1、November 2007DEUTSCHE NORM English price group 12No part of this standard 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 11.040.25!$JJ8“139392
2、1www.din.deDDIN EN ISO 11608-4Pen-injectors for medical use Part 4: Requirements and test methods for electronic andelectromechanical pen-injectors (ISO 11608-4:2006)English version of DIN EN ISO 11608-4:2007-11Pen-Injektoren zur medizinischen Anwendung Teil 4: Anforderungen an und Prfverfahren fr e
3、lektronische und elektromechanischePen-Injektoren (ISO 11608-4:2006)Englische Fassung DIN EN ISO 11608-4:2007-11www.beuth.deDocument comprises 18 pagesDIN EN ISO 11608-4:2007-11 2 National foreword This standard has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medici
4、nal products and intravascular catheters” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-0
5、2-01 AA Injektionssysteme. 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 Requirements and test methods Part 4: Requiremen
6、ts and test methods for electronic and electromechanical pen-injectors The DIN Standards corresponding to the International Standards referred to in the EN is are as follows: ISO 11608-1 DIN EN ISO 11608-1 ISO 11608-2 DIN EN ISO 11608-2 ISO 11608-3 DIN EN ISO 11608-3 IEC 60068-2-27 DIN EN 60068-2-27
7、 IEC 60068-2-30 DIN EN 60068-2-30 IEC 60068-2-64 DIN EN 60068-2-64 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-1 DIN EN 60601-1-1 (VDE 0750-1-1) IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750-1-2) IEC 60721-3-7 DIN EN 60721-3-7 IEC 61000-4-3 DIN EN 61000-4-3 (VDE 0847-4-3) National Annex NA (infor
8、mative) Bibliography DIN EN ISO 11608-1:2001-05, Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods DIN EN ISO 11608-2:2001-05, Pen-injectors for medical use Part 2: Needles Requirements and test methods DIN EN ISO 11608-3:2001-05, Pen-injectors for medical use Part 3:
9、 Finished cartridges Requirements and test methods DIN EN ISO 11608-4:2007-11 3 DIN EN 60068-2-27:1995-03, Basic environmental testing procedures Part 2: Tests Test Ea and guidance: Shock (IEC 60068-2-27:1987) DIN EN 60068-2-30:2006-06, Environmental testing Part 2-30: Tests Test Db: Damp heat, cycl
10、ic (12 h + 12 h cycle) (IEC 60068-2- 30:2005) DIN EN 60068-2-64:1995-08, Environmental testing Part 2: Test methods Test Fh: Vibration, broad-band random (digital control) and guidance (IEC 60068-2-64:1993 + Corrigendum 1993) DIN EN 60601-1:2007-07 (VDE 0750-1), Medical electrical equipment Part 1:
11、General requirements for basic safety and essential performance (IEC 60601-1:2005)/Note: DIN EN 60601-1 (1996-03) remains valid alongside this standard until 2009-09-12) DIN EN 60601-1-1:2002-08 (VDE 0750-1-1), Medical electrical equipment Part 1-1: General requirements for safety Collateral standar
12、d: Safety requirements for medical electrical systems (IEC 60601-1-1:2000) DIN EN 60601-1-2:2006-10 (VDE 0750-1-2), Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2001 + A1:2004) DIN EN 6
13、0721-3-7:1995-09, Classification of environmental conditions Part 3: Classification of groups of environmental parameters and their severities Section 7: Portable and non-stationary use (IEC 60721-3-7:1995) DIN EN 61000-4-3:2006-12 (VDE 0847-4-3), Electromagnetic compatibility (EMC) Part 4-3: Testin
14、g and measurement techniques Radiated, radio-frequency, electromagnetic field immunity test (IEC 61000-4-3:2006) DIN EN ISO 11608-4:2007-11 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11608-4August 2007ICS 11.040.25English VersionPen-injectors for medical
15、 use - Part 4: Requirements and testStylos-injecteurs usage 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 undelektromechanis
16、che Pen-Injektoren (ISO 11608-4:2006)This European Standard 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-d
17、ate lists and bibliographical references concerning such nationalstandards 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
18、 responsibility of a CEN member into its own language and 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,
19、 Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 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
20、 Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11608-4:2007: Emethods for electronic and electromechanical pen-injectors(ISO 11608-4:2006)Contents Page 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 EN
21、 ISO 11608-4:2007 (E)2Foreword. 3 Introduction 4 Scope . 5 Normative references . 5 Terms and definitions. 6 Symbols and abbreviated terms . 6 General requirements. 6 Test conditions . 6 Preconditioning of pen-injectors 6 Reagent and apparatus 9 Determination of dose accuracy . 9 Freedom from defect
22、s 10 Determination of electromagnetic compatibility . 11 Electrical safety. 11 Visual inspection 12 Functional inspection. 12 Test report . 12 Information supplied by the manufacturer 13Bibliography . 14 Foreword The text of ISO 11608-4:2006 has been prepared by Technical Committee ISO/TC 84 “Device
23、s for administration of medicinal products and intravascular catheters” of the International 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 St
24、andard shall be given the status of a national standard, either by publication of an identical 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
25、 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. ISO 11608-4 consists of the following parts under the general title “Pen-injectors for medical use”: Part 1: Pen-injectors - Requirements and test me
26、thods Part 2: Needles - Requirements and test methods Part 3: Finished cartridges - Requirements 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 fo
27、llowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, S
28、lovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11608-4:2006 has been approved by CEN as EN ISO 11608-4:2007 without any modifications. EN ISO 11608-4:2007 (E)3Introduction This part of ISO 11608 covers electro-mechanical driven injectors not covered by
29、 part 1 of ISO 11608. These injectors are mainly intended to administer medicinal products to humans. This part of ISO 11608 provides performance requirements regarding essential aspects of the design so that variations of such injectors are not unnecessarily restricted. The sampling plans for inspe
30、ction selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturers ability to manufacture one “lot” of injectors that conforms to the critical product attributes. These sampling plans for inspection do not intend to replace the more general manufacturing
31、quality systems practices widely used in production, e.g. the ISO 9000 series. Materials to be used for the construction of these injectors 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.
32、 All materials used in these injectors which come in contact with the end-user must be non-toxic and biocompatible. In some countries, national 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 I
33、SO directives (Part 2, A3 and A13) require that the VIM1and GUM2principles are used and incorporated in all future standards and future revisions 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
34、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/TC 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
35、ISO 11608-4:2007 (E)41 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 intende
36、d to deliver medication 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
37、of operating while connected 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 (inc
38、luding any amendments) 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, cy
39、clic (12 h + 12 h cycle) 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: Gener
40、al requirements for 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
41、for safety Collateral standard: Electromagnetic compatibility Requirements and tests EN ISO 11608-4:2007 (E)5IEC 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:
42、2001, Electromagnetic compatibility (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
43、responsible for expelling 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.
44、2 Cool atmosphere See 6.2 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 11608-4:2007 (E
45、)67.3 Preconditioning in cyclical 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 ac
46、cording to the instructions 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
47、 Class 7M3, as follows: acceleration 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
48、 vibration time shall be 1 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
49、 shock test in accordance with 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 Type II represents the device in use (without packaging). 7.7 Preconditioning for the influence of fluid leakage The pu
