1、BS EN ISO 8536-13:2016Infusion equipment for medicalusePart 13: Graduated flow regulators forsingle use with fluid contact(ISO 8536-13:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 8536-13:2016 BRITISH STANDARDNational forewordThis British Standard i
2、s the UK implementation of EN ISO8536-13:2016.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 necessaryprovis
3、ions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83091 4ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published u
4、nder the authority of theStandards Policy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-13 October 2016 ICS 11.040.20 English Version Infusion equipment for medical use
5、 - Part 13: Graduated 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 Durchflussregl
6、er zur einmaligen 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
7、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 official versions (English, French, German). A version
8、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 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
9、 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, Sweden, Switzerland, Turkey andUnited Kingdom. EURO
10、PEAN COMMITTEE FOR 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
11、 EBS EN ISO 8536-13:2016EN ISO 8536-13:2016 (E) 3 European 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” in collaboration with Technical Committe
12、e 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 April 2017, and conflicting national standards shall be withdrawn
13、 at the latest by April 2017. 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 has been prepared under a mandate given to
14、 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 CEN-CENELEC Internal Regulations, the nationa
15、l 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithua
16、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, 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 referenc
17、ed 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 superseded and that its relevant contents can still be
18、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 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 wa
19、y in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 8536-13:2016EN ISO 8536-13:2016 (E) 4 Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as
20、listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 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 be
21、en approved by CEN as EN ISO 8536-13:2016 without any modification. BS EN ISO 8536-13:2016EN ISO 8536-13:2016 (E) 5 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 pr
22、epared under a Commissions standardization request M/295 concerning the development 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 st
23、andard is cited in the Official Journal of the European Union under that Directive 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 Di
24、rective and associated EFTA regulations. NOTE 1 Where a reference from a clause 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 possib
25、le”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, 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
26、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 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard.
27、Table ZA.1 Correspondence between this European Standard and Annex I of Directive 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
28、 addressed. 7.3 5, 6, 7, 8 Sections 7 and 8 refer to ISO 8536-4. ER covered by biological evaluation. BS EN ISO 8536-13:2016EN ISO 8536-13:2016 (E) 6 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 evalua
29、tion can only be provided if the manufacturer chooses to apply the ISO 10993- 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 cove
30、red. The reduction of the risk of infection is not fully covered. 8.5 6.2, 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 confo
31、rmity stays valid only as long as a reference to this European Standard is 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 l
32、egislation may be applicable to the products falling within the scope of this standard. BS EN ISO 8536-13:2016ISO 8536-13:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Design 15 Materials . 26 Physical requirements 26.1 Graduated scale 26.2 Particulate contaminati
33、on . 26.3 Tensile strength 26.4 Leakage 36.5 Flow rates 37 Chemical requirements . 38 Biological requirements . 3Annex A (normative) Physical tests . 4Bibliography 6 ISO 2016 All rights reserved iiiContents PageBS EN ISO 8536-13:2016ISO 8536-13:2016(E)ForewordISO (the International Organization for
34、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 committees. Each member body interested in a subject for which a technical committee has been established has the r
35、ight 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 the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedur
36、es 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 the different types of ISO documents should be noted. This document was drafted in accordance with the editorial r
37、ules 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. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights iden
38、tified 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 document is information given for the convenience of users and does not constitute an endorsement.For an explanation
39、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 Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible
40、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 general title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2 Closures for infusion bot
41、tles 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 closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusio
42、n 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 pressure infusion equipment Part 11: Infusion filters for single use with pressure infusion equipment Part 12: Check val
43、ves Part 13: Graduated flow regulators for single use with fluid contact Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contactiv ISO 2016 All rights reservedBS EN ISO 8536-13:2016INTERNATIONAL STANDARD ISO 8536-13:2016(E)Infusion equipment for medical use P
44、art 13: Graduated flow regulators for single use with fluid contact1 ScopeThis part of ISO 8536 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with flu
45、id contact under gravity feed conditions.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and
46、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 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feedISO 1
47、0993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 80000-4, Quantities and units Part 4: Mechanics3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1graduated flow regulatorGFRsubcomp
48、onent with graduation and with fluid contact for setting certain flow of liquids3.2flow ratevolume per time3.3scalearray of marks, together with any associated figuring, in relation to which the position of the pointer is observed4 DesignThe GFR shall be designed for a constant flow regulation. The
49、GFR shall be designed for a safe use to avoid accidental change of flow rate and shall clearly indicate open and off (closed) positions.A typical design for a GFR is shown in Figure 1. ISO 2016 All rights reserved 1BS EN ISO 8536-13:2016ISO 8536-13:2016(E)Key1 upstream2 downstream3 scale4 pointerFigure 1 Example for the design of a GFR (schematic)5 MaterialsThe materials used shall comply with the requirements specified in Clauses 6, 7 and 8. In addition, the materials of all items described shall be assessed to the req
