BS EN ISO 11608-5-2012 Needle-based injection systems for medical use Requirements and test methods Automated functions《医用针式注射系统 要求和试验方法 自动化功能》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11608-5:2012Needle-based injection systems for medical use Requirements and test methodsPart 5: Automated functions (ISO 11608-5:2012)BS EN ISO 11608-5:2012 BRITISH STA

2、NDARDNational forewordThis British Standard is the UK implementation of EN ISO11608-5:2012.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This p

3、ublication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 69949 8ICS 11.040.25Compliance with a British Standard cannot confer immuni

4、ty fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-5 October 2012 ICS 11.040.25 English V

5、ersion Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) Systmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 5: Fonctions automatises (ISO 11608-5:2012) Nadelbasierte Injektionssysteme zur

6、medizinischen Verwendung - Anforderungen und Prfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2012) This European Standard was approved by CEN on 29 September 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this E

7、uropean Standard the status 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 vers

8、ions (English, French, German). 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,

9、 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, S

10、witzerland, Turkey and United 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 Member

11、s. Ref. No. EN ISO 11608-5:2012: EBS EN ISO 11608-5:2012EN ISO 11608-5:2012 (E) 3 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 C

12、EN/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 endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at

13、 the latest by April 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 identifying any or all such patent rights. This document has been prepared under a mandate given to CE

14、N by the European Commission and 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 standar

15、ds organisations of the 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, Luxe

16、mbourg, Malta, Netherlands, Norway, 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. BS EN ISO 11608-5:2012EN ISO 11608

17、-5:2012 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to pro

18、vide a means of conforming to Essential Requirements of the 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 been implemented as a national standard in at least one Member State, compliance wit

19、h the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Direc

20、tive 93/42/EEC on medical devices Clause(s)/subclause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes Clauses 4.1 to 4.3, all parts 1 Clause 10, all parts of ISO 11608-1 addresses pre-conditioning Clauses 4.1 to 4.4, all parts 2 Clause 10, al

21、l parts of ISO 11608-1 addresses pre-conditioning Clauses 4.1 to 4.3, 5, 6, all parts 3 All clauses of ISO 11608-1 are applicable NA 4 NA 5 Clause 4.1 parts E and G, clause 4.3 all parts 6 Clauses 4.2.2 and 5.1.1 7 Only 7.3 is addressed Clause 4.1 parts D 8 Only 8.3 is addressed Clauses 4.1 to 4.4,

22、all parts 9 9.3 is not addressed Clause 10, all parts of ISO 11608-1 addresses pre-conditioning Clauses 4.2.5, 4.3.3.3, 4.3.5.1, 5.1.4, 5.1.7, 5.1.8.1 and 5.2 10 All clauses of ISO 11608-1 are applicable NA 11 NA 12 Clause 7 13 13.5 is not addressed Clause 5.4, part D and Q and Clause 13, all parts

23、of ISO 11608-1 address ER 13 WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 11608-5:2012ISO 11608-5:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Normative referenc

24、es . 13 Terms and definitions . 24 Requirements . 34.1 General requirements . 34.2 Preparation 44.3 Injection . 54.4 Risk analysis requirements 85 Test methods 85.1 General . 85.2 Dose specification requirements 115.3 Uncertainty of measurements and conformance with specifications 126 Test report .1

25、27 Information to be supplied by the manufacturer 12Annex A (informative) Rationale for requirements 13Bibliography .15BS EN ISO 11608-5:2012ISO 11608-5:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

26、 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 represented on that committee. International organizations, governmental and non-

27、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 Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2

28、.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 International Standard requires approval by at least 75 % of the member bodies casting a v

29、ote.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 11608-5 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal

30、 products and intravascular catheters.ISO 11608 consists of the following parts, under the general title Needle-based injection systems for medical use Requirements and test methods: Part 1: Needle-based injection systems Part 2: Needles Part 3: Finished containers Part 4: Requirements and test meth

31、ods for electronic and electromechanical pen-injectors Part 5: Automated functionsiv ISO 2012 All rights reservedBS EN ISO 11608-5:2012ISO 11608-5:2012(E)IntroductionThis part of ISO 11608 is applicable to needle-based injection systems with automated functions (NIS-AUTO), primarily intended to admi

32、nister 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” than a “vertical” standard. Thus, it tends to specify the results of the design effort instead of the physical and construction requirem

33、ents 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 intentionally avoids addressing more than the most basic elements regarding the safety and performance of NIS-AUTOs in humans. Any intended labelli

34、ng 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 intradermal), or for the administration of specific pharmaceutical drugs or vaccines, falls under the authority of national governments o

35、r supranational agencies regulating the manufacture and marketing of medical NIS-AUTOs and pharmaceutical products. This part of ISO 11608 is expected to be supplemented by additional requirements and might occasionally be superseded by such regulatory authorities. Despite certain advantages for int

36、entional interchangeability for containers designed for different auto-injection systems, as well as the potential risks of inadvertent interchangeability, this part of ISO 11608 avoids setting forth design specifications for the uniform size, shape and interface of such containers. It is left for f

37、uture 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 verify the design, at a high confidence level. The sampling plan does not replace more general manufacturing quality systems, including l

38、ot 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 of 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

39、 if they are performed manually by the user. ISO 2012 All rights reserved vBS EN ISO 11608-5:2012BS EN ISO 11608-5:2012Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions1 ScopeThis part of ISO 11608 specifies requirements and test methods for the

40、 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;f) actuat

41、ion;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 this docum

42、ent. 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 systems ISO 149

43、71, Medical devices Application of risk management to medical devicesIEC 62366, Medical devices Application of usability engineering to medical devicesINTERNATIONAL STANDARD ISO 11608-5:2012(E) ISO 2012 All rights reserved 1BS EN ISO 11608-5:2012ISO 11608-5:2012(E)3 Terms and definitionsFor the purp

44、oses of this document, the following terms and definitions 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 initiate

45、s a NIS-AUTO function (e.g. needle insertion), triggered 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 whi

46、ch does not require user initiation after actuationNOTE 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

47、 depth3.6intended injection depthrange of injection depth 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 a

48、ction of the user and controlled automatically by the 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

49、 prior to use of the needle3.9needle extensionaxial distance 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)2 ISO 2012 All rights reservedBS EN ISO 11608-5:2012ISO 11608-5:2012(E)3.10needle hidingfunction which obscures the needle from the users sight either before, 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