1、April 2015 Translation by DIN-Sprachendienst.English price group 19No 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).ICS
2、11.040.25!%A“2309496www.din.deDDIN EN ISO 11608-1Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems (ISO 11608-1:2014);English version EN ISO 11608-1:2015,English translation of DIN EN ISO 11608-1:2015-04Kanlenbasierte Injektionssystem
3、e zur medizinischen Verwendung Anforderungen und Prfverfahren Teil 1: Kanlenbasierte Injektionssysteme (ISO 11608-1:2014);Englische Fassung EN ISO 11608-1:2015,Englische bersetzung von DIN EN ISO 11608-1:2015-04Systmes dinjection aiguille pour usage mdical Exigences et mthodes dessai Partie 1: Systm
4、es dinjection aiguille (ISO 11608-1:2014);Version anglaise EN ISO 11608-1:2015,Traduction anglaise de DIN EN ISO 11608-1:2015-04SupersedesDIN EN ISO 11608-1:2012-12www.beuth.deDocument comprises 50 pagesIn case of doubt, the German-language original shall be considered authoritative.03.15DIN EN ISO
5、11608-1:2015-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11608-1:2015) 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-a
6、ctive medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-01 AA Injektionssysteme. DIN EN ISO 11608 consists of the following parts, under the general
7、 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 pen-injectors Part 5: Automated functions The DIN Standar
8、ds corresponding to the International Standards referred to in this document are as follows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 10993-1 DIN EN ISO 10993-1 ISO 11608 (all parts) DIN EN ISO 11608 (all parts) ISO 13485 DIN EN ISO 13485 ISO 14253-1 DIN EN ISO 14253-1 ISO 14971 DIN EN
9、ISO 14971 ISO 16269-6 DIN ISO 16269-6 IEC 60068-2-6 DIN EN 60068-2-6 IEC 60068-2-30 DIN EN 60068-2-30 IEC 60601-1-2 DIN EN 60601-1-2 IEC 60601-1-9 DIN EN 60601-1-9 IEC 60601-1-11 DIN EN 60601-1-11 IEC 61000-4-2 DIN EN 61000-4-2 IEC 61000-4-3 DIN EN 61000-4-3 IEC 62304 DIN EN 62304 IEC 62366 DIN EN 6
10、2366 DIN EN ISO 11608-1:2015-04 3 Amendments This standard differs from DIN EN ISO 11608-1:2012-12 as follows: a) in Clause 4 “Symbols and abbreviated terms”, symbol Y, the term “pens” has been changed to “NISs”; b) in Subclause 5.5 n), reference to ISO 11608-4 has been deleted since 5.5. o) already
11、 addresses this; c) in Table 3 “Test matrix”, the word “or” is changed to “and” so that it reads “Condition at 70 C and 40 C, then standard DA”; d) in Subclause 10.1, NOTE 2, an explanation has been inserted; e) in Subclause 10.5 a), system designation B has been deleted; f) in Subclause 10.5 b), sy
12、stem designation D has been deleted; g) in Subclauses 10.5 b) 3) iv) and 10.5 d) 2) iv), the term “replacements” has been changed to “obvious container failures”; h) in Subclause 10.8, the temperature range has been changed from (25 3) C to (5 3) C; i) in Subclauses 10.10.4 and 10.10.5 “five NISs” h
13、as been changed to “20 NISs” according to Table 3; j) in Table 3, references to Subclauses 10.10.4 and 10.10.5 have been added under column A; k) in Subclause 13.2.3, “unit packaging” has been changed into “user packaging”. Previous editions DIN EN ISO 11608-1: 2001-05, 2012-12 DIN EN ISO 11608-1:20
14、15-04 4 National Annex NA (informative) Bibliography DIN EN 60068-2-6 (VDE 0468-02-06), Environmental testing Part 2-6: Tests Test Fc: Vibration (sinusoidal) DIN EN 60068-2-30, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cycle) DIN EN 60601-1-2 (VDE 0750-1-2), Medi
15、cal electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 60601-1-9 (VDE 0750-01-09), Medical electrical equipment Part 1-9: General requirements for basic safety and essential p
16、erformance Collateral standard: Requirements for environmentally conscious design DIN EN 60601-1-11 (VDE 0750-01-11), Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical
17、 electrical systems used in the home healthcare environment DIN EN 61000-4-2 (VDE 0847-04-02), Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test DIN EN 61000-4-3 (VDE 0847-04-03), Electromagnetic compatibility (EMC) Part 4-3: Testi
18、ng and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test DIN EN 62304 (VDE 0750-101), Medical device software Software life-cycle processes DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN ISO 9000, Qualit
19、y management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11608 (all parts), Needle-based injection systems for medic
20、al use Requirements and test methods DIN EN ISO 13485, Medical devices Quality management 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 confo
21、rmity or nonconformity with specifications DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN ISO 16269-6, Statistical interpretation of data Part 6: Determination of statistical tolerance intervals EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-1
22、 January 2015 ICS 11.040.25 Supersedes EN ISO 11608-1:2012English 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:
23、Systmes dinjection aiguille (ISO 11608-1:2014) Kanlenbasierte 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 w
24、ith 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 may be obtained on application to the CEN-CENELEC Man
25、agement 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 notified to the CEN-CENELEC Management Centre has the same s
26、tatus 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Ma
27、lta, Netherlands, Norway, Poland, Portugal, Romania, 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 C
28、EN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-1:2015 EContents PageForeword 4Introduction .51 Scope . 62 Normative references 63 Terms and definitions . 64 Symbols and abbreviated terms . 85 Requirements 95.1 General . 9
29、5.2 System designations 105.3 Risk analysis requirements . 105.4 Uncertainty of measurement and conformance with specifications. 105.5 General design requirements 106 Reagent and apparatus . 126.1 General 126.2 Test liquid . 126.3 Balance 126.4 Test surface for free-fall testing . 127 Determination
30、of dose accuracy 127.1 General 127.2 Dosing regions 137.3 Dose settings 147.3.1 Multi-dose containers (system designations A and C) . 147.3.2 Single-dose containers (system designations B and D) 147.4 Assessment 147.4.1 General. 147.4.2 Determination of dose accuracy limits 157.4.3 Determination of
31、last-dose error and last-dose accuracy limits (system designations A and C) .167.4.4 Calculation of dose delivery efficiency (system designations B1 and D1, user-filled) 167.4.5 Calculation of tolerance intervals .178 Preparation and operation of NISs .179 Test matrix .1810 Test descriptions .2110.1
32、 General 2110.2 Cool, standard and warm atmosphere testing 2110.2.1 Pre-conditioning .2110.2.2 Testing 2110.3 Last-dose testing (system designations A and C only) 2210.3.1 General. 2210.3.2 Pre-conditioning .2210.3.3 Testing 2210.4 Life-cycle testing (systems designations A and B only) Pre-condition
33、ing 2210.5 Free-fall testing 2210.6 Dry-heat and cold-storage testing Pre-conditioning 2410.7 Damp-heat testing (system designations A and B only) Pre-conditioning .2410.8 Cyclical testing (system designations A and B only) Pre-conditioning 2410.9 Vibration testing Pre-conditioning 252EN ISO 11608-1
34、:2015 (E) DIN EN ISO 11608-1:2015-04 10.10 Electromagnetic compatibility (EMC) (systems with electronics only) .2510.10.1 General. 2510.10.2 Exposure to electrostatic discharge Pre-conditioning 2510.10.3 Radiated radio-frequency (RF) fields Pre-conditioning 2510.10.4 Compliance criteria for electros
35、tatic discharge .2510.10.5 Radiated radio-frequency (RF) fields .2611 Inspection .2611.1 Visual inspection 2611.2 Container inspection . 2611.3 Dose accuracy acceptance criteria 2612 Test report 2713 Information supplied by the manufacturer 2713.1 General 2713.2 Marking 2713.2.1 General. 2713.2.2 Ma
36、rking on the NIS .2813.2.3 Marking on the user packaging 2813.3 Instructions for use 28Annex A (informative) Dose replicates, accuracy and testing rationale 30Annex B (normative) One- and two-sided tolerance limit factors, k .34Bibliography .46Annex ZA (informative) Relationship between this Europea
37、n Standard and the Essential Requirements of EU Directive 93/42/EEC .45 3EN ISO 11608-1:2015 (E) DIN EN ISO 11608-1:2015-04 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 collaboratio
38、n 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 national stan
39、dards 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 EN ISO 1
40、1608-1:2012. 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 document.
41、 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, France, Ge
42、rmany, 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 ISO 116
43、08-1:2015 without any modification. 4EN ISO 11608-1:2015 (E) DIN EN ISO 11608-1:2015-04 IntroductionThis part of ISO 11608 covers needle-based injection systems (referred to as NISs) primarily intended for human use. It provides performance requirements regarding essential aspects so that variations
44、 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 of interchangeability and the labelling designations “Type A” (i.e. interchangeable) and “non-Type A”
45、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 different parts of this International Standard, particularly when products are made by different manufactu
46、rers. 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 specific needle-based injector systems. As such, the labelling designation “Type A” has been removed. Th
47、e 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, these design requirements are an insufficient replacement for system testing of the components and, w
48、here possible, direct communication and/or quality agreements between system component manufacturers. Therefore, given the patient convenience benefits associated with cross-platform compatibility, manufacturers of needles, containers and needle-based injectors shall label their products with the sp
49、ecific 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 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
