1、July 2013 Translation by DIN-Sprachendienst.English price group 13No 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 1
2、1.040.20!%c“2042964www.din.deDDIN EN ISO 8536-4Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 +Amd 1:2013);English version EN ISO 8536-4:2013 + A1:2013,English translation of DIN EN ISO 8536-4:2013-07Infusionsgerte zur medizinischen Verwendung
3、Teil 4: Infusionsgerte fr Schwerkraftinfusionen zur einmaligen Verwendung(ISO 8536-4:2010 + Amd 1:2013);Englische Fassung EN ISO 8536-4:2013 + A1:2013,Englische bersetzung von DIN EN ISO 8536-4:2013-07Matriel de perfusion usage mdical Partie 4: Appareils de perfusion non rutilisables, alimentation p
4、ar gravit(ISO 8536-4:2010 + Amd 1:2013);Version anglaise EN ISO 8536-4:2013 + A1:2013,Traduction anglaise de DIN EN ISO 8536-4:2013-07SupersedesDIN EN ISO 8536-4:2011-01www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2607.13 DIN EN
5、 ISO 8536-4:2013-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8536-4:2013 + A1:2013) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” in collaboration wit
6、h Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und -gerte aus Kunstst
7、offen. This standard contains EN ISO 8536-4:2013 and Amendment A1:2013. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 291 DIN EN ISO
8、291 ISO 594-1 DIN EN 20594-1 ISO 594-2 DIN EN 1707 ISO 3696 DIN ISO 3696 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-4 DIN EN ISO 10993-2 ISO 11135 (all parts) DIN EN ISO 11135 (all parts) ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 14644-1 DIN
9、EN ISO 14644-1 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665 (all parts) DIN EN ISO 17665 (all parts) ISO 80000-4 DIN EN ISO 80000-4 DIN (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
10、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 drying closures for infusion bottles (DIN ISO) Part 7: Cap
11、s made of aluminium-plastics combinations for infusion bottles (DIN ISO) Part 8: Infusion equipment for use with pressure infusion apparatus (DIN EN ISO) Part 9: Fluid lines for use with pressure infusion equipment (DIN EN ISO) Part 10: Accessories for fluid lines for use with pressure infusion equi
12、pment (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 8536-4:2013-07 3 Amendments This standard differs from DIN EN ISO 8536-4:2011-01 as follows: a) Annex ZA has been completely revised on the basis of the Europ
13、ean Amendment A1:2013; b) Amd.1:2013 to ISO 8536-4:2010 has been incorporated, principally to be in alignment with ISO 1135-4. Subclauses 9.1, 9.2, A.2, A.6, the title of Figure A.1 and the Bibliography have been modified and a new Clause 11 “Disposal” has been included. Previous editions DIN 58362:
14、 1960x-06 DIN 58375-1: 1966-03 DIN 58375-2: 1966-03 DIN 58362-1: 1975-04, 1982-11, 1988-02, 1989-10, 1994-04 DIN EN ISO 8536-4: 2005-03, 2007-06, 2011-01 DIN EN ISO 8536-4:2013-07 4 National Annex NA (informative) Bibliography DIN EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needl
15、es and certain other medical equipment Lock fittings DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN ISO 291, Plastics Standard atmospheres for conditioning and testing DIN EN ISO 7864, Sterile hyp
16、odermic needles for single use DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-4, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood DIN EN ISO 11135 (all parts),
17、 Sterilization of health care products Ethylene oxide DIN EN ISO 11137 (all parts), Sterilization of health care products Radiation DIN EN ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness DIN EN ISO 15223-1, Medical devices Symbols to be used w
18、ith medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 17665 (all parts), Sterilization of health care products Moist heat DIN EN ISO 80000-4, Quantities and units Part 4: Mechanics DIN ISO 3696, Water for analytical laboratory use Specification a
19、nd test methods DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-4 February 2013 + A1 March 2013 ICS 11.040.20 Supersedes EN ISO 8536-4:2010English Version Infusion equipment for medical use - Part 4: Infusion sets
20、for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013) Matriel de perfusion usage mdical - Partie 4: Appareils de perfusion non rutilisables, alimentation par gravit (ISO 8536-4:2010 + Amd 1:2013) Infusionsgerte zur medizinischen Verwendung - Teil 4: Infusionsgerte fr Schwerkraftinfusionen zur
21、einmaligen Verwendung (ISO 8536-4:2010 + Amd 1:2013) EN ISO 8536-4:2013 was approved by CEN on 2013-01-08 and Amendment A1:2013 on 2013-02-09. 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 na
22、tional standard 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 v
23、ersion 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 same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus
24、, 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, Switzerland, Turkey and United Kingd
25、om. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-4:2013 + A1
26、:2013 EEN ISO 8536-4:2013 + A1:2013 (E) 2 Contents Page Foreword to ISO 8536-4:2010 3 !Foreword to EN ISO 8536-4:2013/A1:2013“ .4 1 Scope 5 2 Normative references 5 3 General requirements 5 4 Designation 8 4.1 Infusion set .8 4.2 Air-inlet device .8 5 Materials .8 6 Physical requirements 9 6.1 Parti
27、culate contamination .9 6.2 Leakage .9 6.3 Tensile strength .9 6.4 Closure-piercing device 9 6.5 Air-inlet device .9 6.6 Tubing .10 6.7 Fluid filter 10 6.8 Drip chamber and drip tube 10 6.9 Flow regulator 10 6.10 Flow rate of infusion fluid .10 6.11 Injection site .10 6.12 Male conical fitting.10 6.
28、13 Protective caps 10 7 Chemical requirements .11 7.1 Reducing (oxidizable) matter 11 7.2 Metal ions .11 7.3 Titration acidity or alkalinity .11 7.4 Residue on evaporation 11 7.5 UV absorption of extract solution 11 8 Biological requirements 11 8.1 General 11 8.2 Sterility 11 8.3 Pyrogenicity .11 8.
29、4 Haemolysis .11 8.5 Toxicity .12 9 Labelling .12 9.1 Unit container .12 9.2 Shelf or multi-unit container .12 10 Packaging .13 11 !Disposal“ .13 Annex A (normative) Physical tests 14 Annex B (normative) Chemical tests .18 Annex C (normative) Biological tests .20 Bibliography 21 Annex ZA (informativ
30、e) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 22 DIN EN ISO 8536-4:2013-07 EN ISO 8536-4:2013 + A1:2013 (E) 3Foreword to ISO 8536-4:2010 The text of ISO 8536-4:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and
31、 injection, and blood processing equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-4:2013 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This Europe
32、an Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn at the latest by August 2013. Attention is drawn to the possibility that some of the element
33、s 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 8536-4:2010. This document has been prepared under a mandate given to CEN by the European Commission and the Europea
34、n 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 following countries
35、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, Norway, Poland,
36、Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8536-4:2010 has been approved by CEN as EN ISO 8536-4:2013 without any modification. DIN EN ISO 8536-4:2013-07 EN ISO 8536-4:2013 + A1:2013 (E) 4 !Foreword to EN ISO 8
37、536-4:2013/A1:2013 This document (EN ISO 8536-4:2013/A1:2013) has been 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”
38、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 September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Atte
39、ntion 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 has been prepared under a mandate given to CEN by the European Commission an
40、d 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 followi
41、ng 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, Nor
42、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8536-4:2010/Amd 1:2013 has been approved by CEN as EN ISO 8536-4:2013/A1:2013 without any modification. “ DIN EN ISO 8536-4:2013-07 EN ISO 8536-4:2013 + A
43、1:2013 (E) 51 Scope This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on spec
44、ifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 2 Normative r
45、eferences The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1, Conical fittings with a 6 %
46、(Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 3696, Water for analytical laboratory use Specification and test m
47、ethods ISO 7864, Sterile hypodermic needles for single use ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness1)ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General re
48、quirements2)3 General requirements 3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2
