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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 11608-1:2001 Th
2、e European Standard EN ISO 11608-1:2000 has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 0
3、7:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 2001 BSI 03-2001 ISBN 0 580 36721 5 BS EN
4、ISO 11608-1:2001 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 11608-1:2000. It is identical with ISO 11608-1:2000. The UK participation in its preparation was entrusted to Technical Committee CH/2,
5、 Hypodermic equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European devel
6、opments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publica
7、tions with their corresponding European publications. The British Standards which implement these international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the F
8、ind facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from lega
9、l obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 25, the annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed
10、in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11608-1 December 2000 ICS 11.040.20 English version Pen-injectors for medi
11、cal use - Part 1: Pen-injectors - Requirements and test methods (ISO 11608-1:2000) Stylos-injecteurs usage mdical - Partie 1: Stylos- injecteurs - Exigences et mthodes dessai (ISO 11608- 1:2000) Pen-Injektoren zur medizinischen Anwendung - Teil 1: Pen- Injektoren - Anforderungen und Prfverfahren (IS
12、O 11608- 1:2000) This European Standard was approved by CEN on 1 December 2000. CEN members are bound to comply with 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 bi
13、bliographical references concerning such national standards may be obtained on application to the 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 translation under the responsibility o
14、f a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Nor
15、way, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide
16、 for CEN national Members. Ref. No. EN ISO 11608-1:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard ISO 11608-1:2000 has been prepared by Technical Committee ISO/TC 84 “Medical devices fo
17、r injections“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices“, the secretariat of which is held by BSI. 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 June 2001,
18、 and conflicting national standards shall be withdrawn at the latest by June 2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, Fra
19、nce, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11608-1:2000 was approved by CEN as a European Standard without any modification. NOTE: Normative
20、 references to International Standards are listed in annex ZA (normative). EN ISO 116081:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11608-1:2000(E) INTERNATIONAL STANDARD ISO 11608-1 First edition 2000-12-15 Pe
21、n-injectors for medical use Part 1: Pen-injectors Requirements and test methods Stylos-injecteurs usage mdical Partie 1: Stylos-injecteurs Exigences et mthodes dessai EN ISO 116081:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN I
22、SO 116081:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806111:(0002E) iii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Symbols and abbreviations3 5General requirements4 6Test
23、 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 cold storage atmosphere.6 7.3Preconditioning in cyclical atmosphere6 7.4Preconditioning by free fall 6 7.5Preconditionin
24、g 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 from defects.14 10.1Defects after being subjected to cyclical preconditioning14 10.2Freedom from defects after being su
25、bjected to vibration.14 10.3Freedom from defects after being subjected to free fall .14 11Determination of electromagnetic compatibility14 11.1Electromagnetic compatibility (EMC)14 11.2Electrostatic discharge .15 11.3Radiated radio frequency (RF) fields.15 12Visual inspection .15 13Functional inspec
26、tion16 13.1Replaceable cartridge .16 13.2Nonreplaceable cartridge16 13.3Accuracy.16 14Test report16 15Information supplied by the manufacturer .16 15.1General16 15.2Marking.17 15.3Instructions for use .17 Annex A (informative) Two-sided tolerance limit factors (k) 19 Bibliography25 EN ISO 116081:200
27、0 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806111:(0002E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inte
28、rnational 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-governmental, in liaison wi
29、th 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. Draft International Stan
30、dards 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 part of ISO 11608 may be
31、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 general title Pen-inje
32、ctors 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. EN ISO 116081:2000 Licensed Copy: sheffieldun sheffieldun,
33、na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806111:(0002E) v 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 res
34、tricted. The devices described in this part of ISO 11608 are designed to be 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
35、 medicinal products, and that future design may change the current concepts. 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 requir
36、ements are imposed on both Type A (interchangeable) and non-Type A needles and 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 t
37、he components are interchangeable (Type A) or not should be given on the unit 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
38、critical product attributes. The sampling plans for inspection do not replace 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 depe
39、nd upon the design, the intended use and the process of manufacture by individual 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
40、this part of ISO 11608. EN ISO 116081:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 116081:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADRIS
41、O -806111:(0002E) 1 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
42、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
43、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
44、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
45、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
46、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,
47、 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. EN ISO 116081:2000 Licensed Copy: sheffieldu
48、n sheffieldun, na, Thu Nov 16 07:04:26 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806111:(0002E) 2 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 mu
49、ltidose cartridge NOTEThe doses may be pre-set by manufacturer or user. 3.2 connector mechanical 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 the pre-set dose 3.6 injection stroke that portion of a parenteral injection involving movement of the injection mechan
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