DIN EN ISO 8536-8-2015 Infusion equipment for medical use - Part 8 Infusion sets for single use with pressure infusion apparatus (ISO 8536-8 2015) German version EN ISO 8536-8 2015.pdf

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!%GNE“2364334www.din.d

2、eDIN EN ISO 8536-8Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015);English version EN ISO 8536-8:2015,English translation of DIN EN ISO 8536-8:2015-11Infusionsgerte zur medizinischen Verwendung Teil 8: Infusionsgerte zur einma

3、ligen Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015);Englische Fassung EN ISO 8536-8:2015,Englische bersetzung von DIN EN ISO 8536-8:2015-11Matriel de perfusion usage mdical Partie 8: Appareils de perfusion non rutilisables avec des appareils de perfusion sous pression (ISO 8536-8:2015);Ve

4、rsion anglaise EN ISO 8536-8:2015,Traduction anglaise de DIN EN ISO 8536-8:2015-11SupersedesDIN EN ISO 8536-8:2005-02www.beuth.deDocument comprises 23 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.15DIN EN ISO 8536-8:2015-

5、11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8536-8:2015) 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 wi

6、th Technical 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 a

7、us Kunststoffen. 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 8536-4 DIN EN ISO 8536-4 ISO 8536-9 DIN EN ISO 8536-9 ISO 10993-4 DIN EN ISO 10993-4 ISO 11135 DIN EN ISO 11135 ISO 11137-1 DIN

8、 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 Part 1: Infusion glass bottles (DIN EN ISO) null Part 2: Closures for infusion bo

9、ttles (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 ISO) null Part 6: Freeze drying closures for infusion bottles (DIN ISO) null P

10、art 7: Caps made of aluminium-plastics combinations for infusion bottles (DIN ISO) null Part 8: Infusion sets for single use with pressure infusion apparatus (DIN EN ISO) null Part 9: Fluid lines for single use with pressure infusion equipment (DIN EN ISO) null Part 10: Accessories for fluid lines f

11、or single use with pressure infusion equipment (DIN EN ISO) null Part 11: Infusion filters for single use with pressure infusion equipment (DIN EN ISO) null Part 12: Check valves (DIN ISO) The following parts are under preparation: null Part 13: Graduated flow regulators for single use with fluid co

12、ntact (DIN EN ISO) null Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (DIN EN ISO) DIN EN ISO 8536-8:2015-11 3 Amendments This standard differs from DIN EN ISO 8536-8:2005-02 as follows: a) the English title of this part has been changed from “infus

13、ion equipment” to “infusion sets”; b) former Clause 4 “Designation” has been deleted; c) 6.14 has been amended and an appropriate Annex B “Storage volume” added; d) Clause 10 on labelling has been amended by a note regarding the usage of the symbol “XXX” according to ISO 7000-2725; e) Clause 11 on d

14、isposal has been added; f) A.3 “Tests for leakage” has been amended; g) the former A.4 specifying a leakage test of male conical fittings has been deleted; h) normative references and the Bibliography have been updated; i) the standard has been editorially revised. Previous editions DIN 58362-2: 198

15、9-10, 1994-04 DIN EN ISO 8536-8: 2005-02 DIN EN ISO 8536-8:2015-11 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 8536-4, Infusion equipment for medical use Part 4

16、: Infusion sets for single use, gravity feed DIN EN ISO 8536-9, Infusion equipment for medical use Part 9: Fluid lines 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 DIN EN ISO 11135,

17、 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 and routine contr

18、ol 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 supplied Part 1: Genera

19、l 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 STANDARD NORME EURO

20、PENNE EUROPISCHE NORM EN ISO 8536-8 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-8:2004 English Version Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) Matriel de perfusion usage mdical - Partie 8: Appareils de perfusion

21、non rutilisables avec des appareils de perfusion sous pression (ISO 8536-8:2015) Infusionsgerte zur medizinischen Verwendung - Teil 8: Infusionsgerte zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015) This European Standard was approved by CEN on 16 April 2015. CEN members are b

22、ound 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

23、 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 Management Centr

24、e 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, Lithuania

25、, 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 KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000

26、 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-8:2015 E European foreword .31 Scope . 52 Normative references 53 Terms and definitions . 54 General requirements . 65 Materials . 96 Physical requirements 96.

27、1 Particulate contamination . 96.2 Tensile strength 96.3 Leakage 96.4 Male conical fitting . 106.5 Injection site . 106.6 Fluid filter . 106.7 Flow rate of infusion fluid 106.8 Closure-piercing device 106.9 Air-inlet device . 106.10 Drip chamber and drip tube . 106.11 Tubing 106.12 Flow regulator 10

28、6.13 Protective caps . 106.14 Storage volume 107 Chemical requirements 108 Biological requirements 109 Packaging 1110 Labelling . 1110.1 General 1110.2 Label on unit container . 1110.3 Label on shelf or multi-unit container . 1111 Disposal . 12Annex A (normative) Physical tests . 13Annex B (normativ

29、e) Storage volume14Bibliography .19Contents PageAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on medical devices 172 EN ISO 8536-8:2015 (E)DIN EN ISO 8536-8:2015-11European foreword This document (EN ISO 8536-8:2015) has b

30、een 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” the secretariat of which is held by DIN. This European Standard sha

31、ll be given the status 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 d

32、ocument 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 supersedes EN ISO 8536-8:2004. In this edition the following changes have been made: the part title has been changed from Infusion equipment to I

33、nfusion sets ; the former Clause 4 on designation has been deleted; 6.14 has been amended and an appropriate Annex B Storage volume added; Clause 10 on labelling was amended by a note regarding the usage of the symbol “XXX” according ISO 7000-2725; Clause 11 on disposal has been added; A.3 Tests for

34、 leakage has been amended; the former A.4 specifying a test of male conical fitting for leakage 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 Commissio

35、n and the European 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 fol

36、lowing 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, Lithuania, Luxembourg, Malta, Netherlands,

37、 Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. 3EN ISO 8536-8:2015 (E)DIN EN ISO 8536-8:2015-11Endorsement notice The text of ISO 8536-8:2015 has been approved by CEN as EN ISO 8536-8:2015 without any modification. Table Correlation

38、s between undated normative references and dated EN and ISO standards 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 8536-4 EN ISO 8536-4:2013 and EN ISO 8536-4:2013/A1:2013 ISO 8536-4:2010 and Amd.1:2013 ISO 15223-1 EN

39、 ISO 15223-1:2012 ISO 15223-1:2012 4 EN ISO 8536-8:2015 (E)DIN EN ISO 8536-8:2015-111 ScopeThis part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).In some countries, the national pharmacopoeia or oth

40、er 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 are indispensable for its application. For dated references, only the edition cited applies.

41、For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 594-21), 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 symb

42、olsISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feedISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this documen

43、t, the following terms and definitions apply.NOTE These terms and definitions are specifically applicable to Annex B.3.1filling volumeVFvolume of tube during pressure less“-filling respectively filling by gravity, the tube remains unstressedNote 1 to entry: The filling volume is to be equated with t

44、he calculated volume of the tube.3.2storage volumeVStube volume during pressurization equal to filling volume (VF) plus bolus volume (VS)VVVSFB=+1) To be replaced by ISO 80369-7.N1): N1) National footnote. In the English-language ISO Standard, the unit for the bolus volume is incorrectly given as (V

45、S). It should read (VB). 5EN ISO 8536-8:2015 (E)DIN EN ISO 8536-8:2015-113.3bolus volumeVBincreased tube volume during pressurization (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 patient 4 bolus vo

46、lume2 occlusion 5 syringe pump3 tubeFigure 1 Bolus volume4 General requirements4.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 2, 3, and 4. These figures illustrate examples of the configuration of infusion sets and air-inlet dev

47、ices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 3 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 3 used with separate air-inlet devices as illustrated in Figure 4, or infusion sets

48、as illustrated in Figure 2 shall be used for rigid containers.6 EN ISO 8536-8:2015 (E)DIN EN ISO 8536-8:2015-11Key1 protective cap of closure-piercing device 8 tubing2 closure-piercing device 9 flow regulator3 air-inlet with air filter and closure 10 injection site4 fluid channel 11 male conical fit

49、ting5 drip tube 12 protective cap of male conical fitting6 drip chamber 13 flow element7 fluid filteraClosure of air inlet is optional.bThe fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 m.cInjection site is optional.dOptional element of infusion set which interfaces with pressure infusion apparatus.Figure 2 Example of a vented infusion set7EN ISO 8536-8:2015 (E)DIN EN ISO 8