EN ISO 11608-4-2007 en Pen-injectors for medical use - Part 4 Requirements and test methods for electronic and electromechanical pen-injectors《医用笔试注射器 第4部分 电子和电动笔式注射器的要求和试验方法》.pdf

1、BRITISH STANDARDBS EN ISO 11608-4:2007Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectorsThe European Standard EN ISO 11608-4:2007 has the status of a British StandardICS 11.040.20; 11.040.25g49g50g3g38g50g51g60g44g49g42g3g58g44g55g4

2、3g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11608-4:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 September 2

3、007 BSI 2007ISBN 978 0 580 54214 5National forewordThis British Standard is the UK implementation of EN ISO 11608-4:2007. It is identical to ISO 11608-4:2006.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organizations represented

4、 on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issue

5、d since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11608-4August 2007ICS 11.040.25English VersionPen-injectors for medical use - Part 4: Requirements and testmethods for electronic and electromechanical pen-injectors (ISO11608-4:2006)Stylos-injecteurs usag

6、e mdical - Partie 4: Exigences etmthodes dessai pour stylos-injecteurs lectroniques etlectro-mcaniques (ISO 11608-4:2006)Pen-Injektoren zur medizinischen Anwendung - Teil 4:Anforderungen an und Prfverfahren fr elektronische undelektromechanische Pen-Injektoren (ISO 11608-4:2006)This European Standar

7、d was approved by CEN on 9 August 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such n

8、ationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and

9、notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, M

10、alta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of explo

11、itation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11608-4:2007: EForeword The text of ISO 11608-4:2006 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International

12、Organization for Standardization (ISO) and has been taken over as EN ISO 11608-4:2007 by 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 identica

13、l text or by endorsement, at the latest by February 2008, and conflicting national standards shall be withdrawn at the latest by February 2008. 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 r

14、esponsible for identifying any or all such patent rights. ISO 11608-4 consists of the following parts under the 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 - Requireme

15、nts and test methods Part 4: Requirements and test methods for electronic and electromechanical pen-injectors 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,

16、Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of IS

17、O 11608-4:2006 has been approved by CEN as EN ISO 11608-4:2007 without any modifications. EN ISO 11608-4:2007Reference numberISO 11608-4:2006(E)INTERNATIONAL STANDARD ISO11608-4First edition2006-03-15Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechan

18、ical pen-injectors Stylos-injecteurs usage mdical Partie 4: Exigences et mthodes dessai pour stylos-injecteurs lectroniques et lectro-mcaniques EN ISO 11608-4:2007ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Symbols and abbreviate

19、d terms . 2 5 General requirements. 2 6 Test conditions . 2 7 Preconditioning of pen-injectors 2 8 Reagent and apparatus 5 9 Determination of dose accuracy . 5 10 Freedom from defects 6 11 Determination of electromagnetic compatibility . 7 12 Electrical safety. 7 13 Visual inspection 8 14 Functional

20、 inspection. 8 15 Test report . 8 16 Information supplied by the manufacturer 9 Bibliography . 10 EN ISO 11608-4:2007iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International St

21、andards 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-governmental, in liaison with ISO, also

22、 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. The main task of technical committee

23、s 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 vote. Attention is drawn to the possib

24、ility 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 11608-4 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular cathete

25、rs. ISO 11608 consists of the following parts, under the 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 Part 4: Requirements and test methods for

26、electronic and electromechanical pen-injectors EN ISO 11608-4:2007vIntroduction This part of ISO 11608 covers electro-mechanical driven injectors not covered by part 1 of ISO 11608. These injectors are mainly intended to administer medicinal products to humans. This part of ISO 11608 provides perfor

27、mance requirements regarding essential aspects of the design so that variations of such injectors are not unnecessarily restricted. 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 “

28、lot” of injectors that conforms to the critical product attributes. These sampling plans for inspection do not intend to replace the more general manufacturing quality systems practices widely used in production, e.g. the ISO 9000 series. Materials to be used for the construction of these injectors

29、are not specified, as their selection, to some extent, will depend upon the design, the intended use and the manufacturing process selected by the manufacturer. All materials used in these injectors which come in contact with the end-user must be non-toxic and biocompatible. In some countries, natio

30、nal regulations may exist and their requirements may supersede or add up to this part of ISO 11608. In relation to specification limits and dose accuracy, the ISO directives (Part 2, A3 and A13) require that the VIM1and GUM2principles are used and incorporated in all future standards and future revi

31、sions of existing standards. The reorganization to be done in relation to this will not affect the technical content of the standards, and only the terminology shall be changed to correspond to VIM, and the principles shall be changed to correspond to GUM. However, with this part of ISO 11608, ISO/T

32、C 84 has decided to await the revision of the ISO 11608 series where the principles will be incorporated in all parts to conform to applicable requirements. EN ISO 11608-4:2007blank1Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

33、 1 Scope This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medicat

34、ion to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors (as covered in ISO 21649) nor infusion pumps (as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while c

35、onnected to an external power supply. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendment

36、s) applies. ISO 11608-1:2000, Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods IEC 60068-2-27:1987, Environmental testing Part 2: Tests. Test Ea and guidance: Shock IEC 60068-2-30:1980, Environmental testing Part 2-30: Tests Test Db: Damp heat, cyclic (12 h + 12 h cy

37、cle) IEC 60068-2-64:1993, Environmental testing Part 2: Test methods Test Fh: Vibration, broad-band random (digital control) and guidance IEC 60529:2001, Degrees of protection provided by enclosures (IP Code) IEC 60601-1:1988, Edition 2: Medical electrical equipment Part 1: General requirements for

38、safety (+ AMD 1:1991 + AMD. 2: 1995) IEC 60601-1-1:2000, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2:2001, Medical electrical equipment Part 1-2: General requirements for safety Collatera

39、l standard: Electromagnetic compatibility Requirements and tests EN ISO 11608-4:20072 IEC 60721-3-7:1995, Classification of environmental conditions Part 3: Classification of groups of environmental parameters and their severities Portable and non-stationary use IEC 61000-4-2:2001, Electromagnetic c

40、ompatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test 3 Terms and definitions For the purposes of this document the terms and definitions given in ISO 11608-1 and the following apply. 3.1 drive system electromechanical mechanism responsible for expelli

41、ng the dose 3.2 pen-injector pen-injector with an electromechanical drive system 4 Symbols and abbreviated terms See Clause 4 of ISO 11608-1:2000. 5 General requirements See Clause 5 of ISO 11608-1:2000. 6 Test conditions 6.1 Standard atmosphere See 6.1 of ISO 11608-1:2000. 6.2 Cool atmosphere See 6

42、.2 of ISO 11608-1:2000. 6.3 Hot atmosphere See 6.3 of ISO 11608-1:2000. 7 Preconditioning of pen-injectors 7.1 Preconditioning in dry heat atmosphere See 7.1 of ISO 11608-1:2000. 7.2 Preconditioning in cold storage atmosphere See 7.2 of ISO 11608-1:2000. EN ISO 11608-4:200737.3 Preconditioning in cy

43、clical atmosphere See 7.3 of ISO 11608-1:2000. 7.4 Preconditioning by free fall See 7.4 of ISO 11608-1:2000. 7.5 Preconditioning by vibration Instead of the vibration test as described in 7.5 of ISO 11608-1:2000, the following applies. Unpack and prepare 5 pen-injectors according to the instructions

44、 for use with a new cartridge. Place the pen-injectors in the box or pouch for transport as instructed by the manufacturer. Subject the pen-injectors to vibration in accordance with IEC 60068-2-64. Subject the pen-injectors to the conditions specified in IEC 60721-3-7:1995 Class 7M3, as follows: acc

45、eleration spectral density 3 m2/s3, frequency range 10 Hz to 200 Hz; acceleration spectral density 1 m2/s3, frequency range 200 Hz to 500 Hz; vibrate the pen-injectors in a vertical direction and in two other directions perpendicular to one other in a horizontal plane. The vibration time shall be 1

46、h. NOTE Injectors with limited conditions for vibration shall be subjected to the test at acceptable conditions, and these acceptable conditions shall be stated in the instructions for use. 7.6 Preconditioning by shock Subject the same 5 pen-injectors as used in 7.5 to the shock test in accordance w

47、ith IEC 60068-2-27. Subject the pen-injectors to the conditions specified in IEC 60721-3-7:1995 Class 7M3, as follows: to a shock response spectrum Type I: 300 m/s2; to a shock response spectrum Type II: 1 000 m/s2. The number of shocks shall be 50 positive and 50 negative. The shock response test T

48、ype II represents the device in use (without packaging). 7.7 Preconditioning for the influence of fluid leakage The purpose of this test is to evaluate the influence of liquid that leaks from the cartridge (back-leakage) or leaks from a broken cartridge into the pen-injector. Remove the cartridge ho

49、lder and pour the contents of one cartridge of the medicinal product into the pen-injector at the most likely point of entry. Using appropriate safety equipment, shake the pen-injector in all directions by hand for 30 s. Allow the medicinal product to drain from the original point of fluid entry, for 10 min. EN ISO 11608-4:20074 Attach a new cartridge, run a self test and monitor any messages (if applicable). Store the pen-injector in a horizontal orientation according