1、BS EN ISO 1135-3:2017Transfusion equipment formedical usePart 3: Blood-taking sets for single use (ISO 1135-3:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 1135-3:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of
2、 EN ISO1135-3:2017. It is identical to ISO 1135-3:2016.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the nece
3、ssary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 87132 0 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standar
4、d was published under the authority of the Standards Policy and Strategy Committee on 28 February 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1135-3 February 2017 ICS 11.040.20 English Version Transfusion equ
5、ipment 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 medizinischen Verwendung - Teil 3: Blutentnahmegerte zur einmaligen Verwendung
6、 (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 status of a national standard without any alteration. Up-to-date lists and b
7、ibliographical 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 in any other language made by translation under the res
8、ponsibility 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 Republic, Denmark, Estonia, Finland, Former Yugoslav R
9、epublic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROP
10、EN 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. Ref. No. EN ISO 1135-3:2017 EBS EN ISO 1135-3:2017EN ISO 1135-3:2017 (E) 3
11、 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/TC 205 “Non-active medical devices” the secr
12、etariat 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 the latest by August 2017. Attention is drawn
13、 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 and the European
14、 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 standards organizations of the following count
15、ries 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, Pol
16、and, 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 referenced document (including any amendments) a
17、pplies. 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 acknowledged st
18、ate-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. NOTE The way in which these referenced do
19、cuments 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 standard Equivalent dated standard EN ISO or IEC
20、 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 7864 EN ISO 7864:2016 ISO 7864:2016 BS EN ISO 1135-3:2017EN ISO 1135-3:2017 (E) 4 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 ISO 14644-1:2015 ISO 15223-1 EN ISO 15223-1:2012
21、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. BS EN ISO 1135-3:2017EN ISO 1135-3:2017 (E) 5 Annex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93/42/
22、EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions standardization request M/295 concerning the development of European standards related to medical devices to provide a voluntary means of conforming to essential requirements of Council Directive 93/42/EEC
23、of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of c
24、onformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 200
25、7/47/EC. This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lowest possible level“, “minimized“ or “removed“, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance
26、 with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to Table 1 of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA
27、.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this EN Remarks/Notes 7.2 3.3, 5.1, 5.2, 5.3, Clause 6, Clause
28、 7, A.1, A.2 The part of ER 7.2 relating to packaging is not addressed (for packaging see Clause 9 of this standard). 7.3 (first part only) Clause 4, 5.1, 5.2, 5.3, Clause 6, Clause 7, A.1, A.2 7.5 5.2, 5.3, Clause 7, A.2 Only the first paragraph is covered. Presumption of conformity with the Essent
29、ial Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the ISO 10993- series standards. BS EN ISO 1135-3:2017EN ISO 1135-3:2017 (E) 6 7.6 5.1, 5.2, 5.3, A.1, A.2 8.1 3.4, 3.5, Clause 5 The part of ER 8.1 relating to handling is not addressed.
30、 Manufacturing processes are not covered. The reduction of the risk of infection is not fully covered. 8.3 3.3, 3.4, 5.9, Clause 9 8.4 7.2 Only the sterilization method is covered. 8.5 5.1, A.1 8.7 8.2, 8.3 9.1 5.4, 5.5 The second sentence of ER 9.1 is not addressed. Coverage of this ER is partly pr
31、ovided by normative reference to EN ISO 7864. 9.2 (first indent) Clause 5, 7.1 Covered in respect of the following: - Particulate contamination; - Leakage; - Tensile strength; - Dimensions; - Physical characteristics of tube and needle. 9.2 (second indent) 5.2 Covered in respect of the following: -
32、Variations in pressure. 9.2 (fourth indent) Clause 4 Covered in respect of the following: - Undesirable effects on blood or fluid used. 12.7.1 5.3 Only tensile strength is addressed. 13.1 Clause 8 Only requirements for labelling are covered. 13.2 8.1, 8.2, 8.3 The final sentence is not addressed. 13
33、.3 b) 8.2 b), 8.3 b) 13.3 c) 8.2 c), 8.3 c) BS EN ISO 1135-3:2017EN ISO 1135-3:2017 (E) 7 13.3 d) 8.2 d), 8.3 d) Only covered if the batch number is preceded by the word “LOT“. 13.3 e) 8.2 e), 8.3 e) 13.3 f) 8.2, 8.3 Requirement “indication of single use must be consistent across the Community“ is n
34、ot addressed in the standard. 13.4 8.2, 8.3 13.4 is addressed regarding to the label. WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained in the list published in the Official Journal of the European Union. Users of this standard shoul
35、d consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 1135-3:2017ISO 1135-3:2016(E)Foreword iv1 Scope . 12 Normative references 13 Gener
36、al requirements . 13.1 Types of sets 13.2 Blood taking assembly 23.3 Air-outlet assembly . 23.4 Sterilization 33.5 Maintenance of sterility. 34 Materials . 35 Physical requirements 35.1 Particulate contamination . 35.2 Leakage 35.3 Tensile strength 35.4 Bottle needle . 35.5 Air-outlet needle 35.6 Bl
37、ood-taking needle 35.7 Tubing . 45.8 Flow regulator . 45.9 Protective caps 46 Chemical requirements . 46.1 Reducing (oxidizable) matter . 46.2 Metal ions 46.3 Titration acidity or alkalinity 46.4 Residue on evaporation . 46.5 UV absorption of extract solution . 57 Biological requirements . 57.1 Gene
38、ral . 57.2 Sterility 57.3 Pyrogenicity . 57.4 Haemolysis . 57.5 Toxicity . 58 Labelling 58.1 General . 58.2 Unit container 58.3 Shelf or multi-unit container 69 Packaging . 610 Disposal 6Annex A (normative) Physical tests . 7Annex B (normative) Chemical tests 9Annex C (normative) Biological tests 11
39、Bibliography .12 ISO 2016 All rights reserved iiiContents PageBS EN ISO 1135-3:2017ISO 1135-3:2016(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
40、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 represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the wo
41、rk. 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 diff
42、erent 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/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document ma
43、y 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 development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/paten
44、ts).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 ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade O
45、rganization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.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 edit
46、ion cancels and replaces the first edition (ISO 1135-3:1986), which has been technically revised with the following changes: part title has been amended by “for single use” in alignment with the other parts of ISO 1135; figures have been updated; subclause 3.6, “Designation examples” has been delete
47、d; physical, chemical and biological requirements have been aligned with ISO 1135-4; Clause 10, “Disposal” has been added; Annexes A, B and C have been aligned with ISO 1135-4; all references have been updated.ISO 1135 consists of the following parts, under the general title Transfusion equipment fo
48、r 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 apparatusiv ISO 2016 All rights reservedBS EN ISO 1135-3:2017INTERNATIONAL STANDARD ISO 1135-3:2016(E)Transfusion equipment for
49、 medical use Part 3: Blood-taking sets for single use1 ScopeThis part of ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.This part of ISO 1135 also aims to providea) specifications relating to the quality and performance of materials used in transfusionequipment, andb) a unified presentation of terms for such equipment.In some countries, the national pharmacop
