1、December 2015 English price group 19No 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!%IQ“2389346www.din.de
2、DIN EN ISO 3826-4Plastics collapsible containers for human blood and blood components Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015);English version EN ISO 3826-4:2015,English translation of DIN EN ISO 3826-4:2015-12Kunststoffbeutel fr menschliches Blut und Blutbestan
3、dteile Teil 4: Apherese-Blutbeutelsysteme mit integrierten Merkmalen (ISO 3826-4:2015);Englische Fassung EN ISO 3826-4:2015,Englische bersetzung von DIN EN ISO 3826-4:2015-12Poches en plastique souple pour le sang et les composants du sang Partie 4: Systmes des poches daphrse pour le sang avec acces
4、soires intgrs (ISO 3826-4:2015);Version anglaise EN ISO 3826-4:2015,Traduction anglaise de DIN EN ISO 3826-4:2015-12www.beuth.deDocument comprises 43 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.15DIN EN ISO 3826-4:2015-1
5、2 2 A comma is used as the decimal marker. National 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” (Secretariat: DIN, Germany) 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 DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-02-02 AA Transfusions-/Infusionsbehltnisse und gerte aus Kun
7、ststoffen und Einmalprobengefe fr die In-vitro-Diagnostik. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1135-4 DIN EN ISO 1135-4 ISO 3696 DIN ISO 3696 ISO 3826-1 DIN EN ISO 3826-1 ISO 3826-2 DIN EN ISO 3826-2 ISO 3826-3 DIN EN ISO 38
8、26-3 ISO 8536-4 DIN EN ISO 8536-4 ISO 10993 (all parts) DIN EN ISO 10993 (all parts) ISO 15223-1 DIN EN ISO 15223-1 ISO 15747 DIN EN ISO 15747 ISO 23908 DIN EN ISO 23908 DIN EN ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blood and blood
9、 components: Part 1: Conventional containers Part 2: Graphical symbols for use on labels and instruction leaflets Part 3: Blood bag systems with integrated features Part 4: Apheresis blood bag systems with integrated features DIN EN ISO 3826-4:2015-12 3 National Annex NA (informative) Bibliography D
10、IN EN ISO 1135-4, Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed 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
11、 blood components Part 2: Graphical symbols for use on labels and instruction leaflets DIN EN ISO 3826-3, Plastics collapsible containers for human blood and blood components Part 3: Blood bag systems with integrated features DIN EN ISO 8536-4, Infusion equipment for medical use Part 4: Infusion set
12、s for single use, gravity feed 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 10993-5, Biologica
13、l evaluation of medical devices Part 5: Tests for in vitro cytotoxicity DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization DIN EN ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity DIN EN ISO 109
14、93-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials 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 15747, Plastic containers for intrav
15、enous injections DIN EN ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN E
16、N ISO 3826-4:2015-12 4 Page intentionally left blank EUROPEAN 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 with integrated features (ISO 382
17、6-4:2015) 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 integrierten Merkmalen (ISO 382
18、6-4:2015) 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. Up-to-date lists and bibliograph
19、ical 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 responsibilit
20、y 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 Republic of
21、 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 STANDARDIZATION COMIT EUROPEN D E NORMALISATI
22、ON 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 E European foreword 4Introduction 61 Scope 72 Normative referen
23、ces . 73 Terms and definitions . 84 Dimensions 105 Design .165.1 Leucocyte filter 165.2 Pilot samples 165.3 Access line needle and return line needle 175.4 Needle stick protection device . 175.5 Pre-collection sampling device 175.6 Red blood cell storage bag . 175.7 Plasma storage bag . 185.8 Platel
24、et storage bag 185.9 Post-collection sampling device 185.10 Collection and transfer tube(s) 185.11 Outlet port(s) . 195.12 Suspension . 196 Requirements .196.1 General 196.2 Physical requirements . 206.2.1 Conditions of manufacture . 206.2.2 Sterilization .206.2.3 Transparency .206.2.4 Coloration .2
25、06.2.5 Thermal stability.206.2.6 Water vapour transmission for plastics containers prefilled with storage solution or anticoagulant 206.2.7 Resistance to leakage 216.2.8 Insertion force .216.2.9 Pull force 216.2.10 Leakage after closure piercing 216.2.11 Particulate contamination 216.3 Chemical requ
26、irements. 226.3.1 Requirements for the raw container or sheeting226.3.2 Requirements for the test fluid 226.4 Biological requirements . 236.4.1 General. 236.4.2 Impermeability for microorganisms .236.4.3 Compatibility 237 Packaging 237.1 General 237.2 Shelf-life . 237.3 Over-package materials 237.4
27、Over-package sealing 237.5 Over-package strength 247.6 Arrangement of components in the over-package 248 Labelling .248.1 General 248.2 Label on plastics containers . 24Contents Page2 EN ISO 3826-4:2015 (E) DIN EN ISO 3826-4:2015-128.3 Label on over-package . 248.4 Package insert or instructions for
28、 use . 258.5 Label on shipping box 258.6 Label requirements 269 Anticoagulant and/or preservative solution .26Annex A (normative) Chemical tests 27Annex B (normative) Physical tests .32Annex C (normative) Biological tests .34Bibliography .39Annex ZA (informative) Relationship between this European S
29、tandard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices3EN ISO 3826-4:2015 (E) DIN EN ISO 3826-4:2015-12.37European foreword This document (EN ISO 3826-4:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing eq
30、uipment 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
31、, at the latest by February 2016, and conflicting national standards shall be withdrawn at the latest by February 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 identifyi
32、ng any or all such patent rights. 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav
33、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 Kingdom. Endorsement notice The text of ISO 3826-4:2015 has be
34、en approved by CEN as EN ISO 3826-4:2015 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 amendments) applies. For dated references, only the editi
35、on 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 state-of-art. When an IEC or ISO standard is ref
36、erred 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 below. NOTE The way in which these references documents are cited in normative requirements determines the ex
37、tent (in whole or in part) to which they apply. 4 EN ISO 3826-4:2015 (E) DIN EN ISO 3826-4:2015-12Table Correlations between 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
38、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 EN 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
39、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 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
40、 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 23908:2013 ISO 23908:2011 a To be published. 5EN ISO 3826-4:2015 (E) DIN EN ISO 3826-4:2015-12IntroductionIn some countries, national pharmacopoeias or other government regulat
41、ions 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 material(s) and the com
42、ponents of the materials and their methods of manufacture, details of manufacture of the plastics containers including the chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastics containers or present in the raw material, as well as full details of an
43、y additives that have been used.Universal leucocyte depletion is mandatory in various countries. This part of ISO 3826 is considered a basic document for other standards which include technical innovations.The requirements in this part of ISO 3826 are intended toa) ensure that the quality of blood a
44、nd blood components is maintained as high as necessary,b) make possible efficient and safe collection, identification, storage, separation, and transfusion of the contents with special attention to reducing or minimizing the risks resulting from contamination, in particular microbiological contamina
45、tion, air embolism, errors in identification of plastics containers and any representative samples of contents, and interaction between the plastics container and its contents,c) ensure functional compatibility when used in combination with transfusion sets as specified in ISO 1135-4 and ISO 1135-5,
46、 andd) provide a package with appropriate resistance to breakage and deterioration.6 EN ISO 3826-4:2015 (E) DIN EN ISO 3826-4:2015-121 ScopeThis part of ISO 3826 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag
47、systems need not contain all of the integrated features identified in this part of ISO 3826.The integrated features refer to: needle stick protection device; leucocyte filter; sterile barrier filter; pre-collection sampling device; red blood cell storage bag; plasma storage bag; platelet storage bag
48、; polymorphonucleic (e.g. stem) cell storage bag; post-collection sampling devices; and connections for storage solutions, anticoagulant, and replacement fluid.This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cell
49、s by apheresis. This part of ISO 3826 can be used on automated or semi-automated blood collection systems.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 3826.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the l
