EN ISO 11608-2:2000
(Main)Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000)
Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000)
Specifies performance and interchangeability dimensions of needles for use with pen-injectors
Pen-Injektoren zur medizinischen Anwendung - Teil 2: Kanülen -Anforderungen und Prüfverfahren (ISO 11608-2:2000)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für sterile Kanülen mit beidseitigem Anschliff fest, die für den Einmalgebrauch in Pen-Injektoren vorgesehen sind und die die Festlegungen von ISO 11608-1 erfüllen.
Stylos-injecteurs à usage médical - Partie 2: Aiguilles -Exigences et méthodes d'essai (ISO 11608-2:2000)
La présente partie de l'ISO 11608 spécifie les exigences et les méthodes d'essai des aiguilles non réutilisables stériles à deux pointes, destinées aux stylos-injecteurs conformes aux spécifications de l'ISO 11608-1. Elle ne s'applique pas aux aiguilles pour usage dentaire.
Peresa za injiciranje za uporabo v medicini - 2. del: Igle - Zahteve in preskusne metode (ISO 11608-2:2000)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2001
Peresa za injiciranje za uporabo v medicini - 2. del: Igle - Zahteve in preskusne
metode (ISO 11608-2:2000)
Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO
11608-2:2000)
Pen-Injektoren zur medizinischen Anwendung - Teil 2: Kanülen -Anforderungen und
Prüfverfahren (ISO 11608-2:2000)
Stylos-injecteurs a usage médical - Partie 2: Aiguilles -Exigences et méthodes d'essai
(ISO 11608-2:2000)
Ta slovenski standard je istoveten z: EN ISO 11608-2:2000
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL ISO
STANDARD 11608-2
First edition
2000-12-15
Pen-injectors for medical use —
Part 2:
Needles — Requirements and test methods
Stylos-injecteurs à usage médical —
Partie 2: Aiguilles — Exigences et méthodes d'essai
Reference number
ISO 11608-2:2000(E)
©
ISO 2000
ISO 11608-2:2000(E)
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ii © ISO 2000 – All rights reserved
ISO 11608-2:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
4.1 Colour coding.2
4.2 Materials .2
4.3 Dimensions.2
4.4 Patency of lumen .3
4.5 Needle points .3
4.6 Freedom from defects .3
4.7 Lubrication .3
4.8 Dislocation of measuring point at the patient-end of Type A needles.4
4.9 Bond between hub and needle tube .4
4.10 Unscrewing torque of the needle.4
4.11 Ease of assembly/disassembly.4
4.12 Sterility.4
5 Sampling.4
6 Preconditioning of needles.5
6.1 Preconditioning in dry heat atmosphere.5
6.2 Preconditioning in cold storage atmosphere .5
6.3 Preconditioning in cyclical atmosphere.5
7 Standard atmosphere and apparatus for tests.6
7.1 Standard test atmosphere .6
7.2 Test apparatus .6
8 Determination of dislocation of measuring point at the patient-end of Type A needles .7
9 Bond between hub and needle tube .7
10 Unscrewing torque of the needle.7
11 Packaging.8
12 Information supplied by the manufacturer .8
12.1 General.8
12.2 Marking .8
12.3 Instructions for use .9
Bibliography.10
ISO 11608-2:2000(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 3.
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 part of ISO 11608 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11608-2 was prepared by Technical Committee ISO/TC 84, Medical devices for
injections.
ISO 11608 consists of the following parts, under the general title Pen-injectors for medical use:
� Part 1: Pen-injectors — Requirements and test methods
� Part 2: Needles — Requirements and test methods
� Part 3: Finished cartridges — Requirements and test methods
iv © ISO 2000 – All rights reserved
ISO 11608-2:2000(E)
Introduction
This part of ISO 11608 covers sterile double-ended needles intended for single use in conjunction with pen-
injectors.
The devices described in this part of ISO 11608 are designed to be used with devices described in ISO 11608-1
and ISO 11608-3.
It is recognized that interchangeability of the components (pen-injector, needle and cartridge) is desirable for some
medicinal products and should be avoided for other medicinal products, and that future design may change the
current concepts. Therefore, ISO 11608-2 and ISO 11608-3 encourage interchangeability by establishing certain
specific requirements for interchangeable needles (Type A) and interchangeable cartridges (Type A) respectively.
Performance requirements are imposed on both interchangeable (Type A) and non-interchangeable (non-Type A)
needles. Additional dimensional requirements are imposed on interchangeable needles (Type A).
Information as to whether the components are interchangeable (Type A) or not should be given on the unit
container.
It is desirable that non-Type A needles do not fit pen-injectors intended for Type A needles.
The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence
level, the manufacturer's ability to manufacture one “lot” of needles that conforms to the critical product attributes.
The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in
standards on quality systems, e.g. the ISO 9000 series.
This part of ISO 11608 does not specify requirements or test methods for freedom from biological hazards,
because international agreement upon the methodology and the pass/fail criteria is incomplete. Guidance on
biological tests relevant to double-ended needles is given in ISO 10993-1, and it is suggested that manufacturers
take this guidance into account when evaluating products. Such evaluation should include the effects of the
process whereby the needles are sterilized. However, national regulations may exist in some countries, and these
may take precedence over the guidance in ISO 10993-1.
In some countries, national regulations exist and their requirements may supersede or complement this part of
ISO 11608.
INTERNATIONAL STANDARD ISO 11608-2:2000(E)
Pen-injectors for medical use —
Part 2:
Needles — Requirements and test methods
1 Scope
This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for
pen-injectors which fulfil the specifications of ISO 11608-1.
It is not applicable to needles for dental use.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11608. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11608 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 6009:1992, Hypodermic needles for single use — Colour coding for identification.
ISO 7864:1993, Sterile hypodermic needles for single use.
ISO 9626:1991, Stainless steel needle tubing for the manufacture of medical devices.
ISO 11608-1:2000, Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods.
IEC 60068-2-30:1980, Environmental testing — Part 2: Test Db and guidance: Damp heat, cyclic (12 + 12-hour
cycle).
3 Terms and definitions
For the purposes of this part of ISO 11608, the following terms and definitions apply.
The nomenclature of some components of a needle for a pen-injector is given in Figure 1.
3.1
primary container
that part of the packaging which maintains sterility of the needle
NOTE The primary container may serve as a needle shield.
3.2
unit container
package intended for customer use
ISO 11608-2:2000(E)
3.3
seal
removable barrier which
...
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