BS EN ISO 3826-4-2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features《人类血液和血液成分用塑料可折叠容器 具有整合特点的机采血袋系统》.pdf

1、BSI Standards PublicationBS EN ISO 3826-4:2015Plastics collapsible containersfor human blood and bloodcomponentsPart 4: Aphaeresis blood bag systems withintegrated featuresBS EN ISO 3826-4:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO3826-4:2015.The U

2、K participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its c

3、orrectapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 81010 7ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strat

4、egy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3826-4 August 2015 ICS 11.040.20 English Version Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems w

5、ith integrated features (ISO 3826-4:2015) Poches en plastique souple pour le sang et les composants du sang - Partie 4: Systmes de poches daphrse pour le sang avec accessoires intgrs (ISO 3826-4:2015) Kunststoffbeutel fr menschliches Blut und Blutbestandteile - Teil 4: Apherese-Blutbeutelsysteme mit

6、 integrierten Merkmalen (ISO 3826-4:2015) This European Standard was approved by CEN on 23 April 2015. 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.

7、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 version in any other language made by tra

8、nslation 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, Czech Republic, Denmark, Estonia, Finl

9、and, 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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATI

10、ON 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 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3826-4:2015 EBS EN ISO 3826-4:2015EN ISO 382

11、6-4:2015 (E) 3 European foreword This document (EN ISO 3826-4:2015) 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 dev

12、ices” 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016.

13、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. According to the CEN-CENELEC Internal Regulations, the national standards organization

14、s 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, Luxembourg, Malta,

15、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 3826-4:2015 has been approved by CEN as EN ISO 3826-4:2015 without any modification. The following referenced documents are indispensable

16、for the application of this document. For undated references, the latest edition of the referenced 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 tha

17、t any referenced document has not been superseded and that its relevant contents can still 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, i

18、f available, and otherwise to the dated ISO or IEC standard, as listed below. NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 3826-4:2015EN ISO 3826-4:2015 (E) 4 Table Correlations between

19、 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 ISO 1135-4 EN ISO 1135-4: aISO 1135-4: aISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 3826-1 EN ISO 3826-1:2013 ISO 3826-1:2013 ISO 3826-2 E

20、N ISO 3826-2:2008 ISO 3826-2:2008 ISO 3826-3 EN ISO 3826-3:2007 ISO 3826-3:2006 ISO 8536-4 EN ISO 8536-4:2013 and EN ISO 8536-4:2013/A1:2013 ISO 8536-4:2010 and Amd.1:2013 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus Amd.1:2006 ISO 10993-5 EN

21、 ISO 10993-5:2009 ISO 10993-5:2009 ISO 10993-10 EN ISO 10993-10:2013 ISO 10993-10:2010 ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2006 ISO 10993-12 EN ISO 10993-12:2012 ISO 10993-12:2012 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO 15747 EN ISO 15747:2011 ISO 15747:2010 ISO 23908 EN ISO

22、23908:2013 ISO 23908:2011 aTo be published. BS EN ISO 3826-4:2015EN ISO 3826-4:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices This European Standard has been prepared under a mandate given to C

23、EN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices Once this standard is cited in the Official Journal of the European Communities under that Directive and has been

24、implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA

25、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 / Directive 90/385/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, t

26、o 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 with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOT

27、E 3 This Annex ZA is based on Normative References according to Table of References, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this Euro

28、pean Standard and Directive 93/42/EEC, Medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2.1, 6.2.3, 6.2.7, 6.2.8, 6.2.9, 6.2.10, 6.2.11, 6.3, 7 7.2 Only the protection to the patients is explicitly addressed. The part o

29、f ER 7.2 regarding the packaging is not fully addressed. For packaging, see Clause 7 of this part of EN ISO 3826. 5.1 to 5.8, 6.2, 6.3, 6.4 7.3 Only the first half sentence of ER 7.3 is addressed. ER covered by biological evaluation. 6.2.7, 6.2.10, 6.3, 6.4 7.5 (first and second paragraph) The part

30、of ER 7.5 relating to phthalates is not explicitly covered. Only the first sentence is covered. Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer chooses to apply the EN ISO 10993 series of standards. BS EN ISO 38

31、26-4:2015EN ISO 3826-4:2015 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.3.1, 5.3.3, 5.4, 5.5.1, 5.5.4, 5.9.1, 5.10.3, 5.10.5, 5.11, 6.1, 6.2.1, 6.2.2, 6.2.6, 6.2.7, 6.2.10, 6.2.11, 6.4.2 7.6 5, 6 8.1 The part of ER 8.1 relat

32、ing to easy handling is not addressed. Manufacturing processes are not covered. Only sterility of product is covered. 7 8.3 6.2.1, 6.2.2 8.4 6.2.1 8.5 5.8, 5.9, 5.10, 5.11 9.1 Restrictions indicated on the label or in the instructions for use are not addressed. 4, 5.4 9.2 6.2.7, 6.2.8, 6.2.9, 6.2.10

33、 12.7.1 Only resistance to mechanical stress is addressed. 8.2 to 8.6 13.1 8.1 13.2 EN ISO 15223-1 and EN ISO 3826-2 are addressed when using symbols. 8.2 to 8.6 13.3 The part of ER 13.3 related to authorized representative is not addressed. 13.3 d) is only covered if the batch number is preceded by

34、 the word LOT. 13.3 f) Requirement indication of single use must be consistent across the Community is not addressed in this part of EN ISO 3826. 13.3 g) and h) are not addressed in this part of EN ISO 3826. 8.2 to 8.6 13.4 WARNING Other requirements and other EU Directives can be applicable to the

35、product(s) falling within the scope of this part of EN ISO 3826. BS EN ISO 3826-4:2015ISO 3826-4:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Dimensions . 45 Design .105.1 Leucocyte filter 105.2 Pilot samples 105.3 Access line needle and return line

36、 needle 115.4 Needle stick protection device . 115.5 Pre-collection sampling device 115.6 Red blood cell storage bag . 115.7 Plasma storage bag . 125.8 Platelet storage bag 125.9 Post-collection sampling device 125.10 Collection and transfer tube(s) 125.11 Outlet port(s) . 135.12 Suspension . 136 Re

37、quirements .136.1 General 136.2 Physical requirements . 146.2.1 Conditions of manufacture . 146.2.2 Sterilization . 146.2.3 Transparency .146.2.4 Coloration . 146.2.5 Thermal stability.146.2.6 Water vapour transmission for plastics containers prefilled with storage solution or anticoagulant 146.2.7

38、Resistance to leakage 156.2.8 Insertion force .156.2.9 Pull force 156.2.10 Leakage after closure piercing 156.2.11 Particulate contamination 156.3 Chemical requirements. 166.3.1 Requirements for the raw container or sheeting166.3.2 Requirements for the test fluid 166.4 Biological requirements . 176.

39、4.1 General. 176.4.2 Impermeability for microorganisms .176.4.3 Compatibility 177 Packaging 177.1 General 177.2 Shelf-life . 177.3 Over-package materials 177.4 Over-package sealing 177.5 Over-package strength 187.6 Arrangement of components in the over-package 188 Labelling .188.1 General 188.2 Labe

40、l on plastics containers . 18 ISO 2015 All rights reserved iiiContents PageBS EN ISO 3826-4:2015ISO 3826-4:2015(E)8.3 Label on over-package . 188.4 Package insert or instructions for use . 198.5 Label on shipping box 198.6 Label requirements 209 Anticoagulant and/or preservative solution .20Annex A

41、(normative) Chemical tests .21Annex B (normative) Physical tests 26Annex C (normative) Biological tests 28Bibliography .31iv ISO 2015 All rights reservedBS EN ISO 3826-4:2015ISO 3826-4:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national stand

42、ards 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 represented on that committee. International orga

43、nizations, 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

44、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/IEC Directives, Part 2 (see www.iso.org/dire

45、ctives).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 development of the document will be in the

46、 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 ISO specific terms and expressions related

47、 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, Transfusion, infusion and injection, and blood pr

48、ocessing equipment for medical and pharmaceutical use.ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blood and blood components: Part 1: Conventional containers Part 2: Graphical symbols for use on labels and instruction leaflets Part 3: B

49、lood bag systems with integrated features Part 4: Aphaeresis blood bag systems with integrated features ISO 2015 All rights reserved vBS EN ISO 3826-4:2015ISO 3826-4:2015(E)IntroductionIn some countries, national pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this part of ISO 3826.The manufacturers of the plastics container or the suppliers are expected to disclose in confidence to the national control authority, if requested by them, full details of the plastics mat