1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Infusion equipment for medical usePart 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactBS EN ISO 853614:2018National forewordThis British Standard is the UK implementation of E
2、N ISO 853614:2018. It is identical to ISO 853614:2016. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.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 nece
3、ssary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 87553 3ICS 11.040.20Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard
4、was published under the authority of the Standards Policy and Strategy Committee on 28 February 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 853614:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 853614February 2018ICS 11.040.20EUROPEAN COM
5、MITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2018 CEN Ref. No. EN ISO 853614:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersInfusion equi
6、pment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 853614:2016)Matriel de perfusion usage mdical Partie 14: Clamps et limiteurs de dbit pour appareils de transfusion et de perfusion sans contact fluide (ISO 853614:2016)Infusion
7、sgerte zur medizinischen Verwendung Teil 14: Klemmen und Durchflussregler fr Transfusions und Infusionsgerte ohne Flssigkeitskontakt (ISO 853614:2016)This European Standard was approved by CEN on 19 December 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipula
8、te the conditions for giving this European Standard the status of a national standard without any alteration. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the CENCENELEC Management Centre or to any CEN member.This European Standar
9、d 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 CENCENELEC Management Centre has the same status as the official versions.CEN members are the national
10、 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, Serbia,
11、 Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 853614:2018 (E)European forewordThis document (EN ISO 853614:2018) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and
12、pharmaceutical use” in collaboration with Technical Committee CEN/TC 205 “Nonactive 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 August
13、2018, and conflicting national standards shall be withdrawn at the latest by February 2021.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This docume
14、nt 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 CE
15、NCENELEC 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, Hungar
16、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.The following referenced documents are indispensable for the application of this document. For undat
17、ed references, 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 the meaning of Annex ZA”, the user should always check that any referenced document has not been supers
18、eded and that its relevant contents can still be considered the generally acknowledged stateofart.When an IEC or ISO standard is referred 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 version
19、of the ISO or IEC standard, as listed below.NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.Table Correlations between normative references and dated EN and ISO standardsNormative references as liste
20、d in Clause 2 of the ISO standardEquivalent dated standardEN ISO or IECISO 109931 EN ISO 109931:2009 ISO 109931:2009Endorsement noticeThe text of ISO 853614:2016 has been approved by CEN as EN ISO 853614:2018 without any modification.2BS EN ISO 853614:2018EN ISO 853614:2018 (E)Annex ZA (informative)
21、 Relationship between this European standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be coveredThis European Standard has been prepared under a Commissions standardization request M/295 concerning the development of European Standards related to medical devices to pro
22、vide one voluntary means of conforming to essential requirements of Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in T
23、able 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 man
24、agement process needs to be in compliance with Directive 93/42/EEC. 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 requirement.NOTE 2 The manufacturers po
25、licy 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 the table of references in the European foreword, replacing the references in the core text.NOTE 4
26、 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.3BS EN ISO 853614:2018EN ISO 853614:2018 (E)Table ZA.1 Correspondence between this European standard and Annex I of Directive 93/42/EEC OJ L 169Essential Requirements of Directiv
27、e 93/42/EECClause(s)/subclause(s) of this EN Remarks/Notes7.2 4, 5, 6 Clause 4 covers ER 7.2 in respect of controlling fluid flow and avoiding puncturing of flexible tubing only.Clause 5 covers ER 7.2 in respect of material physical performance as follows: Tubing specifications Operating temperature
28、 Construction Flow ratesClause 6 covers ER 7.2 in respect of the following items only: Tubing specifications Operating temperature Construction Flow ratesThe part of ER 7.2 relating to packaging is not addressed.7.5 6.3, A.1 Clause 6.3 covers ER 7.5, first para, first sentence in respect of controll
29、ing the flow rate of substances being delivered via the infusion set only.A.1 covers ER 7.5, first para, first sentence in respect of controlling the flow rate of substances being delivered via the infusion set only.ER 7.5, first para, second sentence and ER 7.5, paragraphs two and three are not cov
30、ered.7.6 6.3, A.1 ER 7.6 is covered by Clause 6.3 but only to the extent that the clamp must ensure complete occlusion of the fluid pathway.ER 7.6 is covered by A.1 but only to the extent that the clamp must ensure complete occlusion of the fluid pathway.9.1 4 ER 9.1 is covered by Clause 4 in respec
31、t of the design of the clamp so that accidental operation of the clamp is avoided and flexible tubing is not damaged during operation only.4BS EN ISO 853614:2018EN ISO 853614:2018 (E)Essential Requirements of Directive 93/42/EECClause(s)/subclause(s) of this EN Remarks/Notes12.7.1 4 ER 12.7.1 is cov
32、ered by Clause 4 in respect of the design of the clamp so that accidental operation of the clamp is avoided and flexible tubing is not damaged during operation only.WARNING 1 Presumption of conformity stays valid only as long as a reference to the European Standard is maintained in the list publishe
33、d 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 this standard.5BS EN ISO 853614:20
34、18ISO 853614:2016(E)Foreword vii1 Scope .12 Normative references 13 Terms and definitions .14 Design 15 Materials .26 Physical requirements 26.1 Tubing specifications . 26.2 Operating temperature 26.3 Construction 26.4 Flow rates 3Annex A (normative) Physical tests .4Bibliography 5vi ISO 2016 All ri
35、ghts reservedContents PageBS EN ISO 853614:2018ISO 853614:2016(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 through ISO technical co
36、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 nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
37、 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 th
38、e 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. IS
39、O 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 docum
40、ent 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 T
41、echnical 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 g
42、eneral 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
43、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
44、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 contact ISO 2016 All righ
45、ts reserved viiBS EN ISO 853614:2018This page deliberately left blankInfusion equipment for medical use Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact1 ScopeThis part of ISO 8536 specifies requirements for nonsterile clamps and flow regulators used a
46、s a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precede
47、nce over this part of ISO 8536.2 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
48、 document (including any amendments) applies.ISO 109931, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1clampsubcomponent applied externally
49、 to an infusion/transfusion equipment without fluid contact with an “on/off” function used to terminate or initiate the flow of fluid through the line3.2flow regulatorsubcomponent with or without graduation applied externally to an infusion/transfusion equipment without fluid contact to control the flow of fluid through the line3.3flow ratevolume per time4 DesignClamps and flow regulators shall be designed for their application in controlling fluid transfer i
