1、January 2013 Translation by DIN-Sprachendienst.English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 11.040.99!$“1936197www.din.deDDIN EN ISO 23907Sharps injury protection Requirements and test methods Sharps containers (ISO 23907:2012);English version EN ISO 23907:2012,English translation of DIN EN ISO 23907:2013-01Schutz vor Stich- und Schnittverletzung Anforderungen und Prfverfahren Behlter fr
3、 spitze und scharfe Abflle (ISO 23907:2012);Englische Fassung EN ISO 23907:2012,Englische bersetzung von DIN EN ISO 23907:2013-01Protection contre les blessures par perforants Exigences et mthodes dessai Conteneurs pour objets coupants, tranchants et perforants (ISO 23907:2012);Version anglaise EN I
4、SO 23907:2012,Traduction anglaise de DIN EN ISO 23907:2013-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 16 pages12.12 DIN EN ISO 23907:2013-01 2 A comma is used as the decimal marker. National foreword This document (EN ISO 23907:2
5、012) 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” (Secretariat: DIN, Germany). The responsible German body involved in its preparatio
6、n was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. Re Introduction The use of single-use sharps containers is required in Germany, and the relevant requirements are laid down in 4.1.1.4 of TRBA 250. It can be assumed that containers
7、tested in accordance with DIN EN ISO 23907 also meet the requirements of TRBA 250. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2859-10 DIN ISO 2859-10 ISO 3951 (all parts) DIN ISO 3951 (all parts) ISO 7864 DIN EN ISO 7864 ISO 14971
8、DIN EN ISO 14971 National Annex NA (informative) Bibliography DIN EN ISO 7864, Sterile hypodermic needles for single use DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN ISO 2859-10, Sampling procedures for inspection by attributes Part 10: Introduction to the
9、ISO 2859 series of standards for sampling for inspection by attributes DIN ISO 3951 (all parts), Sampling procedures for inspection by variables TRBA 250, Technische Regeln fr Biologische Arbeitsstoffe 250 Biologische Arbeitsstoffe im Gesundheits-dienst und in der Wohlfahrtspflege (Technical Rule fo
10、r Biological Agents 250 Biological agents in health care and welfare facilities) EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23907 September 2012 ICS 11.040.99 English Version Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012) Protection contre
11、 les blessures par perforants - Exigences et mthodes dessai - Conteneurs pour objets coupants, tranchants et perforants (ISO 23907:2012) Schutz vor Stich- und Schnittverletzung - Anforderungen und Prfverfahren - Behlter fr spitze und scharfe Abflle (ISO 23907:2012) This European Standard was approve
12、d 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 st
13、andards 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
14、 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, Hungar
15、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any
16、 means reserved worldwide for CEN national Members. Ref. No. EN ISO 23907:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Contents Page Foreword . 3 Introduction . 4 1 Scope . 6 2 Normative references 6 3 Terms and definitions 6 4 Requireme
17、nts . 7 4.1 General 7 4.2 Construction . 8 4.2.1 Container stability 8 4.2.2 Strength of handles . 8 4.2.3 Aperture and closure . 8 4.2.4 Resistance to penetration . 8 4.2.5 Resistance to damage or leakage after dropping . 8 4.2.6 Fill line indicator . 8 5 Test methods 9 5.1 Container stability 9 5.
18、2 Strength of handle(s) . 9 5.3 Resistance to penetration . 9 5.3.1 Apparatus 9 5.3.2 Procedure 9 5.4 Resistance to damage and leakage after dropping 9 5.4.1 Apparatus 9 5.4.2 Procedure 9 6 Labelling and marking . 11 7 Instructions for use 12 Annex A (informative) Rationale for gauge size and punctu
19、re value . 13 Annex B (informative) Guidance on selection of test specimens for resistance to penetration test 14 Bibliography 15 2DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) Foreword This document (EN ISO 23907:2012) has been prepared by Technical Committee ISO/TC 84 Devices for administration o
20、f 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 endors
21、ement, 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 identifyin
22、g 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 R
23、epublic 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
24、 approved by CEN as a EN ISO 23907:2012 without any modification. “”3DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) IntroductionSingle-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
25、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
26、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
27、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 m
28、ight supersede or complement this International Standard.4DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) 1 ScopeThis International Standard specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features,
29、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 contain
30、ers used in the transportation of filled single-use sharps containers.2 Normative referencesThe 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 do
31、cument (including any amendments) applies.ISO 7864, Sterile hypodermic needles for single use3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1apertureopening of the sharps container in which sharps are inserted for disposal3.2closure featureflap,
32、 plug, lid or slide that is intended to close the aperture3.3permanent closurecondition when the closure feature is locked/sealed in preparation for final disposal3.4total volume of the containerentire air space in a closed container3.5fill volume of the containerusable volume determined by the manu
33、facturer and indicated by the fill line on the container3.6fill line indicatormark or indicator on the container that represents the fill volume3.7handleappendage, protrusion, flange or recess intended for lifting the container5DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) 3.8integrally attachedtet
34、hered or joined to the container by a permanent means3.9leak-resistantability of a container to prevent escape of fluid under the conditions specified in this International Standard3.10penetrationmovement of a needle through the test specimen until the point of the needle exits on the side opposite
35、the point of entry3.11penetration forceamount of force applied to a hypodermic needle to achieve penetration under the conditions specified in this International StandardNOTE The penetration force is expressed in Newtons.3.12pocket collectorssharps container that has a total capacity equal to or les
36、s than 0,75 l, intended to contain a limited number of sharpsNOTE 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 users pocket.
37、In order to achieve portability and a low profile, these devices have been excluded from certain aspects of the requirements of this International Standard.3.13sharpsobjects capable of cutting or penetrating skinEXAMPLES Needles of various types, syringes, scalpels, broken glass, culture slides, cul
38、ture dishes, broken capillary tubes, broken rigid plastic, exposed ends of dental wires.3.14sharps containment areasurface intended to directly enclose sharps for the purposes of container puncture protection in use and in the final closed configuration3.15single-use sharps containercontainer design
39、ated or intended by the manufacturer for a one-time filling of the container3.16secondary stabilizerattachment or design feature intended to provide extra stability and prevent the device from toppling over when placed on a horizontal surface4 Requirements4.1 GeneralThe principles of risk assessment
40、, as well as human factors, should be considered in the design process of sharps containers, e.g. by applying the relevant requirements of ISO 14971.6DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) 4.2 Construction4.2.1 Container stabilityThe container shall not topple over when tested in accordance
41、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 co
42、njunction with that device.4.2.2 Strength of handlesAll 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
43、, 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 closure4.2.3.1 GeneralSingle-use sharps containers shall be provided with a closu
44、re 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
45、.2.3.2 Requirements for the apertureIt 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
46、 container.NOTE A risk assessment should address the risk of overfilling.4.2.3.3 Requirements for the closure featureClosure 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 col
47、lectors should be provided with a permanent closure.4.2.4 Resistance to penetrationWhen 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 droppingWhen tested in accordance with 5.4, there shall be no ev
48、idence of leakage and no breach of the sharps containment area.4.2.6 Fill line indicatorThe 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
49、 of the container. A fill line indicator is not mandatory for pocket collectors.7DIN EN ISO 23907:2013-01 EN ISO 23907:2012 (E) 5 Test methods5.1 Container stability5.1.1 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 topp
