1、BSI Standards PublicationBS EN ISO 8536-10:2015Infusion equipment for medicalusePart 10: Accessories for fluid lines for singleuse with pressure infusion equipmentBS EN ISO 8536-10:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8536-10:2015. It supersed
2、es BS EN ISO 8536-10:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisio
3、ns of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83294 9ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published und
4、er the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-10 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-10:2004English Version Infusion equipment for medical us
5、e - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) Matriel de perfusion usage mdical - Partie 10 : Accessoires pour tubulures non rutilisables avec un matriel de perfusion sous pression (ISO 8536-10:2015) Infusionsgerte zur medizinischen Verwe
6、ndung - Teil 10: Zubehrteile fr bertragungsleitungen 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 givi
7、ng 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 offi
8、cial 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
9、 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,
10、Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 fo
11、r CEN national Members. Ref. No. EN ISO 8536-10:2015 EBS EN ISO 8536-10:2015EN ISO 8536-10:2015 (E) 3 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 collabo
12、ration 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 nati
13、onal 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 supers
14、edes 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
15、 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 th
16、e 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 standard
17、s 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, Luxem
18、bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN ISO 8536-10:2015EN ISO 8536-10:2015 (E) 4 Endorsement notice The text of ISO 8536-10:2015 has been approved by CEN as EN ISO 8536-10:2015 without any mod
19、ification. Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO 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 8536-4:2010 and
20、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 BS EN ISO 8536-10:2015EN ISO 8536-10:2015 (E) 5 Annex ZA (informative) Relationship b
21、etween this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirement
22、s of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table Z
23、A.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub
24、clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes Clause 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, Clause 6 7.2 The part of ER 7.2 relating to packaging is not addressed. For packaging see Clause 7 of this standard. Clause 3, Clause 6 7.3 ER covered by bio
25、logical evaluation. 4.3, 4.4, A.3, A.4 7.5 Only the first sentence is covered. Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the ISO 10993 series of standards 4.2, 4.3 7.6 4.2, 4.3, 4.4 8.1 Th
26、e part of ER 8.1 relating to handling is not addressed. Manufacturing processes are not covered. Only sterility of products is covered 8.3 6.1 8.4 Only the sterilisation method is covered 4.2 8.5 8.2, 8.3 8.7 4.5, 4.8, 8.2 g) 9.1 The second sentence of ER 9.1 is not addressed Clause 3, 4.1, 4.2, 4.3
27、, 4.4, 4.5, 4.7, 4.8 9.2 BS EN ISO 8536-10:2015EN ISO 8536-10:2015 (E) 6 Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4.3, A.3 12.7.1 Only tensile strength is addressed Clause 8 13.1 8.2 d), e), f), g), 8.3 c), d) 13.2 8.2, 8.3 13.3 T
28、he part of 13.3 a) relating to the authorized representative is not addressed. Presumption of conformity to the rest of 13.3 a) is only provided if the name and address of the manufacturer are given 13.3 d) is only covered if the batch number is preceded by the word LOT 13.3 f) Requirement indicatio
29、n of single use must be consistent across the Community“ is not addressed in the standard 13.3 g), h) is not addressed in the standard 8.2, 8.3 13.4 13.4 is addressed regarding to the label 8.2, 8.3 13.5 13.5 is not addressed regarding to the detachable components 8.2, 8.3 13.6 13.6 e), f), h), i),
30、j), l), m), o) are not applicable for devices according to this standard 13.6 q) is not addressed WARNING Other requirements and other EC Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8536-10:2015ISO 8536-10:2015(E)Foreword iv1 Scope . 12 Normati
31、ve references 13 Materials . 24 Physical requirements 24.1 Avoidance of air bubbles 24.2 Particulate contamination . 24.3 Tensile strength 24.4 Leakage 24.5 Adapters with female and/or male conical fittings . 24.6 Protective caps 24.7 Manipulation of stopcocks 24.8 Unit with injection site . 24.9 Un
32、it with check valve . 25 Chemical requirements . 36 Biological requirements . 36.1 Sterility 36.2 Pyrogens . 36.3 Haemolysis . 37 Packaging . 38 Labelling 38.1 General . 38.2 Label on unit container 38.3 Label on shelf or multi-unit container 49 Disposal 4Annex A (normative) Physical tests . 5Annex
33、B (normative) Chemical tests 6Annex C (normative) Biological tests . 7Bibliography 8 ISO 2015 All rights reserved iiiContents PageBS EN ISO 8536-10:2015ISO 8536-10:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO memb
34、er 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, government
35、al 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.The procedures used to develop this document and those intended for its further maintenance a
36、re described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is
37、 drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or
38、 on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity asse
39、ssment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment
40、for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8536-10:2004), which has been technically revised with the following changes: The former Clause 3 on designation has been deleted; Clause 8 on labelling was amended by a note regarding the usage of th
41、e 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 specifying a test for leakage of adapters with female and/or male conical fittings has been deleted; Normative references and the Bibliography have been updated; Docume
42、nt has been editorially revised.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 Par
43、t 5: Burette infusion sets for single use, gravity feed Part 6: Freeze drying closures for infusion bottlesiv ISO 2015 All rights reservedBS EN ISO 8536-10:2015ISO 8536-10:2015(E) Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion sets for single use with pres
44、sure 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 valvesThe following parts are unde
45、r 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 ISO 2015 All rights reserved vBS EN ISO 8536-10:2015BS EN ISO 8536-10:2015Infusion equipment for medical use Part 10: A
46、ccessories for fluid lines for single use with pressure infusion equipment1 ScopeThis 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-w
47、ay 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 stop
48、cock 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
49、.2 Normative referencesThe 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 594-21), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittingsISO 7000, Graphical symbols for use on equipment Registered symb
