1、BSI Standards PublicationBS EN ISO 1135-5:2015T r a n s f u s i o n e q u i p m e n t f o rmedical usePart 5: Transfusion sets for single use withpressure infusion apparatusBS EN ISO 1135-5:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO1135-5:2015. Tog
2、ether with BS EN ISO 1135-4:2015, it supersedes BS EN ISO 1135-4:2012 which is withdrawn.This standard has been technically revised with the followingchanges:- the scope of BS EN ISO 1135-4:2015 has been restricted to gravity - clause 7.6 “Assessment of blood component depletion” and clause - a new
3、Annex D on Storage volume has been added.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 necessaryprovisions
4、of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83090 7ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under
5、the authority of theStandards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dfeed applications, whereby, this is focused on pressure infusion 7.7 “Assessment of damage to blood components” have been added;applications;EUROPE
6、AN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1135-5 December 2015 ICS 11.040.20 Supersedes EN ISO 1135-4:2012English Version Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) Matriel de transfusion usage mdical -
7、Partie 5: Appareils de transfusion non rutilisables avec les appareils de perfusion sous pression (ISO 1135-5:2015) Transfusionsgerte zur medizinischen Verwendung - Teil 5: Transfusionsgerte zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 1135-5:2015) This European Standard was approved b
8、y CEN on 24 July 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 standar
9、ds 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 noti
10、fied 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, Ic
11、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Man
12、agement 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 1135-5:2015 EEN ISO 1135-5:2015 (E) 3 European foreword This document (EN ISO 1135-5:2015) has been prepared by Technical Co
13、mmittee ISO/TC 76“Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceuticaluse” in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” thesecretariat of which is held by DIN. This European Standard shall be given the status of a nat
14、ional standard, either by publication of anidentical text or by endorsement, at the latest by June 2016, and conflicting national standards shall bewithdrawn at the latest by June 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent right
15、s. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. Together with EN ISO 1135-4:2015 this document supersedes EN ISO 1135-4:2012. This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Associati
16、on, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of thisdocument. According to the CEN-CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to imple
17、ment 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, Sl
18、ovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 1135-5:2015 has been approved by CEN as EN ISO 1135-5:2015 without anymodification. The following referenced documents are indispensable for the application of this document. Forundated ref
19、erences, the latest edition of the referenced document (including any amendments) applies.For dated references, only the edition cited applies. However, for any use of this standard within themeaning of Annex ZA, the user should always check that any referenced document has not beensuperseded and th
20、at its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as anormative reference to the corresponding EN standard, if available, and otherwise to the dated ISO orIEC standar
21、d, as listed in Table 1. NOTE The way in which these references documents are cited in normative requirements determines theextent (in whole or in part) to which they apply. BS EN ISO 1135-5:2015EN ISO 1135-5:2015 (E) 4 Table 1 Correlations between undated normative references and dated EN and ISO s
22、tandards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 - ISO 594-1:1986 ISO 594-2 - ISO 594-2:1998 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:20
23、08 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus ISO 10993-4 AMD 1:2006 ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 BS EN ISO 1135-5:2015EN ISO 1135-5:2015 (E) 5 Annex ZA (informative) Rela
24、tionship between 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 R
25、equirements of the New Approach Directive 93/42/EEC, Medical devices Once this standard is cited in the Official Journal of the European Union 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 Tabl
26、e ZA.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. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk manag
27、ement process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential re
28、quirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on Normative References according to Table of References, replacing the references in the core t
29、ext. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC, Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of D
30、irective 93/42/EEC Qualifying remarks/Notes 4.2, 6.1, 6.2, 6.3, Clause 7, Clause 8 7.2 The part of ER 7.2 relating to packaging is not addressed ( for packaging see Clause 10 of this standard). Clause 5, 6.1, 6.2, 6.3, Clause 7, Clause 8 7.3 ER covered by biological evaluation 6.2, 6.3, 6.10, 9.2, 9
31、.3, A.2, A.4 7.5 Only the first paragraph is covered. 6.1, 6.3 7.6 4.2, Clause 6 8.1 6.12, Clause 9, Clause 10 8.3 Maintenance of sterility in storage is covered. 8.2 8.4 Sterilization process is covered. 6.1, A.1 8.5 9.2, 9.3 8.7 BS EN ISO 1135-5:2015EN ISO 1135-5:2015 (E) 6 Clause(s)/sub-clause(s)
32、 of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.4 9.1 The second sentence of ER 9.1 is not addressed. 6.4 refers to ISO 3826-1. Clauses 4, 5, 6, 7, 8 9.2 6.2, 6.3, A.2 12.7 Only 12.7.1 is addressed. Only tensile strength is addressed. Clause 9 13.1 9.2, 9.3
33、 13.2 ISO 15223-1 and ISO 3826-2 are addressed when using symbols. 9.2 a), b), c), d), e), f), g), i), j), k), 9.3 a), b), c), d), e), f), g) 13.3 The part of 13.3a) relating to the authorized representative is not addressed. Presumption of conformity to the rest of 13.3a) is only provided if the na
34、me and address of the manufacturer are given. 13.3b) is addressed in Clause 3.1 and 4.3. 13.3d) is only covered if the batch number is preceded by the word LOT. 13.3f) Requirement indication of single use must be consistent across the Community“ is not addressed in the standard. 13.3g) and h) are no
35、t addressed in the standard. 9.2, 9.3 13.4 13.4 is addressed regarding to the label. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 1135-5:2015ISO 1135-5:2015(E)Foreword iv1 Scope . 12 Normative references 1
36、3 Terms and definitions . 24 General requirements . 24.1 Nomenclature for components of the transfusion set 24.2 Maintenance of sterility. 35 Materials . 36 Physical requirements 46.1 Particulate contamination . 46.2 Leakage 46.3 Tensile strength 46.4 Closure-piercing device . 46.5 Tubing . 56.6 Fil
37、ter for blood and blood components . 56.7 Drip chamber and drip tube 56.8 Flow regulator . 56.9 Flow rate of blood and blood components . 56.10 Injection site 66.11 Male conical fitting 66.12 Protective caps 66.13 Storage volume . 67 Chemical requirements . 67.1 Reducing (oxidizable) matter . 67.2 M
38、etal ions 67.3 Titration acidity or alkalinity 67.4 Residue on evaporation . 67.5 UV absorption of extract solution . 78 Biological requirements . 78.1 General . 78.2 Sterility 78.3 Pyrogenicity . 78.4 Haemolysis . 78.5 Toxicity . 78.6 Assessment of blood component depletion . 78.7 Assessment of dam
39、age to blood components 79 Labelling 89.1 General . 89.2 Unit container 89.3 Shelf or multi-unit container 910 Packaging . 911 Disposal 9Annex A (normative) Physical tests 10Annex B (normative) Chemical tests .14Annex C (normative) Biological tests 16Annex D (normative) Storage volume 17Bibliography
40、 .20 ISO 2015 All rights reserved iiiContents PageBS EN ISO 1135-5:2015ISO 1135-5:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out
41、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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO coll
42、aborates 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 are described in the ISO/IEC Directives, Part 1. In particular the different approv
43、al 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 drawn to the possibility that some of the elements of this document may be the sub
44、ject 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 on the ISO list of patent declarations received (see www.iso.org/patents).Any trad
45、e 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 assessment, as well as information about ISOs adherence to the WTO principles in the Tec
46、hnical 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 for medical and pharmaceutical use.This first edition of ISO 1135-5, together with I
47、SO 1135-4, cancels and replaces ISO 1135-4:2012, which has been technically revised with the following changes: the scope of ISO 1135-4 has been restricted to gravity feed applications, whereby, ISO 1135-5 is focused on pressure infusion applications; a new Annex D on Storage volume has been added.I
48、SO 1135 consists of the following parts, under the general title Transfusion equipment for medical use: Part 3: Blood-taking sets for single use Part 4: Transfusion sets for single use, gravity feed Part 5: Transfusion sets for single use with pressure infusion apparatusiv ISO 2015 All rights reserv
49、edBS EN ISO 1135-5:2015INTERNATIONAL STANDARD ISO 1135-5:2015(E)Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus1 ScopeThis part of ISO 1135 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.Secondary aims of this part of ISO 1135 are to provid
