SIST EN ISO 7886-4:2007
(Main)Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886.
Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2006)
Dieser Teil von ISO 7886 legt Anforderungen für sterile Einmalspritzen aus Kunststoff mit oder ohne Kanüle fest, die für das Aufziehen von Flüssigkeiten oder für die Injektion von Flüssigkeiten unmittelbar nach ihrem Befüllen vorgesehen und so gestaltet sind, dass die Spritze nach dem Gebrauch unbrauchbar gemacht werden kann.
Dieser Teil von ISO 7886 ist nicht anwendbar auf Glasspritzen (festgelegt in ISO 595), selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (festgelegt in ISO 7886 3) und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten. Wenn Spritzen für andere Anwen¬dungsbereiche verwendet werden, können andere als die in diesem Teil von ISO 7886 festgelegten Normen herangezogen werden.
ANMERKUNG Spritzen, die zur Reduzierung des Verletzungsrisikos durch die Einstichnadel ausgelegt sind, können hinsichtlich ihrer Eigenschaften zur Verhinderung der Wiederverwendung auch mit diesem Teil von ISO 7886 überein¬stimmen. Es ist jedoch festzuhalten, dass andere Eigenschaften der Einstichnadel von Spritzen in diesem Teil von ISO 7886 nicht behandelt werden.
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif empechant la réutilisation (ISO 7886-4:2006)
Sterilne podkožne injekcijske brizge za enkratno uporabo - 4. del: Injekcije, katerih značilnosti preprečujejo ponovno uporabo (ISO 7886-4:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7886-4:2007
01-oktober-2007
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO ,QMHNFLMHNDWHULK
]QDþLOQRVWLSUHSUHþXMHMRSRQRYQRXSRUDER ,62
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2006)
Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur
Verhinderung der Wiederverwendung (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif
empechant la réutilisation (ISO 7886-4:2006)
Ta slovenski standard je istoveten z: EN ISO 7886-4:2006
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-4:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 7886-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.040.25
English Version
Sterile hypodermic syringes for single use - Part 4: Syringes with
re-use prevention feature (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie Sterile Einmalspritzen für medizinische Zwecke - Teil 4:
4: Seringues avec dispositif empêchant la réutilisation (ISO Spritzen mit Vorrichtung zur Verhinderung der
7886-4:2006) Wiederverwendung (ISO 7886-4:2006)
This European Standard was approved by CEN on 19 August 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-4:2006: E
worldwide for CEN national Members.
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EN ISO 7886-4:2006 (E)
Foreword
This document (EN ISO 7886-4:2006) has been prepared by Technical Committee ISO/TC 84
"Medical devices for injections" in collaboration with CMC.
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 April 2007, and conflicting national standards shall
be withdrawn at the latest by April 2007.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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.
Endorsement notice
The text of ISO 7886-4:2006 has been approved by CEN as EN ISO 7886-4:2006 without any
modifications.
2
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EN ISO 7886-4:2006 (E)
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC 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 one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard EU Directive 93/42/EEC
6 7.2 – 7.5
7 7.2 – 7.5
8 7.2 – 7.5
9 7.2 – 7.5
10 10.1
11 10.1
11.1 10.1
11.2 10.1
11.3 10.1
12 9.2
12.1 9.2
12.2 9.2
13.1 1 – 9.2
13.2 1 – 9.2
13.3 10.1
14.1 2
14.2 9.1
15.1 No direct reference/link to MDD Essential Requirements 7.3
93/42/EEC. and 10.1 of the Directive are
the closest links to this design
characteristic of the syringe.
15.2 7.5 – 10.1
15.3 1 – 2 – 8.1
15.4 5
15.5 7.1
3
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EN ISO 7886-4:2006 (E)
Table ZA.1 (continued)
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard EU Directive 93/42/EEC
16.1 7.2, 8.3
16.2 7.2, 8.3
17 13.1
17.2.1 a) 13.2 – 13.3 f
17.2.1 b) 13.2
17.2.1 c) 13.3 a
17.2.1 d) 13.2 – 13.3 c
17.2.1 e) 13.2 – 13.3 d
17.2.1 f) 13.2 – 13.3 e
17.2.1 g) 13.3 b
17.2.2 a) 13.2 – 13.3 f
17.2.2 b) 13.2
17.2.2 c) 13.3 a)
17.2.2 d) 13.2 – 13.3 c
17.2.2 e) 13.2 – 13.3 d
17.2.2 f) 13.2 – 13.3 e
17.2.2 g) 13.3 b
17.3 a) 13.2 – 13.3 f
17.3 b) 13.2
17.3 c) 13.3 a
17.3 d) 13.2 – 13.3 c
17.3 e) 13.2 – 13.3 d
17.3 f) 13.2 – 13.3 e
17.3 g) 13.3 b
17.3 h) 13.3 k
17.3 i) 13.3 k
17.3 j) 13.3 i
17.3 k) 13.6
17.3 l) 13.3 b
17.4 a) 13.3 b
17.4 b) 13.2
17.4 c) 13.2 – 13.3 d
17.4 d) 13.2 – 13.3 e
17.4 e) 13.2 – 13.3 c
17.4 f) 13.3 a
17.4 g) 13.3 i
17.4 h) 13.3 b
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4
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INTERNATIONAL ISO
STANDARD 7886-4
First edition
2006-10-01
Sterile hypodermic syringes for single
use —
Part 4:
Syringes with re-use prevention feature
Seringues hypodermiques stériles, non réutilisables —
Partie 4: Seringues avec dispositif empêchant la réutilisation
Reference number
ISO 7886-4:2006(E)
©
ISO 2006
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ISO 7886-4:2006(E)
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ii © ISO 2006 – All rights reserved
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ISO 7886-4:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Types of syringe . 2
6 Cleanliness . 2
7 Limits for acidity or alkalinity . 2
8 Limits for extractable metals . 2
9 Lubricant. 4
10 Tolerance on graduated capacity. 4
11 Graduated scale . 4
12 Barrel. 4
13 Piston/plunger assembly . 4
14 Syringe nozzle/needle . 5
15 Performance . 5
16 Packaging . 6
17 Labelling . 6
Annex A (normative) Method for preparation of extracts . 9
Annex B (normative) Test method for testing re-use prevention feature for RUP syringes . 10
Annex C (informative) Environmental aspects. 11
Bibliography . 12
© ISO 2006 – All rights reserved iii
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ISO 7886-4:2006(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 7886-4 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 re-use prevention feature
iv © ISO 2006 – All rights reserved
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ISO 7886-4:2006(E)
Introduction
The preparation of this part of ISO 7886 was recognized as a high priority requirement to prevent the re-use of
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. See Reference [1] in the
Bibliography.
The World Health Organisation had produced a specification for syringes that are rendered inactive after use
(commonly referred to as “auto-disable” syringes) for fixed dose immunization and syringes with re-use
prevention features for general purpose. Both the WHO and ISO agreed that additional parts of ISO 7886
would be required to cover syringes with re-use prevention features, whilst leaving in place ISO 7886-1 and
ISO 7886-2 without modification, as a large number of devices in common use would not be intended to
comply with the re-use prevention properties suggested.
This part of ISO 7886 is intended to cover syringes that are rendered inoperable after delivery of the intended
dose. These syringes are not covered by ISO 7886-1 and ISO 7886-3. ISO 7886-2 covers syringes used with
power-driven pumps. Given the diversity of clinical applications, the most appropriate re-use prevention
feature offering the highest level of re-use prevention is to be considered for each specific intended use.
It is recognized that syringes designed to reduce the risk of needlestick injuries can also comply with this part
of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties
of syringes are not in themselves addressed in this part of ISO 7886.
© ISO 2006 – All rights reserved v
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INTERNATIONAL STANDARD ISO 7886-4:2006(E)
Sterile hypodermic syringes for single use —
Part 4:
Syringes with re-use prevention feature
1 Scope
This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics
materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids
immediately after filling and of design such that the syringe can be rendered unusable after use.
This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes
for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address
compatibility with injection fluids. Other standards can be applicable when syringes are used for any other
intended purpose than those specified in this part of ISO 7886.
NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with
regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in
themselves addressed in this part of ISO 7886.
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 780, Packaging — Pictorial marking for handl
...
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