1、English price group 14No 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!%VpH“2517737www.din.deDIN EN ISO 11
2、35-4Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015);English version EN ISO 1135-4:2015,English translation of DIN EN ISO 1135-4:2016-06Transfusionsgerte zur medizinischen Verwendung Teil 4: Transfusionsgerte fr Schwerkrafttransfusionen zu
3、r einmaligen Verwendung (ISO 1135-4:2015);Englische Fassung EN ISO 1135-4:2015,Englische bersetzung von DIN EN ISO 1135-4:2016-06Matriel de transfusion usage mdical Partie 4: Appareils de transfusion non rutilisables alimentation par gravit (ISO 1135-4:2015);Version anglaise EN ISO 1135-4:2015,Tradu
4、ction anglaise de DIN EN ISO 1135-4:2016-06Together withDIN EN ISO 1135-5:2016-06,supersedesDIN EN ISO 1135-4:2012-06www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Document comprises 28 pages June 201606.16DIN EN ISO 11
5、35-4:2016-06 2 A comma is used as the decimal marker. National foreword This document (EN ISO 1135-4:2015) 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 collab
6、oration 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-/Infusionsbehlt-nisse und -
7、gerte aus Kunststoffen und Einmalprobengefe fr die In-vitro-Diagnostik. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 291 DIN EN ISO 291 ISO 594-1 DIN EN 20594-1 ISO 594-2 DIN EN 1707 ISO 3696 DIN ISO 3696 ISO 3826-1 DIN EN ISO 3826-1
8、 ISO 3826-2 DIN EN ISO 3826-2 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 10993-4 ISO 11135 DIN EN ISO 11135 ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 14644-1 DIN EN ISO 14644-1 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665-1 DIN EN IS
9、O 17665-1 IEC 80416-1 DIN EN 80416-1 EN ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use: Part 3: Blood-taking sets for single use (under preparation) Part 4: Transfusion sets for single use, gravity feed Part 5: Transfusion sets for single use
10、with pressure infusion apparatus Amendments This standard differs from DIN EN ISO 1135-4:2012-06 as follows: a) the scope has been restricted to gravity feed applications and the whole document aligned accordingly; transfusion sets for single use used in conjunction with pressure infusion apparatus
11、are now dealt with in Part 5 of the standards series; b) Subclause 3.3 “Designation” has been deleted; DIN EN ISO 1135-4:2016-06 3 c) Clause 8 “Labelling” has been restructured to bring it into line with the current specifications of the European Commissison; d) normative references and the Bibliogr
12、aphy have been updated; e) the European Annex ZA has been updated and brought in line with the current specifications of the European Commission; f) some minor editorial changes have been made. Previous editions DIN 58360: 1959-08 DIN 58360-1: 1975-08, 1982-11, 1991-04 DIN 58375-1: 1966-03 DIN 58375
13、-2: 1966-03 DIN EN ISO 1135-4: 2005-03, 2010-09, 2012-06 DIN EN ISO 1135-4:2016-06 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 20594-1, Conical fittings with a 6 %
14、(Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements DIN EN 80416-1, Basic principles for graphical symbols for use on equipment Part 1: Creation of graphical symbols for registration DIN EN ISO 291, Plastics Standard atmospheres for conditioning and te
15、sting DIN EN ISO 3826-1, Plastics collapsible containers for human blood and blood components Part 1: Conventional containers DIN EN ISO 3826-2, Plastics collapsible containers for human blood and blood components Part 2: Graphical symbols for use on labels and instruction leaflets DIN EN ISO 7864,
16、Sterile hypodermic 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,
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 (all parts), Sterilization of health care products Radiation DIN EN ISO 14644-1, Cleanrooms and associated controlled
18、environments Part 1: Classification of air cleanliness 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 fo
19、r the development, validation and routine control of a sterilization process for medical devices DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM
20、EN ISO 1135-4 December 2015 ICS 11.040.20 Supersedes EN ISO 1135-4:2012 English Version Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) Matriel de transfusion usage mdical Partie 4: Appareils de transfusion non rutilisables alimentation p
21、ar gravit (ISO 1135-4:2015) Transfusionsgerte zur medizinischen Verwendung Teil 4: Transfusionsgerte fr Schwerkrafttransfusionen zur einmaligen Verwendung (ISO 1135-4:2015) This European Standard was approved by CEN on 24 July 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regul
22、ations 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-CENELEC Management Centre or to any CEN membe
23、r. 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 same status as the official versions. CE
24、N 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, Luxembourg, Malta, Netherlands, Norway, Poland,
25、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 2015 CEN All rights of exploitation in a
26、ny form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1135-4:2015 E EN ISO 1135-4:2015 (E) 2 Contents Page European Foreword 4 Foreword 6 1 Scope 7 2 Normative references 7 3 General requirements . 8 3.1 Nomenclature for components of the transfusion set . 8 3.2 Maint
27、enance of sterility 8 4 Materials . 9 5 Physical requirements 9 5.1 Particulate contamination . 9 5.2 Leakage . 9 5.3 Tensile strength . 9 5.4 Closure-piercing device 9 5.5 Tubing 10 5.6 Filter for blood and blood components 10 5.7 Drip chamber and drip tube . 10 5.8 Flow regulator . 10 5.9 Flow rat
28、e of blood and blood components 10 5.10 Injection site 11 5.11 Male conical fitting 11 5.12 Protective caps 11 6 Chemical requirements 11 6.1 Reducing (oxidizable) matter 11 6.2 Metal ions 11 6.3 Titration acidity or alkalinity 11 6.4 Residue on evaporation . 11 6.5 UV absorption of extract solution
29、 11 7 Biological requirements 12 7.1 General . 12 7.2 Sterility 12 7.3 Pyrogenicity . 12 7.4 Haemolysis . 12 7.5 Toxicity 12 7.6 Assessment of blood component depletion 12 7.7 Assessment of damage to blood components 12 8 Labelling 13 8.1 General . 13 8.2 Unit container 13 8.3 Shelf or multi-unit co
30、ntainer . 13 9 Packaging 14 10 Disposal . 14 DIN EN ISO 1135-4:2016-06 EN ISO 1135-4:2015 (E) 3 Annex A (normative) Physical tests 15 Annex B (normative) Chemical tests . 19 Annex C (normative) Biological tests . 21 Annex ZA (informative) Relationship between this European Standard and the Essential
31、 Requirements of EU Directive 93/42/EEC on Medical devices 22 Bibliography . 24 DIN EN ISO 1135-4:2016-06 EN ISO 1135-4:2015 (E) European foreword This document (EN ISO 1135-4:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipmen
32、t 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 standard, either by publication of an identical text or by endorsement, at t
33、he latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. 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
34、such patent rights. Together with EN ISO 1135-5:2015 this document supersedes EN ISO 1135-4:2012. 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
35、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, Belgium, Bulgaria, Croatia, Cyprus, C
36、zech 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 the United King
37、dom. Endorsement notice The text of ISO 1135-4:2015 has been approved by CEN as EN ISO 1135-4:2015 without any modification. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any
38、 amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally ack
39、nowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or IEC standard, as listed in Table 1. NOTE The way in which these references
40、documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. 4DIN EN ISO 1135-4:2016-06 EN ISO 1135-4:2015 (E) Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the
41、ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 - ISO 594-1:1986 ISO 594-2 - ISO 594-2:1998 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 3826-1:2013 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008 ISO 7864 EN ISO 7864:1995 ISO 7864:1993 ISO 10993-1 EN I
42、SO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus ISO 10993-4 AMD 1:2006 ISO 14644-1 EN ISO 14644-1:1999 ISO 14644-1:1999 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 5DIN EN ISO 1135-4:2016-06 ForewordISO (the International Organization for Standardization)
43、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 technical committee has been established has the right to be repres
44、ented 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 matters of electrotechnical standardization.The procedures used to develo
45、p 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 document was drafted in accordance with the editorial rules of the ISO/I
46、EC 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 such patent rights. Details of any patent rights identified during the
47、 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 not constitute an endorsement.For an explanation on the meaning of
48、 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 informationThe committee responsible for this document is ISO/TC 76, Transf
49、usion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This sixth edition of ISO 1135-4, together with the first edition of ISO 1135-5, cancels and replaces the fifth edition (ISO 1135-4:2012), which has been technically revised with the following changes: the scope has been restricted to gravity feed applications and the whole document aligned accordingly; transfusion sets for single use used in conjunction with pressure infusion apparatus are now
