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!%GNG“2364336www.din.d
2、eDIN EN ISO 8536-10Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015);English version EN ISO 8536-10:2015,English translation of DIN EN ISO 8536-10:2015-11Infusionsgerte zur medizinischen Verwendung Teil 10: Zube
3、hrteile fr bertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2015);Englische Fassung EN ISO 8536-10:2015,Englische bersetzung von DIN EN ISO 8536-10:2015-11Matriel de perfusion usage mdical Partie 10: Accessoires pour tubulures non rutilisables avec un matriel d
4、e perfusion sous pression (ISO 8536-10:2015);Version anglaise EN ISO 8536-10:2015,Traduction anglaise de DIN EN ISO 8536-10:2015-11SupersedesDIN EN ISO 8536-10:2005-03www.beuth.deDocument comprises pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be consid
5、ered authoritative.1811.15 DIN EN ISO 8536-10:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8536-10:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
6、use” (Secretariat: DIN, Germany) in collaboration 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 A
7、A Transfusions-/Infusionsbehltnisse und -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 8536-12 DIN ISO 8536-
8、12 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: Part 1:
9、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 single use, gravity feed (DIN EN ISO) Part 6: Freeze dryin
10、g closures for infusion bottles (DIN EN ISO) Part 7: Caps made of aluminium-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
11、 10: Accessories for fluid lines for single use with pressure infusion equipment (DIN EN ISO) Part 11: Infusion filters for single use with pressure infusion equipment (DIN EN ISO) Part 12: Check valves (DIN ISO) DIN EN ISO 8536-10:2015-11 3 The following parts are under preparation: Part 13: Gradua
12、ted flow regulators for single use with fluid contact (DIN EN ISO) 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 8536-10:2005-03 as follows: a) former Clause 3 “Designation” has been dele
13、ted; b) Clause 8 on labelling was amended by a note regarding the usage of the symbol “XXX” according to ISO 7000-2725; c) Clause 9 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 fitting
14、s has been deleted; f) normative references and the Bibliography have been updated; g) the standard has been editorially revised. Previous editions DIN 58362-4: 1989-10, 1994-04 DIN EN ISO 8536-10: 2005-03 DIN EN ISO 8536-10:2015-11 4 National Annex NA (informative) Bibliography DIN EN 1707, Conical
15、 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: Infusion sets for single use, gravity feed DIN EN ISO 8536-8, Infusion equipment for medical use Part 8: Infusion sets for single us
16、e with pressure infusion apparatus DIN EN ISO 10993-4, Biological evaluation 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 steriliz
17、ation process for medical devices DIN EN ISO 11137-1, Sterilization of health 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: Establ
18、ishing 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: General requirements DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation
19、 and routine control of a sterilization process for medical devices DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 8536-12, Infusion equipment for medical use Part 12: Check valves EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-10 June 2015 ICS 11.0
20、40.20 Supersedes EN ISO 8536-10:2004 English Version Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) Matriel de perfusion usage mdical - Partie 10: Accessoires pour tubulures non rutilisables avec un matriel
21、 de perfusion sous pression (ISO 8536-10:2015) Infusionsgerte zur medizinischen Verwendung - Teil 10: Zubehrteile fr bertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2015) This European Standard was approved by CEN on 16 April 2015. CEN members are bound to com
22、ply 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 CEN-CENELE
23、C 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 Centre has the s
24、ame 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, Luxembour
25、g, 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 Brussels 2
26、015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-10:2015 EContents Page European foreword 3 1 Scope 5 2 Normative references . 5 3 Materials . 6 4 Physical requirements 6 4.1 Avoidance of air bubbles 6 4.2 Particulate c
27、ontamination 6 4.3 Tensile strength 6 4.4 Leakage 6 4.5 Adapters with female and/or male conical fittings . 6 4.6 Protective caps 6 4.7 Manipulation of stopcocks 6 4.8 Unit with injection site . 6 4.9 Unit with check valve 6 5 Chemical requirements 7 6 Biological requirements 7 6.1 Sterility 7 6.2 P
28、yrogens 7 6.3 Haemolysis . 7 7 Packaging 7 8 Labelling 7 8.1 General 7 8.2 Label on unit container 7 8.3 Label on shelf or multi-unit container . 8 9 Disposal . 8 Annex A (normative) Physical tests . 9 Annex B (normative) Chemical tests . 10 Annex C (normative) Biological tests 11 Annex ZA (informat
29、ive) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices 12 Bibliography . 14 EN ISO 8536-10:2015 (E) 2 DIN EN ISO 8536-10:2015-11 EN ISO 8536-10:2015 (E) 3 European foreword This document (EN ISO 8536-10:2015) has been prepared by
30、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 national s
31、tandard, 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 patent r
32、ights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-10:2004. In this edition the following changes have been made: the former Clause 3 on designation has been deleted; Clause 8 on labelling was amended by a note
33、regarding the usa ge of the symbol “XXX” according ISO 7000-2725; Clause 9 on disposal has been added; A.4 Tests for leakage has been amended; The former A.5 specifyin a test for leakage of adapters with female and/or male conical fittings has been deleted; Normative references and the Bibliography
34、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 EU Directive(s). For relationship with EU Directive(s), see informative An
35、nex 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland
36、, 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 the United Kingdom. DIN EN ISO 8536-10:2015-11Endorseme
37、nt notice The text of ISO 8536-10:2015 has been approved by CEN as EN ISO 8536-10:2015 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
38、 ISO 7000 ISO 7000:2014 ISO 8536-4 EN ISO 8536-4:2013 and ISO 8536-4:2013/A1:2013 ISO 8536-4:2010 and Amd.1:2013 ISO 8536-8 EN ISO 8536-8:2015 ISO 8536-8:2015 ISO 8536-12 ISO 8536-12:2007 and Amd.1:2012 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus Amd.1:2006 ISO 15223-1 EN ISO 15223-1:2012
39、ISO 15223-1:2012 EN ISO 8536-10:2015 (E) 4 DIN EN ISO 8536-10:2015-11 1 ScopeThis part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.This part of ISO 8536 includes the following:a) two-way stopcocks, three-way s
40、topcocks, four-way stopcocks, and stopcocks manifold;NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock
41、 positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions.b) units with injection site or check valve;c) stoppers or adapters.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 N
42、ormative 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 document (including any amendment
43、s) 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 symbolsISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravit
44、y feedISO 8536-8, Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatusISO 8536-12, Infusion equipment for medical use Part 12: Check valvesISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with bloodI
45、SO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements1) To be replaced by ISO 80369-7.EN ISO 8536-10:2015 (E) 5 DIN EN ISO 8536-10:2015-11 3 MaterialsThe materials from which the accessories are manufactured s
46、hall comply with the requirements as specified in Clause 4, Clause 5, and Clause 6.4 Physical requirements4.1 Avoidance of air bubblesAll components of accessories shall be designed such that no air bubbles are detected in flow channels when tested as specified in A.1.4.2 Particulate contaminationTh
47、e accessories shall be manufactured under conditions that minimize particulate contamination. The fluid pathway surfaces shall be smooth and clean. When tested as specified in A.2, the number of particles shall not exceed the contamination index.4.3 Tensile strengthWhen tested as specified in A.3, t
48、he accessories and connections between components shall withstand a static tensile force of not less than 15 N for 15 s.In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position.4.4 LeakageThe accessories shall be impermeable to air, micro
49、organisms, and fluids. There shall be no leakage of air or water. Stopcocks shall be tight in any plug position. When tested as specified in A.4, there shall be no leakage of air or water.4.5 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
