1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 1135-4:2012T r a n s f u s i o n e q u i p m e n t for medical usePart 4: Transfusion sets for single use (ISO 1135-4:2012)Copyright European Committee for Standardizat
2、ion Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 1135-4:2012. It supersedes BS EN ISO 1135-4:2011,which is withd
3、rawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 2 1 2 , I V D s .A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a co
4、ntract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 73841 8 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the
5、authority of the Standards Policy and Strategy Committee on 31 March 2012.Amendments issued since publicationDate T e x t a f f e c t e dCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from I
6、HS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1135-4 March 2012 ICS 11.040.20 Supersedes EN ISO 1135-4:2011English Version Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012) Matriel de transfusion usage mdical - Partie 4: Appareils de
7、transfusion non rutilisables (ISO 1135-4:2012) Transfusionsgerte zur medizinischen Verwendung - Teil 4: Transfusionsgerte zur einmaligen Verwendung (ISO 1135-4:2012) This European Standard was approved by CEN on 29 February 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulati
8、ons 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.
9、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 m
10、embers are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spa
11、in, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN na
12、tional Members. Ref. No. EN ISO 1135-4:2012: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012 EN ISO 1135-4:2012 (E) 3 Foreword This document (EN ISO 1135-4
13、:2012) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing 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
14、Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2012, and conflicting national standards shall be withdrawn at the latest by September 2012. Attention is drawn to the possibility that some of the elem
15、ents 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 1135-4:2010. This document has been prepared under a mandate given to CEN by the European Commission and the Euro
16、pean Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, 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 countri
17、es are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sloveni
18、a, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 1135-4:2012 has been approved by CEN as a EN ISO 1135-4:2012 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction
19、 or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012EN ISO 1135-4:2012 (E) 4 Annex ZA (informative) Relationship 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
20、given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive
21、and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table 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 ass
22、ociated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 3.2 7.2, 8.1 3.3 13.3 b) 4 1, 2, 3 5.1 7.2 5.2 7.6 5.3 9.1, 12
23、.7.1 5.4 7.6 5.5 12.8 5.6 7.2 5.7 12.8 5.8 10, 12.8 5.9 10, 12.8 5.10 8 5.11 9.1 5.12 8 6 7 7.1 7, 7.5 Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the EN ISO 10993 series standards 7.2 8.4 7
24、.3 7.1, 7.2 7.4 7.1, 7.2 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012 EN ISO 1135-4:2012 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this EN
25、Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 7.5 7.1, 7.2 8 13 The part of 13.3.a) relating to the authorized representative is not addressed. 13.3.f) and 13.6.h) relating to single use are not fully addressed. 13.6.q) is not addressed.9 5, 8.3 10 13.6 n) WARNING Othe
26、r requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 11
27、35-4:2012ISO 1135-4:2012(E) ISO 2012 All rights reserved iiiContents Page Foreword iv 1 Scope 1 2 Normative references 1 3 General requirements . 2 3.1 Nomenclature for components of the transfusion set 2 3.2 Maintenance of sterility . 2 3.3 Designation 3 4 Materials . 3 5 Physical requirements 3 5.
28、1 Particulate contamination. 3 5.2 Leakage 3 5.3 Tensile strength . 3 5.4 Closure-piercing device 3 5.5 Tubing . 4 5.6 Filter for blood and blood components 4 5.7 Drip chamber and drip tube 4 5.8 Flow regulator 4 5.9 Flow rate of blood and blood components . 4 5.10 Injection site . 5 5.11 Male conic
29、al fitting 5 5.12 Protective caps 5 6 Chemical requirements . 5 6.1 Reducing (oxidizable) matter . 5 6.2 Metal ions . 5 6.3 Titration acidity or alkalinity . 5 6.4 Residue on evaporation 5 6.5 UV absorption of extract solution 5 7 Biological requirements 6 7.1 General . 6 7.2 Sterility 6 7.3 Pyrogen
30、icity . 6 7.4 Haemolysis . 6 7.5 Toxicity . 6 8 Labelling . 6 8.1 Unit container 6 8.2 Shelf or multi-unit container 7 9 Packaging . 7 10 Disposal 7 Annex A (normative) Physical tests 8 Annex B (normative) Chemical tests 12 Annex C (normative) Biological tests . 14 Bibliography 15 Copyright European
31、 Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012ISO 1135-4:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International Organization for Standardization) is a worldw
32、ide federation of national standards bodies (ISO member 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 th
33、at committee. International organizations, governmental 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. International Standards are drafted in
34、accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard r
35、equires approval by at least 75 % of the member bodies casting a vote. Attention is 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. ISO 1135-4 was prepared by Tec
36、hnical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This fifth edition cancels and replaces the fourth edition (ISO 1135-4:2010), which has been revised at Figure 2 (dimensions of the closure-piercing device), at 6.1, at
37、 8.2 (Note), and at B.2 (last sentence). ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use: Part 3: Blood-taking set Part 4: Transfusion sets for single use Copyright European Committee for Standardization Provided by IHS under license with CENNo
38、t for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012INTERNATIONAL STANDARD ISO 1135-4:2012(E) ISO 2012 All rights reserved 1Transfusion equipment for medical use Part 4: Transfusion sets for single use 1 Scope This part of ISO 1135 specifies requirem
39、ents for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance
40、of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135. 2 Normative references The following referenced documents
41、are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and c
42、ertain other medical equipment Part 1: General requirements ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 3826-1:2003, Plasti
43、cs collapsible containers for human blood and blood components Part 1: Conventional containers ISO 7864:1993, Sterile hypodermic needles for single use ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 15223-1:1 ), Medical devices Symbo
44、ls to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 1) To be published. (Revision of ISO 15223-1:2007) Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permit
45、ted without license from IHS-,-,-BS EN ISO 1135-4:2012ISO 1135-4:2012(E) 2 ISO 2012 All rights reserved3 General requirements 3.1 Nomenclature for components of the transfusion set The nomenclature for components of transfusion sets is given in Figure 1. Key 1 protective cap of the closure-piercing
46、device 7 tubing 2 closure-piercing device 8 flow regulator 3 fluid channel 9 injection site 4 drip tube 10 male conical fitting 5 drip chamber 11 protective cap of the male conical fitting 6 filter for blood and blood components a Indicates alternative locations of the filter for blood and blood com
47、ponents. Other designs are acceptable if the samesafety aspects are ensured. b Injection site is optional. Figure 1 Example of a transfusion set 3.2 Maintenance of sterility The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the se
48、t is used. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 1135-4:2012ISO 1135-4:2012(E) ISO 2012 All rights reserved 33.3 Designation A transfusion set complying with the requirements of this part of ISO 1135 is designated as follows. Transfusion set ISO 1135-4 4 Materials The materials from which the transfusion sets given in Clause 3 are manufactured shall comply with the requirements specified in Clause 5.
