EN ISO 7864:2016
(Main)Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren (ISO 7864:2016)
Diese Internationale Norm legt Anforderungen an sterile Injektionskanülen zum Einmalgebrauch der metrischen Nenngrößen von 0,18 mm bis 1,2 mm fest.
Sie gilt nicht für jene medizinischen Artikel, die in ihren eigenen Normen behandelt werden, wie Dentalkanülen und Pen-Nadeln.
Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai (ISO 7864:2016)
L'ISO 7864 :2016 fixe les prescriptions des aiguilles hypodermiques stériles, non réutilisables, ayant des dimensions métriques désignées comprises entre 0,18 mm et 1,2 mm.
Elle ne s'applique pas aux dispositifs couverts par leur propre norme, tels que les aiguilles dentaires et les aiguilles à stylo.
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode (ISO 7864:2016)
Ta mednarodni standard določa zahteve za sterilne podkožne igle za enkratno uporabo
z metrično označbo velikosti od 0,18 mm do 1,2 mm.
Ne uporablja se za naprave, ki so obravnavane v svojih standardih, kot so zobozdravniške igle in
igle za peresnike.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2016
1DGRPHãþD
SIST EN ISO 7864:2000
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode (ISO
7864:2016)
Sterile hypodermic needles for single use - Requirements and test methods (ISO
7864:2016)
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren
(ISO 7864:2016)
Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai (ISO
7864:2016)
Ta slovenski standard je istoveten z: EN ISO 7864:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7864
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2016
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7864:1995
English Version
Sterile hypodermic needles for single use - Requirements
and test methods (ISO 7864:2016)
Aiguilles hypodermiques stériles, non réutilisables - Sterile Injektionskanülen für den Einmalgebrauch -
Exigences et méthodes d'essai (ISO 7864:2016) Anforderungen und Prüfverfahren (ISO 7864:2016)
This European Standard was approved by CEN on 15 July 2016.
CEN 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
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 member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7864:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
European foreword
This document (EN ISO 7864:2016) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection, and blood processing equipment for medical and pharmaceutical use" in
collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of
which is held by DIN.
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 February 2017, and conflicting national standards
shall be withdrawn at the latest by February 2017.
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 ISO 7864:1995.
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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or
IEC standard, as listed in Table 1.
NOTE The way in which these references documents are cited in normative requirements determines
the extent (in whole or in part) to which they apply.
Table 1— Correlations between undated normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 594-1 EN 20594-1: 1993/AC: 1996/ ISO 594-1:1986
A1: 1997
ISO 594-2 EN 1707:1996 ISO 594-2:1998
ISO 3696 EN ISO 3696:1995 ISO 3696:1987
ISO 6009 EN ISO 6009:1994/AC:2008 ISO 6009:2016
ISO 8601 -- ISO 8601: 2004
ISO 9626 EN ISO 9626:1995/A1:2001 ISO 9626:2016
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 23908 EN ISO 23908::2013 ISO 23908:2011
ISO 80369-1 EN ISO 80369-1:2010 ISO 80369-1:2010
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
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, 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 the
United Kingdom.
Endorsement notice
The text of ISO 7864:2016 has been approved by CEN as EN ISO 7864:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/295
concerning the development of European Standards related to medical devices 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 160].
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 ZA.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 ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
7.1 4.9.1, 4.9.4, 4.14
7.3 4.4, 4.5, 4.9.1, 4.9.4, 4.14
7.5 4.4, 4.5, 4.9.1, 4.9.4, 4.14 The part of ER 7.5 related to
phthalates is not explicitly
covered.
7.6 4.8.1
8.1 4.14, 5 The part of ER 8.1 relating to
easy handling is not addressed.
8.3 5
8.4 4.14.1, 5.1
9.1 4.8.1
9.2 4.6, 4. 9.3, 4.9.4, 4.10
13.1 6.1
13.2 4.7, 4.8.2, 4.9, 6.2, 6.3
13.3(a) 6.2(e), 6.3(g), 6.4(e)
13.3(b) 6.2(a), 6.3(a), 6.4(a)
13.3 (c) 6.2(b), 6.3(b), 6.4(c)
13.3(d) 6.2(c), 6.3(e),6.4(b)
13.3(e) 6.2 (f), 6.3(f), 6.4(d)
13.3 (f) 6.2(d), 6.3(c)
13.3(i) 6.3(h), 6.4(f)
13.3(k) 6.1, 6.3(d)
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 products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 7864
Fourth edition
2016-08-01
Sterile hypodermic needles for single
use — Requirements and test methods
Aiguilles hypodermiques stériles, non réutilisables — Exigences et
méthodes d’essai
Reference number
ISO 7864:2016(E)
©
ISO 2016
ISO 7864:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved
ISO 7864:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Statistics and reproducibility of test methods . 2
4.3 Cleanliness . 2
4.4 Limits for acidity or alkalinity . 2
4.5 Limits for extractable metals . 2
4.6 Size designation . 3
4.6.1 Tubular needle designation . 3
4.6.2 Tapered needle designation . 3
4.7 Colour coding . 4
4.8 Needle hub . 4
4.8.1 Conical fitting . 4
4.8.2 Colour of hub . 4
4.9 Needle cap
...
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