1、May 2017 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 11.040.20!%eB“2663159www.din.deDIN E
2、N ISO 1135-3Transfusion equipment for medical use Part 3: Bloodtaking sets for single use (ISO 11353:2016);English version EN ISO 11353:2017,English translation of DIN EN ISO 1135-3:2017-05Transfusionsgerte zur medizinischen Verwendung Teil 3: Blutentnahmegerte zur einmaligen Verwendung (ISO 11353:2
3、016);Englische Fassung EN ISO 11353:2017,Englische bersetzung von DIN EN ISO 1135-3:2017-05Matriel de transfusion usage mdical Partie 3: Appareils non rutilisables pour prlvement sanguin (ISO 11353:2016);Version anglaise EN ISO 11353:2017,Traduction anglaise de DIN EN ISO 1135-3:2017-05SupersedesDIN
4、 ISO 11353:198709, withdrawn 200402www.beuth.deDocument comprises 24 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.05.17 DIN EN ISO 1135-3:2017-05 2 A comma is used as the decimal marker. National foreword This document (EN I
5、SO 1135-3:2017) 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 collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN,
6、 Germany) with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-02 AA “Transfusion/infusion containers and equipment made from plastics and disposable sa
7、mple containers for the in-vitro diagnostics“. On the basis of DIN 58372:1979 Transfusion, infusion; taking sets for blood, concepts, requirements, test, the corresponding, identical standard ISO 1135-3 was published in 1986. This ISO Standard has been adopted as DIN ISO 1153-3:1987 and replaces DIN
8、 58372 to formally only have one standard for blood-taking sets. Because applications of blood-taking sets according to DIN ISO 1135-3 dealt with blood donations in glass bottles, and collapsible plastic containers have been used for blood donation in Germany for several years, DIN ISO 1135-3 was wi
9、thdrawn without replacement in 2004. ISO 1135-3 was still valid then, although applications based on this standard declined on the international level. When revising the applications, it was identified that blood-taking sets according to ISO 1153-3 are also still used in some fields in Germany e.g.
10、for therapeutic blood-taking or ozone therapy. For this reason, the responsible ISO Working Group decided to revise the ISO Standard and to adapt it to the current state of the art. A parallel panel on the European level showed that there was a specific interest in converting this standard into a Eu
11、ropean Standard. In light of the CEN framework agreement, this standard has been adopted as a German Standard and replaces DIN ISO 1135-3:1987 which was withdrawn in 2004. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 291 DIN EN ISO 2
12、91 ISO 594-1 DIN EN 20594-1; has been replaced by DIN EN ISO 80369-7 ISO 1773 DIN ISO 1773 ISO 3696 DIN ISO 3696 ISO 3826-2 DIN EN ISO 3826-2 ISO 7000 DIN ISO 7000 ISO 7864 DIN EN ISO 7864 ISO 8536-14 DIN EN ISO 8536-14 ISO 9626 DIN EN ISO 9626 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-4 DIN EN ISO 1
13、0993-4 ISO 11135 DIN EN ISO 11135 ISO 11137 (all parts) DIN EN ISO 11137 (all parts) ISO 11607-1 DIN EN ISO 11607-1 ISO 14644-1:2015 DIN EN ISO 14644-1:2016-06 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665-1 DIN EN ISO 17665-1 IEC 80416-1 DIN EN 80416-1 DIN EN ISO 1135-3:2017-05 3 EN ISO 1135 consists of
14、 the following parts, under the general title Infusion equipment for medical use: Part 3: Blood-taking sets for single use Part 4: Transfusion sets for single use, gravity feed Part 5: Transfusion sets for single use with pressure infusion apparatus Amendments This standard differs from DIN ISO 1135
15、-3:1987-09 (withdrawn 2004-02) as follows: a) the part title has been amended by “for single use” taking into consideration the other parts of the standard series ISO 1135; b) figures have been updated; c) 3.6 “Designation examples” has been deleted; d) physical, chemical and biological requirements
16、 have been aligned with ISO 1135-4; e) Clause 10 “Disposal” has been included; f) Annexes A, C and C have been aligned with ISO 1135-4; g) normative references have been updated; h) Annex ZA (informative) “Relationship between this European Standard and the essential requirements of Directive 93/42/
17、EEC OJ L 169 aimed to be covered” on medical devices has been included. Previous editions DIN 58372: 1979-01 DIN ISO 1135-3: 1987-09 DIN EN ISO 1135-3:2017-05 4 National Annex NA (informative) Bibliography DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain oth
18、er 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 testing DIN EN ISO 3826-2, Plastics collapsible cont
19、ainers for human blood and blood components Part 2: Graphical symbols for use on labels and instruction leaflets DIN ISO 7864, Sterile hypodermic needles for single use Requirements and test methods DIN EN ISO 8536-14, Infusion equipment for medical use Part 14: Clamps and flow regulators for transf
20、usion and infusion equipment without fluid contact)DIN EN ISO 9626, Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN IS
21、O 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 sterilization process for medical devices DIN EN ISO
22、 11137 (all parts), Sterilization of health care products Radiation DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 14644-1:2016-06, Cleanrooms and associated controlled environments
23、Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) 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 Mo
24、ist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 80369-7, Small bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic application
25、s DIN ISO 1773, Laboratory glassware Narrow-necked boiling flasks DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis *) Currently under preparation. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM
26、 EN ISO 1135-3 February 2017 ICS 11.040.20 English Version Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) Matriel de transfusion usage mdical - Partie 3: Appareils non rutilisables pour prlvement sanguin (ISO 1135-3:2016) Transfusionsgerte zur medi
27、zinischen Verwendung - Teil 3: Blutentnahmegerte zur einmaligen Verwendung (ISO 1135-3:2016) This European Standard was approved by CEN on 24 August 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the st
28、atus 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 member. This European Standard exists in three official versions (English, French,
29、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. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cro
30、atia, 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tur
31、key 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 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
32、Ref. No. EN ISO 1135-3:2017 EEuropean foreword .31 Scope . 62 Normative references 63 General requirements . 63.1 Types of sets 63.2 Blood taking assembly 73.3 Air-outlet assembly . 73.4 Sterilization 83.5 Maintenance of sterility. 84 Materials . 85 Physical requirements 85.1 Particulate contaminati
33、on . 85.2 Leakage 85.3 Tensile strength 85.4 Bottle needle . 85.5 Air-outlet needle 85.6 Blood-taking needle 85.7 Tubing . 95.8 Flow regulator . 95.9 Protective caps 96 Chemical requirements . 96.1 Reducing (oxidizable) matter . 96.2 Metal ions 96.3 Titration acidity or alkalinity 96.4 Residue on ev
34、aporation . 96.5 UV absorption of extract solution 107 Biological requirements 107.1 General 107.2 Sterility . 107.3 Pyrogenicity 107.4 Haemolysis 107.5 Toxicity 108 Labelling . 108.1 General 108.2 Unit container . 108.3 Shelf or multi-unit container . 119 Packaging 1110 Disposal . 11Annex A (normat
35、ive) Physical tests 12Annex B (normative) Chemical tests . 14Annex C (normative) Biological tests 16Bibliography .20Contents PageAnnex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered 17 Foreword .5DIN EN
36、ISO 1135-3:2017-05 EN ISO 1135-3:2017 (E) 2 European foreword This document (EN ISO 1135-3:2017) 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/T
37、C 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 the latest by August 2017, and conflicting national standards shall be withdrawn at th
38、e latest by August 2017. 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 has been prepared under a mandate given to CEN
39、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 document. According to the CEN-CENELEC Internal Regulations, the national sta
40、ndards 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
41、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the refer
42、enced document (including any 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
43、be considered the generally acknowledged 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 version of the ISO or IEC standard, as listed below
44、. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO stand
45、ard Equivalent dated standard EN ISO or IEC ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 7864 EN ISO 7864:2016 ISO 7864:2016 DIN EN ISO 1135-3:2017-05 EN ISO 1135-3:2017 (E)3 ISO 11607-1 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 plus ISO 11607-1 Amd 1:2014 ISO 14644-1:2015 EN ISO 14644-1:2015 IS
46、O 14644-1:2015 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 Endorsement notice The text of ISO 1135-3:2016 has been approved by CEN as EN ISO 1135-3:2017 without any modification. DIN EN ISO 1135-3:2017-05 EN ISO 1135-3:2017 (E) 4 ForewordISO (the International Organization for Standardization)
47、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
48、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 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 differe
