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1、Reference number ISO 11608-1:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 11608-1 First edition 2000-12-15 Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods Stylos-injecteurs usage mdical Partie 1: Stylos-injecteurs Exigences et mthodes dessai ISO 11608-1:2000(E) PDF d
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5、l rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country
6、of the requester. ISO copyright office Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reserved ISO 11608-1:2000(E) ISO 2000 All rights reservediii ContentsPage Foreword.iv Introducti
7、on.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Symbols and abbreviations3 5General requirements4 6Test conditions 5 6.1Standard atmosphere5 6.2Cool atmosphere5 6.3Hot atmosphere5 7Preconditioning of pen-injectors .6 7.1Preconditioning in dry heat atmosphere.6 7.2Preconditioning in c
8、old storage atmosphere.6 7.3Preconditioning in cyclical atmosphere6 7.4Preconditioning by free fall 6 7.5Preconditioning by vibration for pen-injectors with electronic components .7 8Reagent and apparatus.7 9Determination of dose accuracy7 9.1Dose accuracy7 9.2Dose accuracy requirements12 10Freedom
9、from defects.14 10.1Defects after being subjected to cyclical preconditioning14 10.2Freedom from defects after being subjected to vibration.14 10.3Freedom from defects after being subjected to free fall .14 11Determination of electromagnetic compatibility14 11.1Electromagnetic compatibility (EMC)14
10、11.2Electrostatic discharge .15 11.3Radiated radio frequency (RF) fields.15 12Visual inspection .15 13Functional inspection16 13.1Replaceable cartridge .16 13.2Nonreplaceable cartridge16 13.3Accuracy.16 14Test report16 15Information supplied by the manufacturer .16 15.1General16 15.2Marking.17 15.3I
11、nstructions for use .17 Annex A (informative) Two-sided tolerance limit factors (k) 19 Bibliography25 ISO 11608-1:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The
12、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-gover
13、nmental, 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 3. Dr
14、aft 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 vote. Attention is drawn to the possibility that some of the elements of this par
15、t of ISO 11608 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 11608-1 was prepared by Technical Committee ISO/TC 84, Medical devices for injections. ISO 11608 consists of the following parts, under the
16、general title Pen-injectors for medical use: ?Part 1: Pen-injectors Requirements and test methods ?Part 2: Needles Requirements and test methods ?Part 3: Finished cartridges Requirements and test methods Annex A of this part of ISO 11608 is for information only. ISO 11608-1:2000(E) ISO 2000 All righ
17、ts reservedv Introduction This part of ISO 11608 covers pen-injectors primarily intended for human use. It provides performance requirements regarding essential aspects, so that variations of design are not unnecessarily restricted. The devices described in this part of ISO 11608 are designed to be
18、used with devices described in ISO 11608-2 and ISO 11608-3. It is recognized that interchangeability of the components (pen-injector, needle and cartridge) is desirable for some medicinal products and to be avoided for other medicinal products, and that future design may change the current concepts.
19、 Therefore, ISO 11608-2 and ISO 11608-3 encourage interchangeability by establishing certain specific requirements for interchangeable needles (Type A) and interchangeable cartridges (Type A) respectively. Performance requirements are imposed on both Type A (interchangeable) and non-Type A needles a
20、nd cartridges. Additional dimensional requirements are imposed on Type A needles and cartridges and hereby indirectly on pen- injectors intended for either Type A needles and/or Type A cartridges. Information as to whether the components are interchangeable (Type A) or not should be given on the uni
21、t container. The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturers ability to manufacture one “lot” of pen-injectors that conforms to the critical product attributes. The sampling plans for inspection do not replac
22、e the more general manufacturing quality systems that appear in standards on quality systems, e.g. the ISO 9000 series. Materials to be used for the construction are not specified, as their selection to some extent will depend upon the design, the intended use and the process of manufacture by indiv
23、idual manufacturers. All materials should be resistant to the medicinal product intended to be injected with the pen-injector. In some countries national regulations exist, and their requirements may supersede or complement this part of ISO 11608. INTERNATIONAL STANDARDISO 11608-1:2000(E) ISO 2000 A
24、ll rights reserved1 Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods 1Scope This part of ISO 11608 specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable prefilled cartridges. This part of IS
25、O 11608 is also applicable to pen-injectors which are not electrically driven, but are equipped with electronic components. This part of ISO 11608 is not applicable to high-pressure injectors and electrically driven injectors. 2Normative references The following normative documents contain provision
26、s which, through reference in this text, constitute provisions of this part of ISO 11608. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 11608 are encouraged to investigate the possibil
27、ity of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 11608-2:2000, Pen-injectors for med
28、ical use Part 2: Needles Requirements and test methods. ISO 11608-3:2000, Pen-injectors for medical use Part 3: Finished cartridges Requirements and test methods. IEC 60068-2-6:1995, Environmental testing Part 2: Tests. Test Fc: Vibration (sinusoidal). IEC 60068-2-6:1995, Corr. 1. IEC 60068-2-30:198
29、0, Environmental testing Part 2: Tests. Test Db and guidance: Damp heat, cyclic (12 + 12- hour cycle). IEC 60068-2-30, Amendment No. 1:1985. IEC 61000-4-2:1999, Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test. IEC 61000-4-3:1998,
30、 Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test. 3Terms and definitions For the purposes of this part of ISO 11608, the following terms and definitions apply. ISO 11608-1:2000(E) 2 ISO 2000 All rights re
31、served The nomenclature of some components of pen-injectors is illustrated in Figure 1. 3.1 pen-injector medical device intended for parenteral administration by injection of medicinal products from a multidose cartridge NOTEThe doses may be pre-set by manufacturer or user. 3.2 connector mechanical
32、arrangement allowing the connection between the needle and the cartridge 3.3 cartridge primary container for the medicinal product 3.4 injection mechanism mechanism which performs the parenteral injection of the pre-set dose 3.5 release mechanism mechanism which initiates the parenteral injection of
33、 the pre-set dose 3.6 injection stroke that portion of a parenteral injection involving movement of the injection mechanism following initiation by the release mechanism NOTEIt does not include the subsequent relaxation of the system components required for the complete injection of the pre-set dose
34、. 3.7 mechanism holder part of the body of the injector containing the injection mechanisms 3.8 selector mechanism which allows pre-setting of a dose 3.9 increment smallest possible difference to be selected between two dose amounts 3.10 indicator means by which the amount of pre-set dose is shown 3
35、.11 residual scale graduated scale which indicates the remainder of medicinal product in the cartridge 3.12 dose accuracy accuracy with which the pen-injector delivers a pre-set dose of medicinal products 3.13 cap part of the pen-injector intended to protect the system ISO 11608-1:2000(E) ISO 2000 A
36、ll rights reserved3 3.14 pre-setting procedure by which individual amounts of medicinal product can be selected for injection by the user 3.15 unit container package intended for customer use 3.16 Type A classification of needles and cartridges for pen-injectors which fulfil certain specific require
37、ments providing interchangeability 3.17 non-Type A classification of needles and cartridges which are not classified as Type A Key 1Cap 2Injection system 3Connector 4Residual scale 5Window 6Cartridge holder 7Mechanism holder 8Release mechanism Figure 1 Schematic presentation of a pen-injector 4Symbo
38、ls and abbreviations VsetOne of the three pre-set doses (expressed as a volume, in millilitres) used in determining the dose accuracy for a given pen-injector. Vsetis defined as one of the following: a)minimum dose (Vset= Vmin) (specified in the instructions for use); b)maximum dose (Vset= Vmax) (sp
39、ecified in the instructions for use); c)midpoint dose (Vset= Vmid), where Vmidis defined as the injector setting closest to (Vmin+ Vmax)/2. NOTERecommended doses as specified in the instruction for use may differ from those doses that can be set. VmeasThe volumetric measurement value for a given Vse
40、t GmeasThe gravimetric measurement value for a given Vset ISO 11608-1:2000(E) 4 ISO 2000 All rights reserved ?Density, expressed in grams per millilitre pProbability content YNumber of pens required for a given test RNumber of replicates required for a given test. A replicate is a random sequence of
41、 Vmin, Vmid, and Vmax. There are six possible replicates. nNumber of measurements (Vmeas) to be made for each Vset xThe sample mean; when based on a random sample, an estimate of the true mean: meas/ xVn? sThe sample standard deviation; when based on a random sample, an estimate of the true standard
42、 deviation: 1/2 meas ()/(1)sVxn ? ? ? ? kTolerance Limit Factor, determined from the confidence level (95 %), probability content (p) and the number of accuracy measurements (n) conducted at each dose setting ?Absolute error (millilitres) used to define the upper and lower specification limits for a
43、 pre-set dose in absolute terms ?Relative error (%) used to define the upper and lower specification limits for a pre-set dose in relative terms TPThe transition point volume (millilitres) at which the definition of the upper and lower specification limits for Vsetchanges from absolute terms to rela
44、tive terms: (100)/TP? UUpper specification limit for a given Vset LLower specification limit for a given Vset 5General requirements When the pen-injector is ready for injection, the cartridge holder shall allow visibility of the deliverable volume. It shall be possible to determine whether sufficien
45、t medicinal product remains in order to administer the maximum pre-settable dose. The pen-injector shall be designed such that it is able to deliver the labelled volume from the cartridge for which it is designed. The pen-injector shall be designed such that the last dose delivered from a cartridge
46、satisfies requirements for dose accuracy. The pen-injector shall indicate the pre-set dose. The pen-injector shall indicate, at least by visual means, that it is ready for injection. There shall be an indication of the pre-setting procedure by tactile or audible means, or both. ISO 11608-1:2000(E) I
47、SO 2000 All rights reserved5 The state of the pen-injector, when ready to deliver a dose, shall be different to its state when the dose has been delivered. The difference shall be visible. The pen-injector shall indicate, by visual, audible or tactile means or any combination of these, that the inje
48、ction stroke has been completed. If the pen-injector is designed for variable doses, it shall be so designed that it is impossible to deliver a second dose after delivery of the first dose without a second pre-setting. The pen-injector shall be so designed that it: ?does not allow a larger dose to b
49、e pre-set than is left in the cartridge; or ?does not allow dose delivery if the pre-set amount exceeds the amount of medicinal product left in the cartridge; or ?indicates the amount of medicinal product delivered; or ?indicates the amount of medicinal product not delivered of the pre-set dose. The pen-injector shall be designed to function with a needle fulfilling the specifications of ISO 11608-2. If the pen-injector is designed to function with a single-compartment cartridge, it shall be designed t