EN ISO 23907-2012 en Sharps injury protection - Requirements and test methods - Sharps containers《锐器损伤防护 试验方法和要求 利器盒》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 23907:2012Sharps injury protection Requirements and test methods Sharps containersBS EN ISO 23907:2012 BRITISH STANDARDNational forewordThis British Standard is the UK

2、implementation of EN ISO 23907:2012. It supersedes BS 7320:1990, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained on request to its secretary.This public

3、ation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 69102 7 ICS 11.040.99 Compliance with a British Standard cannot confer immun

4、ity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23907 September 2012 ICS 11.040.99 Engl

5、ish Version Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012) Protection contre les blessures par perforants - Exigences et mthodes dessai - Conteneurs pour objets coupants, tranchants et perforants (ISO 23907:2012) Schutz vor Stich- und Schnittverletzung

6、- Anforderungen und Prfverfahren - Behlter fr spitze und scharfe Abflle (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

7、 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, Germ

8、an). 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

9、, 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 Unit

10、ed Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23907:20

11、12: EBS EN ISO 23907:2012 EN ISO 23907:2012 (E) 3 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 devi

12、ces” 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. Attenti

13、on 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 th

14、e 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, Netherl

15、ands, 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. BS EN ISO 23907:2012ISO 23907:2012(E)ForewordISO (the Intern

16、ational 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 b

17、een 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 sta

18、ndardization.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

19、 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

20、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 iiiBS EN ISO 23907:2012ISO 23907:2012(E)IntroductionSingle-use sharps containers are designed for the containment and

21、 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

22、 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 includ

23、es 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 j

24、ustification of the current requirements.National regulations exist in some countries; their requirements might supersede or complement this International Standard.iv ISO 2012 All rights reservedBS EN ISO 23907:2012Sharps injury protection Requirements and test methods Sharps containers1 ScopeThis I

25、nternational 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

26、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 referencesThe following referenced d

27、ocuments 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 use3 Terms and definitionsFo

28、r 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, plug, lid or slide that is intended to close the aperture3.3permanent closurecondition when the closure feature is lo

29、cked/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 manufacturer and indicated by the fill line on the container3.6fill line indicatormark or indicator on the container that

30、represents the fill volume3.7handleappendage, protrusion, flange or recess intended for lifting the containerINTERNATIONAL STANDARD ISO 23907:2012(E) ISO 2012 All rights reserved 1BS EN ISO 23907:2012ISO 23907:2012(E)3.8integrally attachedtethered or joined to the container by a permanent means3.9le

31、ak-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 the point of entry3.11penetration forceamount of force app

32、lied 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 less than 0,75 l, intended to contain a limited number of sha

33、rpsNOTE 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. In order to achieve portability and a low profile, these d

34、evices 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, culture dishes, broken capillary tubes, broken rigid plastic,

35、 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 designated or intended by the manufacturer for a one-time fillin

36、g 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, as well as human factors, should be considered in the de

37、sign process of sharps containers, e.g. by applying the relevant requirements of ISO 14971.2 ISO 2012 All rights reservedBS EN ISO 23907:2012ISO 23907:2012(E)4.2 Construction4.2.1 Container stabilityThe container shall not topple over when tested in accordance with 5.1. Containers recommended for us

38、e 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 Streng

39、th 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, protrusions or flanges shall not inte

40、rfere 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 closure feature that is integrally attached.

41、 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 apertureIt

42、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 shoul

43、d 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 collectors should be provided with a perma

44、nent 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 evidence of leakage and no breach of the

45、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 of the container. A fill line indicato

46、r is not mandatory for pocket collectors. ISO 2012 All rights reserved 3BS EN ISO 23907:2012ISO 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 contai

47、ner 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 manufacturers maximum a

48、llowable 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 for 1 h at a temperature of (23 5) C.If the container has more than one i

49、ntended carrying point, at least two of the worst-case carrying points shall be tested.5.2.4 Remove the container from the support and inspect the handle(s) for integrity and for any evidence of detachment of the handle(s) from the container.Check for compliance with the requirements in 4.2.2.5.3 Resistance to penetration5.3.1 Apparatus5.3.1.1 Tensometer, having a load cell capable of measuring the force applied to a needle penetrating a test specimen and means to record the force necessary to just penetrate one surface of the test specimen whe