EN ISO 23908-2013 en Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles u.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 23908:2013Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles use

2、d for blood sampling (ISO 23908:2011)BS EN ISO 23908:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 23908:2013. It is identical to ISO 23908:2011. It supersedes BS EN ISO 23908:2011, which is withdrawn.The UK participation in its preparation was entrus

3、ted to T e c h n i c a l C o m m i t t e e C H / 8 4 , C a t h e t e r s a n d s y r i n g e s .A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are respons

4、ible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013.ISBN 978 0 580 82255 1 ICS 11.040.25; 11.040.99 Compliance with a British Standard cannot confer immunityfrom legal obligations.This British Standard was published under the authority of

5、 the Standards Policy and Strategy Committee on 28 February 2013.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23908 February 2013 ICS 11.040.25; 11.040.99 Supersedes EN ISO 23908:2011English Version Sharps injury protection -

6、 Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) Protection contre les blessures par perforants - Exigences et mthodes dessai - Dispositifs de protection des aiguilles hypoder

7、miques, des introducteurs pour cathters et des aiguilles utilises pour les prlvements sanguins, non rutilisables (ISO 23908:2011) Schutz vor Stich- und Schnittverletzung - Anforderungen und Prfverfahren - Schutzeinrichtungen fr einmalig zu verwendende Nadeln zur subkutanen Injektion, Kathetereinfhru

8、ngen und Nadeln zur Blutentnahme (ISO 23908:2011) This European Standard was approved by CEN on 8 January 2013. 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 alt

9、eration. 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 ma

10、de 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, Esto

11、nia, 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 STAN

12、DARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23908:2013: EBS EN ISO 23908:2013 EN ISO 23908:

13、2013 (E) 3 Foreword The text of ISO 23908:2011 has been prepared by Technical Committee ISO/TC 84 “Devices foradministration of medicinal products and intravascular catheters” of the International Organization forStandardization (ISO) and has been taken over as EN ISO 23908:2013 by Technical Committ

14、ee 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 identicaltext or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn

15、 atthe latest by August 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 23908:2011. This document

16、 has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENEL

17、EC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,Hungary, Icelan

18、d, 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 23908:2011 has been approved by CEN as EN ISO 23908:2013 without any modification.

19、 BS EN ISO 23908:2013EN ISO 23908:2013 (E) 4 Annex ZA (informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commissionand the European

20、Free Trade Association to provide one means of conforming to Essential Requirements ofthe New Approach Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has beenimplemented as a national standard in at least one

21、 Member State, compliance with the clauses of thisstandard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption ofconformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. NOTE This citation under the Directive

22、93/42/EEC is appropriate provided that the sharps protection is a featureintegrated/associated to the medical device. Table ZA.1 Correspondence between this European Standard andDirective 93/42/EEC on Medical Devices Clause(s)/subclause(s)of this European Standard Essential Requirements (ERs)of Dire

23、ctive 93/42/EEC Qualifying remarks/Notes 4.1.1.1, 4.1.1.2, 4.1.1.3, 4.3, 5.3, 5.4, 5.5 8.1 4.1.1.4 9.14.1.1.1, 4.1.1.2, 4.1.1.3, 4.3, 5.3, 5.4, 5.5 9.2 4.2, 5.2 12.7 6 13 The part of ER 13.3 a) relating to theauthorized representative and the partof ER 13.6 h) relating to single-use arenot addressed

24、 in the standard. WARNING Other requirements and other EU Directives may be applicable to the products fallingwithin the scope of this standard. BS EN ISO 23908:2013ISO 23908:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and

25、 definitions .1 4 Requirements.2 4.1 General .2 4.2 Activation of the sharps injury protection feature.3 4.3 Security of safe mode protection 3 5 Test methods .3 5.1 General .3 5.2 Testing activation of a sharps injury protection feature .3 5.2.1 Principle3 5.2.2 Apparatus.4 5.2.3 Procedure.4 5.3 Ch

26、allenging the device in safe mode 5 5.3.1 General .5 5.3.2 Principle5 5.3.3 Apparatus.5 5.3.4 Procedure.5 5.4 Testing access to the sharp in safe mode6 5.5 Testing simulated clinical use .6 5.6 Test report6 6 Information supplied by the manufacturer .6 6.1 General .6 6.2 Marking/labelling .7 6.3 Ins

27、tructions for use .7 Annex A (informative) Guidance on simulated user studies8 Annex B (informative) Method for testing access to the sharp in safe mode 10 Bibliography11 BS EN ISO 23908:2013ISO 23908:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardiza

28、tion) 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

29、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 Standard

30、s 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 Interna

31、tional 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 23908 was

32、 prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters. BS EN ISO 23908:2013ISO 23908:2011(E) ISO 2011 All rights reserved vIntroduction This International Standard addresses sharps injury protection systems designed to protect users

33、of medical devices. These sharps injury protection features are intended to prevent, or reduce the potential for, disease transmission which could result from accidental, post-use sharps injuries. This International Standard is aimed at addressing devices primarily intended for human use, of a wide

34、range of product types, including, among others, hollow-bore needles for injection or infusion of therapeutics into the body, or sampling of fluids from the body, and hollow bore or solid-core needles used for blood sampling (e.g. lancing devices). It addresses sharps injury protection systems which

35、 are either active or passive in their activation after the medical devices intended use. It does not cover solid-core needles used for surgery (e.g. suture needles). Given the broad variation in product design and sharps protection technology, the variety of different types of devices, and in order

36、 to avoid unnecessarily restricting innovation, this International Standard has been developed as “horizontal” in nature, which means it provides for general design, testing and labelling requirements, rather than specific physical and prescriptive design requirements. It therefore differs from more

37、 “vertical” standards, which list specific maximum forces, detailed test fixture designs, test systems to be used or detailed test measures, as such prescriptive details cannot cover the variety of designs and devices, and may impede continuing innovation in new products, features and/or protection

38、mechanisms that lead to future improvements in healthcare. This International Standard presumes that the product developer would use a risk-based approach (consistent with ISO 14971) to determine the device design that best meets the needs of a target user population and expected use settings. Throu

39、gh this risk-based approach, the sharps injury protection system would have performance requirements appropriate to the foreseeable risks associated with the intended use of the device, expected user interfaces, and the settings in which these safety features are expected to be used. This Internatio

40、nal Standard provides guidelines to enable the manufacturer to verify that the design of the sharps injury protection systems complies with the design intent spelled out in the design specification. As part of this verification, the manufacturer is expected to demonstrate that the performance of the

41、 sharps injury protection system is appropriate to the intended users and settings through the use of appropriate simulated or clinical use studies. These simulated or clinical use studies allow the manufacturer to demonstrate that, when used in accordance with the instructions for use, in settings

42、representative of real-life intended use and by intended or foreseeable users, the device functions as intended. Existing products and those currently under development may not fulfil some of the requirements given by this International Standard. However, manufacturers would be well advised to follo

43、w its provisions when improving existing products or developing new products to obtain an even higher level of quality. BS EN ISO 23908:2013BS EN ISO 23908:2013INTERNATIONAL STANDARD ISO 23908:2011(E) ISO 2011 All rights reserved 1Sharps injury protection Requirements and test methods Sharps protect

44、ion features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling 1 Scope This International Standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, f

45、or medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the shar

46、ps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references,

47、 only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2859 (all parts), Sampling procedures for inspection by attributes ISO 3951 (all parts), Sampling procedures for inspection by variables ISO 14971, Medical d

48、evices Application of risk management to medical devices ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 activation deployment of the sha

49、rps protection mechanism 3.2 active safety feature sharps protection feature that requires an additional step by the user to activate, separate from any action needed to perform the primary intended function of the device 3.3 accidental sharps injury unintentional penetration into human tissue by the sharp after the intended use BS EN ISO 23908:2013ISO 23908:2011(E) 2 ISO 2011 All rights reserved3.4 passive safety feature sharps protection feature that does not require an additional step by the user to activate, separate from any action