SVENSK STANDARD SS-EN ISO 9626/A1 Fastställd 2001-11-30 Utgåva 1 Rör av rostfritt stål för tillverkning av medicintekniska produkter (ISO 9626:1991/Amd 1:2001) Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991/Amd 1:2001) ICS 11.040.20 Språk: engelska Tryckt i januari 2002 Copyright SIS. Reproduction in any form without permission is prohibited.
Europastandarden EN ISO 9626:1995/A1:2001 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 9626:1995/A1:2001. The European Standard EN ISO 9626:1995/A1:2001 has the status of a Swedish Standard. This document contains the official English version of EN ISO 9626:1995/A1:2001. Dokumentet består av 11 sidor. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, tel 08-555 520 00. Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Postadress: SIS Förlag AB, 118 80 STOCKHOLM Telefon: 08-555 523 10. Telefax: 08-555 523 11 E-post: sis.sales@sis.se. Internet: www.sisforlag.se
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 9626:1995/A1 June 2001 ICS 11.040.20 Supersedes EN ISO 9626:1995 English version Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991/Amd 1:2001) Tubes d'aiguilles en acier inoxydable pour la fabrication de matériel médical (ISO 9626:1991/AM 1:2001) Edelstahlrohr zur Herstellung von Medizinprodukten (ISO 9626:1991/AM 1:2001) This amendment A1 modifies the European Standard EN ISO 9626:1995; it was approved by CEN on 1 June 2001. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant 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 amendment 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 2001 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9626:1995/A1:2001 E
Page 2 EN ISO 9626:1995/A1:2001 Provläsningsexemplar / Preview Foreword The text of this Amendment EN ISO 9626:1995/A1:2001 to the EN ISO 9626:1995 from Technical Committee ISO/TC 84 "Medical devices for injections" of the International Organization for Standardization (ISO) has been taken over as an Amendment to the European Standard by Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by BSI. This European Standard supersedes EN ISO 9626:1995. This Amendment to the European Standard EN ISO 9626:1995 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2001, and conflicting national standards shall be withdrawn at the latest by December 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. NOTE FROM CMC: The foreword is susceptible to be amended on reception of the German language version. The confirmed or amended foreword, and when appropriate, the normative annex ZA for the references to international publications with their relevant European publications will be circulated with the German version. Endorsement notice The text of the Amendment to the International Standard ISO 9626:1991/Amendment 1:2001 has been approved by CEN as an Amendment to the European Standard without any modification.
Page 3 EN ISO 9626:1995/A1:2001 Introduction The purposes of this amendment are to: a) add specifications for normal- and thin-walled tubing of metric sizes 0,2 mm, 0,23 mm and 0,25 mm to reflect the introduction of thinner tubing to allow greater comfort when injecting, particularly for infants and in paediatric use; b) add minimum inside diameters for thin-walled tubing of metric sizes 0,3 mm to 0,36 mm, as these data are now available; c) revise the maximum outside diameter of 0,6 mm metric size tubing to reflect current manufacturing practice; d) delete the maximum inside diameter of all types of tubing, as this value is not needed to discriminate between normal-, thin- and extra-thin-walled tubing; e) revise the means of specifying the steels to be used, as a result of the withdrawal of ISO 683-13. For clarity in this amendment, the revised values in the new Tables 2, 3 and 4 are given in boldface type.