EN ISO 8536-5-2013 en Infusion equipment for medical use - Part 5 Burette infusion sets for single use gravity feed《医疗用输液设备-第5部分 单独使用滴定管输液器 重力饲料》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8536-5:2013Infusion equipment for medical usePart 5: Burette infusionsets for single use, gravity feedBS EN ISO 8536-5:2013 BRITISH STANDARDNational forewordThis Britis

2、h Standard is the UK implementation of EN ISO 8536-5:2013. It is identical to ISO 8536-5:2004. It supersedes BS EN ISO 8536-5:2011 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/205, Non-active medical devices.A list of organizations represented on

3、 this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 82253

4、7 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUR

5、OPENNE EUROPISCHE NORM EN ISO 8536-5 February 2013 ICS 11.040.20 Supersedes EN ISO 8536-5:2011English Version Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004) Matriel de perfusion usage mdical - Partie 5: Appareils non rutilisables de

6、perfusion burette, alimentation par gravit (ISO 8536-5:2004) Infusionsgerte zur medizinischen Verwendung - Teil 5: Infusionsgerte mit Dosierbehlter fr Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-5:2004) This European Standard was approved by CEN on 8 January 2013. CEN members are bound

7、 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 standards may be obtained on application to the CEN

8、-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 notified to the CEN-CENELEC Management Centre ha

9、s 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, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

10、xembourg, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 C

11、EN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-5:2013: EBS EN ISO 8536-5:2013BS EN ISO 8536-5:2013EN ISO 8536-5:2013 (E) 3 Foreword The text of ISO 8536-5:2004 has been prepared by Technical Committee ISO/TC 76 “Transfusio

12、n, infusionand injection, and blood processing equipment for medical and pharmaceutical use” of the InternationalOrganization for Standardization (ISO) and has been taken over as EN ISO 8536-5:2013 by TechnicalCommittee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.

13、 This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn atthe latest by August 2013. Attention is drawn to the possibility that some of t

14、he elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-5:2011. This document has been prepared under a mandate given to CEN by the European Commission and th

15、eEuropean 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 followingcou

16、ntries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol

17、and, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8536-5:2004 has been approved by CEN as EN ISO 8536-5:2013 without any modification. BS EN ISO 8536-5:2013EN ISO 8536-5:2013 (E) 4 Annex ZA (informative) Relations

18、hip 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 Requir

19、ements of the New Approach Directive 93/42/EEC on 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 Table

20、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. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/su

21、bclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 3.2, 8 7.2 8 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 of sta

22、ndards. However, the part of ER 7.5 relating to phthalates is not specifically addressed in the EN ISO 10993 series. 3.3, 6.2.2, 6.2.3 7.6 3.2 8.1 10 8.3 8 8.4 Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer cho

23、oses to apply the EN ISO 10993 series of standards. However, the part of ER 7.5 relating to phthalates is not specifically addressed in the EN ISO 10993 series. 6.1 9.1 6.3, 6.4 10 6.1 12.7.1 6.2.1 12.8 BS EN ISO 8536-5:2013EN ISO 8536-5:2013 (E) 5 Clause(s)/subclause(s) of this EN Essential Require

24、ments (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 9 13 The part of ER 13.3 a) relating to the authorized representative isnot addressed. ERs 13.3 f) and 13.6 h) relatingto single-use are not fullyaddressed. ER 13.6 q) is not addressed. 4 13.3 WARNING Other requirements and other EU Directi

25、ves may be applicable to the product(s) fallingwithin the scope of this standard. BS EN ISO 8536-5:2013ISO 8536-5:2004(E) ISO 2004 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The

26、work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a tec hnical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-gover

27、nmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The

28、main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. A

29、ttention 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 8536-5 wasprepared byTechnical Committee ISO/TC 76, Transfusion, infusion and injection equipment

30、for medical use. This second edition cancels and replaces the first edition (ISO8536-5:1992), which has been technically revised.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 bottles

31、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: Infusion set

32、s for use with pressure infusion equipment Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid lines for use with pressure infusion equipment Part 11: Infusion filters for use with pressure infusion equipment BS EN ISO 8536-5:2013BS EN ISO 8536-5:2013INTERNATI

33、ONAL STANDA RD ISO 8536-5:2004(E) ISO 2004 All rights reserved 1Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravityfeed1 Scope This part of ISO 8536 specifies require ments for types of single-use, gravity feed burette infusion s ets of 50 ml, 100 ml and 150 ml n

34、ominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. This part of ISO 8536 also provides guidance on specifications relating to the quality and performance of materials used in infusion sets. NOTE In some countries,

35、 national pharmacopoeia or other national regulations are legally binding and takeprecedence over this part of ISO 8536. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated re

36、ferences, the latest edition of the referenceddocument (including any amendments) applies.ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed3 General requirements 3.1 The nomenclature to be used for components of burette infusion sets isgiven in Figure

37、1. Figure 1 illustrate examples of the configuration of burette infusion sets; other configurations may be usedprovided they lead to the same results.3.2 The burette infusion set shall be provided with protective caps to maintain sterility of the internal parts ofthe set until the set is used.3.3 If

38、 a separate air-inlet device is used, it shall comply with ISO 8536-4. BS EN ISO 8536-5:2013ISO 8536-5:2004(E)2 ISO 2004 All rights reservedKey1 protectivecap of the closure-piercing device 9 drip tube 2 closure-piercingdevice a 10fluid filter c3 ON/OFF clamp11tubing4 tubing12flow regulator 5 inject

39、ion site b 3injection site b6 air inlet with air filter and closure 14male conical fitting 7 graduated burette 15 protective cap of the conical fitting 8 shut-off valve a Air inlet with air filter is optional; if an air filter exists, a closure is optional. b Injection site is optional. c The fluid

40、filter may be positioned at other sites, for example preferably near the patient access. Generally a fluid filterhas a nominal pore sizeof15 m. Figure 1 Example of a burette setBS EN ISO 8536-5:2013ISO 8536-5:2004(E) ISO 2004 All rights reserved 34 Designation The designation of a burette infusion s

41、et (BS), gravity feed (G), which complies with this part of ISO 8536 shallinclude the indication of burette set, a reference to this part of ISO8536, the nominal capacityin millilitres (e.g. 100 ml) and the indication of gravity feed, as follows: Burette set ISO8536-5 BS 100 G5 Materials The materia

42、ls from which the burette infusion set and its components as given in Clause 3 are manufactured shall comply with the requirements in Clause 6. Where components of the burette infusion set come intocontact with solutions, the materials additionally shall comply with the requirements specified in Cla

43、uses 7 and 8. 6 Physical requirements 6.1 General Physical requirements for burette infusion sets shall be in accordance with ISO 8536-4 so far as applicable. Inaddition, the burette set shall complywith the requirements in 6.2 to 6.4. 6.2 Design 6.2.1 The burette shall consist of a tube of rigid or

44、 semi-rigid plastics material and shall permit observationof fluid in the chamber. 6.2.2 The burette shall be provided with filtered air-venting capabilitylocated in a position above the topgraduation mark. 6.2.3 The burette shall be capable of receiving fluid from the main container and of being cl

45、osed off andserving as a separate self-vented reservoir.6.3Volume of buretteThe nominal volume of the burette shall be designated by the total graduated capacity.6.4 Graduated scale6.4.1 The burette scale shall be graduated at intervals as given in Table 1.Table 1 Volume andscale intervals for buret

46、tes Scale intervals Numbered scale intervals Nominal volume of burette max. max.Tolerance on any graduated capacityexceeding half nominal volume ml ml ml % 50 1 5 50 5 10 4 BS EN ISO 8536-5:2013ISO 8536-5:2004(E)4 ISO 2004 All rights reserved6.4.2 The graduation lines shall be clear, legible and dur

47、able lines of uniform thickness, evenly spaced, and they shall lie in planes at right angles to the axis of the burette. 6.4.3 The lengths of the graduation lines shall be given in Figure 2. The ends may optionallybe joined by aline parallel to the longitudinal axis of the burette (see Figure 2). 6.

48、4.4 The graduation lines to be numbered shall be as illustrated in Figure 2. The scale numbers shall be bold, durable and legible,and shall be close to, but not touching, the ends of the graduation lines to which they relate. 6.4.5 The zero position mark on the chamber shall be located in a position

49、 which compensates for thevolume displaced by any shut-off device, the position of outlet relative to the bottom of the burette or any otherfeature of the bottom cap which can affect the reading.Nominal volume: 50 ml 100 ml 150 mlNOTE The vertical lines are optional.Figure 2 Typical graduated scales for use in burette sets BS EN ISO 8536-5:2013ISO 8536-5:2004(E) ISO 2004 All rights reserved 57 Chemical requirements The requirements of ISO 8536-4 shall apply.8 Biological requirements The requirements of ISO 853