SVENSK STANDARD SS-EN ISO :2015

Transkript

1 SVENSK STANDARD SS-EN ISO :2015 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 2 Språk/Language: engelska/english ICS: Infusionsutrustning för medicinskt bruk Del 10: Tillbehör till slangsystem för infusion med övertryck för engångsbruk (ISO :2015) Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO :2015)

2 Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Europastandarden EN ISO :2015 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO :2015. Denna standard ersätter SS-EN ISO :2005, utgåva 1. The European Standard EN ISO :2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO :2015. This standard supersedes the Swedish Standard SS-EN ISO :2005, edition 1. Förhållandet till övriga delar under samma huvudtitel - Utdrag ur Förord i ISO :2015/ Relations to other parts under the same general title - Extract from the Foreword of ISO :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 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 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 - där hittar du mer information.

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5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO June 2015 ICS Supersedes EN ISO :2004 English Version Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO :2015) Matériel de perfusion à usage médical - Partie 10 : Accessoires pour tubulures non réutilisables avec un matériel de perfusion sous pression (ISO :2015) Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO :2015) This European Standard was approved by CEN on 16 April 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 :2015 E

6 Contents Page oreword...iv 1 Scope Normative references Materials Physical requirements Avoidance of air bubbles Particulate contamination Tensile strength Leakage Adapters with female and/or male conical fittings Protective caps Manipulation of stopcocks Unit with injection site Unit with check valve Chemical requirements Biological requirements Sterility Pyrogens Haemolysis Packaging Labelling General Label on unit container Label on shelf or multi-unit container 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

7 European foreword This document (EN ISO :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 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 :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 ; 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

8 Endorsement notice The text of ISO :2015 has been approved by CEN as EN ISO :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 ISO 594-2:1998 ISO 7000 ISO 7000:2014 ISO EN ISO :2013 and ISO :2013/A1:2013 ISO ISO :2010 and Amd.1:2013 ISO EN ISO :2015 ISO :2015 ISO ISO :2007 and Amd.1:2012 ISO EN ISO :2009 ISO :2002 plus Amd.1:2006 ISO EN ISO :2012 ISO :2012 v

9 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 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 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 ), 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 , Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed ISO , Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus ISO , Infusion equipment for medical use Part 12: Check valves ISO , Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ISO , 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

10 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 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 Protective caps ISO 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 , the valve shall close tightly to prevent any leakage of water. 2

11 5 Chemical requirements ISO 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 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 Packaging ISO 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 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 ; e) the lot (batch) designation, prefixed by the word LOT, or using the graphical symbol according to ISO ; f) year and month of expiry, accompanied by appropriate wording or the graphical symbol according to ISO ; 3