SIST EN ISO 7886-3:2010

SLOVENSKI STANDARD
SIST EN ISO 7886-3:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 7886-3:2005
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO%UL]JH]DWRþQR
GRORþHQRGPHUHNLPXQL]DFLMHVVLVWHPRP]DVDPRXQLþHQMH,62
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO 7886-3:2005)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO 7886-3:2005)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2009
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-3:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-3:2010

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SIST EN ISO 7886-3:2010


EUROPEAN STANDARD
EN ISO 7886-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2009
ICS 11.040.25 Supersedes EN ISO 7886-3:2005
English Version
Sterile hypodermic syringes for single use - Part 3: Auto-disable
syringes for fixed-dose immunization (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie Sterile Einmalspritzen für medizinische Zwecke - Teil 3:
3: Seringues autobloquantes pour vaccination à dose fixe Selbstblockierende Spritzen für die Injektion mit fixer
(ISO 7886-3:2005) Impfstoffdosis (ISO 7886-3:2005)
This European Standard was approved by CEN on 24 August 2009.

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 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 Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-3:2009: E
worldwide for CEN national Members.

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
Foreword
The text of ISO 7886-3:2005 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 7886-3:2009.
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 March 2010, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 7886-3:2005.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7886-3:2005 has been approved by CEN as a EN ISO 7886-3:2009 without any modification.

3

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
5 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
6 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
7 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
8 1, 7.1, 7.2, 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
9 10.1, 10.3
10 1, 10.1, 10.2, 10.3
11.1 1, 10.1, 10.2
11.2 10.2
12.1 1, 2, 3, 10.2, 12.8.2
12.2 1, 2, 3, 12.8.1, 12.8.2
12.3 10.2
13.1 1, 2
4

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SIST EN ISO 7886-3:2010
EN ISO 7886-3:2009 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs)
EN of Directive 93/42/EEC
13.2 1, 2, 9.1
14.1 1, 2, 10.1, 10.3
14.2 1, 2, 7.5, 7.6
14.3 1, 2, 3, 12.8.2, 8.1
14.4 5
15.1 3, 7.2, 8.3, 8,7
15.2 7.2, 8.3, 8,7
16 13.1, 13.2, 13.3, 13.4, 13.5, 13.6 Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community),
except 13.3 (a) (regarding
representative in the
Community),
nd
except 13.6 (h) – 2 phrase
(information on known
characteristics and technical
factors known to manufacturer
that could pose a risk if reused)
and 13.6 (q) (regarding date of
issue or latest revision of
instructions for use)
NOTE 6 a Requirement on clinical
evaluation not covered by this
standard

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

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SIST EN ISO 7886-3:2010

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SIST EN ISO 7886-3:2010


INTERNATIONAL ISO
STANDARD 7886-3
First edition
2005-03-01


Sterile hypodermic syringes for single
use —
Part 3:
Auto-disable syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe




Reference number
ISO 7886-3:2005(E)
©
ISO 2005

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SIST EN ISO 7886-3:2010
ISO 7886-3:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2010
ISO 7886-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Cleanliness . 3
6 Limits for acidity or alkalinity . 3
7 Limits for extractable metals . 3
8 Lubricant. 3
9 Tolerance on nominal capacity . 3
10 Graduated scale . 3
11 Barrel. 4
12 Piston/plunger assembly. 4
13 Needle. 4
14 Performance . 5
15 Packaging . 6
16 Labelling. 6
Annex A (normative) Method for preparation of extracts . 9
Annex B (informative) Test method for forces required to operate plunger . 10
Annex C (normative) Test method for testing auto-disable feature. 12
Bibliography . 13

iii© ISO 2005 – All rights reserved iii

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SIST EN ISO 7886-3:2010
ISO 7886-3:2005(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.
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 7886-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters, Subcommittee SC 1, Syringes, needles and intravascular catheters for
single use.
ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use:
 Part 1: Syringes for manual use
 Part 2: Syringes for use with power-driven syringe pumps
 Part 3: Auto-disable syringes for fixed-dose immunization
 Part 4: Syringes with reuse prevention feature
For the purposes of this part of ISO 7886, the CEN annex regarding fulfilment of European Council Directives
has been removed.
iv © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2010
ISO 7886-3:2005(E)
Introduction
ISO 7886 was first published in 1984. It was subsequently decided to divide it into two parts, ISO 7886-1
retaining essentially the scope of ISO 7886:1984, and ISO 7886-2 being applicable to sterile, single-use
syringes for use with power-driven pumps.
The preparation of this third part of ISO 7886 was recognized as a high priority requirement to prevent the re-
use of fixed dose immunization syringes in the developing and transitional countries. Re-use of injection
equipment in the absence of sterilization has increasingly led to transmission of blood-borne pathogens.
The World Health Organization had produced a specification for syringes that are rendered inactive after use
(commonly referred to as “auto-disable” syringes). Both the WHO and ISO agreed that an additional part of
ISO 7886 would be required to cover “auto-disable” syringes, whilst leaving in place ISO 7886 Parts 1 and 2
without modification, as a large number of devices in common use would not be intended to comply with the
auto-disable properties suggested.
This part of ISO 7886 is intended to cover “fixed dose” immunization syringes that are rendered inoperable
after delivery of the intended dose. These syringes are not covered by Parts 1 and 2 of ISO 7886.
It is recognized that syringes designed to reduce the risk of needlestick injuries, in addition to preventing
sharps injuries, may also comply with this part of ISO 7886 with regard to their auto-disable properties, but it is
stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886.
v© ISO 2005 – All rights reserved v

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SIST EN ISO 7886-3:2010

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SIST EN ISO 7886-3:2010
INTERNATIONAL STANDARD ISO 7886-3:2005(E)

Sterile hypodermic syringes for single use —
Part 3:
Auto-disable syringes for fixed-dose immunization
1 Scope
This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes with
or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or
for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe is
automatically rendered unusable.
This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of
the manufacturer.
This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made
of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2),
auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address
compatibility with injection fluids/vaccines.
NOTE A fourth part of ISO 7886 is being prepared to cover syringes with reuse prevention feature.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 7886-1:1993, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8537:1991, Sterile single-use syringes, with or without needle, for insulin
ISO 9626, Stainless steel needle tubing for the manufacture of medical devices
ASTM D999-01, Standard methods for vibration testing of shipping containers
ASTM D5276-98, Sta
...