BS-EN-ISO-11608-2-2001.pdf
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 11608-2:2001 The European Standard EN ISO 11608-2:2000 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 Ð Part 2: Needles Ð Requirements and test methods Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 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 36720 7 BS EN ISO 11608-2:2001 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 11608-2:2000. It is identical with ISO 11608-2:2000. The UK participation in its preparation was entrusted to Technical Committee CH/2, Hypodermic equipment, which has the responsibility to: Ð aid enquirers to understand the text; Ð present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; Ð monitor related international and European developments 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 publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled ªInternational Standards Correspondence Indexº, or by using the ªFindº 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 legal 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 10, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 11608-2 December 2000 ICS 11.040.20 English version Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000) Stylos-injecteurs à usage médical - Partie 2: Aiguilles - Exigences et méthodes d'essai (ISO 11608-2:2000) Pen-Injektoren zur medizinischen Anwendung - Teil 2: Kanülen - Anforderungen und Prüfverfahren (ISO 11608- 2:2000) 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 bibliographical 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 of 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, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11608-2:2000 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard ISO 11608-2:2000 has been prepared by Technical Committee ISO/TC 84 “Medical devices for 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, 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, France, 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 11608-2:2000 was approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11608-2:2000(E) INTERNATIONAL STANDARD ISO 11608-2 First edition 2000-12-15 Pen-injectors for medical use Part 2: Needles Requirements and test methods Stylos-injecteurs à usage médical Partie 2: Aiguilles Exigences et méthodes d'essai EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806112:(0002E) iii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 4Requirements.2 4.1Colour coding.2 4.2Materials .2 4.3Dimensions.2 4.4Patency of lumen.3 4.5Needle points .3 4.6Freedom from defects.3 4.7Lubrication .3 4.8Dislocation of measuring point at the patient-end of Type A needles.4 4.9Bond between hub and needle tube4 4.10Unscrewing torque of the needle.4 4.11Ease of assembly/disassembly4 4.12Sterility4 5Sampling.4 6Preconditioning of needles.5 6.1Preconditioning in dry heat atmosphere.5 6.2Preconditioning in cold storage atmosphere.5 6.3Preconditioning in cyclical atmosphere5 7Standard atmosphere and apparatus for tests.6 7.1Standard test atmosphere 6 7.2Test apparatus .6 8Determination of dislocation of measuring point at the patient-end of Type A needles .7 9Bond between hub and needle tube7 10Unscrewing torque of the needle.7 11Packaging.8 12Information supplied by the manufacturer .8 12.1General8 12.2Marking.8 12.3Instructions for use .9 Bibliography10 EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806112:(0002E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The 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-governmental, 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. 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 possibility that some of the elements of this part 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 11608-2 was prepared by Technical Committee ISO/TC 84, Medical devices for injections. 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 EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806112:(0002E) v Introduction This part of ISO 11608 covers sterile double-ended needles intended for single use in conjunction with pen- injectors. The devices described in this part of ISO 11608 are designed to be used with devices described in ISO 11608-1 and ISO 11608-3. It is recognized that interchangeability of the components (pen-injector, needle and cartridge) is desirable for some medicinal products and should be avoided for other 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 requirements are imposed on both interchangeable (Type A) and non-interchangeable (non-Type A) needles. Additional dimensional requirements are imposed on interchangeable needles (Type A). Information as to whether the components are interchangeable (Type A) or not should be given on the unit container. It is desirable that non-Type A needles do not fit pen-injectors intended for Type A needles. The sampling plans for inspection selected for this part of ISO 11608 are intended to verify, at a high confidence level, the manufacturer's ability to manufacture one “lot” of needles that conforms to the 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. This part of ISO 11608 does not specify requirements or test methods for freedom from biological hazards, because international agreement upon the methodology and the pass/fail criteria is incomplete. Guidance on biological tests relevant to double-ended needles is given in ISO 10993-1, and it is suggested that manufacturers take this guidance into account when evaluating products. Such evaluation should include the effects of the process whereby the needles are sterilized. However, national regulations may exist in some countries, and these may take precedence over the guidance in ISO 10993-1. In some countries, national regulations exist and their requirements may supersede or complement this part of ISO 11608. EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADRISO -806112:(0002E) 1 Pen-injectors for medical use Part 2: Needles Requirements and test methods 1Scope This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for pen-injectors which fulfil the specifications of ISO 11608-1. It is not applicable to needles for dental use. 2Normative references The following normative documents contain provisions 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 possibility 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 6009:1992, Hypodermic needles for single use Colour coding for identification. ISO 7864:1993, Sterile hypodermic needles for single use. ISO 9626:1991, Stainless steel needle tubing for the manufacture of medical devices. ISO 11608-1:2000, Pen-injectors for medical use Part 1: Pen-injectors Requirements and test methods. IEC 60068-2-30:1980, Environmental testing Part 2: Test Db and guidance: Damp heat, cyclic (12 + 12-hour cycle). 3Terms and definitions For the purposes of this part of ISO 11608, the following terms and definitions apply. The nomenclature of some components of a needle for a pen-injector is given in Figure 1. 3.1 primary container that part of the packaging which maintains sterility of the needle NOTEThe primary container may serve as a needle shield. 3.2 unit container package intended for customer use EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806112:(0002E) 2 3.3 seal removable barrier which is intended to maintain the sterility of the needle inside the primary container Key 1Seal 2Means of needle assembly attachment 3Needle hub 4Primary container 5Needle shield 6Needle tube 7Jointing medium (if used) Figure 1 Schematic presentation of needle assembly for pen-injectors 4Requirements 4.1Colour coding If colour coding is used for designation of the diameter of the needle, the colour coding shall be in accordance with the requirements of ISO 6009. 4.2Materials The needle should be made of tubing materials in accordance with ISO 683-13. 4.3Dimensions 4.3.1General The tubing diameters should be in accordance with the requirements given in Table 1 of ISO 9626:1991. The dimensions of the attachment part of the needle shall be such that the needle fits and functions with pen- injectors which are in accordance with ISO 11608-1. EN ISO 116082:2000 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:04:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -806112:(0002E) 3 4.3.2Type A needles Type A needles shall fit the test apparatus specified in 7.2 and function with pen-injectors designated and labelled to be used with Type A needles. The length (l2) of the cartridge-end of the needle shall
