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

Status
Published
Publication Date
30-Aug-2016
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
31-Aug-2016
Completion Date
31-Aug-2016

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 7864:2016
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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.
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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.

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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
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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.
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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
---------------------- Page: 12 ----------------------
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.

ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment – Part 1: General requirements

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
...

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