SIST EN ISO 23907-1:2019

SLOVENSKI STANDARD
SIST EN ISO 23907-1:2019
01-april-2019
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SIST EN ISO 23907:2012
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Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps
containers (ISO 23907-1:2019)
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Teil 1:
Einmalbehälter für spitze und scharfe Abfälle (ISO 23907-1:2019)
Protection contre les blessures par perforants - Exigences et méthodes d'essai - Partie
1: Conteneurs à usage unique pour objets piquants ou coupants (ISO 23907-1:2019)
Ta slovenski standard je istoveten z: EN ISO 23907-1:2019
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
SIST EN ISO 23907-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23907-1:2019

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SIST EN ISO 23907-1:2019


EN ISO 23907-1
EUROPEAN STANDARD

NORME EUROPÉENNE

February 2019
EUROPÄISCHE NORM
ICS 11.040.99 Supersedes EN ISO 23907:2012
English Version

Sharps injury protection - Requirements and test methods
- Part 1: Single-use sharps containers (ISO 23907-1:2019)
Protection contre les blessures par perforants - Schutz vor Stich- und Schnittverletzung -
Exigences et méthodes d'essai - Partie 1: Conteneurs à Anforderungen und Prüfverfahren - Teil 1:
usage unique pour objets piquants ou coupants (ISO Einmalbehälter für spitze und scharfe Abfälle (ISO
23907-1:2019) 23907-1:2019)
This European Standard was approved by CEN on 21 December 2018.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23907-1:2019 E
worldwide for CEN national Members.

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SIST EN ISO 23907-1:2019
EN ISO 23907-1:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 23907-1:2019
EN ISO 23907-1:2019 (E)
European foreword
This document (EN ISO 23907-1:2019) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and 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 August 2019, and conflicting national standards shall
be withdrawn at the latest by February 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 23907:2012.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 23907-1:2019 has been approved by CEN as EN ISO 23907-1:2019 without any
modification.


3

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SIST EN ISO 23907-1:2019

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SIST EN ISO 23907-1:2019
INTERNATIONAL ISO
STANDARD 23907-1
First edition
2019-01
Sharps injury protection —
Requirements and test methods —
Part 1:
Single-use sharps containers
Protection contre les blessures par perforants — Exigences et
méthodes d'essai —
Partie 1: Conteneurs à usage unique pour objets piquants ou coupants
Reference number
ISO 23907-1:2019(E)
©
ISO 2019

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SIST EN ISO 23907-1:2019
ISO 23907-1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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SIST EN ISO 23907-1:2019
ISO 23907-1:2019(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General . 3
4.2 Construction . 3
4.2.1 Container stability . 3
4.2.2 Strength of handles . 4
4.2.3 Aperture and closure . 4
4.2.4 Resistance to penetration . 4
4.2.5 Resistance to damage or leakage after dropping . 4
4.2.6 Resistance to damage or leakage after toppling . 5
4.2.7 Fill line indicator . 5
5 Test methods . 5
5.1 Container stability . . 5
5.2 Strength of handle(s) . 5
5.3 Resistance to penetration . 6
5.3.1 Apparatus . 6
5.3.2 Procedure . 6
5.4 Resistance to damage and leakage after dropping . 6
5.4.1 Apparatus . 6
5.4.2 Procedure . 7
5.5 Resistance to spillage by toppling . 8
5.5.1 Apparatus . 8
5.5.2 Procedure . 8
6 Labelling and marking . 8
7 Instructions for use . 9
Annex A (informative) Additional explanation of the rationale underpinning this document .10
Bibliography .12
© ISO 2019 – All rights reserved iii

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SIST EN ISO 23907-1:2019
ISO 23907-1:2019(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters.
This first edition cancels and replaces the first edition (ISO 23907:2012), which has been technically
revised. The main changes compared to the previous edition are as follows:
— Resistance to penetration: increase of the force to a minimum of 16 N;
— Addition of yellow as the base dominant colour;
— Creation of Annex A “Additional explanation of the rationale underpinning this document” and
deletion of the previous Annexes A and B;
— New requirements for the permanent and temporary closures;
— New requirements on resistance to damage or leakage after toppling;
— Clarification of the procedure for the resistance to penetration and the resistance to damage and
leakage after dropping test methods;
— Addition of a new test method for resistance to spillage by toppling.
A list of all parts in the ISO 23907 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

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SIST EN ISO 23907-1:2019
INTERNATIONAL STANDARD ISO 23907-1:2019(E)
Sharps injury protection — Requirements and test
methods —
Part 1:
Single-use sharps containers
1 Scope
This document 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 single-use 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 to the outer containers used in the transportation
of filled single-use sharps containers.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aperture
opening of the sharps (3.15) container through which sharps (3.15) are deposited for disposal
3.2
closure feature
flap, plug, lid or slide that is intended to close the aperture (3.1)
3.3
fill line
mark, indicator or feature on the container that represents the fill volume (3.4)
3.4
fill volume
usable volume determined by the manufacturer and indicated by the fill line (3.3) on the container
© ISO 2019 – All rights reserved 1

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SIST EN ISO 23907-1:2019
ISO 23907-1:2019(E)

3.5
handle
appendage, protrusion, flange or recess intended for lifting the container
3.6
integrally attached
tethered or joined to the container by a permanent means
3.7
leak-resistance
ability of a container to prevent escape of fluid
Note 1 to entry: See conditions specified in 5.4.
3.8
manufacturer's allowable gross mass
maximum mass of the container and contents as recommended by the manufacturer for safe handling
and operation
Note 1 to entry: Mass shall be measured in kilograms (kg).
3.9
needle disconnection feature
feature allowing single-handed sharps (3.15) disconnection
3.10
penetration
movement of a needle through the test specimen (3.19) 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 (3.10)
Note 1 to entry: The penetration force is expressed in newtons (N).
Note 2 to entry: See conditions specified in 5.3.
3.12
permanent closure
closure feature (3.2), integrally attached (3.6) to the container, which once activated cannot be re-
opened manually
3.13
pocket collectors
sharps (3.15) container that has a fill volume (3.4) equal to or less than 0,6 l
Note 1 to entry: The primary design considerations for pocket collectors are to prevent penetration (3.10) of the
sharp(s) (3.15) 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 document.
3.14
secondary stabilizer
attachment or design feature intended to provide extra stability and prevent the device from
toppling over
2 © ISO 2019 – All rights reserved

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SIST EN ISO 23907-1:2019
ISO 23907-1:2019(E)

3.15
sharps
objects capable of cutting or penetrating skin
EXAMPLE Needles of various types, syringes, scalpels, broken glass, culture slides, culture dishes, broken
capillary tubes, broken rigid plastic, exposed ends of dental wires.
3.16
sharps containment area
surface that directly encloses sharps (3.15) for the purposes of container puncture protection while in
use and in the final closed configuration
3.17
single-use sharps container
container designated by the manufacturer to be filled only once
3.18
temporary closure
closure feature (3.2) integrally attached (3.6) to the container which, once activated for closure, can be
re-opened, without being damaged
3.19
test specimen
portion of the container
Note 1 to entry: See conditions specified in 5.3.2.1.
3.20
total volume of the container
entire air space in the closed container
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.
The base dominant colour should be yellow unless local
...