SIST 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)
This International Standard 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
SIST EN ISO 7864:2016
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
SIST EN ISO 7864:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7864:2016
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SIST EN ISO 7864:2016
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.
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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
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
2
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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
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.
3
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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
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.
4
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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
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
5
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SIST EN ISO 7864:2016
EN ISO 7864:2016 (E)
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.
6
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SIST EN ISO 7864:2016
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
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SIST EN ISO 7864:2016
ISO 7864:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 7864:2016
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 . 4
4.10 Needle tube . 5
4.10.1 General. 5
4.10.2 Tolerances on length. 5
4.10.3 Freedom from defects. 6
4.10.4 Lubricant . 6
4.11 Needle point . 6
4.12 Bond between hub and needle tube . 7
4.13 Patency of lumen . 8
4.14 Sharps injury protection . 9
4.15 Sterility and biocompatibility . 9
4.15.1 Sterility . 9
4.15.2 Biocompatibility . 9
5 Packaging . 9
5.1 Unit packaging . 9
5.2 User packaging .10
6 Information supplied by the manufacturer .10
6.1 General .10
6.2 Unit packaging .10
6.3 User packaging .10
6.4 Storage container .11
6.5 Transport wrapping .12
Annex A (normative) Method for preparation of extracts .13
Annex B (informative) Fragmentation test for medical needles .14
Annex C (informative) Determination of flow rate through the needle .16
Annex D (informative) Test method for measuring the penetration force and drag force
for needles.18
Annex E (informative) Needle bonding strength test method .22
Bibliography .24
© ISO 2016 – All rights reserved iii
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SIST EN ISO 7864:2016
ISO 7864:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal
products and catheters.
In some countries, national regulations are legally binding and their requirements take precedence
over the ones in this International Standard.
This fourth edition cancels and replaces the third edition (ISO 7864:1993), which has been technically
revised with the following changes:
a) expansion of the range of gauges;
b) introduction of tapered needle designation;
c) reference to the new ISO 80369- series;
d) new informative annex on penetration force;
e) change in Annex B on fragmentation;
f) deleted informative Annex C for symbol for “do-not-reuse” and added normative reference to
ISO 15223-1;
g) new informative annex on flow rate;
h) new informative annex on needle bonding strength;
i) reference to ISO 23908 on sharps injury protection.
iv © ISO 2016 – All rights reserved
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SIST EN ISO 7864:2016
ISO 7864:2016(E)
Introduction
This International Standard covers sterile hypodermic needles for single use intended to inject or
withdraw fluids from primarily the human body.
Plastics materials to be used for the construction of needles are not specified, as their selection will
depend to some extent upon the design, process of manufacture and method of sterilization employed
by individual manufacturers.
Hypodermic needles specified in this International Standard are intended for use with syringes having
a 6 % Luer conical fitting as specified in ISO 80369-7 in conjunction with ISO 80369-1 and ISO 80369-20.
Devices/connectors intended to mate with hypodermic needles of the standard, but which deviate from
ISO 80369-7 shall provide demonstrated evidence of safe functional performance.
Guidance on transition periods for implementing the requirements of this International Standard is
given in ISO/TR 19244.
© ISO 2016 – All rights reserved v
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SIST EN ISO 7864:2016
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SIST EN ISO 7864:2016
INTERNATIONAL STANDARD ISO 7864:2016(E)
Sterile hypodermic needles for single use — Requirements
and test methods
1 Scope
This International Standard 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.
2 Normative references
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.
1)
ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment – Part 1: General requirements
2)
ISO 594-2 , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment
– Part 2: Lock fittings
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 6009, Hypodermic needles for single use Colour coding for identification
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and
test methods
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 23908, Sharps injury protection — Requirements and test methods — Sharps protection features for
single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
1) Upon its publication, ISO 80369-7 will replace ISO 594-1.
2) Upon its publication, ISO 80369-7 will replace ISO 594-2.
© ISO 2016 – All rights reserved 1
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SIST EN ISO 7864:2016
ISO 7864:2016(E)
3.1
gauge
legacy size designation; a particular gauge size corresponds to a designated metric size defining limits
for outer diameters
3.2
unit packaging
packaging of an individual device, intended to maintain its sterility
3.3
user packaging
packaging, which contains one or more items of unit packaging, designed to provide labelling
information to the user
3.4
needle cap
cover intended to physically protect the needle tube prior to use
3.5
tapered needle
needle with conical needle tube which has an outer diameter spanning at least two consecutive
designated metric sizes
4 Requirements
4.1 General
Testing finished products shall be conducted on sterilized products.
4.2 Statistics and reproducibility of test methods
Any suitable test system can be used when the required accuracy (calibration) and precision [Gauge
repeatability and reproducibility (R&R)] can be obtained.
4.3 Cleanliness
When inspected by normal or corrected-to-normal vision without magnification under an illuminance
of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and
extraneous matter.
When examined under 2,5× magnification, the hub socket (fluid path surface) shall appear free from
particles and extraneous matter.
4.4 Limits for acidity or alkalinity
When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an
extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid.
4.5 Limits for extractable metals
When tested by a recognized microanalytical method, for example by an atomic absorption method,
an extract prepared in accordance with Annex A shall, when corrected for the metals content of the
control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium
content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than
0,1 mg/l.
2 © ISO 2016 – All rights reserved
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SIST EN ISO 7864:2016
ISO 7864:2016(E)
4.6 Size designation
4.6.1 Tubular needle designation
The size of the hypodermic needle shall be designated by the following:
a) the designated metric size of the needle tube, may also be expressed in millimetres
— considering the regional distribution of the products, optionally the needle size expressed in
gauge size;
b) the nominal length of the needle tube, expressed in millimetres (Figure 2);
c) optionally, the wall thickness of the needle, expressed as RW (regular wall), TW (thin wall), ETW
(extra thin wall), or UTW (ultra-thin wall).
EXAMPLE 0,8 mm × 40 mm TW.
4.6.2 Tapered needle designation
Details necessary for the user to identify the needle, including the designated metric size, shall be
provided in accordance with the following expression:
OD (tip)/OD (hub) × L
where
OD (tip) is the designated metric size of the needle tube at the first full diameter from the tip
(measuring point 2, at th
...
SLOVENSKI STANDARD
oSIST prEN ISO 7864:2015
01-marec-2015
Sterilne podkožne igle za enkratno uporabo - Zahteve in preskusne metode
(ISO/DIS 7864:2014)
Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS
7864:2014)
Sterile Injektionskanülen für den Einmalgebrauch - Anforderungen und Prüfverfahren
(ISO/DIS 7864:2014)
Aiguilles hypodermiques stériles, non réutilisables - Exigences et méthodes d'essai
(ISO/DIS 7864:2014)
Ta slovenski standard je istoveten z: prEN ISO 7864 rev
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 7864:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 7864:2015
---------------------- Page: 2 ----------------------
oSIST prEN ISO 7864:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7864
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2014-12-04 2015-05-04
Sterile hypodermic needles for single use — Requirements
and test methods
Aiguilles hypodermiques stériles, non réutilisables
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7864:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
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oSIST prEN ISO 7864:2015
ISO/DIS 7864:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 7864:2015
ISO/DIS 7864
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 2
4.1 General . 2
4.2 Statistics and reproducibility of test methods . 2
4.3 Cleanliness . 3
4.4 Limits for acidity or alkalinity . 3
4.5 Limits for extractable metals . 3
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 . 5
4.9 Needle cap . 5
4.10 Needle tube . 6
4.10.1 General . 6
4.10.2 Tolerances on length . 6
4.10.3 Freedom from defects . 7
4.10.4 Lubricant . 7
4.11 Needle point . 7
4.12 Bond between hub and needle tube . 8
4.13 Patency of lumen . 9
4.14 Sharps injury protection . 10
4.15 Sterility and biocompatibility . 10
4.15.1 Sterility. 10
4.15.2 Biocompatibility . 10
5 Packaging . 10
5.1 Unit packaging . 10
5.2 User packaging . 11
6 Information supplied by the manufacturer . 11
6.1 General . 11
6.2 Unit packaging . 11
6.3 User packaging . 11
6.4 Storage container . 12
6.5 Transport wrapping . 13
Annex A (normative) Method for preparation of extracts . 14
A.1 Principle. 14
A.2 Apparatus and reagents . 14
A.3 Procedure . 14
Annex B (informative) Fragmentation Test for Medical Needles . 15
B.1 General . 15
B.2 Principle. 15
B.3 Apparatus and reagents . 15
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B.4 Test parts and opposite parts . 15
Type Requirements . 15
B.5 Preconditioning . 15
B.6 Procedure . 16
B.7 Test analysis . 16
Annex C (informative) Determination of flow rate through the needle . 17
C.1 Principle . 17
C.2 Reagent . 17
C.3 Apparatus . 17
C.4 Test procedure . 17
C.5 Test analysis . 18
Annex D (informative) Test method for measuring the penetration force and drag force for needles . 20
D.1 Principle . 20
D.2 Apparatus and equipment . 20
D.2.1 Force measurement Apparatus . 20
D.2.2 Substrate for insertion testing . 20
D.2.3 Substrate holder . 20
D.2.4 Penetration depth . 21
D.3 Collection and data analysis . 22
D.4 Procedure . 23
D.5 Test Report . 24
Annex E (informative) Needle bonding strength test method . 25
E.1 Principle . 25
E.2 Materials . 25
E.3 Apparatus . 25
E.4 Preparation and preservation of test samples . 25
E.5 Procedure . 25
E.6 Expression of results . 26
E.7 Test report . 26
Bibliography . 27
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 7864 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products
and catheters.
This second edition cancels and replaces the first edition which has been technically revised.
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Introduction
This International Standard covers sterile hypodermic needles intended for single use intended to inject or
withdraw fluids from primarily the human body.
Plastics materials to be used for the construction of needles are not specified, as their selection will depend to
some extent upon the design, process of manufacture and method of sterilization employed by individual
manufacturers.
Hypodermic needles specified in this International Standard are intended for use with syringes having a 6 %
1)
Luer conical fittings as specified in ISO/DIS 80369-7 in conjunction with ISO 80369-1 and ISO/DIS 80369-
2)
20 .
Devices/connectors intended to mate with hypodermic needles of the standard, but which deviate from ISO
80639-7 shall provide demonstrated evidence of safe functional performance
In some countries, national pharmacopoeia or government regulations are legally binding and their
requirements may take precedence over this International Standard.
Guidance on transition periods for implementing the requirements of this standard is given in ISO/TR 19244
'Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of
medicinal products and catheters'.
1) Under development
2) Under development
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oSIST prEN ISO 7864:2015
DRAFT INTERNATIONAL STANDARD ISO/DIS 7864
Sterile hypodermic needles for single use — Requirements and
test methods
1 Scope
This International Standard 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.
2 Normative references
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.
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
3)
equipment – Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
4)
equipment -- Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use - Specification and test methods
5)
ISO 6009:20XX , Hypodermic needles for single use Colour coding for identification
ISO 8601:2004, Data elements and interchange formats - Information interchange -- Representation of dates
and times
6)
ISO 9626:20XX , Stainless steel needle tubing for the manufacture of medical devices –Requirements and
test methods
ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
ISO 23908:2011, Sharps injury protection - Requirements and test methods - Sharps protection features for
single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements
3) Upon its publication, ISO 80369-7 will replace ISO 594-1.
4) Upon its publication, ISO 80369-7 will replace ISO 594-2.
5) Under revision
6) Under revision
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ISO/DIS 80369-7: Small bore connectors for liquids and gases in healthcare applications - Part 7: Connectors
with 6% (Luer) taper for intravascular or hypodermic applications
ISO/FDIS 80369-20: Small-bore connectors for liquids and gases in healthcare applications -- Part 20:
Common test methods
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information
to be supplied - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
3.1
gauge
measure of how large a needle is in diameter
NOTE to entry Hypodermic needles are available in a wide variety of outer diameters described by gauge numbers.
Smaller gauge numbers indicate larger outer diameters. Inner diameter depends on both gauge and wall thickness.
3.2
unit packaging
packaging of an individual device, intended to maintain its sterility
3.3
user packaging
packaging, which contains one or more items of unit packaging, designed to provide labelling information to
the user
3.4
needle cap
cover intended to physically protect the needle tube prior to use
4 Requirements
4.1 General
Testing finished products shall be conducted on sterilized products.
4.2 Statistics and reproducibility of test methods
Any suitable test system can be used when the required accuracy (calibration) and precision (Gauge
repeatability and reproducibility (R&R)) can be obtained. The repeatability and reproducibility (Gauge R&R) of
the test apparatus shall be no greater than 20 % of the allowed tolerance range for any given measurement.
For destructive test measurements, the Gauge R&R shall be no greater than 30 % of the allowed tolerance
range. At a minimum, the Gauge R&R should cover ±2 standard deviations (thereby covering approximately
95 % of the variation).
EXAMPLE A measurement system with a measurement specification limit of ±0,01 ml (range of 0,02 ml) comes out
of the Gauge R&R with a Gauge R&R/tolerance range ratio of 20 %, which means that the Gauge R&R (4 standard
uncertainties) equals 0,02 ml/5 = 0,004 ml. The uncertainty of the measurement is ±2 standard deviations (Guide to the
Expression of Uncertainty in Measurement, GUM), which equals 0,002 ml.
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4.3 Cleanliness
When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300
lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous
matter.
When examined under x 2,5 magnification, the hub socket shall appear free from particles and
extraneous matter.
4.4 Limits for acidity or alkalinity
When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an
extract prepared in accordance with Annex A shall be within one unit of pH of that of the control fluid.
4.5 Limits for extractable metals
When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract
prepared in accordance with Annex A shall, when corrected for the metals content of the control fluid, contain not
greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when
corrected for the cadmium content of the control fluid, be lower than 0,1 mg/1.
4.6 Size designation
For size designation with regards to wall thickness, reference is made to ISO 9626.
4.6.1 Tubular needle designation
The size of hypodermic needle shall be designated by the following:
a) the nominal outside diameter of the needle tube, expressed in millimeters
- considering the regional distribution of the products, optionally the needle size expressed in gauge size;
b) the nominal length of the needle tube, expressed in millimeters (Figure 2).
c) optionally, the wall thickness of the needle, expressed as RW (regular wall), TW (thin wall), ETW (extra
thin wall), or UTW (ultra-thin wall).
The size shall be referred to as "the designated metric size" and shall be expressed in millimeters.
EXAMPLE 0,8 X 40 mm TW
4.6.2 Tapered needle designation
Details necessary for the user to identify the needle, including the designated metric size, in accordance with
the following expression:
o.d. (tip)/o.d. (hub) × L
In case of limited space on the packaging, the o.d (tip) designation shall be prioritized for the expression of the
size designation.
Where:
o.d. (tip) is the designated metric size of the needle tube at the first full diameter from the tip (1
measuring point, at the end of the bevel geometry as shown in Figure 1) expressed in
millimeters;
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o.d.(hub) is the designated metric size of the needle tube at the hub side, measured at the first full
diameter from the top of the hub or from the top of the jointing medium, if used , expressed in
millimeters, as shown in Figure 1;
L is the nominal length of the needle tube, expressed in millimeters (Figure 2).
EXAMPLE 0,23/0,25 × 6 mm TW.
Key
1 o.d. (hub)
2 o.d. (tip)
Figure 1 — Tapered needle designation
4.7 Colour coding
The designated metric size of hypodermic tubular needles or the first full diameter from the tip of the tapered
needle shall be identified by colour coding in accordance with ISO 6009 applied to the unit container and/or
part of the needle assembly such as the needle hub or the needle cap.
4.8 Needle hub
4.8.1 Conical fitting
The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-1, ISO 594-1
and ISO 594-2
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4.8.2 Colour of hub
The hub shall be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in
accordance with ISO 6009.
4.9 Needle cap
If a separate needle cap is provided, it shall be made either of pigmented or of unpigmented material. If pigmented,
the colour shall be in accordance with ISO 6009.
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Key
1 Hub
2 Jointing medium
3 Needle tube
4 Needle cap
5. Length
Figure 2 — Example of typical hypodermic needle and sheath for single use
NOTE Figure 2 represents a typical configuration of a hypodermic needle. Specific designs may vary on basis of the
packaging designs.
4.10 Needle tube
4.10.1 General
The needle shall be made of tubing in accordance with ISO 9626.
4.10.2 Tolerances on length
The actual length of the needle tube (see dimension L in Figure 2) shall equal the nominal length within the
tolerances given in Table 1.
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Table 1 — Tolerances on length of needle tube
Dimensions expressed in mm
Nominal length of Tolerance
needle tube
<25 +1
-2
25 to 39 +1,5
-2,5
40 0
-4
>40 +1,5
-2,5
4.10.3 Freedom from defects
When examined by normal or corrected vision, the outside surface of the tubing shall be smooth and free from
defects.
4.10.4 Lubricant
If the hypodermic needle tube is lubricated, the lubricant shall not be visible, under normal or corrected vision,
as droplets of fluid on the outside or inner surfaces of the needle tube.
An acceptable lubricant, applied undiluted, is polydimethylsiloxane complying with a national or the European
pharmacopoeia. The quantity of lubricant used should not exceed 0,25 mg per square centimeter of the
lubricated surface area of the needle tube.
4.11 Needle point
When examined under x 2,5 magnification the needle point shall appear sharp and free from feather edges,
burrs and hooks.
NOTE The needle point usually has a bevel with a primary bevel angle of (11 ± 2)° (as illustrated in Figure 3),
but a "short" bevel with other angle, e.g. (17 ± 2)°, can be provided.
The designation of needle point dimensions and the nomenclature used to describe the dimensions and
features is shown for information in Figure 3. The needle points shown are of configurations commonly
manufactured: other configurations may be equally satisfactory. It may not be necessary to use all the
dimensions when describing the point configuration.
The needle point should be designed so as to minimize coring and fra
...
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