1、October 2013 Translation by DIN-Sprachendienst.English price group 11No 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 11.040.25!%)T“2064996www.din.deDDIN EN ISO 23908Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles,introducers for catheters and needles used for blood sampling(ISO 23908:2011);English version EN ISO 23908:2013,English translation of
3、 DIN EN ISO 23908:2013-10Schutz vor Stich- und Schnittverletzung Anforderungen und Prfverfahren Schutzeinrichtungen fr einmalig zu verwendende Kanlen zur subkutanen Injektion,Kathetereinfhrungen und Kanlen zur Blutentnahme (ISO 23908:2011);Englische Fassung EN ISO 23908:2013,Englische bersetzung von
4、 DIN EN ISO 23908:2013-10Protection contre les blessures par perforants Exigences et mthodes dessai Dispositifs de protection des aiguilles hypodermiques, des introducteurs pour cathters etdes aiguilles utilises pour les prlvements sanguins, non rutilisables(ISO 23908:2011);Version anglaise EN ISO 2
5、3908:2013,Traduction anglaise de DIN EN ISO 23908:2013-10SupersedesDIN EN ISO 23908:2011-09www.beuth.deDocument comprises 20 pagesIn case of doubt, the German-language original shall be considered authoritative.09.13 DIN EN ISO 23908:2013-10 2 A comma is used as the decimal marker. National foreword
6、 This document (EN ISO 23908:2013) 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 b
7、ody involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: IEC 62366 DIN EN 62366 ISO 2859 (all parts)
8、DIN ISO 2859 (only Parts 1 to 4 and Part 10; Part 5 is in preparation.) ISO 3951 (all parts) DIN ISO 3951 (only Part 1; Parts 2 to 5 are in preparation.) ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 16269-6 DIN ISO 16269-6 Amendments This standard differs from DIN EN ISO 23908:2011-
9、09 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 a
10、mending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 23908: 2011-09 DIN EN I
11、SO 23908:2013-10 3 National Annex NA (informative) Bibliography DIN EN 62366, Medical devices Application of usability engineering to medical devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medica
12、l device labels, labelling and information to be supplied Part 1: General requirements DIN ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals DIN ISO 2859 (all parts), Sampling procedures for inspection by attributes DIN ISO 3951 (all parts), Sam
13、pling procedures for inspection by variables DIN EN ISO 23908:2013-10 4 This page is intentionally blank EUROPEAN 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 - Requirements and test
14、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 hypodermiques, des introducteu
15、rs 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, Kathetereinfhrungen und Nadeln zur Blu
16、tentnahme (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 alteration. Up-to-date lis
17、ts 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
18、 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 Yu
19、goslav 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 STANDARDIZATION COMIT EUROP
20、EN 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: EContents Page Foreword .3 Introduction.4 1 Scope5 2 Norma
21、tive references5 3 Terms and definitions .5 4 Requirements.6 4.1 General .6 4.2 Activation of the sharps injury protection feature.7 4.3 Security of safe mode protection 7 5 Test methods .7 5.1 General .7 5.2 Testing activation of a sharps injury protection feature .7 5.2.1 Principle7 5.2.2 Apparatu
22、s.8 5.2.3 Procedure.8 5.3 Challenging the device in safe mode 9 5.3.1 General .9 5.3.2 Principle9 5.3.3 Apparatus.9 5.3.4 Procedure.9 5.4 Testing access to the sharp in safe mode10 5.5 Testing simulated clinical use .10 5.6 Test report10 6 Information supplied by the manufacturer .10 6.1 General .10
23、 6.2 Marking/labelling .11 6.3 Instructions for use .11 Annex A (informative) Guidance on simulated user studies12 Annex B (informative) Method for testing access to the sharp in safe mode 14 Bibliography16 Annex ZA (informative) Relationship between this European Standard and the Essential Requirem
24、ents of EU Directive 93/42/EEC on Medical Devices.15EN ISO 23908:2013 (E) DIN EN ISO 23908:2013-10 2 Foreword The text of ISO 23908:2011 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International Organization
25、 for Standardization (ISO) and has been taken over as EN ISO 23908:2013 by 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 en
26、dorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn at the latest by August 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 iden
27、tifying any or all such patent rights. This document supersedes EN ISO 23908:2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive,
28、 see informative Annex ZA, which is an integral part of this document. 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, Denmar
29、k, 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 the United Kingdom. Endorsement noti
30、ce The text of ISO 23908:2011 has been approved by CEN as EN ISO 23908:2013 without any modification. EN ISO 23908:2013 (E) DIN EN ISO 23908:2013-103 Introduction This International Standard addresses sharps injury protection systems designed to protect users of medical devices. These sharps injury
31、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 range of product types, including, among
32、 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 are either active or passive in their a
33、ctivation 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 to avoid unnecessarily restricting inno
34、vation, 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 “vertical” standards, which list specif
35、ic 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 mechanisms that lead to future improveme
36、nts 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. Through this risk-based approach, the sharps
37、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 International Standard provides guidelines to enab
38、le 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 sharps injury protection system is appr
39、opriate 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 representative of real-life intended use
40、 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 follow its provisions when improving existing
41、 products or developing new products to obtain an even higher level of quality. EN ISO 23908:2013 (E) DIN EN ISO 23908:2013-10 4 1 Scope This International Standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or p
42、assive in design, for 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
43、to achieve the sharps 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. Fo
44、r dated references, 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 I
45、SO 14971, Medical devices 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 de
46、ployment of the sharps 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
47、 human tissue by the sharp after the intended use EN ISO 23908:2013 (E) DIN EN ISO 23908:2013-105 3.4 passive safety feature sharps protection feature that does not require an additional step by the user to activate, separate from any action needed to perform the primary intended function of the dev
48、ice 3.5 safe mode state of the device after activation of the safety feature 3.6 sharp part of the device that can penetrate human tissue 3.7 sharps injury protection feature feature that prevents accidental sharps injury 4 Requirements 4.1 General 4.1.1 Where the requirements do not specify forces for activation of the safety feature, the appropriate force shall be determined by using a risk-based approach in accordance with ISO 14971, supported by simulated user studies that mimic actual clinical use by using patien
