1、October 2013Translation by DIN-Sprachendienst.English price group 9No 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
2、11.040.20!%)jE“2067134www.din.deDDIN EN ISO 8536-5Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed(ISO 8536-5:2004);English version EN ISO 8536-5:2013,English translation of DIN EN ISO 8536-5:2013-10Infusionsgerte zur medizinischen Verwendung Teil 5: Infu
3、sionsgerte mit Dosierbehlter fr Schwerkraftinfusionen zur einmaligenVerwendung (ISO 8536-5:2004);Englische Fassung EN ISO 8536-5:2013,Englische bersetzung von DIN EN ISO 8536-5:2013-10Matriel de perfusion usage mdical Partie 5: Appareils non rutilisables de perfusion burette, alimentation par gravit
4、(ISO 8536-5:2004);Version anglaise EN ISO 8536-5:2013,Traduction anglaise de DIN EN ISO 8536-5:2013-10SupersedesDIN EN ISO 8536-5:2012-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 14 pages10.13 2 A comma is used as the decimal mark
5、er. National foreword This document (EN ISO 8536-5:2013) 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” (Secr
6、etariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und -gerte aus Kunststoffen. DIN (EN) ISO 8536 consists of the following parts, under the
7、 general title Infusion equipment for medical use: Part 1: Infusion glass bottles (DIN EN ISO) Part 2: Closures for infusion bottles (DIN EN ISO) Part 3: Aluminium caps for infusion bottles (DIN EN ISO) Part 4: Infusion sets for single use, gravity feed (DIN EN ISO) Part 5: Burette infusion sets for
8、 single use, gravity feed (DIN EN ISO) Part 6: Freeze drying closures for infusion bottles (DIN ISO) Part 7: Caps made of aluminium-plastics combinations for infusion bottles (DIN ISO) Part 8: Infusion equipment for use with pressure infusion apparatus (DIN EN ISO) Part 9: Fluid lines for use with p
9、ressure infusion equipment (DIN EN ISO) Part 10: Accessories for fluid lines for use with pressure infusion equipment (DIN EN ISO) Part 11: Infusion filters for use with pressure infusion equipment (DIN EN ISO) Part 12: Check valves (DIN ISO) Part 13: Clamps, restrictors and flow regulators for tran
10、sfusion and infusion sets (DIN EN ISO) (in preparation) The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 8536-4 DIN EN ISO 8536-4 Amendments This standard differs from DIN EN ISO 8536-5:2012-01 as follows: a) Annex ZA (informative) has been
11、 updated. Previous editions DIN 58362-6: 1994-04 DIN ISO 8536-5: 2006-04 DIN EN ISO 8536-5: 2012-01 DIN EN ISO 8536-5:2013-10 DIN EN ISO 8536-5:2013-10 3 National Annex NA (informative) Bibliography DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity f
12、eed DIN EN ISO 8536-5:2013-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE 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 (I
13、SO 8536-5:2004) Matriel de perfusion usage mdical - Partie 5: Appareils non rutilisables de perfusion burette, alimentation par gravit (ISO 8536-5:2004) Infusionsgerte zur medizinischen Verwendung - Teil 5: Infusionsgerte mit Dosierbehlter fr Schwerkraftinfusionen zur einmaligen Verwendung This Euro
14、pean Standard was approved by CEN on 8 January 2013. 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 any alteration. Up-to-date lists and bibliographical references co
15、ncerning 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 language made by translation under the responsibility of a CEN member
16、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, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France
17、, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMI
18、TEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-5:2013: E(ISO 8536-5:2004) Contents Page Foreword . 3 1 Scope . 4 2 Normative references. 4 3 General
19、 requirements 4 4 Designation . 6 5 Materials 6 6 Physical requirements . 6 6.1 General 6 6.2 Design . 6 6.3 Volume of burette . 6 6.4 Graduated scale . 6 7 Chemical requirements . 8 8 Biological requirements 8 9 Labelling 8 10 Packaging . 8 Annex ZA (informative) Relationship between this European
20、Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 9 2DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E) The text of ISO 8536-5:2004 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and
21、pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-5:2013 by Technical Committee 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 standar
22、d, either by publication of an identical text or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn at the latest by August 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN
23、 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 the European Free Trade Association, and supports essential requiremen
24、ts 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 countries are bound to implement this European Standard: Austria, Bel
25、gium, 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, Slovenia, Spain, Sweden, Switz
26、erland, 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. Foreword3DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E)1 Scope This part of ISO 8536 specifies requirements for types of single-use, gravity
27、 feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal 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
28、 materials used in infusion sets. NOTE In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 2 Normative references The following referenced documents are indispensable for the application of this document. For dat
29、ed 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 feed 3 General requirements 3.1 The nomenclature to be
30、 used for components of burette infusion sets is given in Figure 1. Figure 1 illustrate examples of the configuration of burette infusion sets; other configurations may be used provided they lead to the same results. 3.2 The burette infusion set shall be provided with protective caps to maintain ste
31、rility of the internal parts of the set until the set is used. 3.3 If a separate air-inlet device is used, it shall comply with ISO 8536-4. 4DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E) Key 1 protective cap of the closure-piercing device 9 drip tube 2 closure-piercing device a10 fluid filterc3 ON
32、/OFF clamp 11 tubing 4 tubing 12 flow regulator 5 injection site b13 injection site b6 air inlet with air filter and closure 14 male conical fitting 7 graduated burette 15 protective cap of the conical fitting 8 shut-off valve aAir inlet with air filter is optional; if an air filter exists, a closur
33、e is optional. bInjection site is optional. cThe fluid filter may be positioned at other sites, for example preferably near the patient access. Generally a fluid filter has a nominal pore size of 15 m. Figure 1 Example of a burette set 5DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E)4 Designation Th
34、e designation of a burette infusion set (BS), gravity feed (G), which complies with this part of ISO 8536 shall include the indication of burette set, a reference to this part of ISO 8536, the nominal capacity in millilitres (e.g. 100 ml) and the indication of gravity feed, as follows: Burette set I
35、SO 8536-5 BS 100 G 5 Materials The materials 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 into contact with solutions, the materials additionally shall co
36、mply with the requirements specified in Clauses 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. In addition, the burette set shall comply with the requirements in 6.2 to 6.4. 6.2 Design 6.2.1 Th
37、e burette shall consist of a tube of rigid or semi-rigid plastics material and shall permit observation of fluid in the chamber. 6.2.2 The burette shall be provided with filtered air-venting capability located in a position above the top graduation mark. 6.2.3 The burette shall be capable of receivi
38、ng fluid from the main container and of being closed off and serving as a separate self-vented reservoir. 6.3 Volume of burette The nominal volume of the burette shall be designated by the total graduated capacity. 6.4 Graduated scale 6.4.1 The burette scale shall be graduated at intervals as given
39、in Table 1. Table 1 Volume and scale intervals for burettes Scale intervals Numbered scale intervals Nominal volume of burette max. max. Tolerance on any graduated capacity exceeding half nominal volume ml ml ml % 50 1 5 50 5 10 4 6DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E) 6.4.2 The graduation
40、 lines shall be clear, legible and durable 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 optionally be joined by a line parallel to the longitudina
41、l axis of the burette (see Figure 2). 6.4.4 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 t
42、he chamber shall be located in a position which compensates for the volume displaced by any shut-off device, the position of outlet relative to the bottom of the burette or any other feature of the bottom cap which can affect the reading. Nominal volume: 50 ml 100 ml 150 ml NOTE The vertical lines a
43、re optional. Figure 2 Typical graduated scales for use in burette sets 7DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E)7 Chemical requirements The requirements of ISO 8536-4 shall apply. 8 Biological requirements The requirements of ISO 8536-4 shall apply. 9 Labelling The requirements of ISO 8536-4
44、shall apply. 10 Packaging The requirements of ISO 8536-4 shall apply. 8DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E) 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 prepar
45、ed under a mandate 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 Union under th
46、at 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 ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Dire
47、ctive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(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 th
48、e Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses 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. 3.3, 6.2.2, 6.2.3 7.6 3.2 8.1 10
49、 8.3 8 8.4 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 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 9DIN EN ISO 8536-5:2013-10EN ISO 8536-5:2013 (E)Clause(s)/subclause(s
