1、BSI Standards PublicationBS EN ISO 8536-11:2015Infusion equipment for medicalusePart 11: Infusion filters for single use withpressure infusion equipmentBS EN ISO 8536-11:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8536-11:2015. It supersedes BS EN IS
2、O 8536-11:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a con
3、tract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83295 6ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the auth
4、ority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-11 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-11:2004English Version Infusion equipment for medical use - Part 11
5、: Infusion filters for single use with pressure infusion 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
6、 zur einmaligen Verwendung mit Druckinfusionsapparaten (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 s
7、tandard without any alteration. Up-to-date lists and 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 i
8、n 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 has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
9、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, Switzerland, Turkey and United Kingdom. EURO
10、PEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION 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
11、 EBS EN ISO 8536-11:2015EN ISO 8536-11:2015 (E) 3 European foreword This document (EN ISO 8536-11:2015) has been prepared 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-acti
12、ve medical devices” the secretariat of which is held by DIN. This European Standard shall 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 D
13、ecember 2015. Attention is drawn to the possibility that some of the elements of this document 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 8536-11:2004. The former Clause 3 on des
14、ignation has been deleted; 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/or mal
15、e conical fittings has been deleted; Normative references and 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 requirements of
16、 EU Directive(s). For relationship with EU Directive(s), 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, Be
17、lgium, 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, Swit
18、zerland, Turkey and the United Kingdom. BS EN ISO 8536-11:2015EN ISO 8536-11:2015 (E) 4 Endorsement notice The text 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 Nor
19、mative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 594-2 - ISO 594-2:1998 ISO 7000 - ISO 7000:2014 ISO 8536-8 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 BS EN ISO 8536-
20、11:2015EN ISO 8536-11:2015 (E) 5 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 prepared under a mandate given to CEN by the European Commission and the European Free Trade
21、 Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Membe
22、r 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 Directive and associated EFTA regulations. Table ZA.1 Correspondence between this Euro
23、pean 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 Clause 3, Clause 4, 5.1, 5.2, 5.3, 5.4, 5.5 7.2 The part of ER 7.2 relating to packaging is not addressed. For packaging see Clause
24、8 of this standard. Clause 4, Clause 7 7.3 ER covered by biological evaluation. 5.3, 5.4, A.3, A.4 7.5 Only the first sentence is covered. Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the ISO
25、 10993- series of standards. 5.2, 5.3 7.6 5.2, 5.3, 5.4 8.1 The part of ER 8.1 relating to handling is not addressed. Manufacturing processes are not covered. Only sterility of products is covered. 8.3 7.1 8.4 Only the sterilisation method is covered. 5.2 8.5 9.2, 9.3 8.7 5.5, 9.2 g) 9.1 The second
26、sentence of ER 9.1 is not addressed. Clause 3, Clause 4 9.2 5.3, A.3 12.7.1 Only tensile strength is addressed. BS EN ISO 8536-11:2015EN ISO 8536-11:2015 (E) 6 Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes Clause 9 13.1 9.2 d), e), f),
27、 g), 9.3 c), d) 13.2 9.2, 9.3 13.3 The part of 13.3 a) relating to the authorized representative is not addressed. Presumption of conformity to the rest of 13.3 a) is only provided if the name and address of the manufacturer are given. 13.3 d) is only covered if the batch number is preceded by the w
28、ord LOT. 13.3 g), h) is not addressed in the standard. 9.2, 9.3 13.4 13.4 is addressed regarding to the label. 9.2, 9.3 13.5 13.5 is not addressed regarding to the detachable components. 9.2, 9.3 13.6 13.6 e), f), h), i), j), l), m), o) are not applicable for devices according to this standard. 13.6
29、 q) is not addressed. WARNING Other requirements and other EC Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 8536-11:2015ISO 8536-11:2015(E)Foreword iv1 Scope . 12 Normative references 13 Design 14 Materials . 15 Physical requirements 15.1 Transpa
30、rency 15.2 Particulate contamination . 25.3 Tensile strength 25.4 Leakage 25.5 Adapters with female and/or male conical fittings . 25.6 Protective caps 26 Chemical requirements . 27 Biological requirements . 27.1 Sterility 27.2 Pyrogens . 27.3 Haemolysis . 28 Packaging . 29 Labelling 39.1 General .
31、39.2 Label on unit container 39.3 Label on shelf or multi-unit container 310 Disposal 4Annex A (normative) Physical tests . 5Annex B (normative) Chemical tests 6Annex C (normative) Biological tests . 7Bibliography 8 ISO 2015 All rights reserved iiiContents PageBS EN ISO 8536-11:2015ISO 8536-11:2015(
32、E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a
33、technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matter
34、s of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This docum
35、ent was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention 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 suc
36、h patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does
37、 not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informat
38、ion.The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 8536-11:2004), which has been technically revised with the following ch
39、anges: 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 “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 o
40、f adapters with female and/or male conical fittings has been deleted; Normative references and Bibliography have been updated; document has been editorially revised.ISO 8536 consists of the following parts under the general title Infusion equipment for medical use: Part 1: Infusion glass bottles Par
41、t 2: Closures for infusion bottles 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 bottlesiv ISO 2015 All rights reservedBS EN ISO 8536-11:2015ISO 853
42、6-11:2015(E) Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion sets for single use with pressure infusion apparatus Part 9: Fluid lines for single use with pressure infusion equipment Part 10: Accessories for fluid lines for single use with pressure infusion
43、equipment Part 11: Infusion filters for single use with pressure infusion equipment Part 12: Check valvesThe following parts are under preparation: Part 13: Graduated flow regulators for single use with infusion sets Part 14: Clamps and flow regulators for transfusion and infusion equipment without
44、fluid contact ISO 2015 All rights reserved vBS EN ISO 8536-11:2015BS EN ISO 8536-11:2015Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment1 ScopeThis part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2
45、 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 and take precedence o
46、ver 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 of the referenced docu
47、ment (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 medical use Part 4: Inf
48、usion 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: General requirements3 Design
49、The 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, 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.INTERNATIONAL STAND
