EN ISO 23907-1:2019
(Main)Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)
Sharps injury protection - Requirements and test methods - Part 1: Single-use sharps containers (ISO 23907-1:2019)
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.
Schutz vor Stich- und Schnittverletzung - Anforderungen und Prüfverfahren - Teil 1: Einmalbehälter für spitze und scharfe Abfälle (ISO 23907-1:2019)
Dieses Dokument legt Anforderungen an Einmalbehälter für spitze und scharfe Abfälle fest, die zum Aufnehmen potentiell gefährlicher spitzer und scharfer medizinischer Abfälle mit oder ohne Schutzvorrich-tungen gegen Stich und Schnittverletzungen vorgesehen sind, z. B. Skalpellklingen, Trokare, Injektions-nadeln und Spritzen.
Es ist anwendbar sowohl auf Einmalbehälter für spitze und scharfe Abfälle, die vom Hersteller komplett montiert geliefert werden, als auch auf Behälter, die in Einzelteilen geliefert werden und durch den Benutzer zusammenzusetzen sind.
Es ist nicht anwendbar auf wiederverwendbare Behälter für spitze und scharfe Abfälle oder auf äußere Behälter, die zum Transport gefüllter Einmalbehälter für spitze und scharfe Abfälle verwendet werden.
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)
Le présent document spécifie les exigences relatives aux conteneurs à usage unique pour objets piquants ou coupants conçus pour contenir des objets pointus, perforants ou tranchants à usage médical, potentiellement dangereux et destinés à être éliminés, qu'ils soient munis ou non de dispositifs de protection contre les blessures, tels par exemple les lames de scalpels, les trocarts, les aiguilles et seringues hypodermiques.
Il s'applique aux conteneurs à usage unique pour objets coupants, tranchants et perforants fournis à l'état de produit fini par le fabricant ainsi que des conteneurs pour objets coupants, tranchants et perforants fournis sous forme de composants à assembler par l'utilisateur.
Il ne s'applique pas aux conteneurs pour objets piquants ou coupants réutilisables ni aux conteneurs de suremballage utilisés pour le transport des conteneurs à usage unique remplis.
Zaščita pred poškodbami z ostrimi predmeti - Zahteve in preskusne metode - 1. del: Vsebniki za ostre predmete za enkratno uporabo (ISO 23907-1:2019)
Ta dokument določa zahteve za vsebnike za ostre predmete za enkratno uporabo, namenjene potencialno nevarnim ostrim medicinskim odpadkom z zaščito ali brez, npr. rezilom skalpela, trokarjem, hipodermičnim iglam in brizgalkam.
Uporablja se za vsebnike za ostre predmete za enkratno uporabo, ki jih proizvajalec dobavi pripravljene za uporabo, in tiste, ki so dobavljeni kot sestavni deli, ki jih sestavi uporabnik.
Ne uporablja se za vsebnike za ostre predmete za večkratno uporabo ali druge zunanje vsebnike, ki se uporabljajo pri transportu napolnjenih vsebnikov za ostre predmete za enkratno uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 23907:2012
=DãþLWDSUHGSRãNRGEDPL]RVWULPLSUHGPHWL=DKWHYHLQSUHVNXVQHPHWRGH
GHO 9VHEQLNL]DRVWUHSUHGPHWH]DHQNUDWQRXSRUDER ,62
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 23907-1:2019(E)
© 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.
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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 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 requ
...
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