1、BSI Standards PublicationBS EN ISO 11608-1:2015Needle-based injectionsystems for medical use Requirements and testmethodsPart 1: Needle-based injection systemsBS EN ISO 11608-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11608-1:2015. It is identical
2、 to ISO 11608-1:2014. It supersedes BS ENISO 11608-1:2012 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee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 publication doe
3、s not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 84571 0ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal o
4、bligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 January 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-1 January 2015 ICS 11.040.25 Supersedes EN ISO 11608
5、-1:2012English Version Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) Systmes dinjection aiguille pour usage mdical - Exigences et mthodes dessai - Partie 1: Systmes dinjection aiguille (ISO 11608-1:2014) Kan
6、lenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prfverfahren - Teil 1: Kanlenbasierte Injektionssysteme (ISO 11608-1:2014) This European Standard was approved by CEN on 11 October 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which sti
7、pulate 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 may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European
8、 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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are th
9、e national standards bodies of 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, Norway, Poland, Portugal, Romani
10、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by a
11、ny means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-1:2015 EBS EN ISO 11608-1:2015EN ISO 11608-1:2015 (E) 3 Foreword This document (EN ISO 11608-1:2015) has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and catheters” in coll
12、aboration with 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 endorsement, at the latest by July 2015, and conflicting natio
13、nal standards shall be withdrawn at the latest by July 2015. 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 supersedes
14、EN ISO 11608-1:2012. 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, see informative Annex ZA, which is an integral part of this d
15、ocument. 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, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fr
16、ance, 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 notice The text of ISO 11608-1:2014 has been approved by CEN as EN
17、 ISO 11608-1:2015 without any modification. BS EN ISO 11608-1:2015EN ISO 11608-1:2015 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the Europea
18、n Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a nat
19、ional standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive and associated EFTA regulations. WARNING: Other require
20、ments and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 11608-1:2015ISO 11608-1:2014(E)Contents PageForeword vIntroduction vii1 Scope . 12 Normative references 13 Terms and definitions . 14 Symbols and abbreviated terms . 35 Requirements 4
21、5.1 General . 45.2 System designations . 55.3 Risk analysis requirements 55.4 Uncertainty of measurement and conformance with specifications 55.5 General design requirements . 56 Reagent and apparatus 76.1 General . 76.2 Test liquid 76.3 Balance . 76.4 Test surface for free-fall testing 77 Determina
22、tion of dose accuracy. 77.1 General . 77.2 Dosing regions . 87.3 Dose settings . 97.3.1 Multi-dose containers (system designations A and C) 97.3.2 Single-dose containers (system designations B and D) . 97.4 Assessment . 97.4.1 General 97.4.2 Determination of dose accuracy limits 107.4.3 Determinatio
23、n of last-dose error and last-dose accuracy limits (system designations A and C) .117.4.4 Calculation of dose delivery efficiency (system designations B1 and D1, user-filled) 117.4.5 Calculation of tolerance intervals . 128 Preparation and operation of NISs .129 Test matrix .1310 Test descriptions .
24、1610.1 General 1610.2 Cool, standard and warm atmosphere testing 1610.2.1 Pre-conditioning .1610.2.2 Testing 1610.3 Last-dose testing (system designations A and C only) 1710.3.1 General. 1710.3.2 Pre-conditioning .1710.3.3 Testing 1710.4 Life-cycle testing (systems designations A and B only) Pre-con
25、ditioning 1710.5 Free-fall testing 1710.6 Dry-heat and cold-storage testing Pre-conditioning 1910.7 Damp-heat testing (system designations A and B only) Pre-conditioning .1910.8 Cyclical testing (system designations A and B only) Pre-conditioning 1910.9 Vibration testing Pre-conditioning 20 ISO 2014
26、 All rights reserved iiiBS EN ISO 11608-1:2015ISO 11608-1:2014(E)10.10 Electromagnetic compatibility (EMC) (systems with electronics only) .2010.10.1 General. 2010.10.2 Exposure to electrostatic discharge Pre-conditioning 2010.10.3 Radiated radio-frequency (RF) fields Pre-conditioning 2010.10.4 Comp
27、liance criteria for electrostatic discharge .2010.10.5 Radiated radio-frequency (RF) fields .2111 Inspection .2111.1 Visual inspection 2111.2 Container inspection . 2111.3 Dose accuracy acceptance criteria 2112 Test report 2213 Information supplied by the manufacturer 2213.1 General 2213.2 Marking 2
28、213.2.1 General. 2213.2.2 Marking on the NIS .2313.2.3 Marking on the user packaging 2313.3 Instructions for use 23Annex A (informative) Dose replicates, accuracy and testing rationale .25Annex B (normative) One- and two-sided tolerance limit factors, k 29Bibliography .40iv ISO 2014 All rights reser
29、vedBS EN ISO 11608-1:2015ISO 11608-1:2014(E)ForewordISO (the International 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
30、 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-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Elect
31、rotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of
32、 ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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
33、 responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information
34、 given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the foll
35、owing URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal products and intravascular catheters.This third edition cancels and replaces the second edition (ISO 11608-1:2012), which has been technically revised.ISO
36、 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 methods for electronic and electromechanical
37、pen-injectors Part 5: Automated functionsThis third edition of ISO 11608-1:2014 incorporates the following corrections:a) in 4 Y: the term pens is changed to NISs;b) in 5.5 n): reference to ISO 11608-4 is deleted since 5.5. o) already addresses this;c) in Table 3: the word “or” is changed to “and” s
38、o that it reads “Condition at 70 C and 40 C, then standard DA”;d) in 10.1, NOTE 1: Explanation is inserted;e) in 10.5 a) designation B is deleted;f) in 10.5 b) designation D is deleted;g) in 10.5 b) 3) iv) the term replacements is changed to obvious container failures; ISO 2014 All rights reserved v
39、BS EN ISO 11608-1:2015ISO 11608-1:2014(E)h) in 10.5 d) 2) iv) the term replacements is changed to obvious container failures;i) in 10.8 the temperature range is changed from (25 3) C to (5 3) C;j) in 10.10.4 and 10.10.5 “five NISs” is changed to “20 NISs” according to Table 3;k) in Table 3 reference
40、s to 10.10.4 and 10.10.5 are added under column A;l) in 13.2.3 “unit packaging” has been changed into “user packaging”.vi ISO 2014 All rights reservedBS EN ISO 11608-1:2015ISO 11608-1:2014(E)IntroductionThis part of ISO 11608 covers needle-based injection systems (referred to as NISs) primarily inte
41、nded for human use. It provides performance requirements regarding essential aspects so that variations of design are not unnecessarily restricted.This part of ISO 11608 should be used in conjunction with the other parts of ISO 11608.The first edition of this part of ISO 11608 introduced the concept
42、 of interchangeability and the labelling designations “Type A” (i.e. interchangeable) and “non-Type A” for needles and container systems. Since its promulgation, experience has shown that the complexity of these systems makes it very difficult to ensure functional compatibility as defined in the dif
43、ferent parts of this International Standard, particularly when products are made by different manufacturers. Based on this experience, it is believed that the Type A designation does not represent adequate guidance to the user in making decisions on the compatibility of needles and containers with s
44、pecific needle-based injector systems. As such, the labelling designation “Type A” has been removed. The design requirements related to system function have been maintained as a guide to assist manufacturers during the design phase, supporting the achievement of cross-platform compatibility. However
45、, these design requirements are an insufficient replacement for system testing of the components and, where possible, direct communication and/or quality agreements between system component manufacturers. Therefore, given the patient convenience benefits associated with cross-platform compatibility,
46、 manufacturers of needles, containers and needle-based injectors shall label their products with the specific system components that have been tested and demonstrated to be functionally compatible.The sampling plans for inspection selected for this part of ISO 11608 are intended to verify the design
47、 at a high confidence level. The sampling plans for inspection do not replace the more general manufacturing quality systems that appear in standards on quality systems, for example the ISO 9000 series and ISO 13485.Materials to be used for construction are not specified, as their selection will dep
48、end on the design, the intended use and the process of manufacture used by individual manufacturers.There are other international and national standards and guidance publications and, in some countries, national regulations that are applicable to medical devices and pharmaceuticals. Their requiremen
49、ts might supersede or complement this part of ISO 11608. Developers and manufacturers of NISs are encouraged to investigate and determine whether there are any other requirements relevant to the safety or marketability of their products.Manufacturers are expected to follow a risk-based approach during the design, development and manufacture of the product. Given the specific medicinal product and intended use, this might result in product-specific requirements and test methods that differ from what is outline
