SIST EN ISO 23907:2012

SLOVENSKI STANDARD
SIST EN ISO 23907:2012
01-november-2012
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Sharps injury protection - Requirements and test methods - Part 3: Sharps containers
(ISO 23907:2012)
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Behälter für
spitze und scharfe Abfälle (ISO 23907:2012)
Protection contre les blessures par perforants - Exigences et méthodes d'essai -
Conteneurs pour objets coupants, tranchants et perforants (ISO 23907:2012)
Ta slovenski standard je istoveten z: EN ISO 23907:2012
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
SIST EN ISO 23907:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23907:2012

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SIST EN ISO 23907:2012


EUROPEAN STANDARD
EN ISO 23907

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2012
ICS 11.040.99
English Version
Sharps injury protection - Requirements and test methods -
Sharps containers (ISO 23907:2012)
Protection contre les blessures par perforants - Exigences Schutz vor Stich- und Schnittverletzung - Anforderungen
et méthodes d'essai - Conteneurs pour objets coupants, und Prüfverfahren - Behälter für spitze und scharfe Abfälle
tranchants et perforants (ISO 23907:2012) (ISO 23907:2012)
This European Standard was approved by CEN on 31 August 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23907:2012: E
worldwide for CEN national Members.

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SIST EN ISO 23907:2012
EN ISO 23907:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 23907:2012
EN ISO 23907:2012 (E)
Foreword
This document (EN ISO 23907:2012) has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and intravascular catheters" 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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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 23907:2012 has been approved by CEN as a EN ISO 23907:2012 without any modification.

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SIST EN ISO 23907:2012

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SIST EN ISO 23907:2012
INTERNATIONAL ISO
STANDARD 23907
First edition
2012-09-01
Sharps injury protection — Requirements
and test methods — Sharps containers
Protection contre les blessures par perforants — Exigences et méthodes
d’essai — Conteneurs pour objets coupants, tranchants et perforants
Reference number
ISO 23907:2012(E)
©
ISO 2012

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SIST EN ISO 23907:2012
ISO 23907:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from 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
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 23907:2012
ISO 23907:2012(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 23907 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products
and intravascular catheters.
© ISO 2012 – All rights reserved iii

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SIST EN ISO 23907:2012
ISO 23907:2012(E)
Introduction
Single-use sharps containers are designed for the containment and disposal of sharps such as scalpel blades,
trocars, hypodermic needles and syringes. They are supplied in a wide range of sizes and can be manufactured
from a variety of materials. This International Standard does not specify the size range of the containers or the
materials selected to manufacture the containers.
Sharps containers can be either single-use or reusable. This International Standard covers single-use sharps
containers. The test methods included in this International Standard might be applicable when developing a
reusable sharp container standard.
This International Standard includes informative annexes with rationales on several subjects, which have
undergone profound debate in ISO/TC 84. These rationales have been elaborated to provide further explanation
on the present requirements. In future editions of this International Standard, these rationales will also clarify
the justification of the current requirements.
National regulations exist in some countries; their requirements might supersede or complement this
International Standard.
iv © ISO 2012 – All rights reserved

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SIST EN ISO 23907:2012
INTERNATIONAL STANDARD ISO 23907:2012(E)
Sharps injury protection — Requirements and test methods —
Sharps containers
1 Scope
This International Standard specifies requirements for single-use sharps containers intended to hold potentially
hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars,
hypodermic needles and syringes.
It is applicable to sharps containers that are supplied complete by the manufacturer and to those that are
supplied as components intended to be assembled by the user.
It is not applicable to reusable sharps containers or the outer containers used in the transportation of filled
single-use sharps containers.
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 7864, Sterile hypodermic needles for single use
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aperture
opening of the sharps container in which sharps are inserted for disposal
3.2
closure feature
flap, plug, lid or slide that is intended to close the aperture
3.3
permanent closure
condition when the closure feature is locked/sealed in preparation for final disposal
3.4
total volume of the container
entire air space in a closed container
3.5
fill volume of the container
usable volume determined by the manufacturer and indicated by the fill line on the container
3.6
fill line indicator
mark or indicator on the container that represents the fill volume
3.7
handle
appendage, protrusion, flange or recess intended for lifting the container
© ISO 2012 – All rights reserved 1

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SIST EN ISO 23907:2012
ISO 23907:2012(E)
3.8
integrally attached
tethered or joined to the container by a permanent means
3.9
leak-resistant
ability of a container to prevent escape of fluid under the conditions specified in this International Standard
3.10
penetration
movement of a needle through the test specimen until the point of the needle exits on the side opposite the
point of entry
3.11
penetration force
amount of force applied to a hypodermic needle to achieve penetration under the conditions specified in this
International Standard
NOTE The penetration force is expressed in Newtons.
3.12
pocket collectors
sharps container that has a total capacity equal to or less than 0,75 l, intended to contain a limited number of sharps
NOTE The primary design considerations for pocket collectors is to prevent penetration of the sharp(s) through
the container while providing a compact size that can be easily carried on the person of the user, such as in the user’s
pocket. In order to achieve portability and a low profile, these devices have been excluded from certain aspects of the
requirements of this International Standard.
3.13
sharps
objects capable of cutting or penetrating skin
EXAMPLES Needles of various types, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary
tubes, broken rigid plastic, exposed ends of dental wires.
3.14
sharps containment area
surface intended to directly enclose sharps for the purposes of container puncture protection in use and in the
final closed configuration
3.15
single-use sharps container
container designated or intended by the manufacturer for a one-time filling of the container
3.16
secondary stabilizer
attachment or design feature intended to provide extra stability and prevent the device from toppling over when
placed on a horizontal surface
4 Requirements
4.1 General
The principles of risk assessment, as well as human factors, should be considered in the design process of
sharps containers, e.g. by applying the relevant requirements of ISO 14971.
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SIST EN ISO 23907:2012
ISO 23907:2012(E)
4.2 Construction
4.2.1 Container stability
The container shall not topple over when tested in accordance with 5.1. Containers recommended for use with
a wall mount and pocket collectors are excluded from the requirement specified in 5.1. The requirement applies
to containers intended for use on a horizontal surface. Sharps containers intended to be used with a secondary
stabilizer shall be tested in conjunction with that device.
4.2.2 Strength of handles
All sharps containers excluding pocket collectors shall be provided with one or several handles.
When tested in accordance with 5.2, the handle/carrying feature shall not break or detach during testing. The position
of the handle(s), finger recesses, protrusions or flanges shall not interfere with the normal use of the container.
Finger recesses, if present, shall be sited above the fill line. This requirement does not apply to pocket collectors.
4.2.3 Aperture and closure
4.2.3.1 General
Single-use sharps containers shall be provided with a closure feature that is integrally attached. Pocket
collectors intended for single devices are excluded from the requirements regarding attachment of the closure
device. The aperture shall be designed to minimize the potential for accidental sharps injuries during placement
of sharps into the container.
4.2.3.2 Requirements for the aperture
It shall be possible to place sharps into the sharps container without using a second hand to manipulate the aperture.
The aperture of containers intended to be placed in public access areas should be designed to restrict hand
entry and removal of contents from the container.
NOTE A risk assessment should address the risk of overfilling.
4.2.3.3 Requirements for the closure feature
Closure features shall be capable of being closed without the risk of sharps injury to the user.
The permanent closure, once activated, shall be resistant to manual opening. Pocket collectors should be
provided with a permanent closure.
4.2.4 Resistance to penetration
When tested in accordance with 5.3, the force needed to penetrate test specimens shall be not less than 15 N.
4.2.5 Resistance to damage or leakage after dropping
When tested in accordance with 5.4, there shall be no evidence of leakage and no breach of the sharps
containment area.
4.2.6 Fill line indicator
The fill line indicator shall be determined by the design of the container, taking into account the risk of sharps
extending above the fill line, and shall be at a level no greater than 85 % of the total capacity of the container.
A fill line indicator is not mandatory for pocket collectors.
© ISO 2012 – All rights reserved 3

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SIST EN ISO 23907:2012
ISO 23907:2012(E)
5 Test methods
5.1 Container stability
5.1.1 Fill the container to the fill line with material of a density of (0,20 ± 0,01) kg/l. Do not lock or close the
aperture closure.
5.1.2 Place the container in the most adverse position for toppling on a surface with a minimum inclination
angle of 15°. Ensure that the container does not slide before toppling.
Check for compliance with 4.2.1.
5.2 Strength of handle(s)
5.2.1 Fill the container with a mass equivalent to 150 % of the manufacturer’s maximum allowable gross mass.
5.2.2 Fit the aperture closure and close or lock it as if the sharps container is ready for final disposal.
5.2.3 Suspend the container by its handle(s) at the intended carrying point(s) from a rigid support
...