DIN EN ISO 8536-9-2015 Infusion equipment for medical use - Part 9 Fluid lines for single use with pressure infusion equipment (ISO 8536-9 2015) German version EN ISO 8536-9 2015《医.pdf

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1、November 2015 English price group 12No 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!%GNF“2364335www.din.d

2、eDIN EN ISO 8536-9Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015);English version EN ISO 8536-9:2015,English translation of DIN EN ISO 8536-9:2015-11Infusionsgerte zur medizinischen Verwendung Teil 9: bertragungsleitungen zur e

3、inmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015);Englische Fassung EN ISO 8536-9:2015,Englische bersetzung von DIN EN ISO 8536-9:2015-11Matriel de perfusion usage mdical Partie 9: Tubulures non rutilisables avec des appareils de perfusion sous pression (ISO 8536-9:2015);Version ang

4、laise EN ISO 8536-9:2015,Traduction anglaise de DIN EN ISO 8536-9:2015-11SupersedesDIN EN ISO 8536-9:2005-03www.beuth.deDocument comprises 21 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.10.15 DIN EN ISO 8536-9:2015-11 2 A c

5、omma is used as the decimal marker. National foreword This document (EN ISO 8536-9:2015) 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 Techn

6、ical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und -gerte aus Kunst

7、stoffen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 594-2 DIN EN 1707 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 8536-4 DIN EN ISO 8536-4 ISO 8536-8 DIN EN ISO 8536-8 ISO 8536-10 DIN EN ISO 8536-10 ISO 8536-11 DIN EN ISO 85

8、36-11 ISO 10993-4 DIN EN ISO 10993-4 ISO 11135 DIN EN ISO 11135 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665-1 DIN EN ISO 17665-1 EN ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: null Pa

9、rt 1: Infusion glass bottles (DIN EN ISO) null Part 2: Closures for infusion bottles (DIN EN ISO) null Part 3: Aluminium caps for infusion bottles (DIN EN ISO) null Part 4: Infusion sets for single use, gravity feed (DIN EN ISO) null Part 5: Burette infusion sets for single use, gravity feed (DIN EN

10、 ISO) null Part 6: Freeze drying closures for infusion bottles (DIN ISO) null Part 7: Caps made of aluminium-plastics combinations for infusion bottles (DIN ISO) null Part 8: Infusion sets for use with pressure infusion apparatus (DIN EN ISO) null Part 9: Fluid lines for use with pressure infusion e

11、quipment (DIN EN ISO) null Part 10: Accessories for fluid lines for single use with pressure infusion equipment (DIN EN ISO) null Part 11: Infusion filters for use with pressure infusion equipment (DIN EN ISO) null Part 12: Check valves (DIN ISO) DIN EN ISO 8536-9:2015-11 3 The following parts are u

12、nder preparation: null Part 13: Graduated flow regulators for single use with fluid contact (DIN EN ISO) null Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (DIN EN ISO) Amendments This standard differs from DIN EN ISO 8536-9:2005-03 as follows: a) f

13、ormer Clause 3 “Designation” has been deleted; b) 5.8 has been amended and an appropriate Annex C “Storage volume” added; c) Clause 9 on labelling has been amended by a note regarding the usage of the symbol “XXX” according to ISO 7000-2725; d) Clause 10 on disposal has been added; e) A.4 “Tests for

14、 leakage” has been amended; f) the former A.5 specifying a leakage test of adapters with female and/or male conical fittings has been deleted; g) normative references and the Bibliography have been updated; h) the standard has been editorially revised. Previous editions DIN 58362-3: 1989-10, 1994-04

15、 DIN EN ISO 8536-9: 2005-03 DIN EN ISO 8536-9:2015-11 4 National Annex NA (informative) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings DIN EN ISO 7864, Sterile hypodermic needles for single use DIN EN ISO 853

16、6-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed DIN EN ISO 8536-8, Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion equipment DIN EN ISO 8536-10, Infusion equipment for medical use Part 10: Accessories for fluid

17、 lines for single use with pressure infusion equipment DIN EN ISO 8536-11, Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment DIN EN ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

18、DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation

19、and routine control of a sterilization process for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be suppli

20、ed Part 1: General requirements DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN ST

21、ANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-9 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-9:2004 English Version Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) Matriel de perfusion usage mdical - Partie 9: Tubulure

22、s non rutilisables avec des appareils de perfusion sous pression (ISO 8536-9:2015) Infusionsgerte zur medizinischen Verwendung - Teil 9: bertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015) This European Standard was approved by CEN on 16 April 2015. CEN membe

23、rs 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 concerning such national standards may be obtained on applicatio

24、n 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 into its own language and notified to the CEN-CENELEC Manageme

25、nt 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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, L

26、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T EUR O P EN D E NOR M A L I S ATI O N EUR O P I S C HES KOM I T E E F R NOR M UNG CEN-CENELEC Manage

27、ment Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-9:2015 E European foreword .31 Scope . 52 Normative references 53 Termes and definitions 54 Materials . 65 Physical requir

28、ements 75.1 Transparency 75.2 Particulate contamination . 75.3 Tensile strength 75.4 Leakage 75.5 Adapters with female and/or male conical fittings . 75.6 Accessories . 75.7 Filters 75.8 Storage volume . 75.9 Injection needles . 75.10 Protective caps 76 Chemical requirements . 87 Biological requirem

29、ents . 87.1 Sterility 87.2 Pyrogens . 87.3 Haemolysis . 88 Packaging . 89 Labelling 89.1 General . 89.2 Label on unit container 89.3 Label on shelf or multi-unit container 910 Disposal 9Annex A (normative) Physical tests 10Annex B (normative) Chemical tests . 11Annex C (normative) Storage volume . 1

30、2Bibliography .17Contents PageAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on medical devices 15DIN EN ISO 8536-9:2015-11 EN ISO 8536-9:2015 (E)2 European foreword This document (EN ISO 8536-9:2015) has been prepared by T

31、echnical 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 European Standard shall be given the s

32、tatus of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some of the elements of this document may be th

33、e subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-9:2004. In this edition, the following changes have been made: the former Clause 3 on designation has been deleted; 5.8 has been amended an

34、d an appropriate Annex C added; Clause 9 on labelling was amended by addition of information regarding the usage of the symbol “XXX” according ISO 7000, Symbol 2725; Clause 10 on disposal has been added; A.4 has been amended; the former A.5 specifying a test for leakage of adapters with female and/o

35、r male conical fittings has been deleted; normative references and the Bibliography have been updated; document has been editorially revised This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require

36、ments of EU Directive(s). 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: Austri

37、a, 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, Slovenia, Spain, Sweden,

38、 Switzerland, Turkey and the United Kingdom. DIN EN ISO 8536-9:2015-11 EN ISO 8536-9:2015 (E)3 Endorsement notice The text of ISO 8536-9:2015 has been approved by CEN as EN ISO 8536-9:2015 without any modification. Table Correlations between undated normative references and dated EN and ISO standard

39、s Normative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 594-2 ISO 594-2:1998 ISO 7000 ISO 7000:2014 ISO 7864 EN ISO 7864:1995 ISO 7864:1993 ISO 8536-10 EN ISO 8536-10:2015 ISO 8536-10:2015 ISO 8536-11 EN ISO 8536-11:2015 ISO 8536-11:2015 ISO 10993-4 EN ISO 10993-4:2009 ISO

40、10993-4:2002 plus Amd.1:2006 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 DIN EN ISO 8536-9:2015-11 EN ISO 8536-9:2015 (E)4 1 ScopeThis part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).The following item

41、s are covered by this part of ISO 8536:a) syringe pump lines (SPL);b) connecting lines (CL);c) lines with integrated injection cannula (LIC).In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 Normative refe

42、rencesThe 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 document (including any amendments) applies.IS

43、O 594-2,1)Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittingsISO 7000, Graphical symbols for use on equipment Registered symbolsISO 7864, Sterile hypodermic needles for single useISO 8536-4:2010, Infusion equipment for medical use Pa

44、rt 4: Infusion sets for single use, gravity feedISO 8536-10, Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipmentISO 8536-11, Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipmen

45、tISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with bloodISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Termes and definitionsFor the purposes of th

46、is document, the following terms and definitions apply.NOTE These terms and definitions are specifically applicable to Annex C.1) To be replaced by ISO 80369-7.DIN EN ISO 8536-9:2015-11 EN ISO 8536-9:2015 (E)5 3.1filling volumeVFvolume of tube during pressure less“-filling respectively filling by gr

47、avity, the tube remains unstressedNote 1 to entry: The filling volume is to be equated with the calculated volume of the tube.3.2storage volumeVStube volume during pressurization equal to filling volume (VF) plus bolus volume (VS):VVVSFB=+3.3bolus volumeVBincreased tube volume during pressurization

48、(storage volume VS) in comparison to the unstressed tube (filling volume VF)Note 1 to entry: For illustration of the bolus volume see Figure 1.Key1 patient2 occlusion3 tube4 bolus volume5 syringe pumpFigure 1 Bolus volume4 MaterialsThe materials from which the fluid lines are manufactured shall comply with the requirements as specified in Clause 5, Clause 6, and Clause