SVENSK STANDARD SS-EN ISO 8536-10:2015 Fastställd/Approved: 2015-06-21 Publicerad/Published: 2015-06-25 Utgåva/Edition: 2 Språk/Language: engelska/english ICS: 11.040.20 Infusionsutrustning för medicinskt bruk Del 10: Tillbehör till slangsystem för infusion med övertryck för engångsbruk (ISO 8536-10:2015) Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
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Europastandarden EN ISO 8536-10:2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO 8536-10:2015. Denna standard ersätter SS-EN ISO 8536-10:2005, utgåva 1. The European Standard EN ISO 8536-10:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 8536-10:2015. This standard supersedes the Swedish Standard SS-EN ISO 8536-10:2005, edition 1. Förhållandet till övriga delar under samma huvudtitel - Utdrag ur Förord i ISO 8536-10:2015/ Relations to other parts under the same general title - Extract from the Foreword of ISO 8536-10:2015 ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: - Part 1: Infusion glass bottles - Part 2: Closures for infusion bottles - Part 3: Aluminium caps for infusion bottles - Part 4: Infusion sets for single use, gravity feed - Part 5: Burette infusion sets for single use, gravity feed - Part 6: Freeze drying closures for infusion bottles - Part 7: Caps made of aluminium-plastics combinations for infusion bottles - Part 8: Infusion sets for single use with pressure infusion apparatus - Part 9: Fluid lines for single use with pressure infusion equipment - Part 10: Accessories for fluid lines for single use with pressure infusion equipment - Part 11: Infusion filters for single use with pressure infusion equipment - Part 12: Check valves The following parts are under preparation: - Part 13: Graduated flow regulators for single use with infusion sets - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. 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. You will find the licence in the end of this document. 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. Denna standard är framtagen av kommittén för Förbrukningsmaterial inom sjukvården, SIS / TK 330. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande 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 EN ISO 8536-10 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-10:2004 English Version Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) Matériel de perfusion à usage médical - Partie 10 : Accessoires pour tubulures non réutilisables avec un matériel de perfusion sous pression (ISO 8536-10:2015) Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2015) This European Standard was approved by CEN on 16 April 2015. 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 CEN-CENELEC 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 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 8536-10:2015 E
Contents Page oreword...iv 1 Scope... 1 2 Normative references... 1 3 Materials... 2 4 Physical requirements... 2 4.1 Avoidance of air bubbles... 2 4.2 Particulate contamination... 2 4.3 Tensile strength... 2 4.4 Leakage... 2 4.5 Adapters with female and/or male conical fittings... 2 4.6 Protective caps... 2 4.7 Manipulation of stopcocks... 2 4.8 Unit with injection site... 2 4.9 Unit with check valve... 2 5 Chemical requirements... 3 6 Biological requirements... 3 6.1 Sterility... 3 6.2 Pyrogens... 3 6.3 Haemolysis... 3 7 Packaging... 3 8 Labelling... 3 8.1 General... 3 8.2 Label on unit container... 3 8.3 Label on shelf or multi-unit container... 4 9 Disposal... 4 Annex A (normative) Physical tests... 5 Annex B (normative) Chemical tests... 6 Annex C (normative) Biological tests... 7 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices...8 Bibliography...10 iii
European foreword This document (EN ISO 8536-10:2015) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 Non-active medical devices the secretariat of which is held by DIN. 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 December 2015, and conflicting national standards shall be withdrawn at the latest by December 2015. 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. This document supersedes EN ISO 8536-10:2004. In this edition the following changes have been made: the former Clause 3 on designation has been deleted; Clause 8 on labelling was amended by a note regarding the usage of the symbol XXX according ISO 7000-2725; Clause 9 on disposal has been added; A.4 'Tests for leakage' has been amended; The former A.5 specifyin a test for leakage of adapters with female and/or male conical fittings has been deleted; Normative references and the Bibliography have been updated; Document has been editorially revised. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. 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. iv
Endorsement notice The text of ISO 8536-10:2015 has been approved by CEN as EN ISO 8536-10:2015 without any modification. Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 EN Equivalent dated standard ISO 594-2 ISO 594-2:1998 ISO 7000 ISO 7000:2014 ISO 8536-4 EN ISO 8536-4:2013 and ISO 8536-4:2013/A1:2013 ISO ISO 8536-4:2010 and Amd.1:2013 ISO 8536-8 EN ISO 8536-8:2015 ISO 8536-8:2015 ISO 8536-12 ISO 8536-12:2007 and Amd.1:2012 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus Amd.1:2006 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 v
Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment 1 Scope This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. This part of ISO 8536 includes the following: a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold; NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. b) units with injection site or check valve; c) stoppers or adapters. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-2 1), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 7000, Graphical symbols for use on equipment Registered symbols ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed ISO 8536-8, Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus ISO 8536-12, Infusion equipment for medical use Part 12: Check valves ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 1) To be replaced by ISO 80369-7. 1
3 Materials The materials from which the accessories are manufactured shall comply with the requirements as specified in Clause 4, Clause 5, and Clause 6. 4 Physical requirements 4.1 Avoidance of air bubbles All components of accessories shall be designed such that no air bubbles are detected in flow channels when tested as specified in A.1. 4.2 Particulate contamination The accessories shall be manufactured under conditions that minimize particulate contamination. The fluid pathway surfaces shall be smooth and clean. When tested as specified in A.2, the number of particles shall not exceed the contamination index. 4.3 Tensile strength When tested as specified in A.3, the accessories and connections between components shall withstand a static tensile force of not less than 15 N for 15 s. In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position. 4.4 Leakage The accessories shall be impermeable to air, microorganisms, and fluids. There shall be no leakage of air or water. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no leakage of air or water. 4.5 Adapters with female and/or male conical fittings Adapters shall be provided with a connector with female conical fitting and/or a connector with male conical fitting according to ISO 594-2. 4.6 Protective caps ISO 8536-4 applies. 4.7 Manipulation of stopcocks Stopcocks and stopcock manifolds shall be so designed that when tested as specified in A.5, flow channels can be opened and closed without any adverse effect on the functionality of adjacent components. 4.8 Unit with injection site Units with injection site shall enable injection. When tested as specified in A.6, no more than 10 drops per batch and no more than 2 drops per unit shall be lost. 4.9 Unit with check valve When tested as specified in ISO 8536-12, the valve shall close tightly to prevent any leakage of water. 2
5 Chemical requirements ISO 8536-4 applies. For test methods, see Annex B. 6 Biological requirements 6.1 Sterility The accessories in their unit container shall have been subjected to a validated sterilization process (see Bibliography). 6.2 Pyrogens The accessories shall be assessed for freedom from pyrogens using a suitable test, and the results shall indicate that the accessories are free from pyrogens. Guidance on testing for pyrogenicity is given in ISO 8536-4. 6.3 Haemolysis The accessories shall be assessed for freedom from haemolytic constituents and the result shall indicate that the accessories are free from haemolytic reactions. Guidance on testing for haemolytic constituents is given in ISO 10993-4. 7 Packaging ISO 8536-4 applies. 8 Labelling 8.1 General The labelling shall include the requirements as specified in 8.2 and 8.3. If graphical symbols are used, then refer to ISO 15223-1. NOTE The presence of substances of interest can be indicated by using symbol 2725 of ISO 7000 by replacing the XXX by the abbreviation of the substance. The absence of substances of interest can be indicated by crossing the respective symbol. 8.2 Label on unit container The unit container shall be labelled at least with the following information: a) the name and address of the manufacturer; b) a textual description of the contents, e.g. stopcock manifold for single use; c) indication that the accessory is free from pyrogens, or that the accessory is free from bacterial endotoxins; d) indication that the accessory is sterile, using the graphical symbol as given in ISO 15223-1; e) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according to ISO 15223-1; f) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to ISO 15223-1; 3