO9626:1995/A1:2001 ISO9626:2016ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009ISO14971 ENISO14971:2012 ISO14971:2007ISO 23908 EN ISO 23908:2013 ISO 23908:2011ISO 80369-1 EN ISO 80369-1:2010 ISO 80369-1:2010ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
According to the CEN-CENELEC Internal Regulations the national standards organizations of thefollowing countries are bound to implement this European Standard: 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 theUnited Kingdom.
Endorsement notice
The textofISO7864:2016has been approvedby CEN as ENISO7864:2016without any modification.
