1、January 2013 Translation by DIN-Sprachendienst.English price group 12No 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!$b“1939463www.din.deDDIN EN ISO 11608-5Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions (ISO 11608-5:2012);English version EN ISO 11608-5:2012,English translation of DIN EN ISO 11608-5:2013-01Kanlenbasierte Injektionssysteme zur med
3、izinischen Verwendung Anforderungen und Prfverfahren Teil 5: Automatisierte Funktionen (ISO 11608-5:2012);Englische Fassung EN ISO 11608-5:2012,Englische bersetzung von DIN EN ISO 11608-5:2013-01Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 5: Fonctions automatises
4、 (ISO 11608-5:2012);Version anglaise EN ISO 11608-5:2012,Traduction anglaise de DIN EN ISO 11608-5:2013-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 24 pages01.13 DIN EN ISO 11608-5:2013-01 2 A comma is used as the decimal marker.
5、National foreword This document (EN ISO 11608-5:2012) 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 devices” (Secretariat: DIN, Germany). The r
6、esponsible German body 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: ISO 8537 DIN EN ISO 8537
7、ISO 9000 DIN EN ISO 9000 ISO 13485 DIN EN ISO 13485 ISO 14253-1 DIN EN ISO 14253-1 ISO 14971 DIN EN ISO 14971 ISO 16926-6 DIN ISO 16269-6 ISO 23908 DIN EN ISO 23908 DIN EN ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical use Requirements a
8、nd test methods: Part 1: Needle-based injection systems Part 2: Needles Part 3: Finished containers Part 4: Requirements and test methods for electronic and electromechanical pen-injectors Part 5: Automated functions DIN EN ISO 11608-5:2013-01 3 National Annex NA (informative) Bibliography DIN EN 60
9、068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle) DIN EN ISO 8537, Sterile single-use syringes, with or without needle, for insulin DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 13485, Medical devices Quality manageme
10、nt systems Requirements for regulatory purposes DIN EN ISO 14253-1, Geometrical product specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 1: Decision rules for proving conformance or non-conformance with specifications DIN EN ISO 14971, Medical devices Applica
11、tion of risk management to medical devices DIN ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals DIN EN ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers f
12、or catheters and needles used for blood sampling DIN EN ISO 11608-5:2013-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-5 October 2012 ICS 11.040.25 English Version Needle-based injection systems for medical use - Requirements and test methods -
13、Part 5: Automated functionsSystmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 5: Fonctions automatises (ISO 11608-5:2012) Verwendung - Anforderungen und Prfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012) This European Standard was approved by CEN on
14、 29 September 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 standards
15、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 notifie
16、d 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, Icela
17、nd, 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 means r
18、eserved worldwide for CEN national Members. Ref. No. EN ISO 11608-5:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG(ISO 11608-5:2012) 1Kanlenbasierte Injektionssysteme zur medizinischen Contents Page Foreword . 3 Introduction . 4 1 Scope . 5
19、2 Normative references. 5 3 Terms and definitions 6 4 Requirements . 7 4.1 General requirements 7 4.2 Preparation . 8 4.3 Injection . 9 4.4 Risk analysis requirements . 12 5 Test methods 12 5.1 General 12 5.2 Dose specification requirements 15 5.3 Uncertainty of measurements and conformance with spe
20、cifications 16 6 Test report . 16 7 Information to be supplied by the manufacturer 16 Annex A (informative) Rationale for requirements . 17 Bibliography 19 2DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) Annex ZA (informative) Relationship between this European Standard and the Essential Require
21、ments of EC Directive 93/42/EEC on medical devices 20 Foreword This document (EN ISO 11608-5:2012) 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
22、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 April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Att
23、ention 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. This document has been prepared under a mandate given to CEN by the European Commission a
24、nd the European 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/CENELEC Internal Regulations, the national standards organisations of the follow
25、ing 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, No
26、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11608-5:2012 has been approved by CEN as a EN ISO 11608-5:2012 without any modification. “”3DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) Introducti
27、onThis part of ISO 11608 is applicable to needle-based injection systems with automated functions (NIS-AUTO), primarily intended to administer medicinal products to humans. Because of the anticipated variation in the designs of NIS-AUTOs, this part of ISO 11608 is promulgated more as a “horizontal”
28、than a “vertical” standard. Thus, it tends to specify the results of the design effort instead of the physical and construction requirements used as the basis for NIS-AUTO design, so that innovation in achieving the intended purposes is not unnecessarily restricted.This part of ISO 11608 intentional
29、ly avoids addressing more than the most basic elements regarding the safety and performance of NIS-AUTOs in humans. Any intended labelling of such NIS-AUTOs indicating their use to deliver medicinal products into the body or into specified tissue strata thereof (e.g. intramuscular, subcutaneous or i
30、ntradermal), or for the administration of specific pharmaceutical drugs or vaccines, falls under the authority of national governments or supranational agencies regulating the manufacture and marketing of medical NIS-AUTOs and pharmaceutical products. This part of ISO 11608 is expected to be supplem
31、ented by additional requirements and might occasionally be superseded by such regulatory authorities. Despite certain advantages for intentional interchangeability for containers designed for different auto-injection systems, as well as the potential risks of inadvertent interchangeability, this par
32、t of ISO 11608 avoids setting forth design specifications for the uniform size, shape and interface of such containers. It is left for future initiatives to build upon the specifications in this part of ISO 11608.The sampling plans for inspection selected for this part of ISO 11608 are intended to v
33、erify the design, at a high confidence level. The sampling plan does not replace more general manufacturing quality systems, including lot release, which are addressed in standards on quality management systems, for example the ISO 9000 series or ISO 13485.All references to “function” in this part o
34、f ISO 11608 are by definition to be construed as automated functions (see 3.4). This part of ISO 11608 does not apply to these functions if they are performed manually by the user.4DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) 1 ScopeThis part of ISO 11608 specifies requirements and test method
35、s for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to:a) drug product preparation (e.g. reconstitution);b) needle preparation;c) air removal;d) priming;e) dose setting;
36、f) actuation;g) needle insertion;h) injection of the medicinal product;i) disabling the NIS-AUTO;j) needle retraction;k) needle shielding;l) needle hiding;m) sharps injury protection;n) needle removal.2 Normative referencesThe following referenced documents are indispensable for the application of t
37、his document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11608-1, Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection system
38、s ISO 14971, Medical devices Application of risk management to medical devicesIEC 62366, Medical devices Application of usability engineering to medical devices5DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) 3 Terms and definitionsFor the purposes of this document, the following terms and defini
39、tions apply.3.1accessoryarticle or supplementary part used for convenience or safety in conjunction with a NIS-AUTOEXAMPLES Magnifying lens to aid reading of dose setting, grip enhancer, dose counter of a NIS-AUTO.3.2actuationaction which initiates a NIS-AUTO function (e.g. needle insertion), trigge
40、red by the actions of the NIS-AUTO user (or by another automated function)EXAMPLE Pressing the NIS-AUTO against the injection site.3.3air removalaction to remove air from the container and/or needle of the NIS-AUTO3.4automated functionfunction which does not require user initiation after actuationNO
41、TE A dose counter is considered an automated function if it is initiated by, for example, an automated needle retraction step, and therefore changes its state without any user interference.3.5injectiondelivery of the dose to the intended injection depth3.6intended injection depthrange of injection d
42、epth to which the drug is intended to be deliveredSee Figure 1.3.7needle-based injection system with automated functionsNIS-AUTOinjection system that delivers a medication through a needle wherein one or a series of functions are initiated by an action of the user and controlled automatically by the
43、 injection systemNOTE Accessories that perform automatic functions in combination with manual injection NIS-AUTOs are regarded as NIS-AUTO.3.8needle covercover provided over a needle in order to protect the needle from damage and users from injury prior to use of the needle3.9needle extensionaxial d
44、istance from the patient end of the needle tip to the nearest part of the NIS-AUTO body (defining the point of contact with the patient adjacent to the injection site)6DIN EN ISO 11608-5:2013-01 EN ISO 11608-5:2012 (E) 3.10needle hidingfunction which obscures the needle from the users sight either b
45、efore, during or after the injection cycleNOTE The needle hiding function only has a visual requirement designed to reduce patient trauma in case of needle phobia. It is not subject to any physical or dimensional requirements intended to restrict access to the needle. It does not imply any increased
46、 level of safety from needle stick injuries.3.11insertion of needlefunction which inserts the needle into the patients skin to the intended injection depth prior to the injection of the medicinal product3.12needle shieldingfunction which covers the exposed needle before and/or after the injection cy
47、cle to reduce the likelihood of direct contact with the needleNOTE 1 Needle shielding can reduce the risk of damage and contamination of the needle before use and can cover the needle after use.NOTE 2 Needle shielding does not meet the requirements of a sharps injury protection feature unless it com
48、plies with ISO 23908.3.13primingfunction that makes the dosing mechanism of the NIS-AUTO ready for actuation3.14retraction of needlefunction which removes the needle from the target tissue to a predefined minimum needle point position inside the NIS-AUTO3.15risk assessmentRAoverall process comprisin
49、g a risk analysis (estimation) and a risk evaluationNOTE Adapted from ISO 14971:2007, definition 2.18.3.16sharps injury protection featurefunction that prevents accidental sharps injuryNOTE The NIS-AUTO might provide an active or passive automated function (definitions of active and passive safety features are given in ISO 23908), distinct from needle shielding or hiding, which is designed to minimize the risks of accidental
