1、November 2015 English price group 11No 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!%GNH“2364337www.din.d
2、eDIN EN ISO 8536-11Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015);English version EN ISO 8536-11:2015,English translation of DIN EN ISO 8536-11:2015-11Infusionsgerte zur medizinischen Verwendung Teil 11: Infusionsfilter
3、 zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-11:2015);Englische Fassung EN ISO 8536-11:2015,Englische bersetzung von DIN EN ISO 8536-11:2015-11Matriel de perfusion usage mdical Partie 11: Filtres perfusion non rutilisables avec un matriel de perfusion sous pression (ISO 8536-11:2
4、015);Version anglaise EN ISO 8536-11:2015,Traduction anglaise de DIN EN ISO 8536-11:2015-11SupersedesDIN EN ISO 8536-11:2005-03www.beuth.deDocument comprises pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.1811.15 DIN EN ISO 85
5、36-11:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8536-11:2015) 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 coll
6、aboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und
7、-gerte aus 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 8536-8 DIN EN ISO 8536-8 ISO 10993-4 DIN EN ISO 10993-4 ISO 11135 DIN EN ISO 11135 ISO 111
8、37-1 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: Part 1: Infusion glass bottles (DIN EN ISO) Part 2: Closures for infusion bo
9、ttles (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 single use, gravity feed (DIN EN ISO) Part 6: Freeze drying closures for infusion bottles (DIN ISO) Part 7: Caps made of alumi
10、nium-plastics combinations for infusion bottles (DIN EN ISO) Part 8: Infusion sets for single use with pressure infusion apparatus (DIN EN ISO) Part 9: Fluid lines for single use with pressure infusion equipment (DIN EN ISO) Part 10: Accessories for fluid lines for single use with pressure infusion
11、equipment (DIN EN ISO) Part 11: Infusion filters for use with pressure infusion equipment (DIN EN ISO) Part 12: Check valves (DIN ISO) DIN EN ISO 8536-11:2015-11 3 The following parts are under preparation: Part 13: Graduated flow regulators for single use with fluid contact (DIN EN ISO) Part 14: Cl
12、amps and flow regulators for transfusion and infusion equipment without fluid contact (DIN EN ISO) Amendments This standard differs from DIN EN ISO 8536-11:2005-03 as follows: a) former Clause 3 “Designation” has been deleted; b) Clause 9 on labelling has been amended by a note regarding the usage o
13、f the symbol “XXX” according to ISO 7000-2725; c) Clause 10 on disposal has been added; d) A.4 “Tests for leakage” has been amended; e) the former A.5 specifying a leakage test of adapters with female and/or male conical fittings has been deleted; f) normative references and the Bibliography have be
14、en updated; g) the standard has been editorially revised. Previous editions DIN 58362-5: 1989-10, 1994-04 DIN EN ISO 8536-11: 2005-03 DIN EN ISO 8536-11:2015-11 4 National Annex NA (informative) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain othe
15、r medical equipment Lock fittings DIN EN ISO 8536-4, 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 apparatus DIN EN ISO 10993-4, Biological evalua
16、tion of medical devices Part 4: Selection of tests for interactions with blood 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 h
17、ealth care products Radiation Part 1: Requirements for development, validation 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 Symbol
18、s to be used with medical device labels, labelling and information to be supplied 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
19、ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-11 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-11:2004 English Version Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infu
20、sion equipment (ISO 8536-11:2015)Matriel de perfusion usage mdical - Partie 11: Filtres perfusion non rutilisables avec un matriel de perfusion sous pression (ISO 8536-11:2015) Infusionsgerte zur medizinischen Verwendung - Teil 11: Infusionsfilter zur einmaligen Verwendung mit Druckinfusionsapparate
21、n (ISO 8536-11:2015) This European Standard was approved by CEN on 16 April 2015. 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
22、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 in any other language made by translation under the re
23、sponsibility 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 Republic, Denmark, Estonia, Finland, Former Yugoslav
24、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 and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE N
25、ORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management 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 8536-11:2015 EContents Page European foreword . 3 1 Scope 5 2 Nor
26、mative references 5 3 Design 5 4 Materials . 5 5 Physical requirements 55.1 Transparency 55.2 Particulate contamination . 6 5.3 Tensile strength . 6 5.4 Leakage . 6 5.5 Adapters with female and/or male conical fittings 6 5.6 Protective caps . 6 6 Chemical requirements . 6 7 Biological requirements .
27、 6 7.1 Sterility . 6 7.2 Pyrogens . 6 7.3 Haemolysis 6 8 Packaging . 69 Labelling . 7 9.1 General 7 9.2 Label on unit container . 7 9.3 Label on shelf or multi-unit container . 7 10 Disposal 8 Annex A (normative) Physical tests . 9 Annex B (normative) Chemical tests 10 Annex C (normative) Biological
28、 tests . 11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices 12 Bibliography . 14 2 DIN EN ISO 8536-11:2015-11 EN ISO 8536-11:2015 (E) European foreword This document (EN ISO 8536-11:2015) has been prepared
29、 by Technical Committee ISO/TC 76 “Transfusion, infusion and injection 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 status of a nation
30、al 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 the subject of pate
31、nt rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-11:2004. The former Clause 3 on designation has been deleted; Clause 9 on labelling was amended by addition of information regarding the usage of the symbol
32、 “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/or male conical fittings has been deleted; Normative references and Bibliography have been updated; document has been editorial
33、ly 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 requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this docu
34、ment. According to the CEN-CENELEC Internal Regulations, the national 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, Franc
35、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. 3 DIN EN ISO 8536-11:2015-11 EN ISO 8536-11:2015 (E) Endorsement notice The text
36、of ISO 8536-11:2015 has been approved by CEN as EN ISO 8536-11:2015 without any modification. Table Correlations 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:
37、2014 ISO 8536-8 EN ISO 8536-8:2015 ISO 8536-8:2015 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus Amd.1:2006 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 4 DIN EN ISO 8536-11:2015-11 EN ISO 8536-11:2015 (E) 1 ScopeThis part of ISO 8536 applies to sterilized infusion filters for single use
38、 used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.In some countries, the national pharmacopoeia or other national regulations are legally binding
39、 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. For undated references, the latest edition
40、of the referenced document (including any amendments) applies.ISO 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 8536-4:2010, Infusion equipment for m
41、edical use Part 4: Infusion sets for single use, gravity feedISO 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: Genera
42、l requirements3 DesignThe infusion filter housing shall be provided with a venting system to anticipate the blocking of the filter by the accumulation of air bubbles.4 MaterialsThe materials from which the infusion filters are manufactured shall comply with the requirements as specified in Clause 5,
43、 Clause 6, and Clause 7.5 Physical requirements5.1 TransparencyThe filter housing shall be transparent. When tested as specified in A.1, the air-water interface shall be detectable.1) To be replaced by ISO 80369-7.5 DIN EN ISO 8536-11:2015-11 EN ISO 8536-11:2015 (E) 5.2 Particulate contaminationThe
44、infusion filters shall be manufactured under conditions that minimize particulate contamination. The inner surfaces shall be smooth and clean. When tested as specified in A.2, the number of particles shall not exceed the contamination index.5.3 Tensile strengthWhen tested as specified in A.3, the in
45、fusion filters shall withstand a static longitudinal tensile force of not less than 15 N for 15 s.5.4 LeakageThe filter housing shall be impermeable to microorganisms and fluids. The filter membrane, as well as its connection to the housing, shall not burst. When tested as specified in A.4, there sh
46、all be no leakage of air or water.5.5 Adapters with female and/or male conical fittingsAdapters shall be provided with a connector with female conical fitting and/or a connector with male conical fitting according to ISO 594-2.5.6 Protective capsISO 8536-4 applies.6 Chemical requirementsISO 8536-4 a
47、pplies. For test methods, see Annex B.7 Biological requirements7.1 SterilityThe infusion filters in their unit container shall have been subjected to a validated sterilization process (see Reference 2 to Reference 5).7.2 PyrogensThe infusion filters shall be assessed for freedom from pyrogens using
48、a suitable test and the results shall indicate that the infusion filters are free from pyrogens. Guidance on testing for pyrogenicity is given in ISO 8536-4.7.3 HaemolysisThe infusion filters shall be assessed for freedom from haemolytic constituents and the result shall indicate that the infusion f
49、ilters are free from haemolytic reactions.Guidance on testing for haemolytic constituents is given in ISO 10993-4.8 PackagingISO 8536-4 applies.6 DIN EN ISO 8536-11:2015-11 EN ISO 8536-11:2015 (E) 9 Labelling9.1 GeneralThe labelling shall include the requirements as specified in 9.2 and 9.3. If graphical symbols are used, refer to ISO 15223-1.NOTE The presence of substances
