SVENSK STANDARD SS-EN ISO 8362-1:2010/A1:2016 Fastställd/Approved: 2016-01-13 Publicerad/Published: 2016-01-28 Utgåva/Edition: 1 Språk/Language: engelska/english ICS: 11.040.20 Behållare för injektionsvätskor Del 1: Injektionsflaskor tillverkade av glasrör (ISO 8362-1:2009/Amd 1:2015) Injection containers and accessories Part 1: Injection vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015)
Provläsningsexemplar / Preview Europastandarden EN ISO 8362-1:2009/A1:2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 8362-1:2009/A1:2015. The European Standard EN ISO 8362-1:2009/A1:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 8362-1:2009/A1:2015. Copyright/Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen regleras av slutanvändarlicensen för denna produkt. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon 08-555 520 00. Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone +46 8 555 520 00. Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Standarden är framtagen av koittén för Förbrukningsmaterial inom sjukvården, SIS/TK 330 Har du synpunkter på innehållet i den här standarden, vill du delta i ett koande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på www.sis.se - där hittar du mer information.
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM Provläsningsexemplar / Preview EN ISO 8362-1:2009/A1 December 2015 ICS 11.040.20 English Version Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2009/Amd 1:2015) Récipients et accessoires pour produits injectables - Partie 1: Flacons en verre étiré (ISO 8362-1:2009/Amd 1:2015) Injektionsbehältnisse und Zubehör - Teil 1: Injektionsflaschen aus Röhrenglas (ISO 8362-1:2009/Amd 1:2015) This amendment A1 modifies the European Standard EN ISO 8362-1:2009; it was approved by CEN on 3 October 2015. 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 CEN-CENELEC 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-1:2009/A1:2015 E
SS-EN ISO 8362-1:2010/A1:2016 (E) Provläsningsexemplar / Preview European foreword This document (EN ISO 8362-1:2009/A1:2015) has been prepared by Technical Coittee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use". This Amendment to the European Standard EN ISO 8362-1:2009 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. 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 responsible for identifying any or all such patent rights. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8362-1:2009/Amd 1:2015 has been approved by CEN as EN ISO 8362-1:2009/A1:2015 without any modification.
Provläsningsexemplar / Preview SS-EN ISO 8362-1:2010/A1:2016 (E) Injection containers and accessories Part 1: Injection vials made of glass tubing AMENDMENT 1 Page 2, Table 1 Replace the existing Table 1 by the following one, where injection vials of the sizes 50R and 100R have been added and the masses of all injection vials have been amended. 1
SS-EN ISO 8362-1:2010/A1:2016 (E) Provläsningsexemplar / Preview Table 1 Dimensions, overflow capacity and mass Size desig-nation of injection vial Overflow capacity ml a d1 d2 +0,2 0,3 d3 max. d4 ± 0,2 h1 tol. tol. tol. tol. tol. 2R 4 35 22 4,4 1 16 ±0,15 13 10,5 7 8 2,5 1,5 0,6 4R 6 45 32 5,7 ±0,5 6R 10 40 26 7,9 22 ±0,5 8,5 ±0,5 3,5 1 ±0,04 0,7 8R 11,5 45 31 8,7 1,2 ±0,2 16,5 2 10R 13,5 45 30 9,5 ±1 24 9 4,0 15R 19 20 12,6 60 45 0,7 12,0 20R 26 55 25R 32,5 ±1,5 1,5 30 ±0,25 17,5 65 ±0,7 45 10 ±0,75 5,5 2,5 1,2 ±0,05 1 18,9 30R 37,5 75 55 21,9 50R 62 ±4 2,5 40 ±0,4 20 17,5 c 12,6 73 ±0,75 49 10 ±0,75 6,0 4,0 1,5 ±0,07 0,9 1,5 34,5 100R 123 ±7 3,5 47 ±0,5 20 17,5 c 12,6 100 ±0,75 75 10 ±0,75 6,5 4,0 1,7 ±0,07 0,9 1,5 60,0 h2 min. 35 h3 r1 r2 s1 s2 min. t max. Massa,b 16,2 a Mean values that can deviate about 10 %. b The mass specifications apply to injection vials made of colourless borosilicate glass having a linear expansion coefficient of 5,1 x 10 6 K 1 and a density of 2,34 g/cm 3. The mass of vials made of other glass types (e.g. amber glass or borosilicate glass 3.3) needs to be calculated using the density of the particular glass. c With blow back Type B: 17,7. The slightly larger diameter is necessary due to the different hot-forming process with more glass mass having to be formed. 2