1、January 2017 English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.20!%_=“2605926www.din.deD
2、IN EN ISO 8536-13Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact (ISO 853613:2016);English version EN ISO 853613:2016,English translation of DIN EN ISO 8536-13:2017-01Infusionsgerte zur medizinischen Verwendung Teil 13: Graduierte Durchflussreg
3、ler zur einmaligen Verwendung mit Flssigkeitskontakt (ISO 853613:2016);Englische Fassung EN ISO 853613:2016,Englische bersetzung von DIN EN ISO 8536-13:2017-01Matriel de perfusion usage mdical Partie 13: Rgulateurs de dbit gradus non rutilisables avec contact fluide (ISO 853613:2016);Version anglais
4、e EN ISO 853613:2016,Traduction anglaise de DIN EN ISO 8536-13:2017-01www.beuth.deDocument comprises 15 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.01.17 DIN EN ISO 8536-13:2017-01 2 A comma is used as the decimal marker. N
5、ational foreword This document (EN ISO 8536-13:2016) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 “Non-activ
6、e medical devices” (Secretariat: DIN, Germany) with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und -gerte a
7、us Kunststoffen und Einmalprobengefe fr die In-vitro-Diagnostik. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1135 (all parts) DIN EN ISO 1135 (all parts) ISO 8536-4 DIN EN ISO 8536-4 ISO 10993-1 DIN EN ISO 10993-1 ISO 80000-4 DIN EN
8、 ISO 80000-4*) National Annex NA (informative) Bibliography DIN EN ISO 1135 (all parts), Transfusion equipment for medical use DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1:
9、 Evaluation and testing within a risk management system DIN EN ISO 80000-4, Quantities and units Part 4: Mechanics *) Currently at draft stage. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-13 October 2016 ICS 11.040.20 English Version Infusion equipment for medical use - Part 13: Gr
10、aduated flow regulators for single use with fluid contact(ISO 8536-13:2016) Matriel de perfusion usage mdical - Partie 13: Rgulateurs de dbit gradus non rutilisables avec contact fluide (ISO 8536-13:2016) Infusionsgerte zur medizinischen Verwendung -Teil 13: Graduierte Durchflussregler zur einmalige
11、n Verwendung mit Flssigkeitskontakt(ISO 8536-13:2016) This European Standard was approved by CEN on 17 September 2016. 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
12、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 lang
13、uage 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, Denmar
14、k, 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 andUnited Kingdom. EUROPEAN COMMITTEE FO
15、R STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-13:2016 EForeword 71 Sco
16、pe . 82 Normative references 83 Terms and definitions . 84 Design 85 Materials .96 Physical requirements 96.1 Graduated scale 96.2 Particulate contamination . 96.3 Tensile strength 96.4 Leakage . 106.5 Flow rates . 107 Chemical requirements 108 Biological requirements 10Annex A (normative) Physical
17、tests 11Bibliography . 13Contents PageEuropean foreword 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be covered 5 .DIN EN ISO 8536-13:2017-01 EN ISO 8536-13:2016 (E)2 European foreword This document (EN I
18、SO 8536-13:2016) 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
19、 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 April 2017, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the el
20、ements 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports e
21、ssential 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 Europe
22、an 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, Slove
23、nia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition
24、cited applies. However, for any use of this standard “within the meaning of Annex ZA”, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is refe
25、rred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or IEC standard, as listed in Table 1. NOTE The way in which these referenced documents are cited in normative requirements determines th
26、e extent (in whole or in part) to which they apply. DIN EN ISO 8536-13:2017-01 EN ISO 8536-13:2016 (E)3 Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO
27、8536-4 EN ISO 8536-4:2013 + A1:2013 ISO 8536-4:2010 + Amd.1:2013 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 80000-4 EN ISO 80000-4:2013 ISO 80000-4:2006 Endorsement notice The text of ISO 8536-13:2016 has been approved by CEN as EN ISO 8536-13:2016 without any modification. DIN EN ISO 8536
28、-13:2017-01 EN ISO 8536-13:2016 (E)4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/295 concerning the develop
29、ment of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Direct
30、ive compliance with the normative 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 associated EFTA regulations. NOTE 1 Where a reference from a clause
31、 of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/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”,
32、according to the wording of the corresponding essential requirement. 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 t
33、he table of references in the European foreword, replacing the references in the core text. 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 Annex I of Directi
34、ve 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this EN Remarks/notes 7.2 5, 6, 7, 8 Clause 7 and Clause 8 refer to ISO 8536-4. The part of ER 7.2 relating to packaging is not addressed. 7.3 5, 6, 7, 8 Sections 7 and 8 refer to ISO 8536-4. ER covered by
35、biological evaluation. DIN EN ISO 8536-13:2017-01 EN ISO 8536-13:2016 (E)5 7.5 6.3, 6.4, A.2, A.3 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 1099
36、3- series standards. 7.6 6.2, 6.3, 6.4, A.1, A.2, A.3 8.1 6.2, 6.3, 6.4, 7, 8, A.1, A.2, A.3 Sections 7 and 8 refer to ISO 8536-4. The part of ER 8.1 relating to handling is not addressed. Manufacturing processes are not covered. The reduction of the risk of infection is not fully covered. 8.5 6.2,
37、A.1 ER 8.5 is covered by 6.2 only for particulate contamination. 9.1 4 The second sentence of ER 9.1 is not addressed. 12.7 6.3, A.2 Only 12.7.1 is addressed. Only tensile strength is addressed. WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is
38、maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of th
39、is standard. DIN EN ISO 8536-13:2017-01 EN ISO 8536-13:2016 (E)6 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 through ISO technical co
40、mmittees. 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 collaborates closely with th
41、e 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 approval criteria needed for t
42、he 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 subject of patent rights. I
43、SO 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 trade name used in this docu
44、ment 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 World Trade Organization (WTO) principles in the
45、Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.ISO 8536 consists of the following parts, under the
46、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 closur
47、es 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 pressur
48、e infusion equipment Part 11: Infusion filters for single use with pressure infusion equipment Part 12: Check valves Part 13: Graduated flow regulators for single use with fluid contact Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactDIN EN ISO 8536-13:2017-01 EN ISO 8536-13:2016 (E)7
